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DEPO-MEDRONE 40 MG/ML SUSPENSION FOR INJECTION

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

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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.



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

Keep this leaflet. You may need to read it again.



If you have any further questions, ask your doctor, pharmacist
or nurse.





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



into the Achilles tendon (which is located behind the ankle
joint), or

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.



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).




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

3. How Depo-Medrone is given to you

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



Broken bones or fractures.



What Depo-Medrone looks like

Breakdown of bone due to poor circulation of blood, this causes
pain in the hip.



Depo-Medrone is a white, sterile aqueous suspension for injection
contained in a glass vial fitted with a rubber cap and metal seal.

Joint pain.



Torn muscle tendons causing pain and/or swelling.

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



Muscle cramps or spasms.



Swollen or painful joints due to infection.

Manufacturer
This product is manufactured by Pfizer Manufacturing Belgium NV
Rijksweg 12, B-2870 Puurs, Belgium.

These are common in both adults and children. They can affect
about 5 in every 100 people taking medicines like
methylprednisolone.

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



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

POM

PL: 19488/1531

Acne.



Bruising.



Abscess, especially near injection sites.



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.



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.

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.

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



Hypertension (high blood pressure).



Hypotension (low blood pressure).



Hypothyroidism (an under-active thyroid).



Joint infection.



Kidney or liver disease.



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



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



Osteoporosis (brittle bones).



Pheochromocytoma (a rare tumour of adrenal gland tissue.
The adrenal glands are located above the kidneys).

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:




Leaflet revision date: 28 April 2017

Blind or partially sighted? Is
this leaflet hard to see or read?
Call 02087997607 to obtain the
leaflet in large print, tape, CD
or Braille.
Depo-Medrone is a trademark of Pharmacia Ltd., United Kingdom.

not known




6. Contents of the pack and other information

Product Licence holder

Other nervous system side effects may include convulsions
(seizures), amnesia (loss of memory), cognitive disorder
(mental changes, dizziness and headache.

4. Possible side effects
5. How to store Depo-Medrone

Steroids including methylprednisolone can cause serious mental
health problems.



Talk to your doctor or nurse before taking

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.

Muscle wasting.

Feeling, seeing or hearing things which do not exist. Having
strange and frightening thoughts, changing how you act or
having feelings of being alone.

Warnings and precautions
Depo-Medrone if you have any of the following conditions.

Brittle bones (bones that break easily).



Do not inject this medicine:

2. What you need to know before you are given DepoMedrone



Feeling anxious, having problems sleeping, difficulty in thinking
or being confused and losing your memory.

See your doctor immediately if any of the above applies to you.

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



Feeling high (mania) or moods that go up and down.

You have recently had, or are about to have any vaccination.



Muscle weakness.



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



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







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

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

not known

Feeling depressed, including thinking about suicide.

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.



What Depo-Medrone contains







6. Further information

not known

Do not use Depo-Medrone if:

Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.



Nerves and mood issues

2. What you need to know before you are given Depo-Medrone

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



Metabolism and nutrition disorders
Muscles, bones and joints

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

5. How to store Depo-Medrone

Increased susceptibility to infections which can hide or change
normal reactions to skin tests, such as that for tuberculosis.
Accumulation of fat tissue on localized parts of the body.

PATIENT INFORMATION LEAFLET

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

Immune system
not known

S1531 LEAFLET 20170428

Reporting of side effects

S1531 LEAFLET 20170428






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.

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)



Skin abscess.





Stomach ulcer or other serious stomach or intestinal problems.

Thinning of skin, stretch marks.

joints e.g. rheumatoid arthritis

Small purple/red patches on the skin.



Unusual stress.









Pale or darker patches on your skin, or raised patches which
are an unusual color.

lungs e.g. asthma, severe hay fever or rhinitis, tuberculosis or
inflammation caused by breathing in (aspirating) vomit or
stomach contents

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.



Rash, itching, hives.

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).



Increased hair on the body and face (hirsutism).



Traumatic brain injury.



Increased sweating.

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.

Other medicines and Depo-Medrone

Driving and using machines

Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines.

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.

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)

Depo-Medrone contains sodium

If your symptoms seem to return or get worse as your dose of this
medicine is reduced tell your doctor immediately.

