Skip to Content

DEPO-MEDRONE 40 MG/ML INJECTION

Active substance(s): METHYLPREDNISOLONE ACETATE / METHYLPREDNISOLONE ACETATE / METHYLPREDNISOLONE ACETATE

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

Depo-Medrone ® 40 mg/ml Injection

2572
18.07.17[6]

(methylprednisolone acetate)

 Kidney or liver disease.
 Muscle problems (pain or weakness) have happened while taking
steroid medicines in the past.

PATIENT INFORMATION LEAFLET
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor, pharmacist or nurse.
 If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. See section
4.
The name of your medicine is Depo-Medrone 40mg/ml and will be
referred to as Depo-Medrone in this leaflet.
What is in this leaflet
1. What Depo-Medrone is and what it is used for
2. What you need to know before you are given Depo-Medrone
3. How Depo-Medrone is given to you
4. Possible side effects
5. How to store Depo-Medrone
6. Contents of the pack and other information
1. What Depo-Medrone is and what it is used for
Depo-Medrone contains methylprednisolone acetate.
Methylprednisolone belongs to a group of medicines called
corticosteroids or steroids. Corticosteroids are produced naturally in your
body and are important for many body functions.
Boosting your body with extra corticosteroid such as Depo-Medrone can
help when injected into the body by a doctor or nurse, such as in or near
a joint, to treat local symptoms caused by inflammatory or rheumatic
conditions such as:
 Bursitis: inflammation in the fluid containing spaces around the
shoulder, knee and/or elbow joints. For this condition this medicine will
be injected directly into one or more of these spaces.
 Osteoarthritis and rheumatoid arthritis: inflammation located in
between the joints. For these conditions this medicine will be injected
directly into one or more joint spaces.
 Plantar fasciitis: inflammation of the tissues of the sole of the foot.
 Skin problems: such as alopecia areata (patchy baldness), keloids
(scar tissue), lichen planus or simplex (small, purplish raised patches of
skin or spots), discoid lupus (round-shaped patches, often on the face)
or granuloma annulare (circular warty growths).
 Epicondylitis (tennis elbow) and tenosynovitis: For these conditions
this medicine will be injected into the tendon sheath.
Alternatively this medicine may be injected into a muscle to help treat
more general (systemic) problems affecting the whole body (e.g.
symptoms caused by a hypersensitivity to a medicine), or allergic,
inflammatory or rheumatic problems affecting the:
 brain e.g. meningitis caused by tuberculosis
 bowel and gut e.g. Crohn’s disease (inflammation of the gut) or
ulcerative colitis (inflammation of the lower bowel)
 joints e.g. rheumatoid arthritis
 lungs e.g. asthma, severe hay fever or rhinitis, tuberculosis or
inflammation caused by breathing in (aspirating) vomit or stomach
contents
 skin e.g. Stevens-Johnson syndrome (an autoimmune disorder in
which an immune system causes the skin to blister and peel) or
systemic lupus erythematosus (lupus).
Your doctor may use this medicine to treat conditions other than those
listed above. Ask your doctor if you are unsure why you have been given
this medicine.
2. What you need to know before you are given Depo-Medrone
Do not use Depo-Medrone if:
 You think you have ever suffered an allergic reaction, or any other type
of reaction after being given Depo-Medrone, or any other medicine
containing a corticosteroid or any of the ingredients in this medicine
(listed in section 6). An allergic reaction may cause a skin rash or
reddening, swollen face or lips or shortness of breath.
 You get a rash, or another symptom of an infection.
 You have recently had, or are about to have any vaccination.
See your doctor immediately if any of the above applies to you.
Do not inject this medicine:
 into the Achilles tendon (which is located behind the ankle joint), or
 directly into a vein (intravenous), the spinal cord (intrathecal), the
outer covering of the brain (extradural), into the nostrils (intranasal) or in
the eye (intraocular).
Warnings and precautions
Talk to your doctor or nurse before taking Depo-Medrone if you have any
of the following conditions.
Your doctor may also have to monitor your treatment more closely, alter
your dose or give you another medicine.
 Acute adrenal insufficiency (when your body cannot produce enough
corticosteroid due to problems with your adrenal glands).
 Acute pancreatitis (inflammation of the pancreas).
 Chickenpox, measles, shingles or a herpes eye infection. If you think
you have been in contact with someone with chickenpox, measles or
shingles and you have not already had these illnesses, or if you are
unsure if you have had them.
 Severe depression or manic depression (bipolar disorder). This
includes having had depression before while taking steroid medicines
like Depo-Medrone, or having a family history of these illnesses.
 Cushing’s disease (condition caused by an excess of cortisol hormone
in your body).
 Diabetes (or if there is a family history of diabetes).
 Epilepsy, fits or seizures.
 Glaucoma (increased pressure in the eye) or if there is a family history
of glaucoma.
 You have recently suffered a heart attack.
 Heart problems, including heart failure or infections.
 Hypertension (high blood pressure).
 Hypotension (low blood pressure).
 Hypothyroidism (an under-active thyroid).
 Joint infection.

 Myasthenia gravis (a condition causing tired and weak muscles).
 Osteoporosis (brittle bones).
 Pheochromocytoma (a rare tumour of adrenal gland tissue. The
adrenal glands are located above the kidneys).

 Skin abscess.
 Stomach ulcer or other serious stomach or intestinal problems.
 Unusual stress.
 Thrombophlebitis - vein problems due to thrombosis (clots in the



veins) resulting in phlebitis (red, swollen and tender veins).
Tuberculosis (TB) or if you have suffered tuberculosis in the past.
Traumatic brain injury.

