DEPO-MEDROL 40MG/ML SUSPENSION FOR INJECTION

Active substance: METHYLPREDNISOLONE ACETATE

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can cause low blood pressure and dizziness. This effect may persist for
months.
The amount of certain chemicals (enzymes) called alanine transaminase,
aspartate transaminase and alkaline phosphatase that help the body digest
drugs and other substances in your body may be raised after treatment
with a corticosteroid. The change is usually small and the enzyme levels
return to normal after your medicine has cleared naturally from your
system. You will not notice any symptoms if this happens, but it will show
up if you have a blood test.

Immune system
• Increased susceptibility to infections which can hide or change normal
reactions to skin tests, such as that for tuberculosis.
Muscles, bones and joints

• Muscle weakness or wasting.
• Brittle bones (bones that break easily).
• Broken bones or fractures.
• Breakdown of bone due to poor circulation of blood, this causes pain in the
hip.

• Torn muscle tendons causing pain and/or swelling.
• Muscle cramps or spasms.
• Swollen or painful joints due to infection.

5

Expiry date
Do not use this medicine after the expiry date shown on the carton label or
vial label. Each vial is for single use only. After use, your doctor should take
the container and syringe away. Return any unused medicine to your
pharmacist for safe disposal. Only keep this medicine, if your doctor tells you
to. If your medicine become discoloured or show any other signs of
deterioration, consult your pharmacist (chemist) who will tell you what to do.
Storing your medication
• KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.
• Protect from freezing.
• Do not store above 25°C
Important
Remember this medicine is for you. Only a doctor can prescribe it. Never
give your medicine to anyone, it may harm them, even if their symptoms are
the same as yours. This leaflet does not tell you everything about this
medicine. If you have any questions or are not sure about anything then ask
your doctor or pharmacist.

6
Nerves and mood issues
Steroids including methylprednisolone can cause serious mental health
problems.
These are common in both adults and children. They can affect about 5 in
every 100 people taking medicines like methylprednisolone.
• Feeling depressed, including thinking about suicide.
• Feeling high (mania) or moods that go up and down.
• Feeling anxious, having problems sleeping, difficulty in thinking or being
confused and losing your memory.
• Feeling, seeing or hearing things which do not exist. Having strange and
frightening thoughts, changing how you act or having feelings of being
alone.
• Other nervous system side effects may include breathing problems,
convulsions, dizziness, drowsiness, difficulty breathing, sensation of cold,
heat or numbness, tinnitus or unconsciousness.

Further information

What Depo-Medrone contains
Each 1ml vial contains 40mg methylprednisolone acetate. Each vial also
contains macrogol, sodium chloride, myristyl-gamma-picolinium chloride, and
water for injections.
What a Depo-Medrone looks like
Depo-Medrone is a white, sterile aqueous suspension for injection.
Depo-Medrone is available in cartons of 1 x 1ml vial or 3 x 1ml vials.
Manufacturer and Licence Holder
Depo-Medrone is manufactured by Pfizer Manufacturing Belgium N.V.,
Rijksweg 12, Puurs, Belgium and is procured from within the EU and
repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

POM
Skin
• Abscess, especially near injection sites
• Acne.
• Poor wound healing.
• Thinning of skin with stretch marks.
• Bruising.
• Small purple/red patches on the skin.
• Pale or darker patches on your skin, or raised patches which are an
unusual color.
If you experience any of the side effects listed above tell your doctor
straight immediately.

®

Depo-Medrone 40mg/ml suspension for injection

How to store Depo-Medrone

Depo-Medrone 40mg/ml suspension for injection PL:15184/0927

Depo-Medrone is a registered trademark of Pharmacia & Upjohn Limited.
Leaflet revision date: 14/11/11

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

Ref:0927/141111/1/F

(methylprednisolone acetate)

Patient Information Leaflet
• brain e.g. meningitis caused by tuberculosis
• bowel and gut e.g. Crohn’s disease (inflammation of the gut) or ulcerative

Your medicine is called Depo-Medrone 40mg/ml suspension for injection but
will be referred to as Depo-Medrone throughout this leaflet.

Read all of this leaflet carefully before you start taking this medicine
• Keep this leaflet. You may need to read it again
• If you have any further questions please ask your doctor or pharmacist
• This medicine has been prescribed for you. Do not pass it to others. It may
harm them even if their symptoms are the same as yours
• If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, tell your doctor or pharmacist

In
1
1.
2
2.
3
3.
4
4.
5
5.
6
6.

1

this leaflet:
What Depo-Medrone is and what it is used for
Before you are given Depo-Medrone
How Depo-Medrone is given to you
Possible side effects
How to store Depo-Medrone
Further information

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:

colitis (inflammation of the lower bowel)

• joints e.g. rheumatoid arthritis
• lungs e.g. asthma, severe hay fever or rhinitis, tuberculosis or

inflammation caused by breathing in (aspirating) vomit or stomach contents

• skin e.g. Stevens-Johnson syndrome (an ‘auto-immune disorder in which
an immune system causes the skin to blister and peel) or systemic lupus
erythematosus (lupus),

Your doctor may use this medicine to treat conditions other than those listed
above. Ask your doctor if you are unsure why you have been given this
medicine.

2

Before you are given Depo-Medrone

Do not use Depo-Medrone if:
• You think you have ever suffered an allergic reaction, or any other type of
reaction after being given Depo-Medrone, or any other medicine containing
a corticosteroid or any of the ingredients in this medicine (Section 6 of this
leaflet contains a list of ingredients).An allergic reaction may cause a skin
rash or reddening, swollen face or lips or shortness of breath.
• You get a rash, or another symptom of an infection.
See your doctor immediately if you have any of the above.
Do not inject this medicine into:
• the Achilles tendon (which is located behind the ankle joint), or
• directly into a vein (intravenous), the spinal cord (intrathecal), the outer
covering of the brain (extradural), into the nostrils (intranasal) or in the eye
(intraocular).
Take special care before taking Depo-Medrone:
You must tell your doctor before you take this medicine if you have any of
the following conditions.
Your doctor may also have to monitor your treatment more closely, alter your
dose or give you another medicine.



Chickenpox, shingles or a herpes eye infection. If you think you have
been in contact with someone with chickenpox or shingles and you have
not already had these illnesses, or if you are unsure if you have had them.
• Severe depression or manic depression (bipolar disorder). This includes
having had depression before while taking steroid medicines like
Depo-Medrone, or having a family history of these illnesses.
• Diabetes (or if there is a family history of diabetes).
• Epilepsy.
• Glaucoma (increased pressure in the eye) or if there is a family history of
glaucoma.
• You have recently suffered a heart attack.
• Heart problems, including heart failure or infections.
• Hypertension (high blood pressure).
• Hypothyroidism (an under-active thyroid).
Page 1











Joint infection
Kidney or liver disease.
Muscle problems (pain or weakness) have happened while taking steroid
medicines in the past.
Myasthenia gravis (a condition causing tired and weak muscles).
Osteoporosis (brittle bones).
Skin abscess.
Stomach ulcer or other serious stomach or intestinal problems.
Thrombophlebitis - vein problems due to thrombosis (clots in the veins)
resulting in phlebitis (red, swollen and tender veins).
Tuberculosis (TB) or if you have suffered tuberculosis in the past.

