DEPO-MEDRONE 40 MG/ML SUSPENSION FOR INJECTION

Active substance: METHYLPREDNISOLONE ACETATE

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S1531 LEAFLET 20140210

Reporting of side effects

PATIENT INFORMATION LEAFLET

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.

DEPO-MEDRONE® 40mg/ml
SUSPENSION FOR INJECTION
(methylprednisolone acetate)



The doctor or pharmacist will keep the medicine in a safe place
where children cannot reach or see it.



Do not store this medicine above 25°C. Avoid freezing.



This medicine must not be used after the expiry date ‘EXP’
shown on the container.

Read all of this leaflet carefully before you start taking this
medicine
Keep this leaflet. You may need to read it again

Do not inject this medicine into:

If you have any further questions please ask your doctor or
pharmacist



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).



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

What Depo-Medrone contains



In this leaflet:

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.

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

Your doctor may also have to monitor your treatment more closely,
alter your dose or give you another medicine.

2. Before you are given Depo-Medrone



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.



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:

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.

It also contains macrogol, sodium chloride, myristyl-gammapicolinium chloride and water for injection. It may contain
Sodium hydroxide and/or hydrochloric acid for pH adjustment.

3. How Depo-Medrone is given to you
4. Possible side effects
5. How to store Depo-Medrone

What Depo-Medrone looks like
Depo-Medrone is a white, sterile aqueous suspension for injection
contained in a glass vial fitted with a rubber cap and metal seal.
Depo-Medrone is available in packs containing 1 or 3 vials, each
containing 1 ml of suspension.
Manufacturer
This product is manufactured by Pfizer Manufacturing Belgium NV
Rijksweg 12, B-2870 Puurs, Belgium.
Product Licence holder

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.

Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
POM

You get a rash, or another symptom of an infection.

See your doctor immediately if you have any of the above.



6. Further information
Each 1 ml vial contains 40mg of methlyprednisolone acetate as
the active ingredient.

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.





For single dose use only. Your doctor or pharmacist will discard
the remaining contents after use.



Your medicine is known as Depo-Medrone 40mg/ml Suspension for
Injection but will be referred to as Depo-Medrone throughout the
following leaflet.

5. How to store Depo-Medrone



Do not use Depo-Medrone if:



By reporting side effects, you can help provide more information on
the safety of this medicine.



2. Before you are given Depo-Medrone



PL No: 19488/1531

Leaflet revision date: 10 February 2014

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.



Depo-Medrone is a trademark of Pharmacia Ltd.

Plantar fasciitis: inflammation of the tissues of the sole of the
foot.



Myasthenia gravis (a condition causing tired and weak
muscles).



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).



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.

S1531 LEAFLET 20140210



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 an 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.

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 - anti-biotics 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

Dosage information

4. Possible side effects

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.

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.

Adults
Your doctor/nurse will tell you how many injections you will require
for the condition you are being treated for, and when you will get
them.
Joints - the normal dose for the injections into joint will depend on
the size of the joint. Large joints (e.g. knee, ankle and shoulder)
may require 20 - 80 mg (0.5 - 2 ml), medium sized joints (e.g. elbow
or wrist) 10 - 40 mg (0.25 - 1 ml) and small joints (e.g. finger or toe
joints) may require a 4 - 10 mg (0.1 - 0.25 ml) dose.
Joint injections may be given weekly over a period of several
weeks, depending on how quickly you respond to treatment.
Bursitis and epicondylitis (tennis elbow) - the usual dose is between
4 - 30 mg (0.1 - 0.75 ml). In most cases repeat injections will not be
needed for bursitis and epicondylitis. Repeat injections may be
necessary to treat long standing conditions.
Skin conditions - the usual dose is between 20 - 60 mg (0.5 - 1.5
ml) injected into the affected part or parts of the skin.

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.

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

If you think you have been given too many injections of this
medicine please speak to your doctor immediately.

Tell your doctor if you are breast-feeding as small amounts of
corticosteroid medicines may get into breast milk.

You will need to come off this treatment slowly if you:

Your doctor will decide when it is time to stop your treatment.


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;



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.



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).

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.

Digestive system

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 DepoMedrone (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.



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.

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.



Slowing of normal growth in infants, children and adolescents
which may be permanent.

Acute pancreatitis, stomach pain spreading to your back,
possibly accompanied by vomiting, shock and loss of
consciousness.

have already had a course of corticosteroid tablets or injections
in the last year;

Driving and Using Machines

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.



If you are given more Depo-Medrone than you should

Stopping/reducing the dose of your Depo-Medrone

There are no special precautions while you are being treated with
this medicine.



Children

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.

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.

In certain medical conditions medicines iike 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.





For other more general conditions 40 - 120 mg (1 - 3 ml) of this
medicine may be injected into a large muscle.
Elderly

Hormones and metabolic system



Nausea (feeling sick) or vomiting (being sick).



Bloated stomach.

Eyes

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.

Indigestion.





Ulcers or thrush in the gullet (discomfort on swallowing).



Immune system

Skin


Abscess, especially near injection sites.



Acne.



Poor wound healing.



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).



Thinning of skin with stretch marks.



Bruising.

Damage to the optic nerve or cataracts (indicated by failing
eyesight).



Small purple/red patches on the skin.




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).



Pale or darker patches on your skin, or raised patches which
are an unusual colour.
If you experience any of the side effects listed above tell your
doctor immediately.
S1531 LEAFLET 20140210

S1531 Physician LEAFLET 20140210

Lactation

PHYSICIAN LEAFLET

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.