This medicinal product contains less than 1 mmol sodium (23 mg)
per vial, i.e. essentially ‘sodium-free’.

Mental problems while taking

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.

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 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.

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.

Dosage information

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

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.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although
not everybody gets them. Your doctor will have given you this
medicine for a condition which if not treated properly could become
serious.
In certain medical conditions medicines like Depo-Medrone
(steroids) should not be stopped abruptly. If you suffer from
any of the following symptoms seek IMMEDIATE medical
attention. Your doctor will then decide whether you should
continue taking your medicine.





Skin conditions – the usual dose is between 20 – 60 mg (0.5 – 1.5
ml) injected into the affected part or parts of the skin.
For other more general conditions 40 – 120 mg (1 – 3 ml) of this
medicine may be injected into a large muscle.



Elderly

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.

If you are given more Depo-Medrone than you should



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

Depo-Medrone with drink

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

Do not drink grapefruit juice while taking this medicine.

Stopping/reducing the dose of your

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.

These illnesses can be serious.





Children

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.





Before you have any operation tell your doctor, dentist or
anaesthetist that you are taking this medicine.

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

Mental health problems can happen while taking steroids like DepoMedrone (see also section 4, Possible Side Effects).

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.

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.

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.

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.

Depo-Medrone

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.

Pregnancy and breast-feeding

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.





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.



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.

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

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



Cataracts (indicated by failing eyesight).

Ulcers or bleeding ulcers, symptoms of which are severe
stomach pain which may go through to the back and could be
associated with bleeding from the back passage, black or
bloodstained stools and/or vomiting blood.



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).

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.

General disorders
not known


Poor wound healing.



Irritability in children.



Feeling tired or unwell.

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.



Skin reactions at the site of injection.



Irritability in adults.

Thrombophlebitis (blood clots or thrombosis in a leg vein),
symptoms of which include painful swollen, red and tender
veins.



Pulmonary embolus (blood clot in the lung) symptoms include
sudden sharp chest pain, breathlessness and coughing up
blood.

If you experience any of the following side effects, or notice
any other unusual effects not mentioned in this leaflet, tell your
doctor immediately.

Hepatobiliary disorders
Methylprednisolone can damage your liver, hepatitis and
increase of liver enzymes have been reported.

Hormones and metabolic system
not known


The side effects may occur with certain frequencies, which are
defined as follows:

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.

not known: frequency cannot be estimated from the available
data

S1531 LEAFLET 20170428

Musculoskeletal Effects

Pharmaceutical precautions

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.

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.

Osteoporosis is a common but infrequently recognized adverse effect
associated with a long-term use of large doses of glucocorticoid.

Product Licence holder

Renal and Urinary Disorders
Corticosteroids should be used with caution in patients with renal
insufficiency.
Investigations
Average and large doses of hydrocortisone or cortisone can cause
elevation of blood pressure, salt and water retention, and increased
excretion of potassium. These effects are less likely to occur with the
synthetic derivatives except when used in large doses. Dietary salt
restriction and potassium supplementation may be necessary. All
corticosteroids increase calcium excretion.
Care should be taken for patients receiving cardioactive drugs such as
digoxin because of steroid induced electrolyte disturbance/potassium
loss (see side effects).
Other
Patients should carry ‘Steroid Treatment’ cards which give clear
guidance on the precautions to be taken to minimize risk and which
provide details of prescriber, drug, dosage and the duration of
treatment.
Corticosteroids should be used with caution in patients with a
predisposition to thrombophlebitis.
Aspirin and nonsteroidal anti-inflammatory agents should be used
cautiously in conjunction with corticosteroids.
Pheochromocytoma crisis, which can be fatal, has been reported after
administration of systemic corticosteroids. Corticosteroids should only
be administered to patients with suspected or identified
pheochromocytoma after an appropriate risk/benefit evaluation.
Use in Children
Corticosteroids cause growth retardation in infancy, childhood and
adolescence which may be irreversible. Growth and development of
infants and children on prolonged corticosteroid therapy should be
carefully observed. Treatment should be limited to the minimum dosage
for the shortest possible time and should be restricted to the most
serious indications.
Infants and children on prolonged corticosteroid therapy are at special
risk from raised intracranial pressure. High doses of corticosteroids may
produce pancreatitis in children.
Use in Pregnancy and Lactation
Pregnancy
The ability of corticosteroids to cross the placenta varies between
individual drugs, however, methylprednisolone does cross the placenta.
One retrospective study found an increased incidence of low birth
weights in infants born of mothers receiving corticosteroids.
Administration of corticosteroids to pregnant animals can cause
abnormalities of foetal development including cleft palate, intra-uterine
growth retardation and affects on brain growth and development. There
is no evidence that corticosteroids result in an increased incidence of
congenital abnormalities, such as cleft palate in man, however, when
administered for long periods or repeatedly during pregnancy,
corticosteroids may increase the risk of intra-uterine growth retardation.
Hypoadrenalism may, in theory, occur in the neonate following prenatal
exposure to corticosteroids but usually resolves spontaneously following
birth and is rarely clinically important. Although neonatal adrenal
insufficiency appears to be rare in infants who were exposed in utero to
corticosteroids, those exposed to substantial doses of corticosteroids
must be carefully observed and evaluated for signs of adrenal
insufficiency. As with all drugs, corticosteroids should only be prescribed
when the benefits to the mother and child outweigh the risks. When
corticosteroids are essential, however, patients with normal pregnancies
may be treated as though they were in the non-gravid state.
Cataracts have been observed in infants born to mothers treated with
long-term corticosteroids during pregnancy.
Breast-feeding
Corticosteroids are excreted in small amounts in breast milk, however,
doses of up to 40 mg daily of methylprednisolone are unlikely to cause
systemic effects in the infant. Infants of 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.