You must tell your doctor before you take this medicine if you have any of
the conditions listed above.
Taking other medicines
Always tell your doctor or pharmacist if you are taking any medicines
(including any you have bought without a prescription) as taking
Depo-Medrone with other medicines could be harmful.
You should tell your doctor if you are taking any of the following medicines
which can affect the way Depo-Medrone or the other medicine works:
• Acetazolamide - used to treat glaucoma and epilepsy
• Aminoglutethimide – used for treating cancer
• Anticoagulants - used to ‘thin’ the blood such as acenocoumarol,
phenindione and warfarin
• Anticholinesterases - used to treat myasthenia gravis (a muscle
condition) such as distigmine and neostigmine
• Antibiotics (such as erythromycin)
• Aspirin and non-steroidal anti-inflammatory medicines (also called
NSAIDs) such as ibuprofen used to treat mild to moderate pain
• Barbiturates, carbamazepine, phenytoin and primidone – used to treat
epilepsy
• Carbenoxolone - used for heartburn and acid indigestion
• Ciclosporin - used to treat conditions such as severe rheumatoid arthritis,
severe psoriasis or following an organ or bone marrow transplant
• Digoxin - used for heart failure and/or an irregular heart beat
• Diltiazem or mibefradil – used for heart problems or high blood pressure
• Diuretics – sometimes called water tablets.
• Ketoconazole or itraconazole – used to treat fungal infections
• Pancuronium – or other medicines called neuromuscular blocking agents
which are used in some surgical procedures
• Rifampicin and rifabutin – antibiotics used to treat tuberculosis (TB)
• Vaccines - tell your doctor or nurse if you have recently had, or are about
to have any vaccination. You should not have ‘live’ vaccines while using
this medicine. Other vaccines may be less effective.
If you are taking long term medication(s)
If you are being treated for diabetes, high blood pressure or water retention
(oedema) tell your doctor as he/she may need to adjust the dose of the
medicines used to treat these conditions.
Before you have any operation tell your doctor, dentist or anesthetist that
you are taking this medicine.
If you require a test to be carried out by your doctor or in hospital it is
important that you tell the doctor or nurse that you are taking Depo-Medrone.
This medicine can affect the results of some tests.
Page 2

Pregnancy and breast feeding
You must tell your doctor if you are pregnant, think you might be pregnant or
are trying to become pregnant as this medicine could slow the baby’s growth.
Tell your doctor if you are breast feeding as small amounts of corticosteroid
medicines may get into breast milk.
If you continue breast-feeding while you are having treatment, your baby will
need extra checks to make sure he or she is not being affected by your
medicine.
Driving and Using Machines
There are no special precautions while you are being treated with this
medicine

3

How Depo-Medrone is given to you

Steroid Cards
Remember to always carry a Steroid Treatment Card. Make sure your
doctor or pharmacist has filled out the details of your medicine,
including the dose and how long you will require steroid treatment.
You should show your steroid card to anyone who gives you treatment (such
as a doctor, nurse or dentist) while you are taking this medicine, and for 3
months after your last injection.
If you are admitted to hospital for any reason always tell your doctor or nurse
that you are taking this medicine. You can also wear a medic-alert bracelet or
pendant to let medical staff know that you are taking a steroid if you have an
accident or become unconscious.
Dosage information
Your doctor will decide on the site of injection, how much of the medicine and
how many injections you will receive depending on the condition being
treated and its severity. Your doctor will inject you with the lowest dose for the
shortest possible time to get effective relief of your symptoms.
Adults
Your doctor/nurse will tell you how many injections you will require for the
condition you are being treated for, and when you will get them.
Joints - the normal dose for the injections into joint will depend on the size of
the joint. Large joints (e.g. knee, ankle and shoulder) may require 20 - 80 mg
(0.5 – 2 ml), medium sized joints (e.g. elbow or wrist) 10 - 40 mg (0.25 – 1
ml) and small joints (e.g. finger or toe joints) may require a 4 - 10 mg
(0.1 -0.25 ml) dose.
Joint injections may be given weekly over a period of several weeks,
depending on how quickly you respond to treatment.
Bursitis and epicondylitis (tennis elbow) – the usual dose is between 4-30 mg
(0.1 - 0.75 ml). In most cases repeat injections will not needed for bursitis
and epicondylitis. Repeat injections may be necessary to treat long standing
conditions.
Skin conditions – the usual dose is between 20 – 60mg (0.5 – 1.5ml) injected
into the affected part or parts of the skin.
For other more general conditions 40 – 120 mg (1 – 3ml) of this medicine
may be injected into a large muscle.

Elderly
Treatment will normally be the same as for younger adults. However your
doctor may want to see you more regularly to check how you are getting on
with this medicine.
Children
Corticosteroids can affect growth in children so your doctor will prescribe the
lowest dose that will be effective for your child.






If you are given more Depo-Medrone than you should
If you think you have been given too many injections of this medicine please
speak to your doctor immediately.
Stopping/reducing the dose of your Depo-Medrone
Your doctor will decide when it is time to stop your treatment.
You will need to come off this treatment slowly if you:
• have been given Depo-Medrone for more than 3 weeks;
• have been given high doses of Depo-Medrone, over 32 mg (0.8 ml) daily,
even if it was only for 3 weeks or less;
• have already had a course of corticosteroid tablets or injections in the last
year;
• already have problems with your adrenal glands (adrenocortical
insufficiency) before you started this treatment.
You will need to come off this medicine slowly to avoid withdrawal
symptoms. These symptoms may include itchy skin, fever, muscle and joint
pains, runny nose, sticky eyes, sweating and weight loss.
If your symptoms seem to return or get worse as your dose of this medicine
is reduced tell your doctor immediately.
Mental problems while taking Depo-Medrone
Mental health problems can happen while taking steroids like Depo-Medrone
(see also section 4, Possible Side Effects).
• These illnesses can be serious.
• Usually they start within a few days or weeks of starting the medicine.
• They are more likely to happen at high doses.
• Most of these problems go away if the dose is lowered or the medicine is
stopped. However if the problems do happen they might need treatment.
Talk to a doctor if you (or someone using this medicine) show any signs of
mental problems. This is particularly important if you are depressed, or might
be thinking about suicide. In a few cases mental problems have happened
when doses are being lowered or stopped.

4

Possible side-effects

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





Allergic reactions, such as skin rash, swelling of the face or wheezing
and difficulty breathing. This type of side effect is rare, but can be serious.
Acute pancreatitis, stomach pain spreading to your back, possibly
accompanied by vomiting, shock and loss of consciousness.
Burst or bleeding ulcers, symptoms of which are severe stomach pain
which may go through to the back and could be associated with bleeding
from the back passage, black or bloodstained stools and/or vomiting blood.
Infections. This medicine can hide or change the signs and symptoms of
some infections, or reduce your resistance to the infection, so that they are
hard to diagnose at an early stage. Symptoms might include a raised
temperature and feeling unwell. Symptoms of a flare up of a previous TB
infection could be coughing blood or pain in the chest. This medicine may
also make you more likely to develop a severe infection.
Pulmonary embolus (blood clot in the lung) symptoms include sudden
sharp chest pain, breathlessness and coughing up blood.
Raised pressure within the skull of children (pseudotumour cerebri)
symptoms of which are headaches with vomiting, lack of energy and
drowsiness. This side-effect usually occurs after treatment is stopped.
Thrombophlebitis (blood clots or thrombosis in a leg vein), symptoms of
which include painful swollen, red and tender veins.

