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DEPO-MEDRONE 40 MG/ML

Active substance(s): METHYLPREDNISOLONE ACETATE

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T04800

Depo-Medrone® 40 mg/ml
(methylprednisolone acetate)
Patient Information Leaflet

Your medicine is called Depo-Medrone 40 mg/ml but will be referred to as Depo-Medrone
throughout this leaflet:
Read all of this leaflet carefully before you start taking this medicine
• Keep this leaflet. You may need to read it again
• If you have any further questions please ask your doctor or pharmacist
• This medicine has been prescribed for you. Do not pass it to others. It may harm them
even if their symptoms are the same as yours
• If any of the side effects gets serious, or if you notice any side effects not listed in this
leaflet, tell your doctor or pharmacist
In this leaflet:
1. What Depo-Medrone is and what it is used for
2. 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. Further 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 ‘auto-immune disorder in which an immune
system causes the skin to blister and peel) or systemic lupus erythematosus (lupus),
Your doctor may use this medicine to treat conditions other than those listed above.
Ask your doctor if you are unsure why you have been given this medicine.

2. 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 (Section 6 of this leaflet contains a list of ingredients).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.
See your doctor immediately if you have any of the above.
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).
Take special care before taking Depo-Medrone:
You must tell your doctor before you take this medicine 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.
• Chickenpox, shingles or a herpes eye infection. If you think you have been in contact
with someone with chickenpox 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.
• Diabetes (or if there is a family history of diabetes).
• Epilepsy.
• 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).
• 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).
• Skin abscess.
• Stomach ulcer or other serious stomach or intestinal problems.
• 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.
You must tell your doctor before you take this medicine if you have any of the conditions
listed above.
Taking other medicines
Always tell your doctor or pharmacist if you are taking any medicines (including any you
have bought without a prescription) as taking Depo-Medrone with other medicines could be
harmful.
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 – used for treating cancer
• 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
• Antibiotics (such as erythromycin)
• 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 or mibefradil – used for heart problems or high blood pressure
• Diuretics – sometimes called water tablets.
• Ketoconazole or itraconazole – used to treat fungal infections
• Pancuronium – or other medicines called neuromuscular blocking agents which are
used in some surgical procedures
• Rifampicin and rifabutin – antibiotics used to treat tuberculosis (TB)
• Vaccines - tell your doctor or nurse if you have recently had, or are about to have any
vaccination. You should 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 anesthetist 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.
Pregnancy and breast-feeding
You must tell your doctor if you are pregnant, think you might be pregnant or are trying to
become pregnant as this medicine could slow the baby’s growth.
Tell your doctor if you are breast-feeding 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
There are no special precautions while you are being treated with this medicine.

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 – 60mg (0.5 – 1.5ml) injected into the
affected part or parts of the skin.

BACK PAGE

For other more general conditions 40 – 120 mg (1 – 3ml) of this medicine may be injected
into a large muscle.
Elderly
Treatment will normally be the same as for younger adults. However your doctor may want
to see you more regularly to check how you are getting on with this medicine.
Children
Corticosteroids can affect growth in children so your doctor will prescribe the lowest dose
that will be effective for your child.
If you are given more Depo-Medrone than you should
If you think you have been given too many injections of this medicine please speak to your
doctor immediately.
Stopping/reducing the dose of your Depo-Medrone
Your doctor will decide when it is time to stop your treatment.
You will need to come off this treatment slowly if you:
• have been given Depo-Medrone for more than 3 weeks;
• have been given high doses of Depo-Medrone, over 32 mg (0.8 ml) daily, even if it was
only for 3 weeks or less;
• have already had a course of corticosteroid tablets or injections in the last year;
• already have problems with your adrenal glands (adrenocortical insufficiency) before
you started this treatment.
You will need to come off this medicine slowly to avoid withdrawal symptoms. These
symptoms may include itchy skin, fever, muscle and joint pains, runny nose, sticky eyes,
sweating and weight loss.
If your symptoms seem to return or get worse as your dose of this medicine is reduced tell
your doctor immediately.
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.

