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METHYLPREDNISOLONE ACETATE 40 MG/ML INJECTION

Active substance(s): METHYLPREDNISOLONE ACETATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

®

Depo-Medrone 40 mg/ml Injection
(methylprednisolone acetate)

Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor, pharmacist or nurse.
 If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. See section 4.
 The name of this medicine is Depo-Medrone 40 mg/ml Injection but will
be referred to as Depo-Medrone throughout the remainder of this leaflet.
What is in this leaflet
1. What Depo-Medrone is and what it is used for
2. What you need to know before you are given Depo-Medrone
3. How Depo-Medrone is given to you
4. Possible side effects
5. How to store Depo-Medrone
6. Contents of the pack and other information
1. WHAT DEPO-MEDRONE IS AND WHAT IT IS USED FOR
Depo-Medrone contains methylprednisolone acetate.
Methylprednisolone belongs to a group of medicines called corticosteroids
or steroids. Corticosteroids are produced naturally in your body and are
important for many body functions.
Boosting your body with extra corticosteroid such as Depo-Medrone can
help when injected into the body by a doctor or nurse, such as in or near a
joint, to treat local symptoms caused by inflammatory or rheumatic
conditions such as:
 Bursitis: inflammation in the fluid containing spaces around the
shoulder, knee and/or elbow joints. For this condition this medicine will
be injected directly into one or more of these spaces.
 Osteoarthritis and rheumatoid arthritis: inflammation located in
between the joints. For these conditions this medicine will be injected
directly into one or more joint spaces.
 Plantar fasciitis: inflammation of the tissues of the sole of the foot.
 Skin problems: such as alopecia areata (patchy baldness), keloids
(scar tissue), lichen planus or simplex (small, purplish raised patches of
skin or spots), discoid lupus (round-shaped patches, often on the face) or
granuloma annulare (circular warty growths).
 Epicondylitis (tennis elbow) and tenosynovitis: for these conditions
this medicine will be injected into the tendon sheath.
Alternatively this medicine may be injected into a muscle to help treat more
general (systemic) problems affecting the whole body (e.g. symptoms
caused by a hypersensitivity to a medicine), or allergic, inflammatory or
rheumatic problems affecting the:
 brain e.g. meningitis caused by tuberculosis
 bowel and gut e.g. Crohn’s disease (inflammation of the gut) or
ulcerative colitis (inflammation of the lower bowel)
 joints e.g. rheumatoid arthritis
 lungs e.g. asthma, severe hay fever or rhinitis, tuberculosis or
inflammation caused by breathing in (aspirating) vomit or stomach
contents
 skin e.g. Stev ens-Johnson syndrome (an autoimmune disorder in which
an immune system causes the skin to blister and peel) or systemic lupus
erythematosus (lupus).
Your doctor may use this medicine to treat conditions other than those listed
above. Ask your doctor if you are unsure why you have been given this
medicine.

2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN
DEPO-MEDRONE
Do not use Depo-Medrone if:
 You think you have ever suffered an allergic reaction, or any other type of
reaction after being given Depo-Medrone, or any other medicine
containing a corticosteroid or any of the ingredients in this medicine
(listed in section 6). An allergic reaction may cause a skin rash or
reddening, swollen face or lips or shortness of breath.
 You get a rash, or another symptom of an infection.
 You have recently had, or are about to have any vaccination.
See your doctor immediately if any of the above applies to you.
Do not inject this medicine:
 into the Achilles tendon (which is located behind the ankle joint), or
 directly into a vein (intravenous), the spinal cord (intrathecal), the outer
covering of the brain (extradural), into the nostrils (intranasal) or in the
eye (intraocular).
Warnings and precautions
Talk to your doctor or nurse before taking Depo-Medrone if you have any of
the following conditions.
Your doctor may also have to monitor your treatment more closely, alter
your dose or give you another medicine.
 Acute adrenal insufficiency (when your body cannot produce
enough corticosteroid due to problems with your adrenal glands).
 Acute pancreatitis (inflammation of the pancreas).
 Chickenpox, measles, shingles or a herpes ey e infection. If you
think you have been in contact with someone with chickenpox, measles
or shingles and you have not already had these illnesses, or if you are
unsure if you have had them.
 Severe depression or manic depression (bipolar disorder). This includes
having had depression before while taking steroid medicines like
Depo-Medrone, or having a family history of these illnesses.
 Cushing’s disease (condition caused by an excess of cortisol
hormone in your body).
 Diabetes (or if there is a family history of diabetes).
 Epilepsy, fits or seizures.
 Glaucoma (increased pressure in the eye) or if there is a family
history of glaucoma.
 You have recently suffered a heart attack.
 Heart problems, including heart failure or infections.
 Hypertension (high blood pressure).
 Hypotension (low blood pressure).
 Hypothyroidism (an under -active thyroid).
 Joint infection.
 Kidney or liver disease.
 Muscle problems (pain or weakness) have happened while taking
steroid medicines in the past.
 Myasthenia gravis (a condition causing tired and weak muscles).
 Osteoporosis (brittle bones).
 Pheochromocytoma (a rare tumour of adrenal gland tissue. The
adrenal glands are located above the kidneys).
 Skin abscess.
 Stomach ulcer or other serious stomach or intestinal problems.
 Unusual stress.
 Thrombophlebitis - vein problems due to thrombosis (clots in the veins)
resulting in phlebitis (red, swollen and tender veins).
 Tuberculosis (TB) or if you have suffered tuberculosis in the past.
 Traumatic brain injury.
You must tell your doctor before you take this medicine if you have any of
the conditions listed above.
Other medicines and Depo-Medrone
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.

You should tell your doctor if you are taking any of the following medicines
which can affect the way Depo-Medrone or the other medicine works:
 Acetazolamide - used to treat glaucoma and epilepsy.
 Aminoglutethimide and cyclophosphamide - used for treating cancer.
 Antibacterials (such as isoniazid, erythromycin, clarithromycin and
troleandomycin).
 Anticoagulants - used to ‘thin’ the blood such as acenocoumarol,
phenindione and warfarin.
 Anticholinesterases - used to treat myasthenia gravis (a muscle
condition) such as distigmine and neostigmine.
 Antidiabetics - medicines used to treat high blood sugar.
 Antiemetics (such as aprepitant and fosaprepitant).
 Aspirin and non-steroidal anti-inflammatory medicines (also called
NSAIDs) such as ibuprofen used to treat mild to moderate pain.
 Barbiturates, carbamazepine, phenytoin and primidone - used to
treat epilepsy.
 Carbenoxolone - used for heartburn and acid indigestion.
 Ciclosporin - used to treat conditions such as severe rheumatoid
arthritis, severe psoriasis or following an organ or bone marrow
transplant.
 Digoxin - used for heart failure and/or an irregular heart beat.
 Diltiazem - used for heart problems or high blood pressure.
 Ethinylestradiol and norethindrone - oral contraceptives.
 Indinavir and ritonavir - used to treat HIV infections.
 Ketoconazole or itraconazole - used to treat fungal infections.
 Pancuronium and vecuronium - or other medicines called
neuromuscular blocking agents which are used in some surgical
procedures.
 Potassium depleting agents - such as diuretics (sometimes called water
tablets), amphotericin B, xanthenes or beta2 agonists (e.g. medicines
used to treat asthma).
 Rifampicin and rifabutin - antibiotics used to treat tuberculosis (TB).
 Tacrolimus – used following an organ transplant to prevent rejection of
the organ.
 Vaccines - tell your doctor or nurse if you have recently had, or are about
to have any vaccination. You must not have ‘live’ vaccines while using
this medicine. Other vaccines may be less effective.
If you are taking long term medication(s)
If you are being treated for diabetes, high blood pressure or water retention
(oedema) tell your doctor as he/she may need to adjust the dose of the
medicines used to treat these conditions.
Before you have any operation tell your doctor, dentist or anaesthetist
that you are taking this medicine.
If you require a test to be carried out by your doctor or in hospital it is
important that you tell the doctor or nurse that you are taking
Depo-Medrone. This medicine can affect the results of some tests.
Depo-Medrone with drink
Do not drink grapefruit juice while taking this medicine.
Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice before taking this medicine,
as this medicine could slow the baby’s growth.
Cataracts have been observed in infants born to mothers treated with
long-term corticosteroids during pregnancy.
If you are breast-feeding, ask your doctor or pharmacist for advice before
taking this medicine, as small amounts of corticosteroid medicines may get
into breast milk.
If you continue breast-feeding while you are having treatment, your baby
will need extra checks to make sure he or she is not being affected by your
medicine.
Driving and using machines
Undesirable effects, such as dizziness, vertigo, visual disturbances and
fatigue are possible after treatment with corticosteroids. If you are affected
do not drive or operate machinery.
Depo-Medrone contains sodium
This medicinal product contains less than 1 mmol sodium (23 mg) per vial,
i.e. essentially ‘sodium-free’.

3. HOW DEPO-MEDRONE IS GIVEN TO YOU
Steroid Cards
Remember to always carry a Steroid Treatment Card. Make sure your
doctor or pharmacist has filled out the details of your medicine,
including the dose and how long you will require steroid treatment.
You should show your steroid card to anyone who gives you treatment
(such as a doctor, nurse or dentist) while you are taking this medicine, and
for 3 months after your last injection.
If you are admitted to hospital for any reason always tell your doctor or
nurse that you are taking this medicine. You can also wear a medic-alert
bracelet or pendant to let medical staff know that you are taking a steroid if
you have an accident or become unconscious.
Dosage information
Your doctor will decide on the site of injection, how much of the medicine
and how many injections you will receive depending on the condition being
treated and its severity. Your doctor will inject you with the lowest dose for
the shortest possible time to get effective relief of your symptoms.
Adults
Your doctor/nurse will tell you how many injections you will require for the
condition you are being treated for, and when you will get them.
Joints - the normal dose for the injections into joint will depend on the size
of the joint. Large joints (e.g. knee, ankle and shoulder) may require
20 - 80 mg (0.5 - 2 ml), medium sized joints (e.g. elbow or wrist) 10 - 40 mg
(0.25 - 1 ml) and small joints (e.g. finger or toe joints) may require a
4 - 10 mg (0.1 - 0.25 ml) dose.
Joint injections may be given weekly over a period of several weeks,
depending on how quickly you respond to treatment.
Bursitis and epicondylitis (tennis elbow) - the usual dose is between
4 - 30 mg (0.1 - 0.75 ml). In most cases repeat injections will not be needed
for bursitis and epicondylitis. Repeat injections may be necessary to treat
long standing conditions.
Skin conditions - the usual dose is between 20 - 60 mg (0.5 - 1.5 ml)
injected into the affected part or parts of the skin.
For other more general conditions 40 - 120 mg (1 - 3 ml) of this medicine
may be injected into a large muscle.
Elderly
Treatment will normally be the same as for younger adults. However your
doctor may want to see you more regularly to check how you are getting on
with this medicine.
Children
Corticosteroids can affect growth in children so your doctor will prescribe
the lowest dose that will be effective for your child.
If you are given more Depo-Medrone than you should
If you think you have been given too many injections of this medicine please
speak to your doctor immediately.
Stopping/reducing the dose of your Depo-Medrone
Your doctor will decide when it is time to stop your treatment.
You will need to come off this treatment slowly if you:
 have been given Depo-Medrone for more than 3 weeks
 have been given high doses of Depo-Medrone, over 32 mg (0.8 ml) daily,
even if it was only for 3 weeks or less
 have already had a course of corticosteroid tablets or injections in the last
year
 already have problems with your adrenal glands (adrenocortical
insufficiency) before you started this treatment.
You will need to come off this medicine slowly to avoid withdrawal
symptoms. These symptoms may include itchy skin, fever, muscle and joint
pains, runny nose, sticky eyes, sweating and weight loss.
If your symptoms seem to return or get worse as your dose of this medicine
is reduced tell your doctor immediately.


The following information is intended for healthcare
professionals only: PHYSICIAN LEAFLET

Depo-Medrone® 40 mg/ml Injection
(methylprednisolone acetate)

Presentation
White, sterile aqueous suspension for injection containing 40 mg per ml
methylprednisolone acetate. Also contains polyethylene glycol 3350,
sodium chloride, myristyl-gamma-picolinium chloride, water for injections,
sodium hydroxide and hydrochloric acid (for pH adjustment).
Uses
Depo-Medrone may be used locally or systemically, particularly where oral
therapy is not feasible.
Depo-Medrone may be used by any of the following routes: intramuscular,
intra-articular, periarticular, intrabursal, intralesional or into the tendon
sheath. It must not be used by the intrathecal or intravenous routes.
(See Contraindications and Side effects).
Intramuscular administration:
1. Rheumatic disorders
Rheumatoid arthritis
2. Collagen diseases/arthritis
Systemic lupus erythematosus
3. Dermatological diseases
Severe erythema multiforme (Stevens-Johnson syndrome)
4. Allergic states
Bronchial asthma
Severe seasonal and perennial allergic rhinitis
Drug hypersensitivity reactions
Angioneurotic oedema
5. Gastro-intestinal diseases
Ulcerative colitis
Crohn’s disease
6. Respiratory diseases
Fulminating or disseminated tuberculosis (with appropriate
antituberculous chemotherapy)
Aspiration of gastric contents
7. Miscellaneous
TB meningitis (with appropriate antituberculous chemotherapy)
Intra-articular administration:
Rheumatoid arthritis
Osteo-arthritis with an inflammatory component
Soft tissue administration (intrabursal, periarticular, into tendon sheath):
Synovitis not associated with infection
Epicondylitis
Tenosynovitis
Plantar fasciitis
Bursitis
Intralesional:
Keloids
Localized lichen planus
Localized lichen simplex
Granuloma annulare
Discoid lupus erythematosus
Alopecia areata
Dosage and administration
Depo-Medrone should not be mixed with any other suspending agent
or solution. Parenteral drug products should be inspected visually for
particulate matter and discolouration prior to administration,
whenever suspension and container permit. Depo-Medrone may be
used by any of the following routes: intramuscular, intra-articular,
periarticular, intrabursal, intralesional and into the tendon sheath.
It must not be used by the intrathecal or intravenous routes
(see Contraindications and Side effects).
Undesirable effects may be minimized by using the lowest effective dose for
the minimum period (see special warnings and precautions).
Depo-Medrone vials are intended for single dose use only.