If you experience any of the following side effects, or notice any other
unusual effects not mentioned in this leaflet, tell your doctor
immediately:
Body water and salts
• Swelling and high blood pressure, caused by increased levels of water and
salt content.
• Cramps and spasms, due to the loss of potassium from your body. In rare
cases this can lead to congestive heart failure (when the heart cannot
pump properly).
Digestive system
• Nausea (feeling sick) or vomiting (being sick).
• Ulcers or thrush in the gullet (discomfort on swallowing).
• Indigestion.
• Bloated stomach.
Eyes
• Glaucoma (raised pressure within the eye, causing pain in the eyes and
headaches).
• Swollen optic nerve (causing a condition called papilloedema, and which
may cause sight disturbance).
• Damage to the optic nerve or cataracts (indicated by failing eyesight).
• Thinning of the clear part at the front of the eye (cornea) or of the white
part of the eye (sclera).
• Worsening of viral or fungal eye infections.
• Protruding of the eyeballs (exophthalmos).
Hormones and metabolic system
• Slowing of normal growth in infants, children and adolescents which may
be permanent.
• Irregular or no periods in women.
• Increased hair on the body and face in women (hirsutism).
• Round or moon-shaped face (Cushingoid facies).
• Increased appetite and weight gain.
• Diabetes or worsening of existing diabetes.
• Prolonged therapy can lead to lower levels of some hormones which in turn
Page 3
Ref:0927/141111/1/B



can cause low blood pressure and dizziness. This effect may persist for
months.
The amount of certain chemicals (enzymes) called alanine transaminase,
aspartate transaminase and alkaline phosphatase that help the body digest
drugs and other substances in your body may be raised after treatment
with a corticosteroid. The change is usually small and the enzyme levels
return to normal after your medicine has cleared naturally from your
system. You will not notice any symptoms if this happens, but it will show
up if you have a blood test.

Immune system
• Increased susceptibility to infections which can hide or change normal
reactions to skin tests, such as that for tuberculosis.
Muscles, bones and joints

• Muscle weakness or wasting.
• Brittle bones (bones that break easily).
• Broken bones or fractures.
• Breakdown of bone due to poor circulation of blood, this causes pain in the
hip.

• Torn muscle tendons causing pain and/or swelling.
• Muscle cramps or spasms.
• Swollen or painful joints due to infection.

5

Expiry Date
Do not use this medicine after the expiry date shown on the carton label or
vial label. Each vial is for single use only. After use, your doctor should take
the container and syringe away. Return any unused medicine to your
pharmacist for safe disposal. Only keep this medicine, if your doctor tells you
to. If your medicine become discoloured or show any other signs of
deterioration, consult your pharmacist (chemist) who will tell you what to do.
Storing your medication
• KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.
• Protect from freezing.
• Do not store above 25°C
Important
Remember this medicine is for you. Only a doctor can prescribe it. Never
give your medicine to anyone, it may harm them, even if their symptoms are
the same as yours. This leaflet does not tell you everything about this
medicine. If you have any questions or are not sure about anything then ask
your doctor or pharmacist.

6
Nerves and mood issues
Steroids including methylprednisolone can cause serious mental health
problems.
These are common in both adults and children. They can affect about 5 in
every 100 people taking medicines like methylprednisolone.
• Feeling depressed, including thinking about suicide.
• Feeling high (mania) or moods that go up and down.
• Feeling anxious, having problems sleeping, difficulty in thinking or being
confused and losing your memory.
• Feeling, seeing or hearing things which do not exist. Having strange and
frightening thoughts, changing how you act or having feelings of being
alone.
• Other nervous system side effects may include breathing problems,
convulsions, dizziness, drowsiness, difficulty breathing, sensation of cold,
heat or numbness, tinnitus or unconsciousness.

Further information

What Depo-Medrol contains
Each 1ml vial contains 40mg methylprednisolone acetate. Each vial also
contains macrogol, sodium chloride, myristyl-gamma-picolinium chloride, and
water for injections.
What a Depo-Medrol looks like
Depo-Medrol is a white, sterile aqueous suspension for injection.
Depo-Medrol is available in cartons of 1 x 1ml vial or 3 x 1ml vials.
Manufacturer and Licence Holder
Depo-Medrol is manufactured by Pfizer Manufacturing Belgium N.V.,
Rijksweg 12, Puurs, Belgium and is procured from within the EU and
repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

POM
Skin
• Abscess, especially near injection sites
• Acne.
• Poor wound healing.
• Thinning of skin with stretch marks.
• Bruising.
• Small purple/red patches on the skin.
• Pale or darker patches on your skin, or raised patches which are an
unusual color.
If you experience any of the side effects listed above tell your doctor
straight immediately.

®

Depo-Medrol 40mg/ml suspension for injection

How to store Depo-Medrol

Depo-Medrol 40mg/ml suspension for injection PL:15184/0927

Depo-Medrol is a registered trademark of Pharmacia & Upjohn Limited.
Leaflet revision date: 14/11/11

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

Ref:0927/141111/2/F

(methylprednisolone acetate)

Patient Information Leaflet
• brain e.g. meningitis caused by tuberculosis
• bowel and gut e.g. Crohn’s disease (inflammation of the gut) or ulcerative

Your medicine is called Depo-Medrol 40mg/ml suspension for injection but
will be referred to as Depo-Medrol throughout this leaflet.

Read all of this leaflet carefully before you start taking this medicine
• Keep this leaflet. You may need to read it again
• If you have any further questions please ask your doctor or pharmacist
• This medicine has been prescribed for you. Do not pass it to others. It may
harm them even if their symptoms are the same as yours
• If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, tell your doctor or pharmacist

In
1
1.
2
2.
3
3.
4
4.
5
5.
6
6.

1

this leaflet:
What Depo-Medrol is and what it is used for
Before you are given Depo-Medrol
How Depo-Medrol is given to you
Possible side effects
How to store Depo-Medrol
Further information

What Depo-Medrol is and what it is used for

Depo-Medrol 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-Medrol 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:

colitis (inflammation of the lower bowel)

• joints e.g. rheumatoid arthritis
• lungs e.g. asthma, severe hay fever or rhinitis, tuberculosis or

inflammation caused by breathing in (aspirating) vomit or stomach contents

• skin e.g. Stevens-Johnson syndrome (an ‘auto-immune disorder in which
an immune system causes the skin to blister and peel) or systemic lupus
erythematosus (lupus),

Your doctor may use this medicine to treat conditions other than those listed
above. Ask your doctor if you are unsure why you have been given this
medicine.

2

Before you are given Depo-Medrol

Do not use Depo-Medrol if:
• You think you have ever suffered an allergic reaction, or any other type of
reaction after being given Depo-Medrol, or any other medicine containing
a corticosteroid or any of the ingredients in this medicine (Section 6 of this
leaflet contains a list of ingredients).An allergic reaction may cause a skin
rash or reddening, swollen face or lips or shortness of breath.
• You get a rash, or another symptom of an infection.
See your doctor immediately if you have any of the above.
Do not inject this medicine into:
• the Achilles tendon (which is located behind the ankle joint), or
• directly into a vein (intravenous), the spinal cord (intrathecal), the outer
covering of the brain (extradural), into the nostrils (intranasal) or in the eye
(intraocular).
Take special care before taking Depo-Medrol:
You must tell your doctor before you take this medicine if you have any of
the following conditions.
Your doctor may also have to monitor your treatment more closely, alter your
dose or give you another medicine.



