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DEPO MEDRONE INJECTION 40 MG/ML

Active substance(s): METHYLPREDNISOLONE ACETATE

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date:18-Sep-17 09:47:49

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1. What Depo-Medrone is
and what it is used for

Package leaflet: Information for the
patient

Depo-Medrone 40 mg/ml
®

methylprednisolone acetate

PAA069706
52

Process Black

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.

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

code

PAA069706

guidelines

TSE-I091C

dimensions

866x214/27

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. Stevens-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.

date

22-jun-17 EA

country

ENGLAND/MALTA

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
eye 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 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
Continued overleaf...

The following information is intended for
healthcare professionals only:

PHYSICIAN LEAFLET

Depo-Medrone 40 mg/ml
®

methylprednisolone acetate

Presentation
White, sterile aqueous suspension for injection containing
40 mg per ml methylprednisolone acetate. Also contains
polyethylene glycol, sodium chloride, myristyl-gammapicolinium chloride and sterile water for injections.
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 discoloration 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.
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: 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.
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 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 – 80mg (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 age 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.
The usual sterile precautions should be observed with each
injection.
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).

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
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.
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).

MedDRA (v15)
System Organ Class
Infections and
infestations

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-pituitary-adrenal suppression correlates with
the relative potency of the drug, dosage, timing of
administration and duration of treatment (see Special
warnings and precautions).

Frequency Undesirable Effects

Not Known

Immune system disorders
Blood and lymphatic
system disorders
Endocrine disorders

Not Known
Not Known

Metabolism and
nutrition disorders

Not Known

Psychiatric disorders

Not Known

Nervous system disorders

Not Known

Eye disorders

Not Known

Ear and labyrinth disorders
Cardiac disorders
Vascular disorders
Respiratory, thoracic
and mediastinal disorders
Gastrointestinal
disorders

Not Known
Not Known
Not Known
Not Known

Not Known

Not Known

Hepatobiliary disorders
Skin and
subcutaneous
tissue disorders
Musculoskeletal and
connective tissue
disorders
Reproductive system
and breast disorders
General
disorders and administration site conditions
Investigations

Not known
Not Known

Injury, poisoning and
procedural complications

Not Known
Not Known

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
Drug hypersensitivity, Anaphylactic reaction
Leukocytosis
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.
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
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
Intracranial pressure increased (with Papilloedema [Benign intracranial
hypertension]); Convulsion; Amnesia; Cognitive disorder; Dizziness; Headache
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
Vertigo
Cardiac failure congestive (in susceptible patients)
Hypertension; Hypotension; Embolism arterial Thrombotic events
Pulmonary embolism, Hiccups
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
Hepatitis, Increase of liver enzymes
Ecchymosis; Acne; Angioedema; Petechiae; Skin atrophy; Skin striae;
Skin hyperpigmentation; Skin hypopigmentation; Hirsutism; Rash;
Erythema; Pruritus; Urticaria; Hyperhidrosis
Growth retardation; Osteoporosis; Muscular weakness; Osteonecrosis;
Pathological fracture; Muscle atrophy; Myopathy; Neuropathic arthropathy;
Arthralgia; Myalgia
Menstruation irregular

Not Known

Impaired healing; Oedema peripheral; Irritability (in children); Injection site
reaction; Abscess sterile; Fatigue; Malaise; Irritability (in adults)

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)

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.

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

code

PAA069706

guidelines

TSE-I091C

dimensions

866x214/27

VERSO

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 infected 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.
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

date

22-jun-17 EA

country

ENGLAND/MALTA

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

myasthenia gravis (Also see myopathy statement in
Musculoskeletal Effects section).

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.

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.

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.

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

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.

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.

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.

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.

Corticosteroids should be used with caution in patients with
liver failure or cirrhosis.

Nervous System Effects
Corticosteroids should be used with caution in patients with
seizure disorders.
Corticosteroids should be used with caution in patients with

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.

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 long-term 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
Do not freeze. Depo-Medrone should not be mixed with any
other fluid.
Any unused medicinal product or waste material should be
disposed of in accordance with local requirements.
This leaflet was last revised in: 10/2016
Ref: DM 13_0

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.
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

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.
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 severe 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.
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, lightheadedness, blurred
vision, a rapid or irregular heartbeat
(palpitations).
• Increase of white blood cells (leukocytosis).
• Increased clotting of the blood.
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).
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.
Ears
not known
• A feeling of dizziness or spinning (vertigo).
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).
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.
Immune system
not known
• Increased susceptibility to infections which can
hide or change normal reactions to skin tests,
such as that for tuberculosis.
Metabolism and nutrition disorders
• Accumulation of fat tissue on localized parts of
the body.
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.
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.
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.