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

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

PL: 19488/1531

Leaflet revision date: 28 April 2017

S1531 Physician LEAFLET 20170428

S1531 Physician LEAFLET 20170428

PHYSICIAN LEAFLET

DEPO-MEDRONE® 40mg/ml SUSPENSION FOR INJECTION
(methylprednisolone acetate)
Presentation
White, sterile aqueous suspension for injection containing 40 mg per ml
methylprednisolone acetate. Also contains polyethylene glycol, sodium
chloride, myristyl-gamma-picolinium chloride and sterile water for
injections.
Uses
Depo-Medrone may be used locally or systemically, particularly where
oral therapy is not feasible.
Depo-Medrone may be used by any of the following routes:
intramuscular, intra-articular, periarticular, intrabursal, intralesional or
into the tendon sheath. It must not be used by the intrathecal or
intravenous routes. (See Contraindications and Side effects).
Intramuscular administration:
1. Rheumatic disorders
Rheumatoid arthritis
2.
3.
4.

5.

Collagen diseases/arthritis
Systemic lupus erythematosus
Dermatological diseases
Severe erythema multiforme (Stevens-Johnson syndrome)
Allergic states
Bronchial asthma
Severe seasonal and perennial allergic rhinitis
Drug hypersensitivity reactions
Angioneurotic oedema
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

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

Dosage and administration



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

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. DepoMedrone 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).



for use by the intravenous route

Undesirable effects may be minimized by using the lowest effective
dose for the minimum period (see special warnings and precautions).
Depo-Medrone vials are intended for single dose use only.
Intramuscular – for sustained systemic effect: Allergic conditions (severe
seasonal and perennial allergic rhinitis, asthma, drug reactions). 80 –
120 mg (2 – 3 ml).
Dermatological conditions, 40 – 120 mg (1 – 3 ml).
Rheumatic disorders and collagen diseases (rheumatoid arthritis, SLE),
40 – 120 mg (1 – 3 ml) per week.
Dosage must be individualised and depends on the condition being
treated and its severity.
Note: Depo-Medrone is not intended for the prophylaxis of severe
seasonal and perennial allergic rhinitis or other seasonal allergies and
should be administered only when symptoms are present.
The frequency of intramuscular injections should be determined by the
duration of the clinical response.
In the case of seasonal allergic rhinitis a single injection is frequently
sufficient. If necessary, however, a second injection may be given after
two to three weeks.
On average the effect of a single 2 ml (80 mg) injection may be
expected to last approximately two weeks.
Intra-articular: Rheumatoid arthritis, osteo-arthritis. The dose of DepoMedrone depends upon the size of the joint and the severity of the
condition. Repeated injections, if needed, may be given at intervals of
one to five or more weeks depending upon the degree of relief obtained
from the initial injection. A suggested dosage guide is: large joint (knee,
ankle, shoulder), 20 – 80mg (0.5 – 2 ml); medium joint (elbow, wrist),
10 – 40 mg (0.25 – 1 ml); small joint (metacarpophalangeal,
interphalangeal, sternoclavicular, acromioclavicular), 4 – 10 mg (0.1 –
0.25 ml).
Intrabursal: Subdeltoid bursitis, prepatellar bursitis, olecranon bursitis.
For administration directly into bursae, 4 – 30 mg (0.1 – 0.75 ml). In
most cases, repeat injections are not needed.
Intralesional: Keloids, localized lichen planus, localized lichen simplex,
granuloma annulare, alopecia areata, and discoid lupus erythematosus.
For administration directly into the lesion for local effect in
dermatological conditions, 20 – 60 mg (0.5 – 1.5 ml). For large lesions,
the dose may be distributed by repeated local injections of 20 – 40 mg
(0.5 – 1 ml). One to four injections are usually employed. Care should
be taken to avoid injection of sufficient material to cause blanching,
since this may be followed by a small slough.