Chickenpox, shingles or a herpes eye infection. If you think you have
been in contact with someone with chickenpox or shingles and you have
not already had these illnesses, or if you are unsure if you have had them.
• Severe depression or manic depression (bipolar disorder). This includes
having had depression before while taking steroid medicines like
Depo-Medrol, or having a family history of these illnesses.
• Diabetes (or if there is a family history of diabetes).
• Epilepsy.
• Glaucoma (increased pressure in the eye) or if there is a family history of
glaucoma.
• You have recently suffered a heart attack.
• Heart problems, including heart failure or infections.
• Hypertension (high blood pressure).
• Hypothyroidism (an under-active thyroid).
Page 1











Joint infection
Kidney or liver disease.
Muscle problems (pain or weakness) have happened while taking steroid
medicines in the past.
Myasthenia gravis (a condition causing tired and weak muscles).
Osteoporosis (brittle bones).
Skin abscess.
Stomach ulcer or other serious stomach or intestinal problems.
Thrombophlebitis - vein problems due to thrombosis (clots in the veins)
resulting in phlebitis (red, swollen and tender veins).
Tuberculosis (TB) or if you have suffered tuberculosis in the past.

You must tell your doctor before you take this medicine if you have any of
the conditions listed above.
Taking other medicines
Always tell your doctor or pharmacist if you are taking any medicines
(including any you have bought without a prescription) as taking
Depo-Medrol with other medicines could be harmful.
You should tell your doctor if you are taking any of the following medicines
which can affect the way Depo-Medrol or the other medicine works:
• Acetazolamide - used to treat glaucoma and epilepsy
• Aminoglutethimide – used for treating cancer
• Anticoagulants - used to ‘thin’ the blood such as acenocoumarol,
phenindione and warfarin
• Anticholinesterases - used to treat myasthenia gravis (a muscle
condition) such as distigmine and neostigmine
• Antibiotics (such as erythromycin)
• Aspirin and non-steroidal anti-inflammatory medicines (also called
NSAIDs) such as ibuprofen used to treat mild to moderate pain
• Barbiturates, carbamazepine, phenytoin and primidone – used to treat
epilepsy
• Carbenoxolone - used for heartburn and acid indigestion
• Ciclosporin - used to treat conditions such as severe rheumatoid arthritis,
severe psoriasis or following an organ or bone marrow transplant
• Digoxin - used for heart failure and/or an irregular heart beat
• Diltiazem or mibefradil – used for heart problems or high blood pressure
• Diuretics – sometimes called water tablets.
• Ketoconazole or itraconazole – used to treat fungal infections
• Pancuronium – or other medicines called neuromuscular blocking agents
which are used in some surgical procedures
• Rifampicin and rifabutin – antibiotics used to treat tuberculosis (TB)
• Vaccines - tell your doctor or nurse if you have recently had, or are about
to have any vaccination. You should not have ‘live’ vaccines while using
this medicine. Other vaccines may be less effective.
If you are taking long term medication(s)
If you are being treated for diabetes, high blood pressure or water retention
(oedema) tell your doctor as he/she may need to adjust the dose of the
medicines used to treat these conditions.
Before you have any operation tell your doctor, dentist or anesthetist that
you are taking this medicine.
If you require a test to be carried out by your doctor or in hospital it is
important that you tell the doctor or nurse that you are taking Depo-Medrol.
This medicine can affect the results of some tests.
Page 2

Pregnancy and breast feeding
You must tell your doctor if you are pregnant, think you might be pregnant or
are trying to become pregnant as this medicine could slow the baby’s growth.
Tell your doctor if you are breast feeding as small amounts of corticosteroid
medicines may get into breast milk.
If you continue breast-feeding while you are having treatment, your baby will
need extra checks to make sure he or she is not being affected by your
medicine.
Driving and Using Machines
There are no special precautions while you are being treated with this
medicine

3

How Depo-Medrol is given to you

Steroid Cards
Remember to always carry a Steroid Treatment Card. Make sure your doctor
or pharmacist has filled out the details of your medicine, including the dose
and how long you will require steroid treatment.
You should show your steroid card to anyone who gives you treatment (such
as a doctor, nurse or dentist) while you are taking this medicine, and for 3
months after your last injection.
If you are admitted to hospital for any reason always tell your doctor or nurse
that you are taking this medicine. You can also wear a medic-alert bracelet or
pendant to let medical staff know that you are taking a steroid if you have an
accident or become unconscious.
Dosage information
Your doctor will decide on the site of injection, how much of the medicine and
how many injections you will receive depending on the condition being
treated and its severity. Your doctor will inject you with the lowest dose for the
shortest possible time to get effective relief of your symptoms.
Adults
Your doctor/nurse will tell you how many injections you will require for the
condition you are being treated for, and when you will get them.
Joints - the normal dose for the injections into joint will depend on the size of
the joint. Large joints (e.g. knee, ankle and shoulder) may require 20 - 80 mg
(0.5 – 2 ml), medium sized joints (e.g. elbow or wrist) 10 - 40 mg (0.25 – 1
ml) and small joints (e.g. finger or toe joints) may require a 4 - 10 mg
(0.1 -0.25 ml) dose.
Joint injections may be given weekly over a period of several weeks,
depending on how quickly you respond to treatment.
Bursitis and epicondylitis (tennis elbow) – the usual dose is between 4-30 mg
(0.1 - 0.75 ml). In most cases repeat injections will not needed for bursitis
and epicondylitis. Repeat injections may be necessary to treat long standing
conditions.
Skin conditions – the usual dose is between 20 – 60mg (0.5 – 1.5ml) injected
into the affected part or parts of the skin.
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-Medrol 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-Medrol
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-Medrol for more than 3 weeks;
• have been given high doses of Depo-Medrol, 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-Medrol
Mental health problems can happen while taking steroids like Depo-Medrol
(see also section 4, Possible Side Effects).
• These illnesses can be serious.
• Usually they start within a few days or weeks of starting the medicine.
• They are more likely to happen at high doses.
• Most of these problems go away if the dose is lowered or the medicine is
stopped. However if the problems do happen they might need treatment.
Talk to a doctor if you (or someone using this medicine) show any signs of
mental problems. This is particularly important if you are depressed, or might
be thinking about suicide. In a few cases mental problems have happened
when doses are being lowered or stopped.