You must tell your doctor before you take this medicine if you have any of
the conditions listed above.
Other medicines and Depo-Medrone
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.
You should tell your doctor if you are taking any of the following
medicines which can affect the way Depo-Medrone or the other medicine
works:
 Acetazolamide - used to treat glaucoma and epilepsy.
 Aminoglutethimide and cyclophosphamide - used for treating
cancer.
 Antibacterials (such as isoniazid, erythromycin, clarithromycin and
troleandomycin).
 Anticoagulants - used to ‘thin’ the blood such as acenocoumarol,
phenindione and warfarin.
 Anticholinesterases - used to treat myasthenia gravis (a muscle
condition) such as distigmine and neostigmine.
 Antidiabetics -medicines used to treat high blood sugar.
 Antiemetics (such as aprepitant and fosaprepitant).
 Aspirin and non-steroidal anti-inflammatory medicines (also called
NSAIDs) such as ibuprofen used to treat mild to moderate pain.
 Barbiturates, carbamazepine, phenytoin and primidone - used to
treat epilepsy.
 Carbenoxolone - used for heartburn and acid indigestion.
 Ciclosporin - used to treat conditions such as severe rheumatoid
arthritis, severe psoriasis or following an organ or bone marrow
transplant.
 Digoxin - used for heart failure and/or an irregular heart beat.
 Diltiazem - used for heart problems or high blood pressure.
 Ethinylestradiol and norethindrone - oral contraceptives.
 Indinavir and ritonavir - used to treat HIV infections.
 Ketoconazole or itraconazole - used to treat fungal infections.
 Pancuronium and vecuronium - or other medicines called
neuromuscular blocking agents which are used in some surgical
procedures.
 Potassium depleting agents -such as diuretics (sometimes called
water tablets), amphotericin B, xanthenes or beta2 agonists (e.g.
medicines used to treat asthma).
 Rifampicin and rifabutin - antibiotics used to treat tuberculosis (TB).
 Tacrolimus - used following an organ transplant to prevent rejection of
the organ.
 Vaccines - tell your doctor or nurse if you have recently had, or are
about to have any vaccination. You must not have ‘live’ vaccines while
using this medicine. Other vaccines may be less effective.
If you are taking long term medication(s)
If you are being treated for diabetes, high blood pressure or water
retention (oedema) tell your doctor as he/she may need to adjust the
dose of the medicines used to treat these conditions.
Before you have any operation tell your doctor, dentist or anaesthetist
that you are taking this medicine.

If you are admitted to hospital for any reason always tell your doctor or
nurse that you are taking this medicine. You can also wear a medic-alert
bracelet or pendant to let medical staff know that you are taking a steroid
if you have an accident or become unconscious.
Dosage information
Your doctor will decide on the site of injection, how much of the medicine
and how many injections you will receive depending on the condition
being treated and its severity. Your doctor will inject you with the lowest
dose for the shortest possible time to get effective relief of your
symptoms.
Adults
Your doctor/nurse will tell you how many injections you will require for the
condition you are being treated for, and when you will get them.
Joints - the normal dose for the injections into joint will depend on the size
of the joint. Large joints (e.g. knee, ankle and shoulder) may require 20 80 mg (0.5 - 2 ml), medium sized joints (e.g. elbow or wrist) 10 - 40 mg
(0.25 - 1 ml) and small joints (e.g. finger or toe joints) may require a 4 - 10
mg (0.1 -0.25 ml) dose.
Joint injections may be given weekly over a period of several weeks,
depending on how quickly you respond to treatment.
Bursitis and epicondylitis (tennis elbow) - the usual dose is between 4-30
mg (0.1 - 0.75 ml). In most cases repeat injections will not needed for
bursitis and epicondylitis. Repeat injections may be necessary to treat
long standing conditions.
Skin conditions - the usual dose is between 20 - 60mg (0.5 - 1.5ml)
injected into the affected part or parts of the skin.
For other more general conditions 40 - 120 mg (1 - 3ml) of this medicine
may be injected into a large muscle.
Elderly
Treatment will normally be the same as for younger adults. However your
doctor may want to see you more regularly to check how you are getting
on with this medicine.
Children
Corticosteroids can affect growth in children so your doctor will prescribe
the lowest dose that will be effective for your child.
If you are given more Depo-Medrone than you should
If you think you have been given too many injections of this medicine
please speak to your doctor immediately.
Stopping/reducing the dose of your Depo-Medrone
Your doctor will decide when it is time to stop your treatment.
You will need to come off this treatment slowly if you:
 have been given Depo-Medrone for more than 3 weeks
 have been given high doses of Depo-Medrone, over 32 mg (0.8 ml)
daily, even if it was only for 3 weeks or less
 have already had a course of corticosteroid tablets or injections in the
last year
 already have problems with your adrenal glands (adrenocortical
insufficiency) before you started this treatment.
You will need to come off this medicine slowly to avoid withdrawal
symptoms. These symptoms may include itchy skin, fever, muscle and
joint pains, runny nose, sticky eyes, sweating and weight loss.
If your symptoms seem to return or get worse as your dose of this
medicine is reduced tell your doctor immediately.
Mental problems while taking Depo-Medrone
Mental health problems can happen while taking steroids like 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.

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 DepoMedrone. This medicine can affect the results of some tests.

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.

Depo-Medrone with drink
Do not drink grapefruit juice while taking this medicine.

If you have any further questions on the use of this medicine, ask your
doctor, pharmacist or nurse.

Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice before taking this
medicine, as this medicine could slow the baby’s growth.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them. Your doctor will have given you this medicine for a
condition which if not treated properly could become serious.

Cataracts have been observed in infants born to mothers treated with
long-term corticosteroids during pregnancy.

In certain medical conditions medicines like Depo-Medrone
(steroids) should not be stopped abruptly. If you suffer from any of
the following symptoms seek IMMEDIATE medical attention. Your
doctor will then decide whether you should continue taking your
medicine.
 Allergic reactions, such as skin rash, swelling of the face or wheezing
and difficulty breathing. This type of side effect is rare, but can be
serious.
 Pancreatitis, stomach pain spreading to your back, possibly
accompanied by vomiting, shock and loss of consciousness.
 Ulcers or bleeding ulcers, symptoms of which are severe stomach
pain which may go through to the back and could be associated with
bleeding from the back passage, black or blood-stained stools and/or
vomiting blood.
 Infections, this medicine can hide or change the signs and symptoms
of some infections, or reduce your resistance to the infection, so that
they are hard to diagnose at an early stage. Symptoms might include a
raised temperature and feeling unwell. Symptoms of a flare up of a
previous TB infection could be coughing blood or pain in the chest. This
medicine may also make you more likely to develop a severe infection.
 Peritonitis, an inflammation (irritation) of the peritoneum, the thin tissue
that lines the inner wall of the abdomen and covers most of the
abdominal organs. Symptoms are, the stomach (abdomen) being very
painful or tender, the pain may become worse when the stomach is
touched or when you move.
 Pulmonary embolus (blood clot in the lung) symptoms include sudden
sharp chest pain, breathlessness and coughing up blood.
 Raised pressure within the skull of children (pseudotumour cerebri)
symptoms of which are headaches with vomiting, lack of energy and
drowsiness. This side effect usually occurs after treatment is stopped.