Intra-articular: Rheumatoid arthritis, osteo-arthritis. The dose of
Depo-Medrone depends upon the size of the joint and the severity of the
condition. Repeated injections, if needed, may be given at intervals of one
to five or more weeks depending upon the degree of relief obtained from the
initial injection. A suggested dosage guide is: large joint (knee, ankle,
shoulder), 20 - 80 mg (0.5 - 2 ml); medium joint (elbow, wrist), 10 - 40 mg
(0.25 - 1 ml); small joint (metacarpophalangeal, interphalangeal,
sternoclavicular, acromioclavicular), 4 - 10 mg (0.1 - 0.25 ml).
Intrabursal: Subdeltoid bursitis, prepatellar bursitis, olecranon bursitis.
For administration directly into bursae, 4 - 30 mg (0.1 - 0.75 ml). In most
cases, repeat injections are not needed.
Intralesional: Keloids, localized lichen planus, localized lichen simplex,
granuloma annulare, alopecia areata, and discoid lupus erythematosus.
For administration directly into the lesion for local effect in dermatological
conditions, 20 - 60 mg (0.5 - 1.5 ml). For large lesions, the dose may be
distributed by repeated local injections of 20 - 40 mg (0.5 - 1 ml). One to
four injections are usually employed. Care should be taken to avoid
injection of sufficient material to cause blanching, since this may be
followed by a small slough.
Periarticular: Epicondylitis. Infiltrate 4 - 30 mg (0.1 - 0.75 ml) into the
affected area.
Into the tendon sheath: Tenosynovitis, epicondylitis. For administration
directly into the tendon sheath, 4 - 30 mg (0.1 - 0.75 ml). In recurrent or
chronic conditions, repeat injections may be necessary.
Special precautions should be observed when administering
Depo-Medrone. Intramuscular injections should be made deeply into the
gluteal muscles. The usual technique of aspirating prior to injection should
be employed to avoid intravascular administration. Doses recommended for
intramuscular injection must not be administered superficially or
subcutaneously.
Intra-articular injections should be made using precise, anatomical
localisation into the synovial space of the joint involved. The injection site
for each joint is determined by that location where the synovial cavity is
most superficial and most free of large vessels and nerves. Suitable sites
for intra-articular injection are the knee, ankle, wrist, elbow, shoulder,
phalangeal and hip joints. The spinal joints, unstable joints and those
devoid of synovial space are not suitable. Treatment failures are most
frequently the result of failure to enter the joint space. Intra-articular
injections should be made with care as follows: ensure correct positioning of
the needle into the synovial space and aspirate a few drops of joint fluid.
The aspirating syringe should then be replaced by another containing
Depo-Medrone. To ensure position of the needle, synovial fluid should be
aspirated and the injection made. After injection the joint is moved slightly to
aid mixing of the synovial fluid and the suspension. Subsequent to therapy
care should be taken for the patient not to overuse the joint in which benefit
has been obtained. Negligence in this matter may permit an increase in joint
deterioration that will more than offset the beneficial effects of the steroid.
Intrabursal injections should be made as follows: the area around the
injection site is prepared in a sterile way and a wheal at the site made with
1 per cent procaine hydrochloride solution. A 20 to 24 gauge needle
attached to a dry syringe is inserted into the bursa and the fluid aspirated.
The needle is left in place and the aspirating syringe changed for a small
syringe containing the desired dose. After injection, the needle is withdrawn
and a small dressing applied. In the treatment of tenosynovitis care should
be taken to inject Depo-Medrone into the tendon sheath rather than into the
substance of the tendon. Due to the absence of a true tendon sheath, the
Achilles tendon should not be injected with Depo-Medrone.

Paediatric population: Dosage may be reduced for infants and children but
should be governed more by the severity of the condition and response of
the patient, than by age or size.
Elderly patients: When used according to instructions, there is no
information to suggest that a change in dosage is warranted in the elderly.
However, treatment of elderly patients, particularly if long-term, should be
planned bearing in mind the more serious consequences of the common
side-effects of corticosteroids in old age and close clinical supervision is
required (see Special warnings and precautions).

Rheumatic disorders and collagen diseases (rheumatoid arthritis, SLE),
40 - 120 mg (1 - 3 ml) per week.
Dosage must be individualised and depends on the condition being treated
and its severity.

Administration of live or live, attenuated vaccines is contraindicated in
patients receiving immunosuppressive doses of corticosteroids.

Note: Depo-Medrone is not intended for the prophylaxis of severe seasonal
and perennial allergic rhinitis or other seasonal allergies and should be
administered only when symptoms are present.

Interactions
1. Convulsions have been reported with concurrent use of
methylprednisolone and ciclosporin. Since concurrent administration of
these agents results in a mutual inhibition of metabolism, it is possible
that convulsions and other adverse effects associated with the individual
use of either drug may be more apt to occur.
2. Drugs that induce hepatic enzymes, such as rifampicin, rifabutin,
carbamazepine, phenobarbitone, phenytoin, primidone and
aminoglutethimide enhance the metabolism of corticosteroids and their
therapeutic effect may be reduced. Aminoglutethimide- induced adrenal
suppression may exacerbate endocrine changes caused by prolonged
glucocorticoid treatment. The acetylation rate and clearance of isoniazid,
an antibacterial drug, can be increased by methylprednisolone.
3. Drugs such as erythromycin, itraconazole and ketoconazole may inhibit
the metabolism of corticosteroids and thus decrease their clearance.
Troleandomycin, as well as clarithromycin, erythromycin, itraconazole
and ketoconazole increase the effects and the side effects of
methylprednisolone.

Dermatological conditions, 40 - 120 mg (1 - 3 ml).

The frequency of intramuscular injections should be determined by the
duration of the clinical response.
In the case of seasonal allergic rhinitis a single injection is frequently
sufficient. If necessary, however, a second injection may be given after two
to three weeks.
On average the effect of a single 2 ml (80 mg) injection may be expected to
last approximately two weeks.

Effects on ability to drive and to use machines
The effect of corticosteroids on the ability to drive or use machinery has not
been systematically evaluated. Undesirable effects, such as dizziness,
vertigo, visual disturbances, and fatigue are possible after treatment with
corticosteroids. If affected, patients should not drive or operate machinery.
Other undesirable effects (frequency and seriousness)
Side effects: The incidence of predictable undesirable side effects
associated with the use of corticosteroids, including hypothalamic-pituitaryadrenal suppression correlates with the relative potency of the drug,
dosage, timing of administration and duration of treatment (see Special
warnings and precautions).
MedDRA (v15)
System Organ Class
Infections and
infestations

Frequency
Not Known

The usual sterile precautions should be observed with each injection.

Contraindications
Depo-Medrone is contraindicated:
 in patients with known hypersensitivity to the active substance or to any
of the excipients
 in patients who have systemic infection unless specific anti-infective
therapy is employed
 for use by the intrathecal route (due to its potential for neurotoxicity)
 for use by the intravenous route

Intramuscular - for sustained systemic effect: Allergic conditions (severe
seasonal and perennial allergic rhinitis, asthma, drug reactions).
80 - 120 mg (2 - 3 ml).

4. Steroids may reduce the effects of anticholinesterases in myasthenia
gravis. The desired effects of hypoglycaemic agents (including insulin),
anti-hypertensives and diuretics are antagonized by corticosteroids, and
the hypokalaemic effects of acetazolamide, loop diuretics, thiazide
diuretics and carbenoxolone are enhanced. Antagonism of the
neuromuscular blocking effects of pancuronium and vecuronium has
been reported in patients taking corticosteroids. This interaction may be
expected with all competitive neuromuscular blockers.
5. The effect of methylprednisolone on oral anticoagulants is variable. The
efficacy of coumarin anticoagulants may be enhanced by concurrent
corticosteroid therapy and close monitoring of the INR or prothrombin
time is required to avoid spontaneous bleeding and to maintain the
desired anticoagulant effects. There are also reports of diminished effects
of anticoagulants when given concurrently with corticosteroids.
6. There may be increased incidence of gastrointestinal bleeding and
ulceration when corticosteroids are given with NSAIDs.
Methylprednisolone may increase the clearance of high-dose aspirin,
which can lead to decreased salicylate serum levels. Discontinuation of
methylprednisolone treatment can lead to raised salicylate serum levels,
which could lead to an increased risk of salicylate toxicity. Salicylates and
non-steroidal anti-inflammatory agents should be used cautiously in
conjunction with corticosteroids in hypothrombinaemia.
7. Antidiabetics - Because corticosteroids may increase blood glucose
concentrations, dosage adjustments of antidiabetic agents may be
required.
8. Antiemetics - Aprepitant and fosaprepitant (CYP3A4 inhibitors and
substrates).
9. Antivirals - HIV protease inhibitors:
1) Indinavir and ritonavir (CYP3A4 inhibitors and substrates) may
increase plasma concentrations of corticosteroids.
2) Corticosteroids may induce the metabolism of HIV-protease inhibitors
resulting in reduced plasma concentrations.
10. Calcium channel blocker – Diltiazem.
11. Contraceptives (oral) - Ethinylestradiol/norethindrone.
12. Other immunosuppressants like cyclophosphamide and tacrolimus.
13. Potassium-depleting agents - When corticosteroids are administered
concomitantly with potassium-depleting agents (e.g. diuretics), patients
should be observed closely for development of hypokalaemia. There is
also an increased risk of hypokalaemia with concurrent use of
corticosteroids with amphotericin B, xanthenes, or beta2 agonists.
14. Grapefruit juice – (CYP3A4 inhibitor).

Infection (including increased
susceptibility and severity of
infections with suppression of
clinical symptoms and signs);
Opportunistic infection; Injection
site infection; Peritonitis;
Recurrence of dormant
tuberculosis

Not Known

Blood and lymphatic
system disorders

Not Known

Leukocytosis

Endocrine disorders

Not Known

Cushingoid; Hypopituitarism;
Withdrawal symptoms - Too rapid
a reduction of corticosteroid
dosage following prolonged
treatment can lead to acute
adrenal insufficiency, hypotension
and death. However, this is more
applicable to corticosteroids with
an indication where continuous
therapy is given (see section 4.4
of the SPC).
A 'withdrawal syndrome' may also
occur including, fever, myalgia,
arthralgia, rhinitis, conjunctivitis,
painful itchy skin nodules and loss
of weight.

Not Known

Drug hypersensitivity,
Anaphylactic reaction

Glucose tolerance impaired;
Sodium retention; Fluid retention;
Increased requirements for insulin
(or oral hypoglycemic agents in
diabetics)[not a MedDRA PT];
Alkalosis hypokalaemic;
Dyslipidaemia, Increased appetite
(which may result in Weight
increased); Epidural lipomatosis

Frequency

Undesirable Effects

Psychiatric
disorders

Not Known Affective disorder (including
Depressed mood, Euphoric mood,
Affect lability, psychological
dependence [not a MedDRA PT],
Suicidal ideation). The following
events were most common in children:
Mood swings; Abnormal behaviour;
Insomnia; Psychotic disorder
(including Mania, Delusion,
Hallucination, and Schizophrenia
[aggravation of]); Confusional state;
Mental disorder; Anxiety; Personality
change; Mood swings; Abnormal
behaviour; Insomnia

Nervous system
disorders

Not Known Intracranial pressure increased (with
Papilloedema [Benign intracranial
hypertension]); Convulsion; Amnesia;
Cognitive disorder; Dizziness;
Headache

Eye disorders

Not Known Cataract; Glaucoma; Exophthalmos;
rare instances of blindness associated
with intralesional therapy around the
face and head [not a MedDRA PT];
Increased intra-ocular pressure, with
possible damage to the optic nerve;
Corneal or scleral thinning;
Exacerbation of ophthalmic viral or
fungal disease; Chorioretinopathy

Ear and labyrinth
disorders

Not Known Vertigo

Cardiac disorders

Not Known Cardiac failure congestive
(in susceptible patients)

Vascular disorders Not Known Hypertension; Hypotension;
Embolism arterial Thrombotic events
Respiratory,
thoracic and
mediastinal
disorders

Not Known Pulmonary embolism, Hiccups

Gastrointestinal
disorders

Not Known Peptic ulcer (with possible Peptic ulcer
perforation and Peptic ulcer
haemorrhage); Gastric haemorrhage;
Intestinal perforation; Pancreatitis;
Oesophagitis ulcerative; Oesophagitis;
Abdominal pain; Abdominal
distension; Diarrhoea; Dyspepsia;
Nausea

Hepatobiliary
disorders

Not Known Hepatitis, Increase of liver enzymes

Skin and
subcutaneous
tissue disorders

Not Known Ecchymosis; Acne; Angioedema;
Petechiae; Skin atrophy; Skin striae;
Skin hyperpigmentation; Skin
hypopigmentation; Hirsutism; Rash;
Erythema; Pruritus; Urticaria;
Hyperhidrosis

Musculoskeletal
and connective
tissue disorders

Not Known Growth retardation; Osteoporosis;
Muscular weakness; Osteonecrosis;
Pathological fracture; Muscle atrophy;
Myopathy; Neuropathic arthropathy;
Arthralgia; Myalgia

Reproductive
system and breast
disorders

Not Known Menstruation irregular

General disorders
and administration
site conditions

Not Known Impaired healing; Oedema peripheral;
Irritability (in children); Injection site
reaction; Abscess sterile; Fatigue;
Malaise; Irritability (in adults)

Investigations

Not Known Blood potassium decreased;
Alanine aminotransferase increased;
Aspartate aminotransferase
increased; Blood alkaline
phosphatase increased;
Carbohydrate tolerance decreased;
Urine calcium increased;
suppression of reactions to skin tests
[not a MedDRA PT]; Blood urea
increased; Nitrogen balance negative
(due to protein catabolism)

Injury, poisoning
and procedural
complications

Not Known Tendon rupture (particularly of the
Achilles tendon); Spinal compression
fracture Systemic corticosteroids
should not be used for the
treatment of traumatic brain injury.