4

Possible side-effects

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





Allergic reactions, such as skin rash, swelling of the face or wheezing
and difficulty breathing. This type of side effect is rare, but can be serious.
Acute pancreatitis, stomach pain spreading to your back, possibly
accompanied by vomiting, shock and loss of consciousness.
Burst or bleeding ulcers, symptoms of which are severe stomach pain
which may go through to the back and could be associated with bleeding
from the back passage, black or bloodstained stools and/or vomiting blood.
Infections. This medicine can hide or change the signs and symptoms of
some infections, or reduce your resistance to the infection, so that they are
hard to diagnose at an early stage. Symptoms might include a raised
temperature and feeling unwell. Symptoms of a flare up of a previous TB
infection could be coughing blood or pain in the chest. This medicine may
also make you more likely to develop a severe infection.
Pulmonary embolus (blood clot in the lung) symptoms include sudden
sharp chest pain, breathlessness and coughing up blood.
Raised pressure within the skull of children (pseudotumour cerebri)
symptoms of which are headaches with vomiting, lack of energy and
drowsiness. This side-effect usually occurs after treatment is stopped.
Thrombophlebitis (blood clots or thrombosis in a leg vein), symptoms of
which include painful swollen, red and tender veins.

If you experience any of the following side effects, or notice any other
unusual effects not mentioned in this leaflet, tell your doctor
immediately:
Body water and salts
• Swelling and high blood pressure, caused by increased levels of water and
salt content.
• Cramps and spasms, due to the loss of potassium from your body. In rare
cases this can lead to congestive heart failure (when the heart cannot
pump properly).
Digestive system
• Nausea (feeling sick) or vomiting (being sick).
• Ulcers or thrush in the gullet (discomfort on swallowing).
• Indigestion.
• Bloated stomach.
Eyes
• Glaucoma (raised pressure within the eye, causing pain in the eyes and
headaches).
• Swollen optic nerve (causing a condition called papilloedema, and which
may cause sight disturbance).
• Damage to the optic nerve or cataracts (indicated by failing eyesight).
• Thinning of the clear part at the front of the eye (cornea) or of the white
part of the eye (sclera).
• Worsening of viral or fungal eye infections.
• Protruding of the eyeballs (exophthalmos).
Hormones and metabolic system
• Slowing of normal growth in infants, children and adolescents which may
be permanent.
• Irregular or no periods in women.
• Increased hair on the body and face in women (hirsutism).
• Round or moon-shaped face (Cushingoid facies).
• Increased appetite and weight gain.
• Diabetes or worsening of existing diabetes.
• Prolonged therapy can lead to lower levels of some hormones which in turn
Ref:0927/141111/2/B
Page 3

18. The use of Depo-Medrone in active tuberculosis should be restricted to
those cases of fulminating or disseminated tuberculosis in which the
corticosteroid is used for the management of the disease in conjunction
with an appropriate antituberculous regimen. If corticosteroids are
indicated in patients with latent tuberculosis or tuberculin reactivity, close
observation is necessary as reactivation of the disease may occur. During
prolonged corticosteroid therapy, these patients should receive
chemoprophylaxis.
19. Care should be taken for patients receiving cardioactive drugs such as
digoxin because of steroid induced electrolyte disturbance/potassium loss
(see Side-effects).
20. The following precautions apply for parenteral corticosteroids: Following
intra-articular injection, the occurrence of a marked increase in pain
accompanied by local swelling, further restriction of joint motion, fever,
and malaise are suggestive of septic arthritis. If this complication occurs
and the diagnosis of sepsis is confirmed, appropriate antimicrobial
therapy should be instituted.
Local injection of a steroid into a previously injected joint is to be avoided.
Corticosteroids should not be injected into unstable joints.
Sterile technique is necessary to prevent infections or contamination.
The slower rate of absorption by intramuscular administration should be
recognised.
Special Precautions:
Particular care is required when considering the use of systemic
corticosteroids in patients with the following conditions and frequent patient
monitoring is necessary.
1. Osteoporosis (post-menopausal females are particularly at risk).
2. Hypertension or congestive heart failure.
3. Existing or previous history of severe affective disorders (especially
previous steroid psychosis).
4. Diabetes mellitus (or a family history of diabetes).
5. History of tuberculosis.
6. Glaucoma (or a family history of glaucoma).
7. Previous corticosteroid-induced myopathy
8. Liver failure or cirrhosis.
9. Renal insufficiency.
10 Epilepsy.
11. Peptic ulceration.
12. Fresh intestinal anastomoses.
13. Predisposition to thrombophlebitis.
14. Abscess or other pyogenic infections.
15. Ulcerative colitis.
16. Diverticulitis.
17. Myasthenia gravis.
18. Ocular herpes simplex, for fear of corneal perforation.
19. Hypothyroidism.
20. Patients and/or carers should be warned that potentially severe
psychiatric adverse reactions may occur with systemic steroids (see
section 4.8). Symptoms typically emerge within a few days or weeks of
starting treatment. Risks may be higher with high doses/systemic
exposure (see also section 4.5 Interaction with Other Medicaments and
Other Forms of Interaction that can increase the risk of side effects),
although dose levels do not allow prediction of the onset, type, severity
or duration of reactions. Most reactions recover after either dose
reduction or withdrawal, although specific treatment may be necessary.
Patients/carers should be encouraged to seek medical advice if worrying
psychological symptoms develop, especially if depressed mood or
suicidal ideation is suspected. Patients/carers should be alert to possible
psychiatric disturbances that may occur either during or immediately after
dose tapering/withdrawal of systemic steroids, although such reactions
have been reported infrequently.

®

Particular care is required when considering the use of systemic
corticosteroids in patients with existing or previous history of severe affective
disorders in themselves or in their first degree relatives. These would include
depressive or manic-depressive illness and previous steroid psychosis.
Use in Pregnancy and Lactation:
Pregnancy
The ability of corticosteroids to cross the placenta varies between drugs,
however, methylprednisolone does cross the placenta.
Administration of corticosteroids to pregnant animals can cause abnormalities
of foetal development including cleft palate, intra-uterine growth retardation
and affects on brain growth and development. There is no evidence that
corticosteroids result in an increased incidence of congenital abnormalities,
such as cleft palate in man, however, when administered for long periods or
repeatedly during pregnancy, corticosteroids may increase the risk of
intra-uterine growth retardation. Hypoadrenalism may, in theory, occur in the
neonate following prenatal exposure to corticosteroids but usually resolves
spontaneously following birth and is rarely clinically important. As with all
drugs, corticosteroids should only be prescribed when the benefits to the
mother and child outweigh the risks. When corticosteroids are essential,
however, patients with normal pregnancies may be treated as though they
were in the non-gravid state.
Lactation
Corticosteroids are excreted in small amounts in breast milk, however, doses
of up to 40 mg daily of methylprednisolone are unlikely to cause systemic
effects in the infant. Infants of months taking higher doses than this may have
a degree of adrenal suppression, but the benefits of breastfeeding are likely
to outweigh any theoretical risk.
Use in Children: Corticosteroids cause growth retardation in infancy,
childhood and adolescence which may be irreversible. Treatment should be
limited to the minimum dosage for the shortest possible time.
Use in the Elderly: The common adverse effects of systemic corticosteroids
may be associated with more serious consequences in old age, especially
osteoporosis, hypertension, hypokalaemia, diabetes, susceptibility to infection
and thinning of the skin. Close clinical supervision is required to avoid
life-threatening reactions.
Overdosage: There is no clinical syndrome of acute overdosage with
Depo-Medrone. Following overdosage the possibility of adrenal suppression
should be guarded against by gradual diminution of dose levels over a period
of time. In such event the patient may require to be supported during any
further traumatic episode.
Incompatibilities (major):
None stated.
Pharmaceutical precautions: Protect from freezing. Do not store above
25°C. Depo-Medrone should not be mixed with any other fluid. Discard any
remaining suspension after use.
Legal category: POM
Package quantities: 1 x 1ml vial pack or 3 x 1ml vials packs.
Manufacturer and Licence Holder
This medicine is manufactured by Pfizer Manufacturing Belgium N.V.,
Rijksweg 12, Puurs, Belgium and procured from within the EU and
repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
Depo-Merdone is a registered trademark of Pharmacia & Upjohn Limited.
Leaflet revision date: 14/11/11

Depo-Medrone 40mg/ml suspension for injection

Ref:0927/141111/1P-F

(methylprednisolone acetate)

PHYSICIAN LEAFLET
Presentation
White, sterile aqueous suspension for injection containing 40 mg per ml
methylprednisolone acetate. Also contains macrogol, sodium chloride,
myristyl-gamma-picolinium chloride and sterile water for injections.