If you are breast-feeding, ask your doctor or pharmacist for advice before
taking this medicine, as small amounts of corticosteroid medicines may
get into breast milk.
If you continue breast-feeding while you are having treatment, your baby
will need extra checks to make sure he or she is not being affected by
your medicine.
Driving and Using Machines
Undesirable effects, such as dizziness, vertigo, visual disturbances and
fatigue are possible after treatment with corticosteroids. If you are
affected do not drive or operate machinery.
Depo-Medrone contains sodium
This medicinal product contains less than 1 mmol sodium (23 mg) per
vial, i.e. essentially ‘sodium-free’.
3. How Depo-Medrone is given to you
Steroid Cards
Remember to always carry a Steroid Treatment Card. Make sure
your doctor or pharmacist has filled out the details of your medicine,
including the dose and how long you will require steroid treatment.
You should show your steroid card to anyone who gives you treatment
(such as a doctor, nurse or dentist) while you are taking this medicine,
and for 3 months after your last injection.

 Thrombophlebitis (blood clots or thrombosis in a leg vein), symptoms
of which include painful swollen, red and tender veins.
If you experience any of the following side effects, or notice any
other unusual effects not mentioned in this leaflet, tell your doctor
immediately.
The side effects may occur with certain frequencies, which are defined as
follows:
 not known: frequency cannot be estimated from the available data
Blood, heart and circulation
not known
 High blood pressure, symptoms of which are headaches, or generally
feeling unwell.
 Problems with the pumping of your heart (heart failure) symptoms of
which are swollen ankles, difficulty in breathing and palpitations
(awareness of heart beat) or irregular beating of the heart, irregular or
very fast or slow pulse.
 Low blood pressure, symptoms may include dizziness, fainting,
lightheadedness, blurred vision, a rapid or irregular heartbeat
(palpitations).
 Increase of white blood cells (leukocytosis).
 Increased clotting of the blood.
Body water and salts
not known
 Swelling and high blood pressure, caused by increased levels of water
and salt content.
 Cramps and spasms, due to the loss of potassium from your body. In
rare cases this can lead to congestive heart failure (when the heart
cannot pump properly).
Digestive system
not known
 Ulcers.
 Nausea (feeling sick) or vomiting (being sick).
 Thrush in the gullet (discomfort on swallowing).
 Indigestion.
 Diarrhoea.
 Bloated stomach.
 Abdominal pain.
 Persistent hiccups, especially when high doses are taken.
Ears
not known
 A feeling of dizziness or spinning (vertigo).
Eyes
not known
 Cataracts (indicated by failing eyesight).
 Glaucoma (raised pressure within the eye, causing pain in the eyes and
headaches).
 Swollen optic nerve (causing a condition called papilloedema, and
which may cause sight disturbance).
 Increased intra-ocular pressure, with possible damage to the optic
nerve (indicated by failing eyesight).
 Thinning of the clear part at the front of the eye (cornea) or of the white
part of the eye (sclera).
 Worsening of viral or fungal eye infections.
 Protruding of the eyeballs (exophthalmos).
 Blurred or distorted vision (due to disease of the retina and choroid
membrane).
General disorders
not known
 Poor wound healing.
 Irritability in children.
 Feeling tired or unwell.
 Skin reactions at the site of injection.
 Irritability in adults.
Hepatobiliary disorders
 Methylprednisolone can damage your liver, hepatitis and increase of
liver enzymes have been reported.
Hormones and metabolic system
not known
 Slowing of normal growth in infants, children and adolescents which
may be permanent.
 Round or moon-shaped face (Cushingoid facies).
 Diabetes or worsening of existing diabetes.
 Irregular or no periods in women.
 Increased appetite and weight gain.
 Abnormal localized or tumour-like accumulations of fat in the tissues.
 Prolonged therapy can lead to lower levels of some hormones which in
turn can cause low blood pressure and dizziness. This effect may
persist for months.
 The amount of certain chemicals (enzymes) called alanine
transaminase, aspartate transaminase and alkaline phosphatase that
help the body digest drugs and other substances in your body may be
raised after treatment with a corticosteroid. The change is usually small
and the enzyme levels return to normal after your medicine has cleared
naturally from your system. You will not notice any symptoms if this
happens, but it will show up if you have a blood test.
Immune system
not known
 Increased susceptibility to infections which can hide or change normal
reactions to skin tests, such as that for tuberculosis.
Metabolism and nutrition disorders
 Accumulation of fat tissue on localized parts of the body.
Muscles, bones and joints
not known
 Muscle weakness.
 Brittle bones (bones that break easily).
 Muscle wasting.
 Broken bones or fractures.
 Breakdown of bone due to poor circulation of blood, this causes pain in
the hip.

 Joint pain.
 Torn muscle tendons causing pain and/or swelling.
 Muscle cramps or spasms.
 Swollen or painful joints due to infection.
Nerves and mood issues
not known
Steroids including methylprednisolone can cause serious mental health
problems.
These are common in both adults and children. They can affect about 5 in
every 100 people taking medicines like methylprednisolone.
 Feeling depressed, including thinking about suicide.
 Feeling high (mania) or moods that go up and down.
 Feeling anxious, having problems sleeping, difficulty in thinking or being
confused and losing your memory.
 Feeling, seeing or hearing things which do not exist. Having strange
and frightening thoughts, changing how you act or having feelings of
being alone.
 Other nervous system side effects may include convulsions (seizures),
amnesia (loss of memory), cognitive disorder (mental changes,
dizziness and headache.
 Back pain or weakness (due to Epidural Lipomatosis, a rare disorder in
which an abnormal amount of fat is deposited on or outside the lining of
the spine).
Skin
not known
 Acne.
 Bruising.
 Abscess, especially near injection sites.
 Thinning of skin, stretch marks.
 Small purple/red patches on the skin.
 Pale or darker patches on your skin, or raised patches which are an
unusual color.
 Increased hair on the body and face (hirsutism).

 Rash, itching, hives.
 Increased sweating.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the
safety of this medicine.
5. How to store Depo-Medrone
This medicine must not be used after the expiry date ‘EXP’ shown on the
container.
The doctor or pharmacist will keep the medicine in a safe place where
children cannot see or reach it.
This medicine must be stored in a cool place, but must not be frozen.
Keep out of the sight and reach of children.
Do not freeze.
Each vial is for single use only.
After use, your doctor should take the container and syringe away. If
anything is left behind, return it to your pharmacy for safe disposal. This
medicine should not be used if the product is any colour other than white,
or if particles can be seen in it.
6. Contents of the pack and other information
What Depo-Medrone contains:
Each 1 ml vial contains 40 mg methylprednisolone acetate.
Vial also contains macrogol 3350, sodium chloride, myristyl-gammapicolinium chloride, sodium hydroxide, hydrochloric acid and water for
injection.
What a Depo-Medrone looks like:
Depo-Medrone is available in a glass vial with a rubber cap, metal seal
and a green flip-off cap.
Depo-Medrone is available in packs containing 1, 3 or 10 vials, containing
1 ml of suspension.
Manufacturer and Product Licence holder
Manufactured by Pfizer Manufacturing Belgium NV, Rijksweg 12, B-2870
Puurs, Belgium ,procured from the EU by Product Licence holder Star
Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex HA1 1XD.
Repackaged by Servipharm Ltd.
POM

PL 20636/2572

Leaflet revision and issue date (Ref) 18.07.17[6]
Depo-Medrone is a trademark of Pfizer.

