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DEPO-MEDRONE 40MG/ML INJECTION

Active substance(s): METHYLPREDNISOLONE ACETATE

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500810/PL1e

PATIENT INFORMATION LEAFLET

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

The name of your medicine is Depo-Medrone 40mg/ml
Injection. Throughout this leaflet it will be referred to as
Depo-Medrone.
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

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

Methylprednisolone belongs to a group of medicines
called corticosteroids or steroids. Corticosteroids are
produced naturally in your body and are important for
many body functions.
Boosting your body with extra corticosteroid such as
Depo-Medrone can help when injected into the body by
a doctor or nurse, such as in or near a joint, to treat
local symptoms caused by inflammatory or rheumatic
conditions such as:
• Bursitis: inflammation in the fluid containing
spaces around the shoulder, knee and/or elbow
joints. For this condition this medicine will be
injected directly into one or more of these spaces.
• Osteoarthritis and rheumatoid arthritis:
inflammation located in between the joints. For
these conditions this medicine will be injected
directly into one or more joint spaces.
• Plantar fasciitis: inflammation of the tissues of the
sole of the foot.
• Skin problems: such as alopecia areata (patchy
baldness), keloids (scar tissue), lichen planus or
simplex (small, purplish raised patches of skin or
spots), discoid lupus (round-shaped patches, often
on the face) or granuloma annulare (circular warty
growths).
• Epicondylitis (tennis elbow) and tenosynovitis:
For these conditions this medicine will be injected
into the tendon sheath.
Alternatively this medicine may be injected into a
muscle to help treat more general (systemic) problems
affecting the whole body (e.g. symptoms caused by a
hypersensitivity to a medicine), or allergic, inflammatory
or rheumatic problems affecting the:
• brain e.g. meningitis caused by tuberculosis
• bowel and gut e.g. Crohn’s disease (inflammation
of the gut) or ulcerative colitis (inflammation of the
lower bowel)
• joints e.g. rheumatoid arthritis
• lungs e.g. asthma, severe hay fever or rhinitis,
tuberculosis or inflammation caused by breathing in
(aspirating) vomit or stomach contents
• skin e.g. 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.

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

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

The name of the medicine is Depo-Medrone 40mg/ml
Injection. Throughout this leaflet it will be referred to as
Depo-Medrone.
Presentation
Each 1ml of suspension contains 40mg of
methlyprednisolone acetate.
Sterile, cloudy white suspension (liquid) contained
within a glass vial with a butyl rubber plug and metal
seal. There is a green plastic tamper evident seal on
top of the metal seal.
Also contains macrogol 3350, sodium chloride,
myristyl-gamma-picolinium chloride, water for injections,
sodium hydroxide and hydrochloric acid.
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).

Soft tissue administration (intrabursal, periarticular, into
tendon sheath):
Synovitis not associated with infection
Epicondylitis
Tenosynovitis
Plantar fasciitis
Bursitis
Intralesional:
Keloids
Localised lichen planus
Localised lichen simplex
Granuloma annulare
Discoid lupus erythematosus
Alopecia areata
Dosage and administration
Depo-Medrone should not be mixed with any other
suspending agent or solution. Parenteral drug
products should be inspected visually for
particulate matter and discolouration prior to
administration, whenever suspension and container
permit. Depo-Medrone may be used by any of the
following routes: intramuscular, intra-articular,
periarticular, intrabursal, intralesional and into the
tendon sheath. It must not be used by the intrathecal
or intravenous routes (see Contraindications and Side
effects).
Undesirable effects may be minimized by using the
lowest effective dose for the minimum period (see
special warnings and precautions).

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)

Depo-Medrone vials are intended for single dose use
only.

Intra-articular administration:
Rheumatoid arthritis
Osteo-arthritis with an inflammatory component

On average the effect of a single 2 ml (80 mg) injection
may be expected to last approximately two weeks.

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.

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.

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).

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

• 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.

Dosage information
Your doctor will decide on the site of injection, how
much of the medicine and how many injections you will
receive depending on the condition being treated and
its severity. Your doctor will inject you with the lowest
dose for the shortest possible time to get effective relief
of your symptoms.
Adults
Your doctor/nurse will tell you how many injections you
will require for the condition you are being treated for,
and when you will get them.
Joints - the normal dose for the injections into joint will
depend on the size of the joint. Large joints (e.g. knee,
ankle and shoulder) may require 20 - 80 mg (0.5 - 2 ml),
medium sized joints (e.g. elbow or wrist) 10 - 40 mg
(0.25 - 1 ml) and small joints (e.g. finger or toe joints)
may require a 4 - 10 mg (0.1 - 0.25 ml) dose.
Joint injections may be given weekly over a period of
several weeks, depending on how quickly you respond
to treatment.
Bursitis and epicondylitis (tennis elbow) - the usual
dose is between 4-30 mg (0.1 - 0.75 ml). In most cases
repeat injections will not be needed for bursitis and
epicondylitis. Repeat injections may be necessary to
treat long standing conditions.
Skin conditions – the usual dose is between 20 - 60 mg
(0.5 - 1.5 ml) injected into the affected part or parts of
the skin.
For other more general conditions 40 - 120 mg
(1 - 3 ml) of this medicine may be injected into a large
muscle.
Elderly
Treatment will normally be the same as for younger
adults. However your doctor may want to see you more
regularly to check how you are getting on with this
medicine.
Children
Corticosteroids can affect growth in children so your
doctor will prescribe the lowest dose that will be
effective for your child.