Undesirable Effects

Immune system
disorders

Metabolism and
nutrition disorders

MedDRA (v15)
System Organ
Class

Mental problems while taking Depo-Medrone
Mental health problems can happen while taking steroids like
Depo-Medrone (see also section 4, Possible Side Effects).
 These illnesses can be serious.
 Usually they start within a few days or weeks of starting the medicine.
 They are more likely to happen at high doses.
 Most of these problems go away if the dose is lowered or the medicine is
stopped. However if the problems do happen they might need treatment.
Talk to a doctor if you (or someone using this medicine) show any signs of
mental problems. This is particularly important if you are depressed, or
might be thinking about suicide. In a few cases mental problems have
happened when doses are being lowered or stopped.
If you have any further questions on the use of this medicine, ask your
doctor, pharmacist or nurse.
4. POSSIBLE SIDE EFFECTS

Body water and salts
not known
 Swelling and high blood pressure, caused by increased levels of water
and salt content.
 Cramps and spasms, due to the loss of potassium from your body. In rare
cases this can lead to congestive heart failure (when the heart cannot
pump properly).

Immune system
not known
 Increased susceptibility to infections which can hide or change normal
reactions to skin tests, such as that for tuberculosis.

Digestive system
not known
 Ulcers.
 Nausea (feeling sick) or vomiting (being sick).
 Thrush in the gullet (discomfort on swallowing).
 Indigestion.
 Diarrhoea.
 Bloated stomach.
 Abdominal pain.
 Persistent hiccups, especially when high doses are taken.

Muscles, bones and joints
not known
 Muscle weakness.
 Brittle bones (bones that break easily).
 Muscle wasting.
 Broken bones or fractures.
 Breakdown of bone due to poor circulation of blood, this causes pain in
the hip.
 Joint pain.
 Torn muscle tendons causing pain and/or swelling.
 Muscle cramps or spasms.
 Swollen or painful joints due to infection.

Like all medicines, this medicine can cause side effects, although not
everybody gets them. Your doctor will have given you this medicine for a
condition which if not treated properly could become serious.

Ears
not known
 A feeling of dizziness or spinning (vertigo).

In certain medical conditions medicines like Depo-Medrone (steroids)
should not be stopped abruptly. If you suffer from any of the following
symptoms seek IMMEDIATE medical attention. Your doctor will then
decide whether you should continue taking your medicine.
 Allergic reactions, such as skin rash, swelling of the face or
wheezing and difficulty breathing. This type of side effect is rare, but can
be serious.
 Pancreatitis, stomach pain spreading to your back, possibly
accompanied by vomiting, shock and loss of consciousness.
 Ulcers or bleeding ulcers, symptoms of which are sev ere stomach
pain which may go through to the back and could be associated with
bleeding from the back passage, black or bloodstained stools and/or
vomiting blood.
 Infections, this medicine can hide or change the signs and
symptoms of some infections, or reduce your resistance to the infection,
so that they are hard to diagnose at an early stage. Symptoms might
include a raised temperature and feeling unwell. Symptoms of a flare up
of a previous TB infection could be coughing blood or pain in the chest.
This medicine may also make you more likely to develop a severe
infection.
 Peritonitis, an inflammation (irritation) of the peritoneum, the thin
tissue that lines the inner wall of the abdomen and covers most of the
abdominal organs. Symptoms are, the stomach (abdomen) being very
painful or tender, the pain may become worse when the stomach is
touched or when you move.
 Pulmonary embolus (blood clot in the lung) symptoms include
sudden sharp chest pain, breathlessness and coughing up blood.
 Raised pressure within the skull of children (pseudotumour cerebri)
symptoms of which are headaches with vomiting, lack of energy and
drowsiness. This side effect usually occurs after treatment is stopped.
 Thrombophlebitis (blood clots or thrombosis in a leg vein),
symptoms of which include painful swollen, red and tender veins.

Eyes
not known
 Cataracts (indicated by failing eyesight).
 Glaucoma (raised pressure within the eye, causing pain in the eyes and
headaches).
 Swollen optic nerve (causing a condition called papilloedema, and which
may cause sight disturbance).
 Increased intra-ocular pressure, with possible damage to the optic nerve
(indicated by failing eyesight).
 Thinning of the clear part at the front of the eye (cornea) or of the white
part of the eye (sclera).
 Worsening of viral or fungal eye infections.
 Protruding of the eyeballs (exophthalmos).
 Blurred or distorted vision (due to disease of the retina and choroid
membrane).

If you experience any of the following side effects, or notice any other
unusual effects not mentioned in this leaflet, tell your doctor
immediately.
The side effects may occur with certain frequencies, which are defined as
follows:
 not known: frequency cannot be estimated from the available data
Blood, heart and circulation
not known
 High blood pressure, symptoms of which are headaches, or generally
feeling unwell.
 Problems with the pumping of your heart (heart failure) symptoms of
which are swollen ankles, difficulty in breathing and palpitations
(awareness of heart beat) or irregular beating of the heart, irregular or
very fast or slow pulse.
 Low blood pressure, symptoms may include dizziness, fainting,
light headedness, blurred vision, a rapid or irregular heartbeat
(palpitations).
 Increase of white blood cells (leukocytosis).
 Increased clotting of the blood.

General disorders
not known
 Poor wound healing.
 Irritability in children.
 Feeling tired or unwell.
 Skin reactions at the site of injection.
 Irritability in adults.
Hepatobiliary disorders
 Methylprednisolone can damage your liver, hepatitis and increase of liver
enzymes have been reported.
Hormones and metabolic system
not known
 Slowing of normal growth in infants, children and adolescents which may
be permanent.
 Round or moon-shaped face (Cushingoid facies).
 Diabetes or worsening of existing diabetes.
 Irregular or no periods in women.
 Increased appetite and weight gain.
 Abnormal localized or tumour-like accumulations of fat in the tissues.
 Prolonged therapy can lead to lower levels of some hormones which in
turn can cause low blood pressure and dizziness. This effect may persist
for months.
 The amount of certain chemicals (enzymes) called alanine transaminase,
aspartate transaminase and alkaline phosphatase that help the body
digest drugs and other substances in your body may be raised after
treatment with a corticosteroid. The change is usually small and the
enzyme levels return to normal after your medicine has cleared naturally
from your system. You will not notice any symptoms if this happens, but it
will show up if you have a blood test.

Metabolism and nutrition disorders
 Accumulation of fat tissue on localized parts of the body.

Nerves and mood issues
not known
Steroids including methylprednisolone can cause serious mental health
problems.
These are common in both adults and children.
They can affect about 5 in every 100 people taking medicines like
methylprednisolone.
 Feeling depressed, including thinking about suicide.
 Feeling high (mania) or moods that go up and down.
 Feeling anxious, having problems sleeping, difficulty in thinking or being
confused and losing your memory.
 Feeling, seeing or hearing things which do not exist. Having strange and
frightening thoughts, changing how you act or having feelings of being
alone.
 Other nervous system side effects may include convulsions (seizures),
amnesia (loss of memory), cognitive disorder (mental changes, dizziness
and headache.
 Back pain or weakness (due to Epidural Lipomatosis, a rare disorder in
which an abnormal amount of fat is deposited on or outside the lining of
the spine).
Skin
not known
 Acne.
 Bruising.
 Abscess, especially near injection sites.
 Thinning of skin, stretch marks.
 Small purple/red patches on the skin.
 Pale or darker patches on your skin, or raised patches which are an
unusual color.
 Increased hair on the body and face (hirsutism).
 Rash, itching, hives.
 Increased sweating.

5. HOW TO STORE DEPO-MEDRONE






Keep out of the sight and reach of children.
Do not store above 25oC.
Protect from freezing.
Discard any remaining contents after use.
Do not use Depo-Medrone after the expiry date which is stated on the vial
and the box after “EXP”. The expiry date refers to the last day of that
month.
 If your medicine becomes discoloured or shows any sign of deterioration,
return it to your pharmacist.
 Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Depo-Medrone contains
Each 1 ml vial contains 40 mg methylprednisolone acetate.
The other ingredients are polyethylene glycol 3350, sodium chloride,
myristyl-gamma-picolinium chloride, water for injections,
sodium hydroxide and hydrochloric acid (for pH adjustment).
What Depo-Medrone looks like and contents of the pack
Depo-Medrone is a sterile, white suspension for injection contained in a
glass vial fitted with a rubber cap and a metal seal.
Depo-Medrone is available in packs containing 1 or 10 vials,
containing 1 ml of suspension.
Manufactured by
Pfizer Manufacturing Belgium NV, Rijksweg 12, B-2870 Puurs, Belgium.
Procured from within the EU by the PL Holder:
MPT Pharma Ltd., Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall, WS9 8ER.
Repackaged by MPT Pharma Ltd.
PL: 33532/0799
Leaflet dated 3rd May 2017
Leaflet coded xxxxx

POM

Depo-Medrone® is a registered trademark of Pharmacia Limited.

To request a copy of this leaflet in
Braille, large print or audio please call
01922 745645 and ask for the
Regulatory Department.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the
safety of this medicine.


Particular care is required when considering the use of systemic
corticosteroids in patients with existing or previous history of severe
affective disorders in themselves or in their first degree relatives. These
would include depressive or manic-depressive illness and previous steroid
psychosis.

Intranasal: Permanent/temporary blindness, rhinitis.

Chickenpox is of serious concern since this normally minor illness may be
fatal in immunosuppressed patients. Patients (or parents of children)
without a definite history of chickenpox should be advised to avoid close
personal contact with chickenpox or herpes zoster and if exposed they
should seek urgent medical attention. Passive immunisation with varicella/
zoster immunoglobulin (VZIG) is needed by exposed non-immune patients
who are receiving systemic corticosteroids or who have used them within
the previous 3 months; this should be given within 10 days of exposure to
chickenpox. If a diagnosis of chickenpox is confirmed, the illness warrants
specialist care and urgent treatment. Corticosteroids should not be stopped
and the dose may need to be increased.

Ophthalmic: (Subconjunctival) - Redness and itching, abscess, slough at
injection site, residue at injection site, increased intra-ocular pressure,
decreased vision - blindness, infection.

Live vaccines should not be given to individuals with impaired immune
responsiveness. The antibody response to other vaccines may be
diminished.

There have been reports of epidural lipomatosis in patients taking
corticosteroids, typically with long-term use at high doses.

Miscellaneous injection sites: Scalp, tonsillar fauces, sphenopalatine
ganglion: blindness.

The use of Depo-Medrone in active tuberculosis should be restricted to
those cases of fulminating or disseminated tuberculosis in which the
corticosteroid is used for the management of the disease in conjunction with
an appropriate antituberculous regimen. If corticosteroids are indicated in
patients with latent tuberculosis or tuberculin reactivity, close observation is
necessary as reactivation of the disease may occur. During prolonged
corticosteroid therapy, these patients should receive chemoprophylaxis.

CERTAIN SIDE EFFECTS REPORTED WITH SOME CONTRAINDICATED
AND NON RECOMMENDED ROUTES OF ADMINISTRATION
Intrathecal/Epidural: Usual systemic corticoid adverse reactions, headache,
meningismus, meningitis, paraparesis/paraplegia, spinal fluid abnormalities,
nausea, vomiting, sweating, arachnoiditis, functional gastrointestinal
disorder/bladder dysfunction, convulsions, sensory disturbances. The
frequency of these adverse reactions is not known.
Extradural: Wound dehiscence, loss of sphincter control.