Administration of live or live, attenuated vaccines is contraindicated in
patients receiving immunosuppressive doses of corticosteroids.
Interactions
1. Convulsions have been reported with concurrent use of
methylprednisolone and ciclosporin. Since concurrent administration
of these agents results in a mutual inhibition of metabolism, it is
possible that convulsions and other adverse effects associated with
the individual use of either drug may be more apt to occur.
2. Drugs that induce hepatic enzymes, such as rifampicin, rifabutin,
carbamazepine, phenobarbitone, phenytoin, primidone and
aminoglutethimide enhance the metabolism of corticosteroids and
their therapeutic effect may be reduced. Aminoglutethimide- induced
adrenal suppression may exacerbate endocrine changes caused by
prolonged glucocorticoid treatment. The acetylation rate and
clearance of isoniazid, an antibacterial drug, can be increased by
methylprednisolone.
3. Drugs such as erythromycin, itraconazole and ketoconazole may
inhibit the metabolism of corticosteroids and thus decrease their
clearance. Troleandomycin, as well as clarithromycin, erythromycin,
itraconazole and ketoconazole increase the effects and the side
effects of methylprednisolone.
4. Steroids may reduce the effects of anticholinesterases in
myasthenia gravis. The desired effects of hypoglycaemic agents
(including insulin), anti-hypertensives and diuretics are antagonized
by corticosteroids, and the hypokalaemic effects of acetazolamide,
loop diuretics, thiazide diuretics and carbenoxolone are enhanced.
Antagonism of the neuromuscular blocking effects of pancuronium
and vecuronium has been reported in patients taking
corticosteroids. This interaction may be expected with all
competitive neuromuscular blockers.
5. The effect of methylprednisolone on oral anticoagulants is variable.
The efficacy of coumarin anticoagulants may be enhanced by
concurrent corticosteroid therapy and close monitoring of the INR or
prothrombin time is required to avoid spontaneous bleeding and to
maintain the desired anticoagulant effects. There are also reports of
diminished effects of anticoagulants when given concurrently with
corticosteroids.
6. There may be increased incidence of gastrointestinal bleeding and
ulceration when corticosteroids are given with NSAIDs.
Methylprednisolone may increase the clearance of high-dose
aspirin, which can lead to decreased salicylate serum levels.
Discontinuation of methylprednisolone treatment can lead to raised
salicylate serum levels, which could lead to an increased risk of
salicylate toxicity. Salicylates and non-steroidal anti-inflammatory
agents should be used cautiously in conjunction with corticosteroids
in hypothrombinaemia.

7. Antidiabetics - Because corticosteroids may increase blood glucose
concentrations, dosage adjustments of antidiabetic agents may be
required.
8. Antiemetics - Aprepitant and fosaprepitant (CYP3A4 inhibitors and
substrates).

Ear and labyrinth
disorders

9. Antivirals - HIV protease inhibitors:

Cardiac disorders

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.