Blind or partially sighted?
Is this leaflet hard to see or read?
Call 020 8423 2111 to obtain the
leaflet in a format suitable for you.

PHYSICIAN LEAFLET

2572
18.07.17[H-6]

Depo-Medrone ® 40 mg/ml Injection
(methylprednisolone acetate)
Presentation
White, sterile aqueous suspension for injection containing 40 mg per ml
methylprednisolone acetate. Also contains macrogol 3350, sodium chloride,
myristyl-gamma-picolinium chloride, sodium hydroxide, hydrochloric acid and water
for injection.
Uses
Depo-Medrone may be used locally or systemically, particularly where oral therapy
is not feasible.
Depo-Medrone may be used by any of the following routes: intramuscular, intraarticular, periarticular, intrabursal, intralesional or into the tendon sheath. It must
not be used by the intrathecal or intravenous routes. (See Contraindications and
Side effects).
Intramuscular administration:
1. Rheumatic disorders
Rheumatoid arthritis
2. Collagen diseases/arthritis
Systemic lupus erythematosus
3. Dermatological diseases
Severe erythema multiforme (Stevens-Johnson syndrome)
4. Allergic states
Bronchial asthma
Severe seasonal and perennial allergic rhinitis
Drug hypersensitivity reactions
Angioneurotic oedema
5. Gastro-intestinal diseases
Ulcerative colitis
Crohn’s disease
6. Respiratory diseases
Fulminating or disseminated tuberculosis (with appropriate antituberculous
chemotherapy)
Aspiration of gastric contents
7. Miscellaneous
TB meningitis (with appropriate antituberculous chemotherapy)
Intra-articular administration:
Rheumatoid arthritis
Osteo-arthritis with an inflammatory component
Soft tissue administration (intrabursal, periarticular, into tendon sheath):
Synovitis not associated with infection
Epicondylitis
Tenosynovitis
Plantar fasciitis
Bursitis
Intralesional:
Keloids
Localized lichen planus
Localized lichen simplex
Granuloma annulare
Discoid lupus erythematosus
Alopecia areata
Dosage and administration
Depo-Medrone should not be mixed with any other suspending agent or
solution. Parenteral drug products should be inspected visually for particulate
matter and discoloration prior to administration, whenever suspension and
container permit. Depo-Medrone may be used by any of the following routes:
intramuscular, intra-articular, periarticular, intrabursal, intralesional and into
the tendon sheath. It must not be used by the intrathecal or intravenous routes
(see Contraindications and Side effects).
Undesirable effects may be minimized by using the lowest effective dose for the
minimum period (see special warnings and precautions).
Depo-Medrone vials are intended for single dose use only.
Intramuscular-for sustained systemic effect: Allergic conditions (severe seasonal
and perennial allergic rhinitis, asthma, drug reactions). 80 - 120 mg (2 - 3 ml).
Dermatological conditions, 40 - 120 mg (1 - 3 ml).
Rheumatic disorders and collagen diseases (rheumatoid arthritis, SLE), 40 -120 mg
(1 - 3 ml) per week.
Dosage must be individualised and depends on the condition being treated and its
severity.
Note: Depo-Medrone is not intended for the prophylaxis of severe seasonal and
perennial allergic rhinitis or other seasonal allergies and should be administered
only when symptoms are present.
The frequency of intramuscular injections should be determined by the duration of
the clinical response.
In the case of seasonal allergic rhinitis a single injection is frequently sufficient. If
necessary, however, a second injection may be given after two to three weeks.
On average the effect of a single 2 ml (80 mg) injection may be expected to last
approximately two weeks.
Infra-articular: Rheumatoid arthritis, osteo-arthritis. The dose of Depo- Medrone
depends upon the size of the joint and the severity of the condition. Repeated
injections, if needed, may be given at intervals of one to five or more weeks
depending upon the degree of relief obtained from the initial injection. A suggested
dosage guide is: large joint (knee, ankle, shoulder), 20 - 80mg (0.5 - 2 ml); medium
joint (elbow, wrist), 10 - 40 mg (0.25 - 1 ml); small joint (metacarpophalangeal,
interphalangeal, sternoclavicular, acromioclavicular), 4 -10 mg (0.1 - 0.25 ml).
Intrabursal: Subdeltoid bursitis, prepatellar bursitis, olecranon bursitis. For
administration directly into bursae, 4-30 mg (0.1 - 0.75 ml). In most cases, repeat
injections are not needed.
Intralesional: Keloids, localized lichen planus, localized lichen simplex, granuloma
annulare, alopecia areata, and discoid lupus erythematosus. For administration
directly into the lesion for local effect in dermatological conditions, 20 - 60 mg (0.5 1.5 ml). For large lesions, the dose may be distributed by repeated local injections of
20 - 40 mg (0.5 -1 ml). One to four injections are usually employed. Care should be
taken to avoid injection of sufficient material to cause blanching, since this may be
followed by a small slough.
Periarticular: Epicondylitis. Infiltrate 4-30 mg (0.1 - 0.75 ml) into the affected area.
Into the tendon sheath: Tenosynovitis, epicondylitis. For administration directly into
the tendon sheath, 4 - 30 mg (0.1 - 0.75 ml). In recurrent or chronic conditions,
repeat injections may be necessary.

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.