Special warnings and precautions
Warnings and Precautions:
Undesirable effects may be minimized by using the lowest effect dose for
the minimum period. Frequent patient review is required to appropriately
titrate the dose against disease activity (see Dosage and administration).
Depo-Medrone vials are intended for single dose use only. Any multidose
use of the product may lead to contamination.
Depo-Medrone is not recommended for epidural, intranasal, intra-ocular, or
any other unapproved route of administration. Severe medical events have
been reported in association with the intrathecal/epidural routes of
administration (see section 4.8 of the SPC). Appropriate measures must be
taken to avoid intravascular injection.
Due to the absence of a true tendon sheath, the Achilles tendon should not
be injected with Depo-Medrone.
While crystals of adrenal steroids in the dermis suppress inflammatory
reactions, their presence may cause disintegration of the cellular elements
and physiochemical changes in the ground substance of the connective
tissue. The resultant infrequently occurring dermal and/or subdermal
changes may form depressions in the skin at the injection site. The degree
to which this reaction occurs will vary with the amount of adrenal steroid
injected. Regeneration is usually complete within a few months or after all
crystals of the adrenal steroid have been absorbed. In order to minimize the
incidence of dermal and subdermal atrophy, care must be exercised not to
exceed recommended doses in injections. Multiple small injections into the
area of the lesion should be made whenever possible. The technique of
intra-articular and intramuscular injection should include precautions against
injection or leakage into the dermis. Injection into the deltoid muscle should
be avoided because of a high incidence of subcutaneous atrophy.
Intralesional doses should not be placed too superficially, particularly in
easily visible sites in patients with deeply pigmented skins, since there have
been rare reports of subcutaneous atrophy and depigmentation.
Systemic absorption of methylprednisolone occurs following intra-articular
injection of Depo-Medrone. Systemic as well as local effects can therefore
be expected.
Adrenal cortical atrophy develops during prolonged therapy and may persist
for months after stopping treatment. In patients who have received more
than physiological doses of systemic corticosteroids (approximately 6 mg
methylprednisolone) for greater than 3 weeks, withdrawal should not be
abrupt. How dose reduction should be carried out depends largely on
whether the disease is likely to relapse as the dose of systemic
corticosteroids is reduced. Clinical assessment of disease activity may be
needed during withdrawal. If the disease is unlikely to relapse on withdrawal
of systemic corticosteroids, but there is uncertainty about HPA suppression,
the dose of systemic corticosteroid may be reduced rapidly to physiological
doses. Once a daily dose of 6 mg methylprednisolone is reached, dose
reduction should be slower to allow the HPA-axis to recover.
The following precautions apply for parenteral corticosteroids: Following
intra–articular injection, the occurrence of a marked increase in pain
accompanied by local swelling, further restriction of joint motion, fever, and
malaise are suggestive of septic arthritis. If this complication occurs and the
diagnosis of sepsis is confirmed, appropriate antimicrobial therapy should
be instituted.
Local injection of a steroid into a previously injected joint is to be avoided.
Intra-articular corticosteroids are associated with a substantially increased
risk of inflammatory response in the joint, particularly bacterial infection
introduced with the injection. Charcot-like arthropathies have been reported
particularly after repeated injections. Appropriate examination of any joint
fluid present is necessary to exclude any bacterial infection, prior to
injection.
Corticosteroids should not be injected into unstable joints.
Sterile technique is necessary to prevent infections or contamination.
The slower rate of absorption by intramuscular administration should be
recognised.
Immunosuppressant Effects/Increased Susceptibility to Infections
Corticosteroids may increase susceptibility to infection, may mask some
signs of infection, and new infections may appear during their use.
Suppression of the inflammatory response and immune function increases
the susceptibility to fungal, viral and bacterial infections and their severity.
The clinical presentation may often be atypical and may reach an advanced
stage before being recognised.
With increasing doses of corticosteroids, the rate of occurrence of infectious
complications increases. Do not use intra-synovially, intrabursally or
intratendinous administration for local effect in the presence of acute
infection.
Persons who are on drugs which suppress the immune system are more
susceptible to infections than healthy individuals. Chickenpox and measles,
for example, can have a more serious or even fatal course in non-immune
children or adults on corticosteroids.

The role of corticosteroids in septic shock has been controversial, with early
studies reporting both beneficial and detrimental effects. More recently,
supplemental corticosteroids have been suggested to be beneficial in
patients with established septic shock who exhibit adrenal insufficiency.
However, their routine use in septic shock is not recommended. A
systematic review of short-course high-dose corticosteroids did not support
their use. However, meta-analyses and a review suggest that longer
courses (5-11 days) of low-dose corticosteroids might reduce mortality,
especially in patients with vasopressor-dependent septic shock.
Immune System Effects
Allergic reactions may occur. Because rare instances of skin reactions and
anaphylactic/anaphylactoid reactions have occurred in patients receiving
corticosteroid therapy, appropriate precautionary measures should be taken
prior to administration, especially when the patient has a history of drug
allergy.
Endocrine Effects
Pharmacologic doses of corticosteroids administered for prolonged periods
may result in hypothalamic-pituitary-adrenal (HPA) suppression
(secondary adrenocortical insufficiency). The degree and duration of
adrenocortical insufficiency produced is variable among patients and
depends on the dose, frequency, time of administration, and duration of
glucocorticoid therapy. This effect may be minimized by use of alternateday therapy.
In addition, acute adrenal insufficiency leading to a fatal outcome may occur
if glucocorticoids are withdrawn abruptly. Drug-induced secondary
adrenocortical insufficiency may therefore be minimized by gradual
reduction of dosage. This type of relative insufficiency may persist for
months after discontinuation of therapy; therefore, in any situation of stress
occurring during that period, hormone therapy should be reinstituted.
A steroid “withdrawal syndrome,” seemingly unrelated to adrenocortical
insufficiency, may also occur following abrupt discontinuance of
glucocorticoids. This syndrome includes symptoms such as: anorexia,
nausea, vomiting, lethargy, headache, fever, joint pain, desquamation,
myalgia, weight loss, and/or hypotension. These effects are thought to be
due to the sudden change in glucocorticoid concentration rather than to low
corticosteroid levels.
Abrupt withdrawal of systemic corticosteroid treatment, which has continued
up to 3 weeks is appropriate if it considered that the disease is unlikely to
relapse. Abrupt withdrawal of doses up to 32 mg daily of
methylprednisolone for 3 weeks is unlikely to lead to clinically relevant
HPA-axis suppression, in the majority of patients. In the following patient
groups, gradual withdrawal of systemic corticosteroid therapy should be
considered
even after courses lasting 3 weeks or less:
 Patients who have had repeated courses of systemic corticosteroids,
particularly if taken for greater than 3 weeks.
 When a short course has been prescribed within one year of cessation of
long-term therapy (months or years).
 Patients who may have reasons for adrenocortical insufficiency other
than exogenous corticosteroid therapy.
 Patients receiving doses of systemic corticosteroid greater than 32 mg
daily of methylprednisolone.
 Patients repeatedly taking doses in the evening.
Because glucocorticoids can produce or aggravate Cushing’s syndrome,
glucocorticoids should be avoided in patients with Cushing’s disease.
There is an enhanced effect of corticosteroids on patients with
hypothyroidism.
Metabolism and Nutrition
Corticosteroids, including methylprednisolone, can increase blood glucose,
worsen pre-existing diabetes, and predispose those on long-term
corticosteroid therapy to diabetes mellitus.
Psychiatric Effects
Patients and/or carers should be warned that potentially severe psychiatric
adverse reactions may occur with systemic steroids (see section 4.8 of the
SPC). Symptoms typically emerge within a few days or weeks of starting
treatment. Risks may be higher with high doses/systemic exposure (see
interactions), although dose levels do not allow prediction of the onset, type,
severity or duration of reactions. Most reactions recover after either dose
reduction or withdrawal, although specific treatment may be necessary.
Patients/carers should be encouraged to seek medical advice if worrying
psychological symptoms develop, especially if depressed mood or suicidal
ideation is suspected. Patients/carers should be alert to possible psychiatric
disturbances that may occur either during or immediately after dose
tapering/withdrawal of systemic steroids, although such reactions have
been reported infrequently.

Nervous System Effects
Corticosteroids should be used with caution in patients with seizure
disorders.
Corticosteroids should be used with caution in patients with myasthenia
gravis (Also see myopathy statement in Musculoskeletal Effects section).

Ocular Effects
Prolonged use of corticosteroids may produce posterior subcapsular
cataracts and nuclear cataracts (particularly in children), exophthalmos, or
increased intraocular pressure, which may result in glaucoma with possible
damage to the optic nerves, and may enhance the establishment of
secondary ocular infections due to fungi or viruses.
Corticosteroids should be used cautiously in patients with ocular herpes
simplex, because of possible corneal perforation.
Corticosteroid therapy has been associated with central serous
chorioretinopathy, which may lead to retinal detachment.
Cardiac Effects
Adverse effects of glucocorticoids on the cardiovascular system, such as
dyslipidaemia and hypertension, may predispose treated patients with
existing cardiovascular risk factors to additional cardiovascular effects, if
high doses and prolonged courses are used. Accordingly, corticosteroids
should be employed judiciously in such patients and attention should be
paid to risk modification and additional cardiac monitoring if needed.
Systemic corticosteroids should be used with caution, and only if strictly
necessary, in cases of congestive heart failure.
Vascular Effects
Corticosteroids should be used with caution in patients with hypertension.
Gastrointestinal Effects
There is no universal agreement on whether corticosteroids per se are
responsible for peptic ulcers encountered during therapy; however,
glucocorticoid therapy may mask the symptoms of peptic ulcer so that
perforation or haemorrhage may occur without significant pain. In
combination with NSAIDs, the risk of developing gastrointestinal ulcers is
increased.
Corticosteroids should be used with caution in nonspecific ulcerative colitis,
if there is a probability of impending perforation, abscess or other pyogenic
infection. Caution must also be used in diverticulitis, fresh intestinal
anastomoses, active or latent peptic ulcer, when steroids are used as direct
or adjunctive therapy.
Hepatobiliary Effects
High doses of corticosteroids may produce acute pancreatitis.
Corticosteroids should be used with caution in patients with liver failure or
cirrhosis.
Musculoskeletal Effects
An acute myopathy has been reported with the use of high doses of
corticosteroids, most often occurring in patients with disorders of
neuromuscular transmission (e.g. myasthenia gravis), or in patients
receiving concomitant therapy with anticholinergics, such as neuromuscular
blocking drugs (e.g. pancuronium). This acute myopathy is generalized,
may involve ocular and respiratory muscles, and may result in
quadriparesis. Elevations of creatine kinase may occur. Clinical
improvement or recovery after stopping corticosteroids may require weeks
to years.
Osteoporosis is a common but infrequently recognized adverse effect
associated with a long-term use of large doses of glucocorticoid.
Renal and Urinary Disorders
Corticosteroids should be used with caution in patients with renal
insufficiency.
Investigations
Average and large doses of hydrocortisone or cortisone can cause
elevation of blood pressure, salt and water retention, and increased
excretion of potassium. These effects are less likely to occur with the
synthetic derivatives except when used in large doses. Dietary salt
restriction and potassium supplementation may be necessary. All
corticosteroids increase calcium excretion.
Care should be taken for patients receiving cardioactive drugs such as
digoxin because of steroid induced electrolyte disturbance/potassium loss
(see side effects).
Other
Patients should carry ‘Steroid Treatment’ cards which give clear guidance
on the precautions to be taken to minimize risk and which provide details of
prescriber, drug, dosage and the duration of treatment.
Corticosteroids should be used with caution in patients with a predisposition
to thrombophlebitis.
Aspirin and nonsteroidal anti-inflammatory agents should be used
cautiously in conjunction with corticosteroids.
Pheochromocytoma crisis, which can be fatal, has been reported after
administration of systemic corticosteroids. Corticosteroids should only be
administered to patients with suspected or identified pheochromocytoma
after an appropriate risk/benefit evaluation.

Use in Children
Corticosteroids cause growth retardation in infancy, childhood and
adolescence which may be irreversible. Growth and development of infants
and children on prolonged corticosteroid therapy should be carefully
observed. Treatment should be limited to the minimum dosage for the
shortest possible time and should be restricted to the most serious
indications.
Infants and children on prolonged corticosteroid therapy are at special risk
from raised intracranial pressure.
High doses of corticosteroids may produce pancreatitis in children.
Use in Pregnancy and Lactation
Pregnancy
The ability of corticosteroids to cross the placenta varies between individual
drugs, however, methylprednisolone does cross the placenta. One
retrospective study found an increased incidence of low birth weights in
infants born of mothers receiving corticosteroids.
Administration of corticosteroids to pregnant animals can cause
abnormalities of foetal development including cleft palate, intra-uterine
growth retardation and affects on brain growth and development. There is
no evidence that corticosteroids result in an increased incidence of
congenital abnormalities, such as cleft palate in man, however, when
administered for long periods or repeatedly during pregnancy,
corticosteroids may increase the risk of intra-uterine growth retardation.
Hypoadrenalism may, in theory, occur in the neonate following prenatal
exposure to corticosteroids but usually resolves spontaneously following
birth and is rarely clinically important. Although neonatal adrenal
insufficiency appears to be rare in infants who were exposed in utero to
corticosteroids, those exposed to substantial doses of corticosteroids must
be carefully observed and evaluated for signs of adrenal insufficiency.
As with all drugs, corticosteroids should only be prescribed when the
benefits to the mother and child outweigh the risks. When corticosteroids
are essential, however, patients with normal pregnancies may be treated as
though they were in the non-gravid state.
Cataracts have been observed in infants born to mothers treated with longterm corticosteroids during pregnancy.
Breast-feeding
Corticosteroids are excreted in small amounts in breast milk, however,
doses of up to 40 mg daily of methylprednisolone are unlikely to cause
systemic effects in the infant. Infants of months taking higher doses than
this may have a degree of adrenal suppression, but the benefits of
breastfeeding are likely to outweigh any theoretical risk.
Corticosteroids distributed into breast milk may suppress growth and
interfere with endogenous glucocorticoid production in nursing infants.
Since adequate reproductive studies have not been performed in humans
with glucocorticoids, these drugs should be administered to nursing mothers
only if the benefits of therapy are judged to outweigh the potential risks to
the infant.
Overdosage
Following overdosage the possibility of adrenal suppression should be
guarded against by gradual diminution of dose levels over a period of time.
In such event the patient may require to be supported during any further
traumatic episode.
Reports of acute toxicity and/or death following overdosage of
corticosteroids are rare. In the event of overdosage, no specific antidote is
available; treatment is supportive and symptomatic.
Methylprednisolone is dialyzable.
Incompatibilities (major)
None stated.
Pharmaceutical precautions
Keep out of the sight and reach of children.
Do not store above 25oC.
Protect from freezing.
Depo-Medrone should not be mixed with any other fluid.
Discard any remaining contents after use.
Any unused medicinal product or waste material should be disposed of in
accordance with local requirements.
Leaflet dated 3rd May 2017
Leaflet coded xxxxx