4. POSSIBLE SIDE-EFFECTS
Like all steroids 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.
• Acute pancreatitis, stomach pain spreading to your back, possibly accompanied by
vomiting, shock and loss of consciousness.
• Burst 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.
• 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:
Body water and salts
• 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
• Nausea (feeling sick) or vomiting (being sick).
• Ulcers or thrush in the gullet (discomfort on swallowing).
• Indigestion.
• Bloated stomach.
Eyes
• 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).
• Damage to the optic nerve or cataracts (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).

Hormones and metabolic system
• Slowing of normal growth in infants, children and adolescents which may be permanent.
• Irregular or no periods in women.
• Increased hair on the body and face in women (hirsutism).
• Round or moon-shaped face (Cushingoid facies).
• Increased appetite and weight gain.
• Diabetes or worsening of existing diabetes.
• 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
• Increased susceptibility to infections which can hide or change normal reactions to skin
tests, such as that for tuberculosis.
Muscles, bones and joints
• Muscle weakness or wasting.
• Brittle bones (bones that break easily).
• Broken bones or fractures.
• Breakdown of bone due to poor circulation of blood, this causes pain in the hip.
• Torn muscle tendons causing pain and/or swelling.
• Muscle cramps or spasms.
• Swollen or painful joints due to infection.
Nerves and mood issues
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 breathing problems, convulsions,
dizziness, drowsiness, difficulty breathing, sensation of cold, heat or numbness, tinnitus
or unconsciousness.
Skin
• Abscess, especially near injection sites
• Acne.
• Poor wound healing.
• Thinning of skin with stretch marks.
• Bruising.
• Small purple/red patches on the skin.
• Pale or darker patches on your skin, or raised patches which are an unusual color.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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
This medicine must not be used after the expiry date ‘EXP’ shown on the container.
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not store above 25°C. Avoid freezing
If the medicine become discoloured or show any other signs of deterioration, you should
seek the advice of your doctor or pharmacist who will tell you what to do.

6. FURTHER INFORMATION
What Depo-Medrone contains:
Each 1 ml vial contains 40 mg of methlyprednisolone acetate as the active ingredient.
This medicine also contains macrogol, sodium chloride, myristyl-gamma-picolinium
chloride and water for injection.
What a Depo-Medrone looks like and contents of the pack:
Depo-Medrone is a white sterile aqueous suspension in a Type I flint glass vial with a butyl
rubber plug, metal seal and light green plastic flip off cap.
Depo-Medrone is available in packs containing 1 vial, containing 1 ml of suspension.
Product Licence Holder and Manufacturer
This product is manufactured by Pfizer manufacturing Belgium NV/SA, Rijksweg 12, 2870
Puurs, Belgium. It is procured from within the EU by the PL Holder: Swinghope Ltd,
Brandon House, Marlowe Way, Croydon CR0 4XS and repackaged by Interport Ltd,
Marlowe Way, Croydon CR0 4XS.
POM

PL No: 10380/1408

Leaflet revision date: 17/06/2014
Depo-Medrone® is a registered trademark of Pfizer Limited.