Not
Known

Nervous system
disorders

Not
Known

Eye disorders

Not
Known

Ear and labyrinth
disorders
Cardiac disorders

Not
Known
Not
Known
Not
Known
Not
Known

The usual sterile precautions should be observed with each injection.
Paediatric population: Dosage may be reduced for infants and children but should
be governed more by the severity of the condition and response of the patient, than
by age or size.
Elderly patients: When used according to instructions, there is no information to
suggest that a change in dosage is warranted in the elderly. However, treatment of
elderly patients, particularly if long-term, should be planned bearing in mind the
more serious consequences of the common side-effects of corticosteroids in old age
and close clinical supervision is required (see Special warnings and precautions).
Contraindications
Depo-Medrone is contraindicated:

in patients with known hypersensitivity to the active substance or to any of the
excipients

in patients who have systemic infection unless specific anti-infective therapy is
employed

for use by the intrathecal route (due to its potential for neurotoxicity)

for use by the intravenous route

Vascular
disorders
Respiratory,
thoracic and
mediastinal
disorders
Gastrointestinal
disorders

Not
Known

Administration of live or live, attenuated vaccines is contraindicated in patients
receiving immunosuppressive doses of corticosteroids.
Interactions
1. Convulsions have been reported with concurrent use of methylprednisolone and
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. Aminoglutethimide- induced adrenal suppression may exacerbate
endocrine changes caused by prolonged glucocorticoid treatment. The
acetylation rate and clearance of isoniazid, an antibacterial drug, can be
increased by methylprednisolone.
3. Drugs such as erythromycin, itraconazole and ketoconazole may inhibit the
metabolism of corticosteroids and thus decrease their clearance.
Troleandomycin, as well as clarithromycin, erythromycin, itraconazole and
ketoconazole increase the effects and the side effects of methylprednisolone.
4. Steroids may reduce the effects of anticholinesterases in myasthenia gravis.
The desired effects of hypoglycaemic agents (including insulin), antihypertensives and diuretics are antagonized by corticosteroids, and the
hypokalaemic effects of acetazolamide, loop diuretics, thiazide diuretics and
carbenoxolone are enhanced. Antagonism of the neuromuscular blocking
effects of pancuronium and vecuronium has been reported in patients taking
corticosteroids. This interaction may be expected with all competitive
neuromuscular blockers.
5. The effect of methylprednisolone on oral anticoagulants is variable. The efficacy
of coumarin anticoagulants may be enhanced by concurrent corticosteroid
therapy and close monitoring of the INR or prothrombin time is required to avoid
spontaneous bleeding and to maintain the desired anticoagulant effects. There
are also reports of diminished effects of anticoagulants when given concurrently
with corticosteroids.
6. There may be increased incidence of gastrointestinal bleeding and ulceration
when corticosteroids are given with NSAIDs. Methylprednisolone may increase
the clearance of high-dose aspirin, which can lead to decreased salicylate
serum levels. Discontinuation of methylprednisolone treatment can lead to
raised salicylate serum levels, which could lead to an increased risk of
salicylate toxicity. Salicylates and non-steroidal anti-inflammatory agents should
be used cautiously in conjunction with corticosteroids in hypothrombinaemia.
7. Antidiabetics - Because corticosteroids may increase blood glucose
concentrations, dosage adjustments of antidiabetic agents may be required.
8. Antiemetics - Aprepitant and fosaprepitant (CYP3A4 inhibitors and substrates).
9. Antivirals - HIV protease inhibitors:
1) Indinavir and ritonavir (CYP3A4 inhibitors and substrates) may increase
plasma concentrations of corticosteroids.
2) Corticosteroids may induce the metabolism of HIV-protease inhibitors
resulting in reduced plasma concentrations.
10. Calcium channel blocker – Diltiazem.
11. Contraceptives (oral) - Ethinylestradiol/norethindrone.
12. Other immunosuppressants like cyclophosphamide and tacrolimus.
13. Potassium-depleting agents - When corticosteroids are administered
concomitantly with potassium-depleting agents (e.g. diuretics), patients should
be observed closely for development of hypokalaemia. There is also an
increased risk of hypokalaemia with concurrent use of corticosteroids with
amphotericin B, xanthenes, or beta2 agonists.
14. Grapefruit juice – (CYP3A4 inhibitor).
Effects on ability to drive and to use machines
The effect of corticosteroids on the ability to drive or use machinery has not been
systematically evaluated. Undesirable effects, such as dizziness, vertigo, visual
disturbances, and fatigue are possible after treatment with corticosteroids. If
affected, patients should not drive or operate machinery.
Other undesirable effects (frequency and seriousness)
Side effects: The incidence of predictable undesirable side effects associated with
the use of corticosteroids, including hypothalamic-pituitary- adrenal suppression
correlates with the relative potency of the drug, dosage, timing of administration and
duration of treatment (see Special warnings and precautions).
System Organ
Class
Infections and
infestations

Frequency

Undesirable Effects

Not
Known

Immune system
disorders
Blood and
lymphatic system
disorders
Endocrine
disorders

Not
Known
Not
Known

Infection (including increased susceptibility
and severity of infections with suppression of
clinical symptoms and signs); Opportunistic
infection; Injection site infection; Peritonitis;
Recurrence of dormant tuberculosis
Drug hypersensitivity, Anaphylactic reaction

Metabolism and
nutrition
disorders

Not
Known

Not
Known

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. Intraarticular 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

Psychiatric
disorders

Leukocytosis

Cushingoid; Hypopituitarism;
Withdrawal symptoms - Too rapid a reduction
of corticosteroid dosage following prolonged
treatment can lead to acute adrenal
insufficiency, hypotension and death.
However, this is more applicable to
corticosteroids with an indication where
continuous therapy is given (see section 4.4
of the SPC).
A 'withdrawal syndrome' may also occur
including, fever, myalgia, arthralgia, rhinitis,
conjunctivitis, painful itchy skin nodules and
loss of weight.
Glucose tolerance impaired; Sodium
retention; Fluid retention; Increased
requirements for insulin (or oral hypoglycemic
agents in diabetics)[not a MedDRA PT];
Alkalosis hypokalaemic; Dyslipidaemia,
Increased appetite (which may result in
Weight increased); Epidural lipomatosis

Hepatobiliary
disorders
Skin and
subcutaneous
tissue disorders

Not known

Musculoskeletal
and connective
tissue disorders

Not
Known

Reproductive
system and breast
disorders
General disorders
and
administration
site conditions
Investigations

Not
Known

Injury, poisoning
and procedural
complications

Not
Known

Not
Known

Not
Known

Not
Known

Affective disorder (including Depressed
mood, Euphoric mood, Affect lability,
psychological dependence [not a MedDRA
PT], Suicidal ideation). The following events
were most common in children: Mood swings;
Abnormal behaviour; Insomnia; Psychotic
disorder (including Mania, Delusion,
Hallucination, and Schizophrenia [aggravation
of]); Confusional state; Mental disorder;
Anxiety; Personality change; Mood swings;
Abnormal behaviour; Insomnia
Intracranial pressure increased (with
Papilloedema [Benign intracranial
hypertension]); Convulsion; Amnesia;
Cognitive disorder; Dizziness; Headache;
Epidural lipomatosis
Cataract; Glaucoma; Exophthalmos; rare
instances of blindness associated with
intralesional therapy around the face and
head [not a MedDRA PT]; Increased intraocular pressure, with possible damage to the
optic nerve; Corneal or scleral thinning;
Exacerbation of ophthalmic viral or fungal
disease; Chorioretinopathy
Vertigo
Cardiac failure congestive (in susceptible
patients)
Hypertension; Hypotension; Embolism arterial
Thrombotic events
Pulmonary embolism, Hiccups