PACKAGE LEAFLET: INFORMATION FOR THE USER

Methylprednisolone Acetate
40 mg/ml Injection
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor, pharmacist or nurse.
 If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. See section 4.
 The name of this medicine is Methylprednisolone Acetate 40 mg/ml
Injection but will be referred to as Methylprednisolone Acetate throughout
the remainder of this leaflet.
What is in this leaflet
1. What Methylprednisolone Acetate is and what it is used for
2. What you need to know before you are given Methylprednisolone
Acetate
3. How Methylprednisolone Acetate is given to you
4. Possible side effects
5. How to store Methylprednisolone Acetate
6. Contents of the pack and other information
1. WHAT METHYLPREDNISOLONE ACETATE IS AND WHAT IT IS
USED FOR
Methylprednisolone Acetate contains methylprednisolone acetate.
Methylprednisolone belongs to a group of medicines called corticosteroids
or steroids. Corticosteroids are produced naturally in your body and are
important for many body functions.
Boosting your body with extra corticosteroid such as Methylprednisolone
Acetate can help when injected into the body by a doctor or nurse, such as
in or near a joint, to treat local symptoms caused by inflammatory or
rheumatic conditions such as:
 Bursitis: inflammation in the fluid containing spaces around the
shoulder, knee and/or elbow joints. For this condition this medicine will
be injected directly into one or more of these spaces.
 Osteoarthritis and rheumatoid arthritis: inflammation located in
between the joints. For these conditions this medicine will be injected
directly into one or more joint spaces.
 Plantar fasciitis: inflammation of the tissues of the sole of the foot.
 Skin problems: such as alopecia areata (patchy baldness), keloids
(scar tissue), lichen planus or simplex (small, purplish raised patches of
skin or spots), discoid lupus (round-shaped patches, often on the face) or
granuloma annulare (circular warty growths).
 Epicondylitis (tennis elbow) and tenosynovitis: for these conditions
this medicine will be injected into the tendon sheath.
Alternatively this medicine may be injected into a muscle to help treat more
general (systemic) problems affecting the whole body (e.g. symptoms
caused by a hypersensitivity to a medicine), or allergic, inflammatory or
rheumatic problems affecting the:
 brain e.g. meningitis caused by tuberculosis
 bowel and gut e.g. Crohn’s disease (inflammation of the gut) or
ulcerative colitis (inflammation of the lower bowel)
 joints e.g. rheumatoid arthritis
 lungs e.g. asthma, severe hay fever or rhinitis, tuberculosis or
inflammation caused by breathing in (aspirating) vomit or stomach
contents
 skin e.g. Stev ens-Johnson syndrome (an autoimmune disorder in which
an immune system causes the skin to blister and peel) or systemic lupus
erythematosus (lupus).
Your doctor may use this medicine to treat conditions other than those listed
above. Ask your doctor if you are unsure why you have been given this
medicine.

2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN
METHYLPREDNISOLONE ACETATE
Do not use Methylprednisolone Acetate if:
 You think you have ever suffered an allergic reaction, or any other type of
reaction after being given Methylprednisolone Acetate, or any other
medicine containing a corticosteroid or any of the ingredients in this
medicine (listed in section 6). An allergic reaction may cause a skin rash
or reddening, swollen face or lips or shortness of breath.
 You get a rash, or another symptom of an infection.
 You have recently had, or are about to have any vaccination.
See your doctor immediately if any of the above applies to you.
Do not inject this medicine:
 into the Achilles tendon (which is located behind the ankle joint), or
 directly into a vein (intravenous), the spinal cord (intrathecal), the outer
covering of the brain (extradural), into the nostrils (intranasal) or in the
eye (intraocular).
Warnings and precautions
Talk to your doctor or nurse before taking Methylprednisolone Acetate if you
have any of the following conditions.
Your doctor may also have to monitor your treatment more closely, alter
your dose or give you another medicine.
 Acute adrenal insufficiency (when your body cannot produce
enough corticosteroid due to problems with your adrenal glands).
 Acute pancreatitis (inflammation of the pancreas).
 Chickenpox, measles, shingles or a herpes ey e infection. If you
think you have been in contact with someone with chickenpox, measles
or shingles and you have not already had these illnesses, or if you are
unsure if you have had them.
 Severe depression or manic depression (bipolar disorder). This includes
having had depression before while taking steroid medicines like
Methylprednisolone Acetate, or having a family history of these illnesses.
 Cushing’s disease (condition caused by an excess of cortisol
hormone in your body).
 Diabetes (or if there is a family history of diabetes).
 Epilepsy, fits or seizures.
 Glaucoma (increased pressure in the eye) or if there is a family
history of glaucoma.
 You have recently suffered a heart attack.
 Heart problems, including heart failure or infections.
 Hypertension (high blood pressure).
 Hypotension (low blood pressure).
 Hypothyroidism (an under -active thyroid).
 Joint infection.
 Kidney or liver disease.
 Muscle problems (pain or weakness) have happened while taking
steroid medicines in the past.
 Myasthenia gravis (a condition causing tired and weak muscles).
 Osteoporosis (brittle bones).
 Pheochromocytoma (a rare tumour of adrenal gland tissue. The
adrenal glands are located above the kidneys).
 Skin abscess.
 Stomach ulcer or other serious stomach or intestinal problems.
 Unusual stress.
 Thrombophlebitis - vein problems due to thrombosis (clots in the veins)
resulting in phlebitis (red, swollen and tender veins).
 Tuberculosis (TB) or if you have suffered tuberculosis in the past.
 Traumatic brain injury.
You must tell your doctor before you take this medicine if you have any of
the conditions listed above.
Other medicines and Methylprednisolone Acetate
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.

You should tell your doctor if you are taking any of the following medicines
which can affect the way Methylprednisolone Acetate or the other medicine
works:
 Acetazolamide - used to treat glaucoma and epilepsy.
 Aminoglutethimide and cyclophosphamide - used for treating cancer.
 Antibacterials (such as isoniazid, erythromycin, clarithromycin and
troleandomycin).
 Anticoagulants - used to ‘thin’ the blood such as acenocoumarol,
phenindione and warfarin.
 Anticholinesterases - used to treat myasthenia gravis (a muscle
condition) such as distigmine and neostigmine.
 Antidiabetics - medicines used to treat high blood sugar.
 Antiemetics (such as aprepitant and fosaprepitant).
 Aspirin and non-steroidal anti-inflammatory medicines (also called
NSAIDs) such as ibuprofen used to treat mild to moderate pain.
 Barbiturates, carbamazepine, phenytoin and primidone - used to
treat epilepsy.
 Carbenoxolone - used for heartburn and acid indigestion.
 Ciclosporin - used to treat conditions such as severe rheumatoid
arthritis, severe psoriasis or following an organ or bone marrow
transplant.
 Digoxin - used for heart failure and/or an irregular heart beat.
 Diltiazem - used for heart problems or high blood pressure.
 Ethinylestradiol and norethindrone - oral contraceptives.
 Indinavir and ritonavir - used to treat HIV infections.
 Ketoconazole or itraconazole - used to treat fungal infections.
 Pancuronium and vecuronium - or other medicines called
neuromuscular blocking agents which are used in some surgical
procedures.
 Potassium depleting agents - such as diuretics (sometimes called water
tablets), amphotericin B, xanthenes or beta2 agonists (e.g. medicines
used to treat asthma).
 Rifampicin and rifabutin - antibiotics used to treat tuberculosis (TB).
 Tacrolimus – used following an organ transplant to prevent rejection of
the organ.
 Vaccines - tell your doctor or nurse if you have recently had, or are about
to have any vaccination. You must not have ‘live’ vaccines while using
this medicine. Other vaccines may be less effective.
If you are taking long term medication(s)
If you are being treated for diabetes, high blood pressure or water retention
(oedema) tell your doctor as he/she may need to adjust the dose of the
medicines used to treat these conditions.
Before you have any operation tell your doctor, dentist or anaesthetist
that you are taking this medicine.

3. HOW METHYLPREDNISOLONE ACETATE IS GIVEN TO YOU
Steroid Cards
Remember to always carry a Steroid Treatment Card. Make sure your
doctor or pharmacist has filled out the details of your medicine,
including the dose and how long you will require steroid treatment.
You should show your steroid card to anyone who gives you treatment
(such as a doctor, nurse or dentist) while you are taking this medicine, and
for 3 months after your last injection.
If you are admitted to hospital for any reason always tell your doctor or
nurse that you are taking this medicine. You can also wear a medic-alert
bracelet or pendant to let medical staff know that you are taking a steroid if
you have an accident or become unconscious.
Dosage information
Your doctor will decide on the site of injection, how much of the medicine
and how many injections you will receive depending on the condition being
treated and its severity. Your doctor will inject you with the lowest dose for
the shortest possible time to get effective relief of your symptoms.
Adults
Your doctor/nurse will tell you how many injections you will require for the
condition you are being treated for, and when you will get them.
Joints - the normal dose for the injections into joint will depend on the size
of the joint. Large joints (e.g. knee, ankle and shoulder) may require
20 - 80 mg (0.5 - 2 ml), medium sized joints (e.g. elbow or wrist) 10 - 40 mg
(0.25 - 1 ml) and small joints (e.g. finger or toe joints) may require a
4 - 10 mg (0.1 - 0.25 ml) dose.
Joint injections may be given weekly over a period of several weeks,
depending on how quickly you respond to treatment.
Bursitis and epicondylitis (tennis elbow) - the usual dose is between
4 - 30 mg (0.1 - 0.75 ml). In most cases repeat injections will not be needed
for bursitis and epicondylitis. Repeat injections may be necessary to treat
long standing conditions.
Skin conditions - the usual dose is between 20 - 60 mg (0.5 - 1.5 ml)
injected into the affected part or parts of the skin.
For other more general conditions 40 - 120 mg (1 - 3 ml) of this medicine
may be injected into a large muscle.
Elderly
Treatment will normally be the same as for younger adults. However your
doctor may want to see you more regularly to check how you are getting on
with this medicine.

If you require a test to be carried out by your doctor or in hospital it is
important that you tell the doctor or nurse that you are taking
Methylprednisolone Acetate. This medicine can affect the results of some
tests.

Children
Corticosteroids can affect growth in children so your doctor will prescribe
the lowest dose that will be effective for your child.

Methylprednisolone Acetate with drink
Do not drink grapefruit juice while taking this medicine.

If you are given more Methylprednisolone Acetate than you should
If you think you have been given too many injections of this medicine please
speak to your doctor immediately.

Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice before taking this medicine,
as this medicine could slow the baby’s growth.
Cataracts have been observed in infants born to mothers treated with
long-term corticosteroids during pregnancy.
If you are breast-feeding, ask your doctor or pharmacist for advice before
taking this medicine, as small amounts of corticosteroid medicines may get
into breast milk.
If you continue breast-feeding while you are having treatment, your baby
will need extra checks to make sure he or she is not being affected by your
medicine.
Driving and using machines
Undesirable effects, such as dizziness, vertigo, visual disturbances and
fatigue are possible after treatment with corticosteroids. If you are affected
do not drive or operate machinery.

Stopping/reducing the dose of your Methylprednisolone Acetate
Your doctor will decide when it is time to stop your treatment.
You will need to come off this treatment slowly if you:
 have been given Methylprednisolone Acetate for more than 3 weeks
 have been given high doses of Methylprednisolone Acetate, over 32 mg
(0.8 ml) daily, even if it was only for 3 weeks or less
 have already had a course of corticosteroid tablets or injections in the last
year
 already have problems with your adrenal glands (adrenocortical
insufficiency) before you started this treatment.
You will need to come off this medicine slowly to avoid withdrawal
symptoms. These symptoms may include itchy skin, fever, muscle and joint
pains, runny nose, sticky eyes, sweating and weight loss.
If your symptoms seem to return or get worse as your dose of this medicine
is reduced tell your doctor immediately.

Methylprednisolone Acetate contains sodium
This medicinal product contains less than 1 mmol sodium (23 mg) per vial,
i.e. essentially ‘sodium-free’.


The following information is intended for healthcare
professionals only: PHYSICIAN LEAFLET

Methylprednisolone Acetate
40 mg/ml Injection
Presentation
White, sterile aqueous suspension for injection containing 40 mg per ml
methylprednisolone acetate. Also contains polyethylene glycol 3350,
sodium chloride, myristyl-gamma-picolinium chloride, water for injections,
sodium hydroxide and hydrochloric acid (for pH adjustment).
Uses
Methylprednisolone Acetate may be used locally or systemically, particularly
where oral therapy is not feasible.
Methylprednisolone Acetate may be used by any of the following routes:
intramuscular, intra-articular, periarticular, intrabursal, intralesional or into
the tendon sheath. It must not be used by the intrathecal or intravenous
routes. (See Contraindications and Side effects).
Intramuscular administration:
1. Rheumatic disorders
Rheumatoid arthritis
2. Collagen diseases/arthritis
Systemic lupus erythematosus
3. Dermatological diseases
Severe erythema multiforme (Stevens-Johnson syndrome)
4. Allergic states
Bronchial asthma
Severe seasonal and perennial allergic rhinitis
Drug hypersensitivity reactions
Angioneurotic oedema
5. Gastro-intestinal diseases
Ulcerative colitis
Crohn’s disease
6. Respiratory diseases
Fulminating or disseminated tuberculosis (with appropriate
antituberculous chemotherapy)
Aspiration of gastric contents
7. Miscellaneous
TB meningitis (with appropriate antituberculous chemotherapy)
Intra-articular administration:
Rheumatoid arthritis
Osteo-arthritis with an inflammatory component
Soft tissue administration (intrabursal, periarticular, into tendon sheath):
Synovitis not associated with infection
Epicondylitis
Tenosynovitis
Plantar fasciitis
Bursitis
Intralesional:
Keloids
Localized lichen planus
Localized lichen simplex
Granuloma annulare
Discoid lupus erythematosus
Alopecia areata
Dosage and administration
Methylprednisolone Acetate should not be mixed with any other
suspending agent or solution. Parenteral drug products should be
inspected visually for particulate matter and discolouration prior to
administration, whenever suspension and container permit.
Methylprednisolone Acetate may be used by any of the following
routes: intramuscular, intra-articular, periarticular, intrabursal,
intralesional and into the tendon sheath. It must not be used by the
intrathecal or intravenous routes (see Contraindications and Side effects).
Undesirable effects may be minimized by using the lowest effective dose for
the minimum period (see special warnings and precautions).
Methylprednisolone Acetate vials are intended for single dose use only.
Intramuscular - for sustained systemic effect: Allergic conditions (severe
seasonal and perennial allergic rhinitis, asthma, drug reactions).
80 - 120 mg (2 - 3 ml).
Dermatological conditions, 40 - 120 mg (1 - 3 ml).
Rheumatic disorders and collagen diseases (rheumatoid arthritis, SLE),
40 - 120 mg (1 - 3 ml) per week.
Dosage must be individualised and depends on the condition being treated
and its severity.
Note: Methylprednisolone Acetate is not intended for the prophylaxis of
severe seasonal and perennial allergic rhinitis or other seasonal allergies
and should be administered only when symptoms are present.
The frequency of intramuscular injections should be determined by the
duration of the clinical response.
In the case of seasonal allergic rhinitis a single injection is frequently
sufficient. If necessary, however, a second injection may be given after two
to three weeks.
On average the effect of a single 2 ml (80 mg) injection may be expected to
last approximately two weeks.

