DEPO-MEDRONE 40MG/ML INJECTION

Active substance: METHYLPREDNISOLONE ACETATE

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ASSESSED AGAINST UK PIL DATED JUNE 2010
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
• 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
1. 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 (roundshaped 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, carbamezipine, 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 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.
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.

Continued overleaf…

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 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 DepoMedrone 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 hypothalamicpituitary-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-pituitaryadrenal 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. 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.
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.
GENERAL – Leucocytosis, hypersensitivity including anaphylaxis,
thrombo-embolism, nausea, vertigo.
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).

Continued overleaf…

ASSESSED AGAINST UK PIL DATED JUNE 2010
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
20-60mg (0.5-1.5ml) injected into the
Affected part or parts of the skin.
For other more general conditions 40-120mg
(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 32mg (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.

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

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).

13.
14.

15.

16.

17.
18.

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.
Since mineralocorticoid secretion may be impaired, salt and/or a
mineralocorticoid should be administered concurrently.
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.
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 recognized.
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
immunization 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 antituberculosis 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

• 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.

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.
Local injection of a steroid into a previously infected 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.
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

• 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 colour.

6. Further 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.
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 and Manufacturer
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.
Manufactured by 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 19th August 2011.
To request a copy of this leaflet in Braille, large print or audio
please call 01622 693000.

If you experience any of the side effects listed
above tell your doctor immediately.

5. How to store
Depo-Medrone
This medicine must not be used after the expiry
date ‘EXP’ shown on the container.
Do not store above 25°C.
Do not freeze.
Keep out of the reach and sight of children.
If you notice any sign of discolouration or
deterioration of this medicine, please tell your
pharmacist immediately.

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.
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 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.
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.
Do not freeze.
Depo-Medrone should not be mixed with any other fluid. Discard any remaining
suspension after use.
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
Manufactured by 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 19th August 2011.
Depo-Medrone® is a registered trademark.

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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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