Undesirable effects may be minimized by using the lowest effective dose for
the minimum period (see special warnings and precautions).

Uses
Depo-Medrone may be used locally or systemically, particularly where oral
therapy is not feasible.

Intramuscular – for sustained systemic effect: Allergic conditions (severe
seasonal and perennial allergic rhinitis, asthma, drug reactions). 80 – 120 mg
(2 – 3 ml).

Depo-Medrone may be used by any of the following routes: intramuscular,
intra-articular, periarticular, intrabursal, intralesional or into the tendon sheath.
It must not be used by the intrathecal or intravenous routes. (See
Contra-indications and Side-effects).

Dermatological conditions, 40 – 120 mg (1 – 3 ml).

Intramuscular administration:
1.Rheumatic disorders
Rheumatoid arthritis
2.Collagen diseases/arthritis
Systemic lupus erythematosus
3.Dermatological diseases
Severe erythema multiforme (Stevens-Johnson syndrome)
4. Allergic states
Bronchial asthma
Severe seasonal and perennial allergic rhinitis
Drug hypersensitivity reactions
Angioneurotic oedema
5 Gastro-intestinal diseases
Ulcerative colitis Crohn’s disease
6. Respiratory diseases
Fulminating or disseminated tuberculosis (with appropriate antituberculous
chemotherapy) Aspiration of gastric contents
7. Miscellaneous
TB meningitis (with appropriate antituberculous chemotherapy)
Intra-articular administration:
Rheumatoid arthritis
Osteo-arthritis with an inflammatory component
Soft tissue administration (intrabursal, periarticular, into tendon
sheath):
Synovitis not associated with infection
Epicondylitis
Tenosynovitis
Plantar fasciitis
Bursitis
Intralesional:
Keloids
Localized lichen planus
Localized lichen simplex
Granuloma annulare
Discoid lupus erythematosus
Alopecia areata
Dosage and administration
Depo-Medrone should not be mixed with any other suspending agent or
solution. Parenteral drug products should be inspected visually for
particulate matter and discoloration prior to administration, whenever
suspension and container permit. Depo-Medrone may be used by any
of the following routes: intramuscular, intra-articular, periarticular,
intrabursal, intralesional and into the tendon sheath. It must not be used
by the intrathecal or intravenous routes (see Contra-indications and
Side-effects).

Depo-Medrone vials are intended for single dose use only.

Rheumatic disorders and collagen diseases (rheumatoid arthritis, SLE),
40 – 120 mg (1 – 3 ml) per week.
Dosage must be individualised and depends on the condition being treated
and its severity.
Note: Depo-Medrone is not intended for the prophylaxis of severe seasonal
and perennial allergic rhinitis or other seasonal allergies and should be
administered only when symptoms are present.
The frequency of intramuscular injections should be determined by the
duration of the clinical response.
In the case of seasonal allergic rhinitis a single injection is frequently
sufficient. If necessary, however, a second injection may be given after two to
three weeks.
On average the effect of a single 2 ml (80 mg) injection may be expected to
last approximately two weeks.
Intra-articular: Rheumatoid arthritis, osteo-arthritis. The dose of
Depo-Medrone depends upon the size of the joint and the severity of the
condition. Repeated injections, if needed, may be given at intervals of one to
five or more weeks depending upon the degree of relief obtained from the
initial injection. A suggested dosage guide is: large joint (knee, ankle,
shoulder), 20 – 80mg (0.5 – 2 ml); medium joint (elbow, wrist), 10 – 40 mg
(0.25 – 1 ml); small joint (metacarpophalangeal, interphalangeal,
sternoclavicular, acromioclavicular), 4 – 10 mg (0.1 – 0.25 ml).
Intrabursal: Subdeltoid bursitis, prepatellar bursitis, olecranon bursitis. For
administration directly into bursae, 4 – 30 mg (0.1 – 0.75 ml). In most cases,
repeat injections are not needed.
Intralesional: Keloids, localized lichen planus, localized lichen simplex,
granuloma annulare, alopecia areata, and discoid lupus erythematosus.
For administration directly into the lesion for local effect in dermatological
conditions, 20 – 60 mg (0.5 – 1.5 ml). For large lesions, the dose may be
distributed by repeated local injections of 20 – 40 mg (0.5 – 1 ml). One to
four injections are usually employed. Care should be taken to avoid injection
of sufficient material to cause blanching, since this may be followed by a
small slough.
Periarticular: Epicondylitis. Infiltrate 4 – 30 mg (0.1 – 0.75 ml) into the
affected area.
Into the tendon sheath: Tenosynovitis, epicondylitis. For administration
directly into the tendon sheath, 4 – 30 mg (0.1 – 0.75 ml). In recurrent or
chronic conditions, repeat injections may be necessary.
Special precautions should be observed when administering Depo-Medrone.
Intramuscular injections should be made deeply into the gluteal muscles. The
usual technique of aspirating prior to injection should be employed to avoid
intravascular administration. Doses recommended for intramuscular injection
must not be administered superficially or subcutaneously.
Page 1