Depo-Medrone is available in packs containing
1 or 10 vials, containing 1 ml, 2 ml or 3 ml of
suspension.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Pfizer Limited, Ramsgate Road, Sandwich, Kent
CT13 9NJ, UK.
Manufacturer
Pharmacia NV/SA, Rijksweg 12, B-2870,
Puurs, Belgium.
Company contact address:
For further information on your medicine
contact Medical Information at the following
address:
Pfizer Limited, Walton Oaks, Dorking Road
Tadworth, Surrey, KT20 7NS.
Tel: 01304 616161.
This leaflet was last revised in: 10/2016
Ref: DM 13_0

Text Free area

Process Black

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.
Intranasal: Permanent/temporary blindness, rhinitis.
Ophthalmic: (Subconjunctival) – Redness and itching,
abscess, slough at injection site, residue at injection site,
increased intra-ocular pressure, decreased vision –
blindness, infection.
Miscellaneous injection sites: Scalp, tonsillar fauces,
sphenopalatine ganglion: blindness.

5. How to store
Depo-Medrone

Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date
which is stated on the label and carton after EXP.
The expiry date refers to the last day of that month.
Do not freeze.
Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help to protect the environment.

6. Contents of the pack and
other information

What Depo-Medrone contains
The active substance is methylprednisolone
acetate. Each millilitre contains 40 mg of
methylprednisolone acetate.
The other ingredients are sodium chloride,
polyethylene glycol, myristyl-gamma-picolinium
chloride and water for injections.
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 metal seal.

PAA069706

methylprednisolone acetate

date:28-sep-17 15:12:57

Presentation
White, sterile aqueous suspension for injection containing 40 mg
per ml methylprednisolone acetate. Also contains polyethylene glycol,
sodium chloride, myristyl-gamma-picolinium chloride and sterile
water for injections.
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

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 age 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.
The usual sterile precautions should be observed with each injection.
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).
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
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

2.

3.

4.

5.

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.
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. Aminoglutethimideinduced 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.
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.
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.
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)
MedDRA (v15)
System Organ Class
Infections and infestations

Immune system disorders
Blood and lymphatic
system disorders
Endocrine disorders

Side effects: The incidence of predictable undesirable side effects
associated with the use of corticosteroids, including
hypothalamic-pituitary-adrenal suppression correlates with the
relative potency of the drug, dosage, timing of administration and
duration of treatment (see Special warnings and precautions).

Frequency

Undesirable Effects

Not Known

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
Drug hypersensitivity, Anaphylactic reaction
Leukocytosis

Not Known
Not Known
Not Known

Metabolism and
nutrition disorders

Not Known

Psychiatric 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.
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
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]);

MedDRA (v15)
System Organ Class

Frequency

Nervous system disorders

Not Known

Eye disorders

Not Known

Ear and labyrinth disorders
Cardiac disorders
Vascular disorders
Respiratory, thoracic
and mediastinal disorders
Gastrointestinal disorders

Not Known
Not Known
Not Known
Not Known
Not Known

Hepatobiliary disorders
Skin and subcutaneous
tissue disorders

Not known
Not Known

Musculoskeletal and
connective tissue disorders

Not Known

Reproductive system
and breast disorders

Not Known

Undesirable Effects
Confusional state; Mental disorder; Anxiety; Personality change; Mood swings; Abnormal
behaviour; Insomnia
Intracranial pressure increased (with Papilloedema [Benign intracranial hypertension]);
Convulsion; Amnesia; Cognitive disorder; Dizziness; Headache
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
Vertigo
Cardiac failure congestive (in susceptible patients)
Hypertension; Hypotension; Embolism arterial Thrombotic events
Pulmonary embolism, Hiccups
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
Hepatitis, Increase of liver enzymes
Ecchymosis; Acne; Angioedema; Petechiae; Skin atrophy; Skin striae; Skin
hyperpigmentation; Skin hypopigmentation; Hirsutism; Rash; Erythema; Pruritus; Urticaria;
Hyperhidrosis
Growth retardation; Osteoporosis; Muscular weakness; Osteonecrosis;
Pathological fracture; Muscle atrophy; Myopathy; Neuropathic arthropathy; Arthralgia;
Myalgia
Menstruation irregular

country

ENGLAND/MALTA

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.
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
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 – 80mg (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

date

Depo-Medrone® 40 mg/ml

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
discoloration 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.
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.

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.

03-Jul-17 CDH

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

3. How Depo-Medrone is given to you

dimensions

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.

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).

210x880/37

1. What Depo-Medrone is and what it is used for

2. What you need to know before you are given Depo-Medrone

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 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

guidelines

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

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’.

TSE-I013H

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.

• 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.

code

methylprednisolone acetate

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 eye 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.

PAA085252

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Process structure
Black

Depo-Medrone® 40 mg/ml

• 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. Stevens-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.