Intra-articular: Rheumatoid arthritis, osteo-arthritis. The dose of
Methylprednisolone Acetate depends upon the size of the joint and the
severity of the condition. Repeated injections, if needed, may be given at
intervals of one to five or more weeks depending upon the degree of relief
obtained from the initial injection. A suggested dosage guide is: large joint
(knee, ankle, shoulder), 20 - 80 mg (0.5 - 2 ml); medium joint (elbow, wrist),
10 - 40 mg (0.25 - 1 ml); small joint (metacarpophalangeal, interphalangeal,
sternoclavicular, acromioclavicular), 4 - 10 mg (0.1 - 0.25 ml).
Intrabursal: Subdeltoid bursitis, prepatellar bursitis, olecranon bursitis.
For administration directly into bursae, 4 - 30 mg (0.1 - 0.75 ml). In most
cases, repeat injections are not needed.
Intralesional: Keloids, localized lichen planus, localized lichen simplex,
granuloma annulare, alopecia areata, and discoid lupus erythematosus.
For administration directly into the lesion for local effect in dermatological
conditions, 20 - 60 mg (0.5 - 1.5 ml). For large lesions, the dose may be
distributed by repeated local injections of 20 - 40 mg (0.5 - 1 ml). One to
four injections are usually employed. Care should be taken to avoid
injection of sufficient material to cause blanching, since this may be
followed by a small slough.
Periarticular: Epicondylitis. Infiltrate 4 - 30 mg (0.1 - 0.75 ml) into the
affected area.
Into the tendon sheath: Tenosynovitis, epicondylitis. For administration
directly into the tendon sheath, 4 - 30 mg (0.1 - 0.75 ml). In recurrent or
chronic conditions, repeat injections may be necessary.
Special precautions should be observed when administering
Methylprednisolone Acetate. Intramuscular injections should be made
deeply into the gluteal muscles. The usual technique of aspirating prior to
injection should be employed to avoid intravascular administration. Doses
recommended for intramuscular injection must not be administered
superficially or subcutaneously.
Intra-articular injections should be made using precise, anatomical
localisation into the synovial space of the joint involved. The injection site
for each joint is determined by that location where the synovial cavity is
most superficial and most free of large vessels and nerves. Suitable sites
for intra-articular injection are the knee, ankle, wrist, elbow, shoulder,
phalangeal and hip joints. The spinal joints, unstable joints and those
devoid of synovial space are not suitable. Treatment failures are most
frequently the result of failure to enter the joint space. Intra-articular
injections should be made with care as follows: ensure correct positioning of
the needle into the synovial space and aspirate a few drops of joint fluid.
The aspirating syringe should then be replaced by another containing
Methylprednisolone Acetate. To ensure position of the needle, synovial fluid
should be aspirated and the injection made. After injection the joint is
moved slightly to aid mixing of the synovial fluid and the suspension.
Subsequent to therapy care should be taken for the patient not to overuse
the joint in which benefit has been obtained. Negligence in this matter may
permit an increase in joint deterioration that will more than offset the
beneficial effects of the steroid.
Intrabursal injections should be made as follows: the area around the
injection site is prepared in a sterile way and a wheal at the site made with
1 per cent procaine hydrochloride solution. A 20 to 24 gauge needle
attached to a dry syringe is inserted into the bursa and the fluid aspirated.
The needle is left in place and the aspirating syringe changed for a small
syringe containing the desired dose. After injection, the needle is withdrawn
and a small dressing applied. In the treatment of tenosynovitis care should
be taken to inject Methylprednisolone Acetate into the tendon sheath rather
than into the substance of the tendon. Due to the absence of a true tendon
sheath, the Achilles tendon should not be injected with Methylprednisolone
Acetate.

4. Steroids may reduce the effects of anticholinesterases in myasthenia
gravis. The desired effects of hypoglycaemic agents (including insulin),
anti-hypertensives and diuretics are antagonized by corticosteroids, and
the hypokalaemic effects of acetazolamide, loop diuretics, thiazide
diuretics and carbenoxolone are enhanced. Antagonism of the
neuromuscular blocking effects of pancuronium and vecuronium has
been reported in patients taking corticosteroids. This interaction may be
expected with all competitive neuromuscular blockers.
5. The effect of methylprednisolone on oral anticoagulants is variable. The
efficacy of coumarin anticoagulants may be enhanced by concurrent
corticosteroid therapy and close monitoring of the INR or prothrombin
time is required to avoid spontaneous bleeding and to maintain the
desired anticoagulant effects. There are also reports of diminished effects
of anticoagulants when given concurrently with corticosteroids.
6. There may be increased incidence of gastrointestinal bleeding and
ulceration when corticosteroids are given with NSAIDs.
Methylprednisolone may increase the clearance of high-dose aspirin,
which can lead to decreased salicylate serum levels. Discontinuation of
methylprednisolone treatment can lead to raised salicylate serum levels,
which could lead to an increased risk of salicylate toxicity. Salicylates and
non-steroidal anti-inflammatory agents should be used cautiously in
conjunction with corticosteroids in hypothrombinaemia.
7. Antidiabetics - Because corticosteroids may increase blood glucose
concentrations, dosage adjustments of antidiabetic agents may be
required.
8. Antiemetics - Aprepitant and fosaprepitant (CYP3A4 inhibitors and
substrates).
9. Antivirals - HIV protease inhibitors:
1) Indinavir and ritonavir (CYP3A4 inhibitors and substrates) may
increase plasma concentrations of corticosteroids.
2) Corticosteroids may induce the metabolism of HIV-protease inhibitors
resulting in reduced plasma concentrations.
10. Calcium channel blocker – Diltiazem.
11. Contraceptives (oral) - Ethinylestradiol/norethindrone.
12. Other immunosuppressants like cyclophosphamide and tacrolimus.
13. Potassium-depleting agents - When corticosteroids are administered
concomitantly with potassium-depleting agents (e.g. diuretics), patients
should be observed closely for development of hypokalaemia. There is
also an increased risk of hypokalaemia with concurrent use of
corticosteroids with amphotericin B, xanthenes, or beta2 agonists.
14. Grapefruit juice – (CYP3A4 inhibitor).
Effects on ability to drive and to use machines
The effect of corticosteroids on the ability to drive or use machinery has not
been systematically evaluated. Undesirable effects, such as dizziness,
vertigo, visual disturbances, and fatigue are possible after treatment with
corticosteroids. If affected, patients should not drive or operate machinery.
Other undesirable effects (frequency and seriousness)
Side effects: The incidence of predictable undesirable side effects
associated with the use of corticosteroids, including hypothalamic-pituitaryadrenal suppression correlates with the relative potency of the drug,
dosage, timing of administration and duration of treatment (see Special
warnings and precautions).
MedDRA (v15)
System Organ Class
Infections and
infestations

Frequency
Not Known

The usual sterile precautions should be observed with each injection.

Infection (including increased
susceptibility and severity of
infections with suppression of
clinical symptoms and signs);
Opportunistic infection; Injection
site infection; Peritonitis;
Recurrence of dormant
tuberculosis

Immune system
disorders

Not Known

Elderly patients: When used according to instructions, there is no
information to suggest that a change in dosage is warranted in the elderly.
However, treatment of elderly patients, particularly if long-term, should be
planned bearing in mind the more serious consequences of the common
side-effects of corticosteroids in old age and close clinical supervision is
required (see Special warnings and precautions).

Blood and lymphatic
system disorders

Not Known

Leukocytosis

Endocrine disorders

Not Known

Cushingoid; Hypopituitarism;
Withdrawal symptoms - Too rapid
a reduction of corticosteroid
dosage following prolonged
treatment can lead to acute
adrenal insufficiency, hypotension
and death. However, this is more
applicable to corticosteroids with
an indication where continuous
therapy is given (see section 4.4
of the SPC).
A 'withdrawal syndrome' may also
occur including, fever, myalgia,
arthralgia, rhinitis, conjunctivitis,
painful itchy skin nodules and loss
of weight.

Administration of live or live, attenuated vaccines is contraindicated in
patients receiving immunosuppressive doses of corticosteroids.
Interactions
1. Convulsions have been reported with concurrent use of
methylprednisolone and ciclosporin. Since concurrent administration of
these agents results in a mutual inhibition of metabolism, it is possible
that convulsions and other adverse effects associated with the individual
use of either drug may be more apt to occur.
2. Drugs that induce hepatic enzymes, such as rifampicin, rifabutin,
carbamazepine, phenobarbitone, phenytoin, primidone and
aminoglutethimide enhance the metabolism of corticosteroids and their
therapeutic effect may be reduced. Aminoglutethimide- induced adrenal
suppression may exacerbate endocrine changes caused by prolonged
glucocorticoid treatment. The acetylation rate and clearance of isoniazid,
an antibacterial drug, can be increased by methylprednisolone.
3. Drugs such as erythromycin, itraconazole and ketoconazole may inhibit
the metabolism of corticosteroids and thus decrease their clearance.
Troleandomycin, as well as clarithromycin, erythromycin, itraconazole
and ketoconazole increase the effects and the side effects of
methylprednisolone.

Metabolism and
nutrition disorders

Not Known

Drug hypersensitivity,
Anaphylactic reaction

Glucose tolerance impaired;
Sodium retention; Fluid retention;
Increased requirements for insulin
(or oral hypoglycemic agents in
diabetics)[not a MedDRA PT];
Alkalosis hypokalaemic;
Dyslipidaemia, Increased appetite
(which may result in Weight
increased); Epidural lipomatosis

Frequency

Undesirable Effects

Psychiatric
disorders

Not Known Affective disorder (including
Depressed mood, Euphoric mood,
Affect lability, psychological
dependence [not a MedDRA PT],
Suicidal ideation). The following
events were most common in children:
Mood swings; Abnormal behaviour;
Insomnia; Psychotic disorder
(including Mania, Delusion,
Hallucination, and Schizophrenia
[aggravation of]); Confusional state;
Mental disorder; Anxiety; Personality
change; Mood swings; Abnormal
behaviour; Insomnia

Nervous system
disorders

Not Known Intracranial pressure increased (with
Papilloedema [Benign intracranial
hypertension]); Convulsion; Amnesia;
Cognitive disorder; Dizziness;
Headache

Eye disorders

Not Known Cataract; Glaucoma; Exophthalmos;
rare instances of blindness associated
with intralesional therapy around the
face and head [not a MedDRA PT];
Increased intra-ocular pressure, with
possible damage to the optic nerve;
Corneal or scleral thinning;
Exacerbation of ophthalmic viral or
fungal disease; Chorioretinopathy

Ear and labyrinth
disorders

Not Known Vertigo

Cardiac disorders

Not Known Cardiac failure congestive
(in susceptible patients)

Vascular disorders Not Known Hypertension; Hypotension;
Embolism arterial Thrombotic events
Respiratory,
thoracic and
mediastinal
disorders

Not Known Pulmonary embolism, Hiccups

Gastrointestinal
disorders

Not Known Peptic ulcer (with possible Peptic ulcer
perforation and Peptic ulcer
haemorrhage); Gastric haemorrhage;
Intestinal perforation; Pancreatitis;
Oesophagitis ulcerative; Oesophagitis;
Abdominal pain; Abdominal
distension; Diarrhoea; Dyspepsia;
Nausea

Hepatobiliary
disorders

Not Known Hepatitis, Increase of liver enzymes

Skin and
subcutaneous
tissue disorders

Not Known Ecchymosis; Acne; Angioedema;
Petechiae; Skin atrophy; Skin striae;
Skin hyperpigmentation; Skin
hypopigmentation; Hirsutism; Rash;
Erythema; Pruritus; Urticaria;
Hyperhidrosis

Musculoskeletal
and connective
tissue disorders

Not Known Growth retardation; Osteoporosis;
Muscular weakness; Osteonecrosis;
Pathological fracture; Muscle atrophy;
Myopathy; Neuropathic arthropathy;
Arthralgia; Myalgia

Reproductive
system and breast
disorders

Not Known Menstruation irregular

General disorders
and administration
site conditions

Not Known Impaired healing; Oedema peripheral;
Irritability (in children); Injection site
reaction; Abscess sterile; Fatigue;
Malaise; Irritability (in adults)

Investigations

Not Known Blood potassium decreased;
Alanine aminotransferase increased;
Aspartate aminotransferase
increased; Blood alkaline
phosphatase increased;
Carbohydrate tolerance decreased;
Urine calcium increased;
suppression of reactions to skin tests
[not a MedDRA PT]; Blood urea
increased; Nitrogen balance negative
(due to protein catabolism)

Injury, poisoning
and procedural
complications

Not Known Tendon rupture (particularly of the
Achilles tendon); Spinal compression
fracture Systemic corticosteroids
should not be used for the
treatment of traumatic brain injury.