If you are 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.
Continued overleaf…

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).
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).

MedDRA (v15)
System Organ Class

Frequency

Undesirable Effects

Infections and
infestations

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

Immune system disorders

Not Known

Drug hypersensitivity, Anaphylactic reaction

Blood and lymphatic
system disorders

Not Known

Leukocytosis

Endocrine disorders

Not Known

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

Metabolism and nutrition
disorders

Not Known

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

Psychiatric disorders

Not Known

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

Nervous system disorders

Not Known

Intracranial pressure increased (with Papilloedema [Benign
intracranial hypertension]); Convulsion; Amnesia; Cognitive disorder;
Dizziness; Headache

Eye disorders

Not Known

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

Ear and labyrinth disorders

Not Known

Vertigo

Cardiac disorders

Not Known

Cardiac failure congestive (in susceptible patients)

Vascular disorders

Not Known

Hypertension; Hypotension; Embolism arterial Thrombotic events

Respiratory, thoracic and
mediastinal disorders

Not Known

Pulmonary embolism, Hiccups

Gastrointestinal disorders

Not Known

Peptic ulcer (with possible Peptic ulcer perforation and Peptic ulcer
haemorrhage); Gastric haemorrhage; Intestinal perforation;
Pancreatitis; Oesophagitis ulcerative; Oesophagitis; Abdominal pain;
Abdominal distension; Diarrhoea; Dyspepsia; Nausea

Hepatobiliary disorders

Not Known

Hepatitis, Increase of liver enzymes

Skin and subcutaneous
tissue disorders

Not Known

Ecchymosis; Acne; Angioedema; Petechiae; Skin atrophy; Skin
striae; Skin hyperpigmentation; Skin hypopigmentation; Hirsutism;
Rash; Erythema; Pruritus; Urticaria; Hyperhidrosis

Musculoskeletal and
Not Known
connective tissue disorders

Growth retardation; Osteoporosis; Muscular weakness;
Osteonecrosis; Pathological fracture; Muscle atrophy; Myopathy;
Neuropathic arthropathy; Arthralgia; Myalgia

Reproductive system and
breast disorders

Menstruation irregular

Not Known

Continued overleaf…

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.

MedDRA (v15)
System Organ Class

Frequency

Undesirable Effects

General disorders and
administration site
conditions

Not Known

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

Investigations

Not Known

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

Injury, poisoning and
procedural complications

Not Known

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

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.
Special warnings and precautions
Warnings and Precautions:
Undesirable effects may be minimised 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
minimise the incidence of dermal and subdermal
atrophy, care must be exercised not to exceed
recommended doses in injections. Multiple small
injections into the area of the lesion should be made
whenever possible.

The technique of intra-articular and intramuscular
injection should include precautions against injection or
leakage into the dermis. Injection into the deltoid
muscle should be avoided because of a high incidence
of subcutaneous atrophy. Intralesional doses should not
be placed too superficially, particularly in easily visible
sites in patients with deeply pigmented skins, since
there have been rare reports of subcutaneous atrophy
and depigmentation.
Systemic absorption of methylprednisolone occurs
following intra-articular injection of Depo-Medrone.
Systemic as well as local effects can therefore be
expected.
Adrenal cortical atrophy develops during prolonged
therapy and may persist for months after stopping
treatment. In patients who have received more than
physiological doses of systemic corticosteroids
(approximately 6 mg methylprednisolone) for greater
than 3 weeks, withdrawal should not be abrupt.
How dose reduction should be carried out depends
largely on whether the disease is likely to relapse as the
dose of systemic corticosteroids is reduced.
Clinical assessment of disease activity may be needed
during withdrawal. If the disease is unlikely to relapse
on withdrawal of systemic corticosteroids, but there is
uncertainty about HPA suppression, the dose of
systemic corticosteroid may be reduced rapidly to
physiological doses. Once a daily dose of 6 mg
methylprednisolone is reached, dose reduction should
be slower to allow the HPA-axis to recover.
The following precautions apply for parenteral
corticosteroids: Following intra–articular injection, the
occurrence of a marked increase in pain accompanied
by local swelling, further restriction of joint motion, fever,
and malaise are suggestive of septic arthritis. If this
complication occurs and the diagnosis of sepsis is
confirmed, appropriate antimicrobial therapy should be
instituted.
Local injection of a steroid into a previously 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.



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).

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 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.

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 localised 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.