Process Black

Package leaflet: Information for the patient

RECTO

4. Possible side effects

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.
Ears
not known
• A feeling of dizziness or spinning (vertigo).
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).
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.
Immune system
not known
• Increased susceptibility to infections which can hide or change normal reactions to skin tests, such as that
for tuberculosis.
Metabolism and nutrition disorders
• Accumulation of fat tissue on localized parts of the body.
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.

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

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.

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.
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.

5. How to store Depo-Medrone

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

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date
refers to the last day of that month.
Do not freeze.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Depo-Medrone contains
The active substance is methylprednisolone acetate. Each millilitre contains 40 mg of methylprednisolone
acetate.
The other ingredients are sodium chloride, polyethylene glycol, myristyl-gamma-picolinium chloride and water
for injections.
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
metal seal.
Depo-Medrone is available in packs containing 1 or 10 vials, containing 1 ml, 2 ml or 3 ml of suspension.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Pfizer Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ, UK.
Manufacturer
Pharmacia NV/SA, Rijksweg 12, B-2870, Puurs, Belgium.
Company contact address:
For further information on your medicine
contact Medical Information at the following address:
Pfizer Limited, Walton Oaks, Dorking Road Tadworth, Surrey, KT20 7NS.
Tel: 01304 616161.
This leaflet was last revised in: 10/2016
Ref: DM 13_0

PAA085252

long-term 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
Do not freeze. Depo-Medrone should not be mixed with any other
fluid.
Any unused medicinal product or waste material should be disposed
of in accordance with local requirements.
This leaflet was last revised in: 10/2016
Ref: DM 13_0

date

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

dimensions

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
Not Known
Tendon rupture (particularly of the Achilles tendon); Spinal compression fracture Systemic
procedural complications
corticosteroids should not be used for the treatment of traumatic brain injury.
CERTAIN SIDE EFFECTS REPORTED WITH SOME CONTRAINDICATED
administration).
AND NON RECOMMENDED ROUTES OF ADMINISTRATION
Depo-Medrone vials are intended for single dose use only. Any
Intrathecal/Epidural: Usual systemic corticoid adverse reactions,
multidose use of the product may lead to contamination.
headache, meningismus, meningitis, paraparesis/paraplegia, spinal
Depo-Medrone is not recommended for epidural, intranasal,
fluid abnormalities, nausea, vomiting, sweating, arachnoiditis,
intra-ocular, or any other unapproved route of administration. Severe
functional gastrointestinal disorder/bladder dysfunction, convulsions,
medical events have been reported in association with the
sensory disturbances. The frequency of these adverse reactions is not intrathecal/epidural routes of administration (see section 4.8 of the
known.
SPC). Appropriate measures must be taken to avoid intravascular
Extradural: Wound dehiscence, loss of sphincter control.
injection.
Intranasal: Permanent/temporary blindness, rhinitis.
Due to the absence of a true tendon sheath, the Achilles tendon
Ophthalmic: (Subconjunctival) – Redness and itching, abscess,
should not be injected with Depo-Medrone.
slough at injection site, residue at injection site, increased
While crystals of adrenal steroids in the dermis suppress
intra-ocular pressure, decreased vision – blindness, infection.
inflammatory reactions, their presence may cause disintegration of
Miscellaneous injection sites: Scalp, tonsillar fauces, sphenopalatine
the cellular elements and physiochemical changes in the ground
ganglion: blindness.
substance of the connective tissue. The resultant infrequently
occurring dermal and/or subdermal changes may form depressions in
Special warnings and precautions
the skin at the injection site. The degree to which this reaction occurs
Warnings and Precautions:
Undesirable effects may be minimized by using the lowest effect dose will vary with the amount of adrenal steroid injected. Regeneration is
usually complete within a few months or after all crystals of the
for the minimum period. Frequent patient review is required to
appropriately titrate the dose against disease activity (see Dosage and adrenal steroid have been absorbed. In order to minimize the

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

210x880/37

Not Known

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 alternate-day 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

guidelines

Impaired healing; Oedema peripheral; Irritability (in children); Injection site
reaction; Abscess sterile; Fatigue; Malaise; Irritability (in adults)

appropriate antimicrobial therapy should be instituted.
Local injection of a steroid into a previously infected 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.
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

TSE-I013H

Not Known

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,

code

Undesirable Effects

PAA085252

Frequency

Process Black

MedDRA (v15)
System Organ Class
General disorders and
administration site
conditions
Investigations

03-Jul-17 CDH

country

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.
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 severe 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.
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, lightheadedness, blurred vision, a rapid or
irregular heartbeat (palpitations).
• Increase of white blood cells (leukocytosis).
• Increased clotting of the blood.
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).

ENGLAND/MALTA

• 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.
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.

VERSO

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