Undesirable Effects

Paediatric population: Dosage may be reduced for infants and children but
should be governed more by the severity of the condition and response of
the patient, than by age or size.

Contraindications
Methylprednisolone Acetate is contraindicated:
 in patients with known hypersensitivity to the active substance or to any
of the excipients
 in patients who have systemic infection unless specific anti-infective
therapy is employed
 for use by the intrathecal route (due to its potential for neurotoxicity)
 for use by the intravenous route

MedDRA (v15)
System Organ
Class

Mental problems while taking Methylprednisolone Acetate
Mental health problems can happen while taking steroids like
Methylprednisolone Acetate (see also section 4, Possible Side Effects).
 These illnesses can be serious.
 Usually they start within a few days or weeks of starting the medicine.
 They are more likely to happen at high doses.
 Most of these problems go away if the dose is lowered or the medicine is
stopped. However if the problems do happen they might need treatment.
Talk to a doctor if you (or someone using this medicine) show any signs of
mental problems. This is particularly important if you are depressed, or
might be thinking about suicide. In a few cases mental problems have
happened when doses are being lowered or stopped.
If you have any further questions on the use of this medicine, ask your
doctor, pharmacist or nurse.
4. POSSIBLE SIDE EFFECTS

Body water and salts
not known
 Swelling and high blood pressure, caused by increased levels of water
and salt content.
 Cramps and spasms, due to the loss of potassium from your body. In rare
cases this can lead to congestive heart failure (when the heart cannot
pump properly).

Immune system
not known
 Increased susceptibility to infections which can hide or change normal
reactions to skin tests, such as that for tuberculosis.

Digestive system
not known
 Ulcers.
 Nausea (feeling sick) or vomiting (being sick).
 Thrush in the gullet (discomfort on swallowing).
 Indigestion.
 Diarrhoea.
 Bloated stomach.
 Abdominal pain.
 Persistent hiccups, especially when high doses are taken.

Muscles, bones and joints
not known
 Muscle weakness.
 Brittle bones (bones that break easily).
 Muscle wasting.
 Broken bones or fractures.
 Breakdown of bone due to poor circulation of blood, this causes pain in
the hip.
 Joint pain.
 Torn muscle tendons causing pain and/or swelling.
 Muscle cramps or spasms.
 Swollen or painful joints due to infection.

Like all medicines, this medicine can cause side effects, although not
everybody gets them. Your doctor will have given you this medicine for a
condition which if not treated properly could become serious.

Ears
not known
 A feeling of dizziness or spinning (vertigo).

In certain medical conditions medicines like Methylprednisolone
Acetate (steroids) should not be stopped abruptly. If you suffer from
any of the following symptoms seek IMMEDIATE medical attention.
Your doctor will then decide whether you should continue taking your
medicine.
 Allergic reactions, such as skin rash, swelling of the face or
wheezing and difficulty breathing. This type of side effect is rare, but can
be serious.
 Pancreatitis, stomach pain spreading to your back, possibly
accompanied by vomiting, shock and loss of consciousness.
 Ulcers or bleeding ulcers, symptoms of which are sev ere stomach
pain which may go through to the back and could be associated with
bleeding from the back passage, black or bloodstained stools and/or
vomiting blood.
 Infections, this medicine can hide or change the signs and
symptoms of some infections, or reduce your resistance to the infection,
so that they are hard to diagnose at an early stage. Symptoms might
include a raised temperature and feeling unwell. Symptoms of a flare up
of a previous TB infection could be coughing blood or pain in the chest.
This medicine may also make you more likely to develop a severe
infection.
 Peritonitis, an inflammation (irritation) of the peritoneum, the thin
tissue that lines the inner wall of the abdomen and covers most of the
abdominal organs. Symptoms are, the stomach (abdomen) being very
painful or tender, the pain may become worse when the stomach is
touched or when you move.
 Pulmonary embolus (blood clot in the lung) symptoms include
sudden sharp chest pain, breathlessness and coughing up blood.
 Raised pressure within the skull of children (pseudotumour cerebri)
symptoms of which are headaches with vomiting, lack of energy and
drowsiness. This side effect usually occurs after treatment is stopped.
 Thrombophlebitis (blood clots or thrombosis in a leg vein),
symptoms of which include painful swollen, red and tender veins.

Eyes
not known
 Cataracts (indicated by failing eyesight).
 Glaucoma (raised pressure within the eye, causing pain in the eyes and
headaches).
 Swollen optic nerve (causing a condition called papilloedema, and which
may cause sight disturbance).
 Increased intra-ocular pressure, with possible damage to the optic nerve
(indicated by failing eyesight).
 Thinning of the clear part at the front of the eye (cornea) or of the white
part of the eye (sclera).
 Worsening of viral or fungal eye infections.
 Protruding of the eyeballs (exophthalmos).
 Blurred or distorted vision (due to disease of the retina and choroid
membrane).

If you experience any of the following side effects, or notice any other
unusual effects not mentioned in this leaflet, tell your doctor
immediately.
The side effects may occur with certain frequencies, which are defined as
follows:
 not known: frequency cannot be estimated from the available data
Blood, heart and circulation
not known
 High blood pressure, symptoms of which are headaches, or generally
feeling unwell.
 Problems with the pumping of your heart (heart failure) symptoms of
which are swollen ankles, difficulty in breathing and palpitations
(awareness of heart beat) or irregular beating of the heart, irregular or
very fast or slow pulse.
 Low blood pressure, symptoms may include dizziness, fainting,
light headedness, blurred vision, a rapid or irregular heartbeat
(palpitations).
 Increase of white blood cells (leukocytosis).
 Increased clotting of the blood.

General disorders
not known
 Poor wound healing.
 Irritability in children.
 Feeling tired or unwell.
 Skin reactions at the site of injection.
 Irritability in adults.
Hepatobiliary disorders
 Methylprednisolone can damage your liver, hepatitis and increase of liver
enzymes have been reported.
Hormones and metabolic system
not known
 Slowing of normal growth in infants, children and adolescents which may
be permanent.
 Round or moon-shaped face (Cushingoid facies).
 Diabetes or worsening of existing diabetes.
 Irregular or no periods in women.
 Increased appetite and weight gain.
 Abnormal localized or tumour-like accumulations of fat in the tissues.
 Prolonged therapy can lead to lower levels of some hormones which in
turn can cause low blood pressure and dizziness. This effect may persist
for months.
 The amount of certain chemicals (enzymes) called alanine transaminase,
aspartate transaminase and alkaline phosphatase that help the body
digest drugs and other substances in your body may be raised after
treatment with a corticosteroid. The change is usually small and the
enzyme levels return to normal after your medicine has cleared naturally
from your system. You will not notice any symptoms if this happens, but it
will show up if you have a blood test.

Metabolism and nutrition disorders
 Accumulation of fat tissue on localized parts of the body.

Nerves and mood issues
not known
Steroids including methylprednisolone can cause serious mental health
problems.
These are common in both adults and children.
They can affect about 5 in every 100 people taking medicines like
methylprednisolone.
 Feeling depressed, including thinking about suicide.
 Feeling high (mania) or moods that go up and down.
 Feeling anxious, having problems sleeping, difficulty in thinking or being
confused and losing your memory.
 Feeling, seeing or hearing things which do not exist. Having strange and
frightening thoughts, changing how you act or having feelings of being
alone.
 Other nervous system side effects may include convulsions (seizures),
amnesia (loss of memory), cognitive disorder (mental changes, dizziness
and headache.
 Back pain or weakness (due to Epidural Lipomatosis, a rare disorder in
which an abnormal amount of fat is deposited on or outside the lining of
the spine).
Skin
not known
 Acne.
 Bruising.
 Abscess, especially near injection sites.
 Thinning of skin, stretch marks.
 Small purple/red patches on the skin.
 Pale or darker patches on your skin, or raised patches which are an
unusual color.
 Increased hair on the body and face (hirsutism).
 Rash, itching, hives.
 Increased sweating.

5. HOW TO STORE METHYLPREDNISOLONE ACETATE






Keep out of the sight and reach of children.
Do not store above 25oC.
Protect from freezing.
Discard any remaining contents after use.
Do not use Methylprednisolone Acetate after the expiry date which is
stated on the vial and the box after “EXP”. The expiry date refers to the
last day of that month.
 If your medicine becomes discoloured or shows any sign of deterioration,
return it to your pharmacist.
 Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Methylprednisolone Acetate contains
Each 1 ml vial contains 40 mg methylprednisolone acetate.
The other ingredients are polyethylene glycol 3350, sodium chloride,
myristyl-gamma-picolinium chloride, water for injections,
sodium hydroxide and hydrochloric acid (for pH adjustment).
What Methylprednisolone Acetate looks like and contents of the pack
Methylprednisolone Acetate is a sterile, white suspension for injection
contained in a glass vial fitted with a rubber cap and a metal seal.
Methylprednisolone Acetate is available in packs containing 1 or 10 vials,
containing 1 ml of suspension.
Manufactured by
Pfizer Manufacturing Belgium NV, Rijksweg 12, B-2870 Puurs, Belgium.
Procured from within the EU by the PL Holder:
MPT Pharma Ltd., Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall, WS9 8ER.
Repackaged by MPT Pharma Ltd.
PL: 33532/0799
Leaflet dated 3rd May 2017
Leaflet coded xxxxx

POM

To request a copy of this leaflet in
Braille, large print or audio please call
01922 745645 and ask for the
Regulatory Department.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the
safety of this medicine.


Particular care is required when considering the use of systemic
corticosteroids in patients with existing or previous history of severe
affective disorders in themselves or in their first degree relatives. These
would include depressive or manic-depressive illness and previous steroid
psychosis.

Intranasal: Permanent/temporary blindness, rhinitis.

Chickenpox is of serious concern since this normally minor illness may be
fatal in immunosuppressed patients. Patients (or parents of children)
without a definite history of chickenpox should be advised to avoid close
personal contact with chickenpox or herpes zoster and if exposed they
should seek urgent medical attention. Passive immunisation with varicella/
zoster immunoglobulin (VZIG) is needed by exposed non-immune patients
who are receiving systemic corticosteroids or who have used them within
the previous 3 months; this should be given within 10 days of exposure to
chickenpox. If a diagnosis of chickenpox is confirmed, the illness warrants
specialist care and urgent treatment. Corticosteroids should not be stopped
and the dose may need to be increased.

Ophthalmic: (Subconjunctival) - Redness and itching, abscess, slough at
injection site, residue at injection site, increased intra-ocular pressure,
decreased vision - blindness, infection.

Live vaccines should not be given to individuals with impaired immune
responsiveness. The antibody response to other vaccines may be
diminished.

There have been reports of epidural lipomatosis in patients taking
corticosteroids, typically with long-term use at high doses.

Miscellaneous injection sites: Scalp, tonsillar fauces, sphenopalatine
ganglion: blindness.

The use of Methylprednisolone Acetate in active tuberculosis should be
restricted to those cases of fulminating or disseminated tuberculosis in
which the corticosteroid is used for the management of the disease in
conjunction with an appropriate antituberculous regimen. If corticosteroids
are indicated in patients with latent tuberculosis or tuberculin reactivity,
close observation is necessary as reactivation of the disease may occur.
During prolonged corticosteroid therapy, these patients should receive
chemoprophylaxis.

CERTAIN SIDE EFFECTS REPORTED WITH SOME CONTRAINDICATED
AND NON RECOMMENDED ROUTES OF ADMINISTRATION
Intrathecal/Epidural: Usual systemic corticoid adverse reactions, headache,
meningismus, meningitis, paraparesis/paraplegia, spinal fluid abnormalities,
nausea, vomiting, sweating, arachnoiditis, functional gastrointestinal
disorder/bladder dysfunction, convulsions, sensory disturbances. The
frequency of these adverse reactions is not known.
Extradural: Wound dehiscence, loss of sphincter control.