Vascular
disorders
Respiratory,
thoracic and
mediastinal
disorders

Not
Known
Not
Known
Not
Known

Not
Known

12. Other immunosuppressants like cyclophosphamide and tacrolimus.

thinning; Exacerbation of
ophthalmic viral or fungal
disease; Chorioretinopathy

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.

Vertigo

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.

Cardiac failure congestive (in
susceptible patients)
Hypertension; Hypotension;
Embolism arterial Thrombotic
events
Pulmonary embolism, Hiccups

14. Grapefruit juice – (CYP3A4 inhibitor).

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

Effects on ability to drive and to use machines

Diarrhoea; Dyspepsia;
Nausea

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.

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 hypothalamicpituitary-adrenal suppression correlates with the relative potency of the
drug, dosage, timing of administration and duration of treatment (see
Special warnings and precautions).
MedDRA (v15)

Hepatobiliary
disorders

Skin and
subcutaneous
tissue disorders

Not
Known
Not
Known

Not
Known

Undesirable Effects
Not
Known

Infections and
infestations

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

Immune system
disorders

Not
Known

Drug hypersensitivity,
Anaphylactic reaction

Blood and
lymphatic system
disorders

Not
Known

Leukocytosis

Not
Known

Endocrine
disorders

Not
Known

Metabolism and
nutrition
disorders

Not
Known

Psychiatric
disorders

Not
Known
Nervous system
disorders

Not
Known

Eye disorders

Gastrointestinal
disorders

Musculoskeletal
and connective
tissue disorders

Frequency

System Organ
Class

Not
Known

Cushingoid; Hypopituitarism;
Withdrawal symptoms - Too
rapid a reduction of
corticosteroid dosage
following prolonged treatment
can lead to acute adrenal
insufficiency, hypotension and
death. However, this is more
applicable to corticosteroids
with an indication where
continuous therapy is given
(see section 4.4 of the SPC).
A 'withdrawal syndrome' may
also occur including, fever,
myalgia, arthralgia, rhinitis,
conjunctivitis, painful itchy
skin nodules and loss of
weight.
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
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
Cataract; Glaucoma;
Exophthalmos; rare instances
of blindness associated
with intralesional therapy
around the face and head [not
a MedDRA PT]; Increased
intra-ocular pressure, with
possible damage to the optic
nerve; Corneal or scleral

Reproductive
system and
breast disorders
General disorders
and
administration
site conditions

Not
Known
Not
Known

Not
Known

Investigations

Not
Known
Injury, poisoning
and procedural
complications

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
CONTRAINDICATED AND NON RECOMMENDED ROUTES OF
ADMINISTRATION
Intrathecal/Epidural: Usual systemic corticoid adverse reactions,
headache, meningismus, meningitis, paraparesis/paraplegia, spinal fluid
abnormalities, nausea, vomiting, sweating, arachnoiditis, functional
gastrointestinal disorder/bladder dysfunction, convulsions, sensory
disturbances. The frequency of these adverse reactions is not known.
Extradural: Wound dehiscence, loss of sphincter control.
Intranasal: Permanent/temporary blindness, rhinitis.
Ophthalmic: (Subconjunctival) – Redness and itching, abscess, slough
at injection site, residue at injection site, increased intra-ocular pressure,
decreased vision – blindness, infection.
Miscellaneous injection sites: Scalp, tonsillar fauces, sphenopalatine
ganglion: blindness.
Special warnings and precautions
Warnings and Precautions:
Undesirable effects may be 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 DepoMedrone. 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