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 minimised 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 minimised by gradual
reduction of dosage. This type of relative insufficiency
may persist for months after discontinuation of therapy;
therefore, in any situation of stress occurring during that
period, hormone therapy should be reinstituted.
A steroid “withdrawal syndrome,” seemingly unrelated
to adrenocortical insufficiency, may also occur following
abrupt discontinuance of glucocorticoids.
This syndrome includes symptoms such as: anorexia,
nausea, vomiting, lethargy, headache, fever, joint pain,
desquamation, myalgia, weight loss, and/or
hypotension. These effects are thought to be due to the
sudden change in glucocorticoid concentration rather
than to low corticosteroid levels.
Abrupt withdrawal of systemic corticosteroid treatment,
which has continued up to 3 weeks is appropriate if it
considered that the disease is unlikely to relapse.
Abrupt withdrawal of doses up to 32 mg daily of
methylprednisolone for 3 weeks is unlikely to lead to
clinically relevant HPA-axis suppression, in the majority
of patients. In the following patient groups, gradual
withdrawal of systemic corticosteroid therapy should be
considered even after courses lasting 3 weeks or less:
• Patients who have had repeated courses of
systemic corticosteroids, particularly if taken for
greater than 3 weeks.
• When a short course has been prescribed within
one year of cessation of long-term therapy (months
or years).
• Patients who may have reasons for adrenocortical
insufficiency other than exogenous corticosteroid
therapy.
• Patients receiving doses of systemic corticosteroid
greater than 32 mg daily of methylprednisolone.
• Patients repeatedly taking doses in the evening.
Because glucocorticoids can produce or aggravate
Cushing’s syndrome, glucocorticoids should be avoided
in patients with Cushing’s disease.
There is an enhanced effect of corticosteroids on
patients with hypothyroidism.
Metabolism and Nutrition
Corticosteroids, including methylprednisolone, can
increase blood glucose, worsen pre-existing diabetes,
and predispose those on long-term corticosteroid
therapy to diabetes mellitus.
Psychiatric Effects
Patients and/or carers should be warned that potentially
severe psychiatric adverse reactions may occur with
systemic steroids (see section 4.8 of the SPC).
Symptoms typically emerge within a few days or weeks
of starting treatment. Risks may be higher with high
doses/systemic exposure (see interactions), although
dose levels do not allow prediction of the onset, type,
severity or duration of reactions. Most reactions recover
after either dose reduction or withdrawal, although
specific treatment may be necessary. Patients/carers
should be encouraged to seek medical advice if
worrying psychological symptoms develop, especially if
depressed mood or suicidal ideation is suspected.

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 localised 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).

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.
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.
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.

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 colour.
• 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 or search for MHRA
Yellow Card in the Google Play or Apple App Store.
By reporting side effects, you can help provide more
information on the safety of this medicine.

5. How to store Depo-Medrone

Keep 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 store above 25°C. 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.
If you notice any sign of discolouration or deterioration
of this medicine, please tell your pharmacist
immediately.

What Depo-Medrone looks like
Depo-Medrone is a sterile, cloudy white, suspension
(liquid) contained within a clear glass vial with a butyl
rubber cap and metal seal. There is a green plastic
tamper proof seal on top of the aluminium/rubber seal.
Depo-Medrone is available in a packs containing 1 vial.
Product Licence Holder
Procured from within the EU. Product Licence Holder
Ginova Ltd and repackager Ginova UK Ltd both at St
James’ House, 8 Overcliffe, Gravesend, Kent, DA11
0HJ.
Manufacturer
Pfizer Manufacturing Belgium NV/SA, Rijksweg 12,
Puurs, B-2870, Belgium
Depo-Medrone 40mg/ml Injection
PL No: 18067/0292
POM
Depo-Medrone® is a registered trademark.
Date leaflet last revised on: 23rd October 2017.

To request a copy of this
leaflet in Braille, large print
or audio please call 01622
690172.

6. Contents of the pack and other
information
What Depo-Medrone contains
Each 1 ml of suspension contains 40mg of
methyl-prednisolone acetate.
This medicine also contains sodium chloride, macrogol
3350, myristyl-gamma-picolinium chloride, sodium
hydroxide, hydrochloric acid and water for injections.

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 generalised, 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
minimise 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 mothers 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 store above 25°C. Do not freeze. Depo-Medrone
should not be mixed with any other fluid. Discard any
remaining suspension after use. Any unused medicinal
product or waste material should be disposed of in
accordance with local requirements.
Legal category

POM

Packaging quantities
Depo-Medrone is available in packs containing 1 vial.
Product Licence Holder
Procured from within the EU. Product Licence Holder
Ginova Ltd and repackager Ginova UK Ltd both at
St James’ House, 8 Overcliffe, Gravesend, Kent,
DA11 0HJ.
Manufacturer
Pfizer Manufacturing Belgium NV/SA, Rijksweg 12,
Puurs, B-2870, Belgium
Depo-Medrone 40mg/ml Injection
PL No: 18067/0292
Date leaflet last revised on: 23rd October 2017.
Depo-Medrone® is a registered trademark.

500810/PL1e

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