Intra-articular injections should be made using precise, anatomical
localisation into the synovial space of the joint involved. The injection site for
each joint is determined by that location where the synovial cavity is most
superficial and most free of large vessels and nerves. Suitable sites for
intra-articular injection are the knee, ankle, wrist, elbow, shoulder, phalangeal
and hip joints. The spinal joints, unstable joints and those devoid of synovial
space are not suitable. Treatment failures age most frequently the result of
failure to enter the joint space. Intra-articular injections should be made with
care as follows: ensure correct positioning of the needle into the synovial
space and aspirate a few drops of joint fluid. The aspirating syringe should
then be replaced by another containing Depo-Medrone. To ensure position of
the needle, synovial fluid should be aspirated and the injection made. After
injection the joint is moved slightly to aid mixing of the synovial fluid and the
suspension. Subsequent to therapy care should be taken for the patient not
to overuse the joint in which benefit has been obtained. Negligence in this
matter may permit an increase in joint deterioration that will more than offset
the beneficial effects of the steroid.
Intrabursal injections should be made as follows: the area around the
injection site is prepared in a sterile way and a wheal at the site made with 1
per cent procaine hydrochloride solution. A 20 to 24 gauge needle attached
to a dry syringe is inserted into the bursa and the fluid aspirated. The needle
is left in place and the aspirating syringe changed for a small syringe
containing the desired dose. After injection, the needle is withdrawn and a
small dressing applied. In the treatment of tenosynovitis care should be taken
to inject Depo-Medrone into the tendon sheath rather than into the substance
of the tendon. Due to the absence of a true tendon sheath, the Achilles
tendon should not be injected with Depo-Medrone.
Children: Dosage may be reduced for infants and children but should be
governed more by the severity of the condition and response of the patient,
than by age or size.
Elderly patients: When used according to instructions, there is no information
to suggest that a change in dosage is warranted in the elderly. However,
treatment of elderly patients, particularly if long-term, should be planned
bearing in mind the more serious consequences of the common side-effects
of corticosteroids in old age and close clinical supervision is required (see
Special warnings and precautions).
Contra-indications, warnings, etc.
Contra-indications: Depo-Medrone is contra-indicated where there is known
hypersensitivity to components and in systemic infection unless specific
anti-infective therapy is employed.
Due to its potential for neurotoxicity, Depo-Medrone must not be given by the
intrathecal route. In addition, as the product is a suspension it must not be
given by the intravenous route (see Side-effects).
Interactions:
1. Convulsions have been reported with concurrent use of
methylprednisolone and cyclosporin. Since concurrent administration of
these agents results in a mutual inhibition of metabolism, it is possible
that convulsions and other adverse effects associated with the individual
use of either drug may be more apt to occur.
2. Drugs that induce hepatic enzymes, such as rifampicin, rifabutin,
carbamazepine, phenobarbitone, phenytoin, primidone and
aminoglutethimide enhance the metabolism of corticosteroids and their
therapeutic effect may be reduced.
3. Drugs such as erythromycin and ketoconazole may inhibit the metabolism
of corticosteroids and thus decrease their clearance.
4. Steroids may reduce the effects of anticholinesterases in myasthenia
gravis. The desired effects of hypoglycaemic agents (including insulin),
anti-hypertensives and diuretics are antagonized by corticosteroids, and
the hypokalaemic effects of acetazolamide, loop diuretics, thiazide
diuretics and carbenoxolone are enhanced.
5. The efficacy of coumarin anticoagulants may be enhanced by concurrent
corticosteroid therapy and close monitoring of the INR or prothrombin time
is required to avoid spontaneous bleeding.
Page 2

6. The renal clearance of salicylates is increased by corticosteroids and
steroid withdrawal may result in salicylate intoxication. Salicylates and
non-steroid anti-inflammatory agents should be used cautiously in con
junction with corticosteroids in hypothrombinaemia.
7. Steroids have been reported to interact with neuromuscular blocking
agents such as pancuronium with partial reversal of the neuromuscular
block.
Effects on ability to drive and to use machines: None stated.
Other undesirable effects (frequency and seriousness)
Side-effects: The incidence of predictable undesirable side-effects associated
with the use of corticosteroids, including hypothalamic-pituitary-adrenal
suppression correlates with the relative potency of the drug, dosage, timing
of administration and duration of treatment (see Special warnings and
precautions).

OPHTHALMIC – Increased intra-ocular pressure, glaucoma, papilloedema,
cataracts with possible damage to the optic nerve, corneal or scleral thinning,
exacerbation of ophthalmic viral or fungal disease, exophthalmos.
GENERAL – Leucocytosis, hypersensitivity including anaphylaxis,
thrombo-embolism, nausea, vertigo.
WITHDRAWAL SYMPTOMS – too rapid a reduction of corticosteroid dosage
following prolonged treatment can lead to acute adrenal insufficiency,
hypotension and death. However, this is more applicable to corticosteroids
with an indication where continuous therapy is given (see Special warnings
and precautions).
A ‘withdrawal syndrome’ may also occur including fever, myalgia, arthralgia,
rhinitis, conjunctivitis, painful itchy skin nodules and loss of weight.

PARENTERAL CORTICOSTEROID THERAPY – Anaphylactic reaction or
allergic reactions, hypopigmentation or hyperpigmentation, subcutaneous and
cutaneous atrophy, sterile abscess, post injection flare (following
intra-articular use), Charcot-like arthropathy, rare instances of blindness
associated with intralesional therapy around the face and head.

CERTAIN SIDE-EFFECTS REPORTED WITH SOME NON
RECOMMENDED ROUTES OF ADMINISTRATION
Intrathecal: Usual systemic corticoid adverse reactions, headache,
meningismus, meningitis, paraplegia, spinal fluid abnormalities, nausea,
vomiting, sweating, arachnoiditis, convulsions.

GASTRO-INTESTINAL – Dyspepsia, peptic ulceration with perforation and
haemorrhage, abdominal distension, oesophageal ulceration, oesophageal
candidiasis, acute pancreatitis, perforation of bowel.

Extradural: Wound dehiscence, loss of sphincter control.
Intranasal: Permanent/temporary

Increases in alanine transaminase (ALT, SGPT) aspartate transaminase
(AST, SGOT) and alkaline phosphatase have been observed following
corticosteroid treatment. These changes are usually small, not associated
with any clinical syndrome and are reversible upon discontinuation.
ANTI-INFLAMMATORY AND IMMUNOSUPPRESSIVE EFFECTS –
Increased susceptibility and severity of infections with suppression of clinical
symptoms and signs, opportunistic infections, may suppress reactions to skin
tests, recurrence of dormant tuberculosis (see Special warnings and
precautions).
MUSCULOSKELETAL – Proximal myopathy, osteoporosis, vertebral and long
bone fractures, avascular osteonecrosis, tendon rupture, aseptic necrosis,
muscle weakness.
FLUID AND ELECTROLYTE DISTURBANCE – Sodium and water retention,
potassium loss, hypertension, hypokalaemic alkalosis, congestive heart
failure in susceptible patients.
DERMATOLOGICAL – Impaired healing, petechiae and ecchymosis, thin
fragile skin, skin atrophy, bruising, striae, telangiectasia, acne.
ENDOCRINE/METABOLIC – Suppression of the hypothalamo-pituitaryadrenal axis, growth suppression in infancy, childhood and adolescence,
menstrual irregularity and amenorrhoea. Cushingoid facies, hirsutism, weight
gain, impaired carbohydrate tolerance with increased requirement for
antidiabetic therapy, negative nitrogen and calcium balance, increased
appetite.
NEUROPSYCHIATRIC – A wide range of psychiatric reactions including
affective disorders (such as irritable, euphoric, depressed and labile mood
psychological dependence and suicidal thoughts), psychotic reactions
(including mania, delusions, hallucinations and aggravation of schizophrenia),
behavioural disturbances, irritability, anxiety, sleep disturbances, and
cognitive dysfunction including confusion and amnesia have been reported
for all corticosteroids. Reactions are common and may occur in both adults
and children. In adults, the frequency of severe reactions was estimated to
be 5-6%. Psychological effects have been reported on withdrawal of
corticosteroids; the frequency is unknown. Increased intra-cranial pressure
with papilloedema in children (pseudotumour cerebri) has been reported,
usually after treatment withdrawal of methylprednisolone.