Systemic absorption of methylprednisolone occurs following intraarticular injection of Depo-Medrone. Systemic as well as local effects
can therefore be expected.
Adrenal cortical atrophy develops during prolonged therapy and may
persist for months after stopping treatment. In patients who have
received more than physiological doses of systemic corticosteroids
(approximately 6 mg methylprednisolone) for greater than 3 weeks,
withdrawal should not be abrupt. How dose reduction should be carried
out depends largely on whether the disease is likely to relapse as the
dose of systemic corticosteroids is reduced. Clinical assessment of
disease activity may be needed during withdrawal. If the disease is
unlikely to relapse on withdrawal of systemic corticosteroids, but there is
uncertainty about HPA suppression, the dose of systemic corticosteroid
may be reduced rapidly to physiological doses. Once a daily dose of 6
mg methylprednisolone is reached, dose reduction should be slower to
allow the HPA-axis to recover.
The following precautions apply for parenteral
corticosteroids: Following intra–articular injection, the occurrence of a
marked increase in pain accompanied by local swelling, further
restriction of joint motion, fever, and malaise are suggestive of septic
arthritis. If this complication occurs and the diagnosis of sepsis is
confirmed, appropriate antimicrobial therapy should be instituted.
Local injection of a steroid into a previously infected joint is to be
avoided.
Intra-articular corticosteroids are associated with a substantially
increased risk of inflammatory response in the joint, particularly bacterial
infection introduced with the injection. Charcot-like arthropathies have
been reported particularly after repeated injections. Appropriate
examination of any joint fluid present is necessary to exclude any
bacterial infection, prior to injection.
Corticosteroids should not be injected into unstable joints.
Sterile technique is necessary to prevent infections or contamination.
The slower rate of absorption by intramuscular administration should be
recognised.
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 nonimmune 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.
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.
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.
Abrupt withdrawal of systemic corticosteroid treatment, which has
continued up to 3 weeks is appropriate if it considered that the disease
is unlikely to relapse. Abrupt withdrawal of doses up to 32 mg daily of
methylprednisolone for 3 weeks is unlikely to lead to clinically relevant
HPA-axis suppression, in the majority of patients. In the following patient
groups, gradual withdrawal of systemic corticosteroid therapy should be
considered even after courses lasting 3 weeks or less:


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



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



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



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



Patients repeatedly taking doses in the evening.

Because glucocorticoids can produce or aggravate Cushing’s
syndrome, glucocorticoids should be avoided in patients with Cushing’s
disease.
There is an enhanced effect of corticosteroids on patients with
hypothyroidism.
Metabolism and Nutrition
Corticosteroids, including methylprednisolone, can increase blood
glucose, worsen pre-existing diabetes, and predispose those on longterm 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 manic-depressive illness and previous
steroid psychosis.
Nervous System Effects
Corticosteroids should be used with caution in patients with seizure
disorders.
Corticosteroids should be used with caution in patients with myasthenia
gravis (Also see myopathy statement in Musculoskeletal Effects
section).
There have been reports of epidural lipomatosis in patients taking
corticosteroids, typically with long-term use at high doses.
Ocular Effects
Prolonged use of corticosteroids may produce posterior subcapsular
cataracts and nuclear cataracts (particularly in children), exophthalmos,
or increased intraocular pressure, which may result in glaucoma with
possible damage to the optic nerves, and may enhance the
establishment of secondary ocular infections due to fungi or viruses.
Corticosteroids should be used cautiously in patients with ocular herpes
simplex, because of possible corneal perforation.
Corticosteroid therapy has been associated with central serous
chorioretinopathy, which may lead to retinal detachment.
Cardiac Effects
Adverse effects of glucocorticoids on the cardiovascular system, such
as dyslipidaemia and hypertension, may predispose treated patients
with existing cardiovascular risk factors to additional cardiovascular
effects, if high doses and prolonged courses are used. Accordingly,
corticosteroids should be employed judiciously in such patients and
attention should be paid to risk modification and additional cardiac
monitoring if needed.
Systemic corticosteroids should be used with caution, and only if strictly
necessary, in cases of congestive heart failure.
Vascular Effects
Corticosteroids should be used with caution in patients with
hypertension.
Gastrointestinal Effects
There is no universal agreement on whether corticosteroids per se are
responsible for peptic ulcers encountered during therapy; however,
glucocorticoid therapy may mask the symptoms of peptic ulcer so that
perforation or haemorrhage may occur without significant pain. In
combination with NSAIDs, the risk of developing gastrointestinal ulcers
is increased.
Corticosteroids should be used with caution in nonspecific ulcerative
colitis, if there is a probability of impending perforation, abscess or other
pyogenic infection. Caution must also be used in diverticulitis, fresh
intestinal anastomoses, active or latent peptic ulcer, when steroids are
used as direct or adjunctive therapy.
Hepatobiliary Effects
High doses of corticosteroids may produce acute pancreatitis.
Corticosteroids should be used with caution in patients with liver failure
or cirrhosis.
S1531 Physician LEAFLET 20170428

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.

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