Special warnings and precautions
Warnings and Precautions:
Undesirable effects may be minimized by using the lowest effect dose for
the minimum period. Frequent patient review is required to appropriately
titrate the dose against disease activity (see Dosage and administration).
Methylprednisolone Acetate vials are intended for single dose use only. Any
multidose use of the product may lead to contamination.
Methylprednisolone Acetate is not recommended for epidural, intranasal,
intra-ocular, or any other unapproved route of administration. Severe
medical events have been reported in association with the intrathecal/
epidural routes of administration (see section 4.8 of the SPC). Appropriate
measures must be taken to avoid intravascular injection.
Due to the absence of a true tendon sheath, the Achilles tendon should not
be injected with Methylprednisolone Acetate.
While crystals of adrenal steroids in the dermis suppress inflammatory
reactions, their presence may cause disintegration of the cellular elements
and physiochemical changes in the ground substance of the connective
tissue. The resultant infrequently occurring dermal and/or subdermal
changes may form depressions in the skin at the injection site. The degree
to which this reaction occurs will vary with the amount of adrenal steroid
injected. Regeneration is usually complete within a few months or after all
crystals of the adrenal steroid have been absorbed. In order to minimize the
incidence of dermal and subdermal atrophy, care must be exercised not to
exceed recommended doses in injections. Multiple small injections into the
area of the lesion should be made whenever possible. The technique of
intra-articular and intramuscular injection should include precautions against
injection or leakage into the dermis. Injection into the deltoid muscle
should be avoided because of a high incidence of subcutaneous atrophy.
Intralesional doses should not be placed too superficially, particularly in
easily visible sites in patients with deeply pigmented skins, since there have
been rare reports of subcutaneous atrophy and depigmentation.
Systemic absorption of methylprednisolone occurs following intra-articular
injection of Methylprednisolone Acetate. Systemic as well as local effects
can therefore be expected.
Adrenal cortical atrophy develops during prolonged therapy and may persist
for months after stopping treatment. In patients who have received more
than physiological doses of systemic corticosteroids (approximately 6 mg
methylprednisolone) for greater than 3 weeks, withdrawal should not be
abrupt. How dose reduction should be carried out depends largely on
whether the disease is likely to relapse as the dose of systemic
corticosteroids is reduced. Clinical assessment of disease activity may be
needed during withdrawal. If the disease is unlikely to relapse on withdrawal
of systemic corticosteroids, but there is uncertainty about HPA suppression,
the dose of systemic corticosteroid may be reduced rapidly to physiological
doses. Once a daily dose of 6 mg methylprednisolone is reached, dose
reduction should be slower to allow the HPA-axis to recover.
The following precautions apply for parenteral corticosteroids: Following
intra–articular injection, the occurrence of a marked increase in pain
accompanied by local swelling, further restriction of joint motion, fever, and
malaise are suggestive of septic arthritis. If this complication occurs and the
diagnosis of sepsis is confirmed, appropriate antimicrobial therapy should
be instituted.
Local injection of a steroid into a previously injected joint is to be avoided.
Intra-articular corticosteroids are associated with a substantially increased
risk of inflammatory response in the joint, particularly bacterial infection
introduced with the injection. Charcot-like arthropathies have been reported
particularly after repeated injections. Appropriate examination of any joint
fluid present is necessary to exclude any bacterial infection, prior to
injection.
Corticosteroids should not be injected into unstable joints.
Sterile technique is necessary to prevent infections or contamination.
The slower rate of absorption by intramuscular administration should be
recognised.
Immunosuppressant Effects/Increased Susceptibility to Infections
Corticosteroids may increase susceptibility to infection, may mask some
signs of infection, and new infections may appear during their use.
Suppression of the inflammatory response and immune function increases
the susceptibility to fungal, viral and bacterial infections and their severity.
The clinical presentation may often be atypical and may reach an advanced
stage before being recognised.
With increasing doses of corticosteroids, the rate of occurrence of infectious
complications increases. Do not use intra-synovially, intrabursally or
intratendinous administration for local effect in the presence of acute
infection.
Persons who are on drugs which suppress the immune system are more
susceptible to infections than healthy individuals. Chickenpox and measles,
for example, can have a more serious or even fatal course in non-immune
children or adults on corticosteroids.

The role of corticosteroids in septic shock has been controversial, with early
studies reporting both beneficial and detrimental effects. More recently,
supplemental corticosteroids have been suggested to be beneficial in
patients with established septic shock who exhibit adrenal insufficiency.
However, their routine use in septic shock is not recommended. A
systematic review of short-course high-dose corticosteroids did not support
their use. However, meta-analyses and a review suggest that longer
courses (5-11 days) of low-dose corticosteroids might reduce mortality,
especially in patients with vasopressor-dependent septic shock.
Immune System Effects
Allergic reactions may occur. Because rare instances of skin reactions and
anaphylactic/anaphylactoid reactions have occurred in patients receiving
corticosteroid therapy, appropriate precautionary measures should be taken
prior to administration, especially when the patient has a history of drug
allergy.
Endocrine Effects
Pharmacologic doses of corticosteroids administered for prolonged periods
may result in hypothalamic-pituitary-adrenal (HPA) suppression
(secondary adrenocortical insufficiency). The degree and duration of
adrenocortical insufficiency produced is variable among patients and
depends on the dose, frequency, time of administration, and duration of
glucocorticoid therapy. This effect may be minimized by use of alternateday therapy.
In addition, acute adrenal insufficiency leading to a fatal outcome may occur
if glucocorticoids are withdrawn abruptly. Drug-induced secondary
adrenocortical insufficiency may therefore be minimized by gradual
reduction of dosage. This type of relative insufficiency may persist for
months after discontinuation of therapy; therefore, in any situation of stress
occurring during that period, hormone therapy should be reinstituted.
A steroid “withdrawal syndrome,” seemingly unrelated to adrenocortical
insufficiency, may also occur following abrupt discontinuance of
glucocorticoids. This syndrome includes symptoms such as: anorexia,
nausea, vomiting, lethargy, headache, fever, joint pain, desquamation,
myalgia, weight loss, and/or hypotension. These effects are thought to be
due to the sudden change in glucocorticoid concentration rather than to low
corticosteroid levels.
Abrupt withdrawal of systemic corticosteroid treatment, which has continued
up to 3 weeks is appropriate if it considered that the disease is unlikely to
relapse. Abrupt withdrawal of doses up to 32 mg daily of
methylprednisolone for 3 weeks is unlikely to lead to clinically relevant
HPA-axis suppression, in the majority of patients. In the following patient
groups, gradual withdrawal of systemic corticosteroid therapy should be
considered even after courses lasting 3 weeks or less:
 Patients who have had repeated courses of systemic corticosteroids,
particularly if taken for greater than 3 weeks.
 When a short course has been prescribed within one year of cessation of
long-term therapy (months or years).
 Patients who may have reasons for adrenocortical insufficiency other
than exogenous corticosteroid therapy.
 Patients receiving doses of systemic corticosteroid greater than 32 mg
daily of methylprednisolone.
 Patients repeatedly taking doses in the evening.
Because glucocorticoids can produce or aggravate Cushing’s syndrome,
glucocorticoids should be avoided in patients with Cushing’s disease.
There is an enhanced effect of corticosteroids on patients with
hypothyroidism.
Metabolism and Nutrition
Corticosteroids, including methylprednisolone, can increase blood glucose,
worsen pre-existing diabetes, and predispose those on long-term
corticosteroid therapy to diabetes mellitus.
Psychiatric Effects
Patients and/or carers should be warned that potentially severe psychiatric
adverse reactions may occur with systemic steroids (see section 4.8 of the
SPC). Symptoms typically emerge within a few days or weeks of starting
treatment. Risks may be higher with high doses/systemic exposure (see
interactions), although dose levels do not allow prediction of the onset, type,
severity or duration of reactions. Most reactions recover after either dose
reduction or withdrawal, although specific treatment may be necessary.
Patients/carers should be encouraged to seek medical advice if worrying
psychological symptoms develop, especially if depressed mood or suicidal
ideation is suspected. Patients/carers should be alert to possible psychiatric
disturbances that may occur either during or immediately after dose
tapering/withdrawal of systemic steroids, although such reactions have
been reported infrequently.

Nervous System Effects
Corticosteroids should be used with caution in patients with seizure
disorders.
Corticosteroids should be used with caution in patients with myasthenia
gravis (Also see myopathy statement in Musculoskeletal Effects section).

Ocular Effects
Prolonged use of corticosteroids may produce posterior subcapsular
cataracts and nuclear cataracts (particularly in children), exophthalmos, or
increased intraocular pressure, which may result in glaucoma with possible
damage to the optic nerves, and may enhance the establishment of
secondary ocular infections due to fungi or viruses.
Corticosteroids should be used cautiously in patients with ocular herpes
simplex, because of possible corneal perforation.
Corticosteroid therapy has been associated with central serous
chorioretinopathy, which may lead to retinal detachment.
Cardiac Effects
Adverse effects of glucocorticoids on the cardiovascular system, such as
dyslipidaemia and hypertension, may predispose treated patients with
existing cardiovascular risk factors to additional cardiovascular effects, if
high doses and prolonged courses are used. Accordingly, corticosteroids
should be employed judiciously in such patients and attention should be
paid to risk modification and additional cardiac monitoring if needed.
Systemic corticosteroids should be used with caution, and only if strictly
necessary, in cases of congestive heart failure.
Vascular Effects
Corticosteroids should be used with caution in patients with hypertension.
Gastrointestinal Effects
There is no universal agreement on whether corticosteroids per se are
responsible for peptic ulcers encountered during therapy; however,
glucocorticoid therapy may mask the symptoms of peptic ulcer so that
perforation or haemorrhage may occur without significant pain. In
combination with NSAIDs, the risk of developing gastrointestinal ulcers is
increased.
Corticosteroids should be used with caution in nonspecific ulcerative colitis,
if there is a probability of impending perforation, abscess or other pyogenic
infection. Caution must also be used in diverticulitis, fresh intestinal
anastomoses, active or latent peptic ulcer, when steroids are used as direct
or adjunctive therapy.
Hepatobiliary Effects
High doses of corticosteroids may produce acute pancreatitis.
Corticosteroids should be used with caution in patients with liver failure or
cirrhosis.
Musculoskeletal Effects
An acute myopathy has been reported with the use of high doses of
corticosteroids, most often occurring in patients with disorders of
neuromuscular transmission (e.g. myasthenia gravis), or in patients
receiving concomitant therapy with anticholinergics, such as neuromuscular
blocking drugs (e.g. pancuronium). This acute myopathy is generalized,
may involve ocular and respiratory muscles, and may result in
quadriparesis. Elevations of creatine kinase may occur. Clinical
improvement or recovery after stopping corticosteroids may require weeks
to years.
Osteoporosis is a common but infrequently recognized adverse effect
associated with a long-term use of large doses of glucocorticoid.
Renal and Urinary Disorders
Corticosteroids should be used with caution in patients with renal
insufficiency.
Investigations
Average and large doses of hydrocortisone or cortisone can cause
elevation of blood pressure, salt and water retention, and increased
excretion of potassium. These effects are less likely to occur with the
synthetic derivatives except when used in large doses. Dietary salt
restriction and potassium supplementation may be necessary. All
corticosteroids increase calcium excretion.
Care should be taken for patients receiving cardioactive drugs such as
digoxin because of steroid induced electrolyte disturbance/potassium loss
(see side effects).
Other
Patients should carry ‘Steroid Treatment’ cards which give clear guidance
on the precautions to be taken to minimize risk and which provide details of
prescriber, drug, dosage and the duration of treatment.
Corticosteroids should be used with caution in patients with a predisposition
to thrombophlebitis.
Aspirin and nonsteroidal anti-inflammatory agents should be used
cautiously in conjunction with corticosteroids.
Pheochromocytoma crisis, which can be fatal, has been reported after
administration of systemic corticosteroids. Corticosteroids should only be
administered to patients with suspected or identified pheochromocytoma
after an appropriate risk/benefit evaluation.

Use in Children
Corticosteroids cause growth retardation in infancy, childhood and
adolescence which may be irreversible. Growth and development of infants
and children on prolonged corticosteroid therapy should be carefully
observed. Treatment should be limited to the minimum dosage for the
shortest possible time and should be restricted to the most serious
indications.
Infants and children on prolonged corticosteroid therapy are at special risk
from raised intracranial pressure.
High doses of corticosteroids may produce pancreatitis in children.
Use in Pregnancy and Lactation
Pregnancy
The ability of corticosteroids to cross the placenta varies between individual
drugs, however, methylprednisolone does cross the placenta. One
retrospective study found an increased incidence of low birth weights in
infants born of mothers receiving corticosteroids.
Administration of corticosteroids to pregnant animals can cause
abnormalities of foetal development including cleft palate, intra-uterine
growth retardation and affects on brain growth and development. There is
no evidence that corticosteroids result in an increased incidence of
congenital abnormalities, such as cleft palate in man, however, when
administered for long periods or repeatedly during pregnancy,
corticosteroids may increase the risk of intra-uterine growth retardation.
Hypoadrenalism may, in theory, occur in the neonate following prenatal
exposure to corticosteroids but usually resolves spontaneously following
birth and is rarely clinically important. Although neonatal adrenal
insufficiency appears to be rare in infants who were exposed in utero to
corticosteroids, those exposed to substantial doses of corticosteroids must
be carefully observed and evaluated for signs of adrenal insufficiency.
As with all drugs, corticosteroids should only be prescribed when the
benefits to the mother and child outweigh the risks. When corticosteroids
are essential, however, patients with normal pregnancies may be treated as
though they were in the non-gravid state.
Cataracts have been observed in infants born to mothers treated with longterm corticosteroids during pregnancy.
Breast-feeding
Corticosteroids are excreted in small amounts in breast milk, however,
doses of up to 40 mg daily of methylprednisolone are unlikely to cause
systemic effects in the infant. Infants of months taking higher doses than
this may have a degree of adrenal suppression, but the benefits of
breastfeeding are likely to outweigh any theoretical risk.
Corticosteroids distributed into breast milk may suppress growth and
interfere with endogenous glucocorticoid production in nursing infants.
Since adequate reproductive studies have not been performed in humans
with glucocorticoids, these drugs should be administered to nursing mothers
only if the benefits of therapy are judged to outweigh the potential risks to
the infant.
Overdosage
Following overdosage the possibility of adrenal suppression should be
guarded against by gradual diminution of dose levels over a period of time.
In such event the patient may require to be supported during any further
traumatic episode.
Reports of acute toxicity and/or death following overdosage of
corticosteroids are rare. In the event of overdosage, no specific antidote is
available; treatment is supportive and symptomatic.
Methylprednisolone is dialyzable.
Incompatibilities (major)
None stated.
Pharmaceutical precautions
Keep out of the sight and reach of children.
Do not store above 25oC.
Protect from freezing.
Methylprednisolone Acetate should not be mixed with any other fluid.
Discard any remaining contents after use.
Any unused medicinal product or waste material should be disposed of in
accordance with local requirements.
Leaflet dated 3rd May 2017
Leaflet coded xxxxx

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