®

DEPO-MEDRONE 40mg/ml SUSPENSION FOR INJECTION
(methylprednisolone acetate)
Presentation
White, sterile aqueous suspension for injection containing 40mg per ml
methylprednisolone acetate. Also contains macrogol, sodium chloride,
myristyl-gamma-picolinium chloride and water for injection. It may
contain Sodium hydroxide and/or hydrochloric acid for pH adjustment.
Uses
Depo-Medrone may be used locally or systemically, particularly where
oral therapy is not feasible.
Depo-Medrone may be used by any of the following routes:
intramuscular, intra-articular, periarticular, intrabursal, intralesional or
into the tendon sheath. It must not be used by the intrathecal or
intravenous routes. (See Contra-indications and Side effects).

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).

Intramuscular administration:
1. Rheumatic disorders
Rheumatoid arthritis

Intrabursal: Subdeltoid bursitis, prepatellar bursitis, olecranon bursitis.
For administration directly into bursae, 4 – 30 mg (0.1 – 0.75 ml). In
most cases, repeat injections are not needed.

2.

Collagen diseases/arthritis
Systemic lupus erythematosus

Pharmaceutical precautions

3.

Do not store this medicine above 25°C. Avoid freezing. Depo-Medrone
should not be mixed with any other fluid. Discard any remaining
suspension after use.

Dermatological diseases
Severe erythema multiforme (Stevens- Johnson syndrome)

4.

Allergic states
Bronchial asthma
Severe seasonal and perennial allergic rhinitis
Drug hypersensitivity reactions
Angioneurotic oedema

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.

Incompatibilities (major):
None stated.

Package quantities
Depo-Medrone is available in packs containing 1 or 3 vials, each
containing 1 ml of suspension.

5.

Gastro-intestinal diseases
Ulcerative colitis
Crohn’s disease

Into the tendon sheath: Tenosynovitis, epicondylitis. For administration
directly into the tendon sheath, 4 – 30 mg (0.1 – 0.75ml). In recurrent or
chronic conditions, repeat injections may be necessary.

6.

Respiratory diseases
Fulminating or disseminated tuberculosis (with appropriate
antituberculous chemotherapy)
Aspiration of gastric contents

7.

Miscellaneous
TB meningitis (with appropriate antituberculous chemotherapy)

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.

Product Licence holder
Procured from within the EU and repackaged by the Product Licence
holder: S&M Medical Ltd, Wembley, HA0 1DX.
POM

PL No: 19488/1531

Leaflet revision date: 10 February 2014
S1531 Physician LEAFLET 20140210

Periarticular: Epicondylitis. Infiltrate 4 – 30 mg (0.1 – 0.75 ml) into the
affected area.

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).

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.

Dosage must be individualised and depends on the condition being
treated and its severity.

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.

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.

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.

Dermatological conditions, 40 – 120 mg (1 – 3 ml).
Rheumatic disorders and collagen diseases (rheumatoid arthritis, SLE),
40 – 120 mg (1 – 3 ml) per week.

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.

2.

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.
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.

6.

7.

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.
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.
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).

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).
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

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.

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, intraocular, or any other unapproved route of administration. See Side
effects section for details of side effects reported from some nonrecommended 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.

DERMATOLOGICAL – Impaired healing, petechiae and ecchymosis,
thin fragile skin, skin atrophy, bruising, striae, telangiectasia, acne.

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 intraarticular 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

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.
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.

Patients who have had repeated courses of systemic
corticosteroids, particularly if taken for greater than 3 weeks.

11. Peptic ulceration.



When a short course has been prescribed within one year of
cessation of long-term therapy (months or years).

13. Predisposition to thrombophlebitis.



Patients who may have reasons for adrenocortical insufficiency
other than exogenous corticosteroid therapy.

15. Ulcerative colitis.



Patients receiving doses of corticosteroid greater than 32 mg daily
of methylprednisolone.

17. Myasthenia gravis.



Patients repeatedly taking doses in the evening.

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.

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.

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:

Extradural: Wound dehiscence, loss of sphincter control.

FLUID AND ELECTROLYTE DISTURBANCE – Sodium and water
retention, potassium loss, hypertension, hypokalaemic alkalosis,
congestive heart failure in susceptible patients.

NEUROPSYCHIATRIC – A wide range of pscychiartic 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

11. Following a single dose of Depo-Medrone, plasma cortisol levels
are reduced and there is evidence of hypothalamic-pituitaryadrenal (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).

Intrathecal: Usual systemic corticoid adverse reactions, headache,
meningismus, meningitis, paraplegia, spinal fluid abnormalities, nausea,
vomiting, sweating, arachnoiditis, convulsions.

MUSCULOSKELETAL – Proximal myopathy, osteoporosis, vertebral
and long bone fractures, avascular osteonecrosis, tendon rupture,
aseptic necrosis, muscle weakness.

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.

injections. Appropriate examination of any joint fluid present is
necessary to exclude any bacterial infection, prior to injection.



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.
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).

6. Glaucoma (or a family history of glaucoma).
7. Previous corticosteroid-induced myopathy
8. Liver failure or cirrhosis.
9. Renal insufficiency.
10. Epilepsy.
12. Fresh intestinal anastomoses.
14. Abscess or other pyogenic infections.
16. Diverticulitis.
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.
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.

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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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