T04800

FRONT PAGE

T04801

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

Presentation
Depo-Medrone is a white sterile aqueous suspension in a Type I flint glass vial with a butyl rubber
plug, metal seal and light green plastic flip off cap.
Each 1ml vial contains 40 mg of methlyprednisolone acetate as the active ingredient.
This medicine also contains macrogol, sodium chloride, myristyl-gamma-picolinium chloride and
water for injection.
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 Contra-indications 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 Contra-indications 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.
Children: 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).
Contra-indications, warnings, etc.
Contra-indications: Depo-Medrone is contra-indicated where there is known hypersensitivity to
components and in systemic infection unless specific anti-infective therapy is employed.
Due to its potential for neurotoxicity, Depo-Medrone must not be given by the intrathecal route. In
addition, as the product is a suspension it must not be given by the intravenous route (see Side
effects).
Interactions:
1. Convulsions have been reported with concurrent use of methylprednisolone and cyclosporin. 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.
3. Drugs such as erythromycin and ketoconazole may inhibit the metabolism of corticosteroids and
thus decrease their clearance.
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.
5. 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.
6. The renal clearance of salicylates is increased by corticosteroids and steroid withdrawal may result
in salicylate intoxication. Salicylates and non-steroid anti-inflammatory agents should be used
cautiously in conjunction with corticosteroids in hypothrombinaemia.
7. Steroids have been reported to interact with neuromuscular blocking agents such as pancuronium
with partial reversal of the neuromuscular block.
Effects on ability to drive and to use machines: None stated.
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).
PARENTERAL CORTICOSTEROID THERAPY – Anaphylactic reaction or allergic reactions,
hypopigmentation or hyperpigmentation, subcutaneous and cutaneous atrophy, sterile abscess, post
injection flare (following intra-articular use), Charcot-like arthropathy, rare instances of blindness
associated with intralesional therapy around the face and head.
GASTRO-INTESTINAL – Dyspepsia, peptic ulceration with perforation and haemorrhage, abdominal
distension, oesophageal ulceration, oesophageal candidiasis, acute pancreatitis, perforation of
bowel.
Increases in alanine transaminase (ALT, SGPT) aspartate transaminase (AST, SGOT) and alkaline
phosphatase have been observed following corticosteroid treatment. These changes are usually
small, not associated with any clinical syndrome and are reversible upon discontinuation.
ANTI-INFLAMMATORY AND IMMUNOSUPPRESSIVE EFFECTS – Increased susceptibility and
severity of infections with suppression of clinical symptoms and signs, opportunistic infections, may
suppress reactions to skin tests, recurrence of dormant tuberculosis (see Special warnings and
precautions).
MUSCULOSKELETAL – Proximal myopathy, osteoporosis, vertebral and long bone fractures,
avascular osteonecrosis, tendon rupture, aseptic necrosis, muscle weakness.
FLUID AND ELECTROLYTE DISTURBANCE – Sodium and water retention, potassium loss,
hypertension, hypokalaemic alkalosis, congestive heart failure in susceptible patients.
DERMATOLOGICAL – Impaired healing, petechiae and ecchymosis, thin fragile skin, skin atrophy,
bruising, striae, telangiectasia, acne.
ENDOCRINE/METABOLIC – Suppression of the hypothalamo-pituitary-adrenal axis, growth
suppression in infancy, childhood and adolescence, menstrual irregularity and amenorrhoea.
Cushingoid facies, hirsutism, weight gain, impaired carbohydrate tolerance with increased
requirement for antidiabetic therapy, negative nitrogen and calcium balance, increased appetite.
NEUROPSYCHIATRIC – A wide range of psychiatric reactions including affective disorders (such as
irritable, euphoric, depressed and labile mood psychological dependence and suicidal thoughts),
psychotic reactions (including mania, delusions, hallucinations and aggravation of schizophrenia),
behavioural disturbances, irritability, anxiety, sleep disturbances, and cognitive dysfunction including
confusion and amnesia have been reported for all corticosteroids.

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Reactions are common and may occur in both adults and children. In adults, the frequency of severe
reactions was estimated to be 5-6%. Psychological effects have been reported on withdrawal of
corticosteroids; the frequency is unknown. Increased intra-cranial pressure with papilloedema in
children (pseudotumour cerebri) has been reported, usually after treatment withdrawal of
methylprednisolone.

GENERAL – Leucocytosis, hypersensitivity including anaphylaxis, thrombo-embolism, nausea,
vertigo.

18. 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.
19. Care should be taken for patients receiving cardioactive drugs such as digoxin because of steroid
induced electrolyte disturbance/potassium loss (see Side effects).
20. 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.

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 Special
warnings and precautions).

Local injection of a steroid into a previously injected joint is to be avoided.
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.

A ‘withdrawal syndrome’ may also occur including fever, myalgia, arthralgia, rhinitis, conjunctivitis,
painful itchy skin nodules and loss of weight.

Special Precautions:
Particular care is required when considering the use of systemic corticosteroids in patients with the
following conditions and frequent patient monitoring is necessary.
1. Osteoporosis (post-menopausal females are particularly at risk).
2. Hypertension or congestive heart failure.
3. Existing or previous history of severe affective disorders (especially previous steroid psychosis).
4. Diabetes mellitus (or a family history of diabetes).
5. History of tuberculosis.
6. Glaucoma (or a family history of glaucoma).
7. Previous corticosteroid-induced myopathy
8. Liver failure or cirrhosis.
9. Renal insufficiency.
10. Epilepsy.
11. Peptic ulceration.
12. Fresh intestinal anastomoses.
13. Predisposition to thrombophlebitis.
14. Abscess or other pyogenic infections.
15. Ulcerative colitis.
16. Diverticulitis.
17. Myasthenia gravis.
18. Ocular herpes simplex, for fear of corneal perforation.
19. Hypothyroidism.
20. Patients and/or carers should be warned that potentially severe psychiatric adverse reactions
may occur with systemic steroids (see section 4.8). Symptoms typically emerge within a few
days or weeks of starting treatment. Risks may be higher with high doses/systemic exposure (see
also section 4.5 Interaction with Other Medicaments and Other Forms of Interaction that can
increase the risk of side effects), 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.