Peptic ulcer (with possible Peptic ulcer
perforation and Peptic ulcer haemorrhage);
Gastric haemorrhage; Intestinal perforation;
Pancreatitis; Oesophagitis ulcerative;
Oesophagitis; Abdominal pain; Abdominal
distension; Diarrhoea; Dyspepsia; Nausea
Hepatitis, Increase of liver enzymes
Ecchymosis; Acne; Angioedema; Petechiae;
Skin atrophy; Skin striae; Skin
hyperpigmentation; Skin hypopigmentation;
Hirsutism; Rash; Erythema; Pruritus;
Urticaria; Hyperhidrosis
Growth retardation; Osteoporosis; Muscular
weakness; Osteonecrosis; Pathological
fracture; Muscle atrophy; Myopathy;
Neuropathic arthropathy; Arthralgia; Myalgia
Menstruation irregular

Impaired healing; Oedema peripheral;
Irritability (in children); Injection site reaction;
Abscess sterile; Fatigue; Malaise; Irritability
(in adults)
Blood potassium decreased; Alanine
aminotransferase increased; Aspartate
aminotransferase increased; Blood alkaline
phosphatase increased; Carbohydrate
tolerance decreased; Urine calcium
increased; suppression of reactions to skin
tests [not a MedDRA PT]; Blood urea
increased; Nitrogen balance negative (due to
protein catabolism)
Tendon rupture (particularly of the Achilles
tendon); Spinal compression fracture
Systemic corticosteroids should not be used
for the treatment of traumatic brain injury.

CERTAIN SIDE-EFFECTS REPORTED WITH SOME NON RECOMMENDED
ROUTES OF ADMINISTRATION
Intrathecal/Epidural: Usual systemic corticoid adverse reactions, headache,
meningismus, meningitis, paraparesis/paraplegia, spinal fluid abnormalities, nausea,
vomiting, sweating, arachnoiditis, functional gastrointestinal disorder/bladder
dysfunction, convulsions, sensory disturbances. The frequency of these adverse
reactions is not known.
Extradural: Wound dehiscence, loss of sphincter control.
Intranasal: Permanent/temporary blindness, rhinitis.
Ophthalmic: (Subconjunctival) - Redness and itching, abscess, slough at injection
site, residue at injection site, increased intra-ocular pressure, decreased vision blindness, infection.
Miscellaneous injection sites- Scalp, tonsillar fauces, sphenopalatine ganglion:
blindness.
Special warnings and precautions
Warnings and Precautions:
Undesirable effects may be minimized by using the lowest effect dose for the
minimum period. Frequent patient review is required to appropriately titrate the dose
against disease activity (see Dosage and administration).
Depo-Medrone vials are intended for single dose use only. Any multidose use of the
product may lead to contamination.
Depo-Medrone is not recommended for epidural, intranasal, intra-ocular, or any
other unapproved route of administration. Severe medical events have been
reported in association with the intrathecal/epidural routes of administration (see
section 4.8 of the SPC). Appropriate measures must be taken to avoid intravascular
injection.
Due to the absence of a true tendon sheath, the Achilles tendon should not be
injected with Depo-Medrone.
While crystals of adrenal steroids in the dermis suppress inflammatory reactions,
their presence may cause disintegration of the cellular elements and physiochemical
changes in the ground substance of the connective tissue. The resultant infrequently
occurring dermal and/or subdermal changes may form depressions in the skin at the
injection site. The degree to which this reaction occurs will vary with the amount of
adrenal steroid injected. Regeneration is usually complete within a few months or
after all crystals of the adrenal steroid have been absorbed. In order to minimize the
incidence of dermal and subdermal atrophy, care must be exercised not to exceed
recommended doses in injections. Multiple small injections into the area of the
lesion should be made whenever possible. The technique of intra-articular and
intramuscular injection should include precautions against injection or leakage into
the dermis. Injection into the deltoid muscle should be avoided because of a high
incidence of subcutaneous atrophy.
Intralesional doses should not be placed too superficially, particularly in easily visible
sites in patients with deeply pigmented skins, since there have been rare reports of
subcutaneous atrophy and depigmentation.
Systemic absorption of methylprednisolone occurs following intra-articular injection
of Depo-Medrone. Systemic as well as local effects can therefore be expected.
Adrenal cortical atrophy develops during prolonged therapy and may persist for
months after stopping treatment. In patients who have received more than
physiological doses of systemic corticosteroids (approximately 6 mg
methylprednisolone) for greater than 3 weeks, withdrawal should not be abrupt. How
dose reduction should be carried out depends largely on whether the disease is
likely to relapse as the dose of systemic corticosteroids is reduced. Clinical
assessment of disease activity may be needed during withdrawal. If the disease is
unlikely to relapse on withdrawal of systemic corticosteroids, but there is uncertainty
about HPA suppression, the dose of systemic corticosteroid may be reduced rapidly
to physiological doses. Once a daily dose of 6 mg methylprednisolone is reached,
dose reduction should be slower to allow the HPA-axis to recover.
The following precautions apply for parenteral corticosteroids: Following intraarticular injection, the occurrence of a marked increase in pain accompanied by
local swelling, further restriction of joint motion, fever, and malaise are suggestive of
septic arthritis. If this complication occurs and the diagnosis of sepsis is confirmed,
appropriate antimicrobial therapy should be instituted.

Local injection of a steroid into a previously infected joint is to be avoided.
Intra-articular corticosteroids are associated with a substantially increased risk of
inflammatory response in the joint, particularly bacterial infection introduced with the
injection. Charcot-like arthropathies have been reported particularly after repeated
injections. Appropriate examination of any joint fluid present is necessary to exclude
any bacterial infection, prior to injection.

Ocular Effects
Prolonged use of corticosteroids may produce posterior subcapsular cataracts and
nuclear cataracts (particularly in children), exophthalmos, or increased intraocular
pressure, which may result in glaucoma with possible damage to the optic nerves,
and may enhance the establishment of secondary ocular infections due to fungi or
viruses.

Corticosteroids should not be injected into unstable joints.

Corticosteroids should be used cautiously in patients with ocular herpes simplex,
because of possible corneal perforation.

Sterile technique is necessary to prevent infections or contamination.
The slower rate of absorption by intramuscular administration should be recognised.
Immunosuppressant Effects/Increased Susceptibility to Infections
Corticosteroids may increase susceptibility to infection, may mask some signs of
infection, and new infections may appear during their use. Suppression of the
inflammatory response and immune function increases the susceptibility to fungal,
viral and bacterial infections and their severity. The clinical presentation may often
be atypical and may reach an advanced stage before being recognised.
With increasing doses of corticosteroids, the rate of occurrence of infectious
complications increases. Do not use intra-synovially, intrabursally or intratendinous
administration for local effect in the presence of acute infection.
Persons who are on drugs which suppress the immune system are more susceptible
to infections than healthy individuals. Chickenpox and measles, for example, can
have a more serious or even fatal course in non-immune children or adults on
corticosteroids.
Chickenpox is of serious concern since this normally minor illness may be fatal in
immunosuppressed patients. Patients (or parents of children) without a definite
history of chickenpox should be advised to avoid close personal contact with
chickenpox or herpes zoster and if exposed they should seek urgent medical
attention. Passive immunisation with varicella/zoster immunoglobulin (VZIG) is
needed by exposed non-immune patients who are receiving systemic corticosteroids
or who have used them within the previous 3 months; this should be given within 10
days of exposure to chickenpox. If a diagnosis of chickenpox is confirmed, the
illness warrants specialist care and urgent treatment. Corticosteroids should not be
stopped and the dose may need to be increased.
Live vaccines should not be given to individuals with impaired immune
responsiveness. The antibody response to other vaccines may be diminished.
The use of Depo-Medrone in active tuberculosis should be restricted to those cases
of fulminating or disseminated tuberculosis in which the corticosteroid is used for the
management of the disease in conjunction with an appropriate antituberculous
regimen. If corticosteroids are indicated in patients with latent tuberculosis or
tuberculin reactivity, close observation is necessary as reactivation of the disease
may occur. During prolonged corticosteroid therapy, these patients should receive
chemoprophylaxis.
The role of corticosteroids in septic shock has been controversial, with early studies
reporting both beneficial and detrimental effects. More recently, supplemental
corticosteroids have been suggested to be beneficial in patients with established
septic shock who exhibit adrenal insufficiency. However, their routine use in septic
shock is not recommended. A systematic review of short-course high-dose
corticosteroids did not support their use. However, meta-analyses and a review
suggest that longer courses (5-11 days) of low-dose corticosteroids might reduce
mortality, especially in patients with vasopressor-dependent septic shock.
Immune System Effects
Allergic reactions may occur. Because rare instances of skin reactions and
anaphylactic/anaphylactoid reactions have occurred in patients receiving
corticosteroid therapy, appropriate precautionary measures should be taken prior to
administration, especially when the patient has a history of drug allergy.

Corticosteroid therapy has been associated with central serous chorioretinopathy,
which may lead to retinal detachment.
Cardiac Effects
Adverse effects of glucocorticoids on the cardiovascular system, such as
dyslipidaemia and hypertension, may predispose treated patients with existing
cardiovascular risk factors to additional cardiovascular effects, if high doses and
prolonged courses are used. Accordingly, corticosteroids should be employed
judiciously in such patients and attention should be paid to risk modification and
additional cardiac monitoring if needed.
Systemic corticosteroids should be used with caution, and only if strictly necessary,
in cases of congestive heart failure.
Vascular Effects
Corticosteroids should be used with caution in patients with hypertension.
Gastrointestinal Effects
There is no universal agreement on whether corticosteroids per se are responsible
for peptic ulcers encountered during therapy; however, glucocorticoid therapy may
mask the symptoms of peptic ulcer so that perforation or haemorrhage may occur
without significant pain. In combination with NSAIDs, the risk of developing
gastrointestinal ulcers is increased.
Corticosteroids should be used with caution in nonspecific ulcerative colitis, if there
is a probability of impending perforation, abscess or other pyogenic infection.
Caution must also be used in diverticulitis, fresh intestinal anastomoses, active or
latent peptic ulcer, when steroids are used as direct or adjunctive therapy.
Hepatobiliary Effects
High doses of corticosteroids may produce acute pancreatitis.
Corticosteroids should be used with caution in patients with liver failure or cirrhosis.
Musculoskeletal Effects
An acute myopathy has been reported with the use of high doses of corticosteroids,
most often occurring in patients with disorders of neuromuscular transmission (e.g.
myasthenia gravis), or in patients receiving concomitant therapy with
anticholinergics, such as neuromuscular blocking drugs (e.g. pancuronium). This
acute myopathy is generalized, may involve ocular and respiratory muscles, and
may result in quadriparesis. Elevations of creatine kinase may occur. Clinical
improvement or recovery after stopping corticosteroids may require weeks to years.
Osteoporosis is a common but infrequently recognized adverse effect associated
with a long-term use of large doses of glucocorticoid.
Renal and Urinary Disorders
Corticosteroids should be used with caution in patients with renal insufficiency.
Investigations
Average and large doses of hydrocortisone or cortisone can cause elevation of
blood pressure, salt and water retention, and increased excretion of potassium.
These effects are less likely to occur with the synthetic derivatives except when
used in large doses. Dietary salt restriction and potassium supplementation may be
necessary. All corticosteroids increase calcium excretion.

Endocrine Effects
Pharmacologic doses of corticosteroids administered for prolonged periods may
result in hypothalamic-pituitary-adrenal (HPA) suppression (secondary
adrenocortical insufficiency). The degree and duration of adrenocortical insufficiency
produced is variable among patients and depends on the dose, frequency, time of
administration, and duration of glucocorticoid therapy. This effect may be minimized
by use of alternate-day therapy.

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

In addition, acute adrenal insufficiency leading to a fatal outcome may occur if
glucocorticoids are withdrawn abruptly. Drug-induced secondary adrenocortical
insufficiency may therefore be minimized by gradual reduction of dosage. This type
of relative insufficiency may persist for months after discontinuation of therapy;
therefore, in any situation of stress occurring during that period, hormone therapy
should be reinstituted.
A steroid “withdrawal syndrome,” seemingly unrelated to adrenocortical
insufficiency, may also occur following abrupt discontinuance of glucocorticoids.
This syndrome includes symptoms such as: anorexia, nausea, vomiting, lethargy,
headache, fever, joint pain, desquamation, myalgia, weight loss, and/or
hypotension. These effects are thought to be due to the sudden change in
glucocorticoid concentration rather than to low corticosteroid levels.