OPHTHALMIC – Increased intra-ocular pressure, glaucoma, papilloedema, cataracts with possible
damage to the optic nerve, corneal or scleral thinning, exacerbation of ophthalmic viral or fungal
disease, exophthalmos.

CERTAIN SIDE-EFFECTS REPORTED WITH SOME NON RECOMMENDED ROUTES OF
ADMINISTRATION
Intrathecal: Usual systemic corticoid adverse reactions, headache, meningismus, meningitis,
paraplegia, spinal fluid abnormalities, nausea, vomiting, sweating, arachnoiditis, convulsions.
Extradural: Wound dehiscence, loss of sphincter control.
Intranasal: Permanent/temporary
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:
1. A Patient Information Leaflet is provided in the pack by the manufacturer.
2. 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).
3. 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.
4. Depo-Medrone vials are intended for single dose use only. Any multidose use of the product may
lead to contamination.
5. Depo-Medrone is not recommended for epidural, intranasal, intra-ocular, or any other unapproved
route of administration. See Side effects section for details of side effects reported from some
non-recommended routes of administration.
6. Due to the absence of a true tendon sheath, the Achilles tendon should not be injected with
Depo-Medrone.
7. 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.
8. 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.
9. Systemic absorption of methylprednisolone occurs following intra-articular injection of
Depo-Medrone. Systemic as well as local effects can therefore be expected.
10. 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.
11. Following a single dose of Depo-Medrone, plasma cortisol levels are reduced and there is
evidence of hypothalamic-pituitary-adrenal (HPA) axis suppression. This suppression lasts for a
variable period of up to 4 weeks. The usual dynamic tests of HPA axis function can be used to
diagnose evidence of impaired activity (e.g. Synacthen test).
12. 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.
Abrupt withdrawal of systemic corticosteroid treatment, which has continued up to 3 weeks is
appropriate if it is 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,
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 corticosteroid greater than 32 mg daily of methylprednisolone.
• Patients repeatedly taking doses in the evening.
13. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be
administered concurrently.
14. Because rare instances of anaphylactic reactions have occurred in patients receiving parenteral
corticosteroid therapy, appropriate precautionary measures should be taken prior to
administration, especially when the patient has a history of drug allergy.
15. Corticosteroids 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.
16. 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.
17. Live vaccines should not be given to individuals with impaired immune responsiveness. The
antibody response to other vaccines may be diminished.

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.
Use in Pregnancy and Lactation:
Pregnancy
The ability of corticosteroids to cross the placenta varies between drugs, however,
methylprednisolone does cross the placenta.
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. 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.
Lactation
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.
Use in Children: Corticosteroids cause growth retardation in infancy, childhood and adolescence
which may be irreversible. Treatment should be limited to the minimum dosage for the shortest
possible time.
Use in the Elderly: The common adverse effects of systemic corticosteroids may be associated with
more serious consequences in old age, especially osteoporosis, hypertension, hypokalaemia,
diabetes, susceptibility to infection and thinning of the skin. Close clinical supervision is required to
avoid life-threatening reactions.
Overdosage: There is no clinical syndrome of acute overdosage with Depo-Medrone. 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.
Incompatibilities (major):
None stated.
Pharmaceutical precautions
Do not store above 25°C. Avoid freezing
Depo-Medrone should not be mixed with any other fluid. Discard any remaining suspension after use.
Legal Category
POM
Package quantities
1 ml vials packed singly.
Product licence number
PL 10380/1408
Holder of product licence
Swinghope Limited, Brandon House, Marlowe Way, Croydon CR0 4XS.
Leaflet revision date: 17/06/2014
Depo-Medrone® is a registered trademark of Pfizer Limited.

T04801

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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