Corticosteroids should be used with caution in patients with a predisposition to
thrombophlebitis.

Abrupt withdrawal of systemic corticosteroid treatment, which has continued up to 3
weeks is appropriate if it considered that the disease is unlikely to relapse. Abrupt
withdrawal of doses up to 32 mg daily of methylprednisolone for 3 weeks is unlikely
to lead to clinically relevant HPA-axis suppression, in the majority of patients. In the
following patient groups, gradual withdrawal of systemic corticosteroid therapy
should be considered even after courses lasting 3 weeks or less:
• Patients who have had repeated courses of systemic corticosteroids, particularly if
taken for greater than 3 weeks.
• When a short course has been prescribed within one year of cessation of longterm therapy (months or years).
• Patients who may have reasons for adrenocortical insufficiency other than
exogenous corticosteroid therapy.
• Patients receiving doses of systemic corticosteroid greater than 32 mg daily of
methylprednisolone.
• Patients repeatedly taking doses in the evening.
Because glucocorticoids can produce or aggravate Cushing’s syndrome,
glucocorticoids should be avoided in patients with Cushing’s disease.
There is an enhanced effect of corticosteroids on patients with hypothyroidism.
Metabolism and Nutrition
Corticosteroids, including methylprednisolone, can increase blood glucose, worsen
pre-existing diabetes, and predispose those on long-term corticosteroid therapy to
diabetes mellitus.
Psychiatric Effects
Patients and/or carers should be warned that potentially severe psychiatric adverse
reactions may occur with systemic steroids (see section 4.8 of the SPC). Symptoms
typically emerge within a few days or weeks of starting treatment. Risks may be
higher with high doses/systemic exposure (see interactions), although dose levels
do not allow prediction of the onset, type, severity or duration of reactions. Most
reactions recover after either dose reduction or withdrawal, although specific
treatment may be necessary. Patients/carers should be encouraged to seek medical
advice if worrying psychological symptoms develop, especially if depressed mood or
suicidal ideation is suspected. Patients/carers should be alert to possible psychiatric
disturbances that may occur either during or immediately after dose
tapering/withdrawal of systemic steroids, although such reactions have been
reported infrequently.
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 manicdepressive illness and previous steroid psychosis.
Nervous System Effects
Corticosteroids should be used with caution in patients with seizure disorders.
Corticosteroids should be used with caution in patients with myasthenia gravis (Also
see myopathy statement in Musculoskeletal Effects section).
There have been reports of epidural lipomatosis in patients taking corticosteroids,
typically with long-term use at high doses.

Other
Patients should carry ‘Steroid Treatment’ cards which give clear guidance on the
precautions to be taken to minimize risk and which provide details of prescriber,
drug, dosage and the duration of treatment.

Aspirin and nonsteroidal anti-inflammatory agents should be used cautiously in
conjunction with corticosteroids.
Pheochromocytoma crisis, which can be fatal, has been reported after
administration of systemic corticosteroids. Corticosteroids should only be
administered to patients with suspected or identified pheochromocytoma after an
appropriate risk/benefit evaluation.
Use in Children
Corticosteroids cause growth retardation in infancy, childhood and adolescence
which may be irreversible. Growth and development of infants and children on
prolonged corticosteroid therapy should be carefully observed. Treatment should be
limited to the minimum dosage for the shortest possible time and should be
restricted to the most serious indications.
Infants and children on prolonged corticosteroid therapy are at special risk from
raised intracranial pressure.
High doses of corticosteroids may produce pancreatitis in children
Use in Pregnancy and Lactation
Pregnancy
The ability of corticosteroids to cross the placenta varies between individual drugs,
however, methylprednisolone does cross the placenta. One retrospective study
found an increased incidence of low birth weights in infants born of mothers
receiving corticosteroids.
Administration of corticosteroids to pregnant animals can cause abnormalities of
foetal development including cleft palate, intra-uterine growth retardation and affects
on brain growth and development. There is no evidence that corticosteroids result in
an increased incidence of congenital abnormalities, such as cleft palate in man,
however, when administered for long periods or repeatedly during pregnancy,
corticosteroids may increase the risk of intra-uterine growth retardation.
Hypoadrenalism may, in theory, occur in the neonate following prenatal exposure to
corticosteroids but usually resolves spontaneously following birth and is rarely
clinically important. Although neonatal adrenal insufficiency appears to be rare in
infants who were exposed in utero to corticosteroids, those exposed to substantial
doses of corticosteroids must be carefully observed and evaluated for signs of
adrenal insufficiency.
As with all drugs, corticosteroids should only be prescribed when the benefits to the
mother and child outweigh the risks. When corticosteroids are essential, however,
patients with normal pregnancies may be treated as though they were in the nongravid state.
Cataracts have been observed in infants born to mothers treated with long-term
corticosteroids during pregnancy.
Breast-feeding
Corticosteroids are excreted in small amounts in breast milk, however, doses of up
to 40 mg daily of methylprednisolone are unlikely to cause systemic effects in the
infant. Infants of months taking higher doses than this may have a degree of adrenal
suppression, but the benefits of breastfeeding are likely to outweigh any theoretical
risk.
Corticosteroids distributed into breast milk may suppress growth and interfere with
endogenous glucocorticoid production in nursing infants. Since adequate
reproductive studies have not been performed in humans with glucocorticoids, these
drugs should be administered to nursing mothers only if the benefits of therapy are
judged to outweigh the potential risks to the infant.
Overdosage
Following overdosage the possibility of adrenal suppression should be guarded
against by gradual diminution of dose levels over a period of time. In such event the
patient may require to be supported during any further traumatic episode.

Reports of acute toxicity and/or death following overdosage of corticosteroids are
rare. In the event of overdosage, no specific antidote is available; treatment is
supportive and symptomatic.
Methylprednisolone is dialyzable.
Incompatibilities (major)
None stated.
Pharmaceutical precautions
Do not freeze. Depo-Medrone should not be mixed with any other fluid.
Discard any remaining suspension after use.
Legal Category

POM
Package quantities
1ml vials, 3 x 1 ml vials or 10 x 1ml vials
Product licence number
PL 20636/2572
Manufacturer and Product Licence Holder
Depo-Medrone is made by Pfizer Manufacturing Belgium NV,
Rijksweg 12, B-2870 Puurs, Belgium, procured from within the EU by Product
Licence holder Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex,
UK, HA1 1XD. Repackaged by Servipharm Ltd.
Leaflet revision and issue date (Ref) 18.07.17[H-6]
Depo-Medrone is a trademark of Pfizer.

Expand Transcript

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.

Hide