Ophthalmic: (Subconjunctival) – Redness and itching, abscess, slough at
injection site, residue at injection site, increased intra-ocular pressure,
decreased vision – blindness, infection.
Miscellaneous injection sites – Scalp, tonsillar fauces, sphenopalatine
ganglion: blindness.
Special warnings and precautions
Warnings and Precautions:
1. A Patient Information Leaflet is provided in the pack by the manufacturer.
2. Undesirable effects may be minimized by using the lowest effect dose for
the minimum period. Frequent patient review is required to appropriately
titrate the dose against disease activity (see Dosage and administration).
3. Patients should carry ‘Steroid Treatment’ cards which give clear guidance
on the precautions to be taken to minimize risk and which provide details
of prescriber, drug, dosage and the duration of treatment.
4. Depo-Medrone vials are intended for single dose use only. Any multidose
use of the product may lead to contamination.
5. Depo-Medrone is not recommended for epidural, intranasal, intra-ocular, or
any other unapproved route of administration. See Side-effects section for
details of side-effects reported from some non-recommended routes of
administration.
6. Due to the absence of a true tendon sheath, the Achilles tendon should
not be injected with Depo-Medrone.
7. While crystals of adrenal steroids in the dermis suppress inflammatory
reactions, their presence may cause disintegration of the cellular elements
and physiochemical changes in the ground substance of the connective
tissue. The resultant infrequently occurring dermal and/or subdermal
changes may form depressions in the skin at the injection site. The degree
to which this reaction occurs will vary with the amount of adrenal steroid
injected. Regeneration is usually complete within a few months or after all
crystals of the adrenal steroid have been absorbed. In order to minimize
the incidence of dermal and subdermal atrophy, care must be exercised
not to exceed recommended doses in injections. Multiple small injections
into the area of the lesion should be made whenever possible. The
technique of intra-articular and intramuscular injection should include
precautions against injection or leakage into the dermis. Injection into the
deltoid muscle should be avoided because of a high incidence of
subcutaneous atrophy.
8. Intralesional doses should not be placed too superficially, particularly in
easily visible sites in patients with deeply pigmented skins, since there
have been rare reports of subcutaneous atrophy and depigmentation.
9. Systemic absorption of methylprednisolone occurs following intra-articular
injection of Depo-Medrone. Systemic as well as local effects can therefore
be expected.

10. Intra-articular corticosteroids are associated with a substantially
increased risk of inflammatory response in the joint, particularly bacterial
infection introduced with the injection. Charcot-like arthropathies have
been reported particularly after repeated injections. Appropriate
examination of any joint fluid present is necessary to exclude any
bacterial infection, prior to injection.
11. Following a single dose of Depo-Medrone, plasma cortisol levels are
reduced and there is evidence of hypothalamic-pituitary-adrenal (HPA)
axis suppression. This suppression lasts for a variable period of up to 4
weeks. The usual dynamic tests of HPA axis function can be used to
diagnose evidence of impaired activity (e.g. Synacthen test).
12. Adrenal cortical atrophy develops during prolonged therapy and may
persist for months after stopping treatment. In patients who have
received more than physiological doses of systemic corticosteroids
(approximately 6 mg methylprednisolone) for greater than 3 weeks,
withdrawal should not be abrupt. How dose reduction should be carried
out depends largely on whether the disease is likely to relapse as the
dose of systemic corticosteroids is reduced. Clinical assessment of
disease activity may be needed during withdrawal. If the disease is
unlikely to relapse on withdrawal of systemic corticosteroids, but there is
uncertainty about HPA suppression, the dose of systemic corticosteroid
may be reduced rapidly to physiological doses. Once a daily dose of
6 mg methylprednisolone is reached, dose reduction should be slower to
allow the HPA-axis to recover.
Abrupt withdrawal of systemic corticosteroid treatment, which has continued
up to 3 weeks is appropriate if it is considered that the disease is unlikely to
relapse. Abrupt withdrawal of doses up to 32 mg daily of methylprednisolone
for 3 weeks is unlikely to lead to clinically relevant HPA-axis, in the majority
of patients. In the following patient groups, gradual withdrawal of systemic
corticosteroid therapy should be considered even after courses lasting 3
weeks or less:
• Patients who have had repeated courses of systemic corticosteroids,
particularly if taken for greater than 3 weeks.
• When a short course has been prescribed within one year of
cessation of long-term therapy (months or years).
• Patients who may have reasons for adrenocortical insufficiency other
than exogenous corticosteroid therapy.
• Patients receiving doses of corticosteroid greater than 32 mg daily of
methylprednisolone.
• Patients repeatedly taking doses in the evening.
13. Since mineralocorticoid secretion may be impaired, salt and/or a miner
alocorticoid should be administered concurrently.
14. Because rare instances of anaphylactic reactions have occurred in
patients receiving parenteral corticosteroid therapy, appropriate
precautionary measures should be taken prior to administration,
especially when the patient has a history of drug allergy.
15. Corticosteroids may mask some signs of infection, and new infections
may appear during their use. Suppression of the inflammatory response
and immune function increases the susceptibility to fungal, viral and
bacterial infections and their severity. The clinical presentation may often
be atypical and may reach an advanced stage before being recognised.
16. Chickenpox is of serious concern since this normally minor illness may
be fatal in immunosuppressed patients. Patients (or parents of children)
without a definite history of chickenpox should be advised to avoid close
personal contact with chickenpox or herpes zoster and if exposed they
should seek urgent medical attention. Passive immunisation with
varicella/zoster immunoglobulin (VZIG) is needed by exposed
non-immune patients who are receiving systemic corticosteroids or who
have used them within the previous 3 months; this should be given within
10 days of exposure to chickenpox. If a diagnosis of chickenpox is
confirmed, the illness warrants specialist care and urgent treatment.
Corticosteroids should not be stopped and the dose may need to be
increased.
17. Live vaccines should not be given to individuals with impaired immune
responsiveness. The antibody response to other vaccines may be
diminished.
Ref:0927/141111/1P-B

Page 3

18. The use of Depo-Medrol in active tuberculosis should be restricted to
those cases of fulminating or disseminated tuberculosis in which the
corticosteroid is used for the management of the disease in conjunction
with an appropriate antituberculous regimen. If corticosteroids are
indicated in patients with latent tuberculosis or tuberculin reactivity, close
observation is necessary as reactivation of the disease may occur. During
prolonged corticosteroid therapy, these patients should receive
chemoprophylaxis.
19. Care should be taken for patients receiving cardioactive drugs such as
digoxin because of steroid induced electrolyte disturbance/potassium loss
(see Side-effects).
20. The following precautions apply for parenteral corticosteroids: Following
intra-articular injection, the occurrence of a marked increase in pain
accompanied by local swelling, further restriction of joint motion, fever,
and malaise are suggestive of septic arthritis. If this complication occurs
and the diagnosis of sepsis is confirmed, appropriate antimicrobial
therapy should be instituted.
Local injection of a steroid into a previously injected joint is to be avoided.
Corticosteroids should not be injected into unstable joints.
Sterile technique is necessary to prevent infections or contamination.
The slower rate of absorption by intramuscular administration should be
recognised.
Special Precautions:
Particular care is required when considering the use of systemic
corticosteroids in patients with the following conditions and frequent patient
monitoring is necessary.
1. Osteoporosis (post-menopausal females are particularly at risk).
2. Hypertension or congestive heart failure.
3. Existing or previous history of severe affective disorders (especially
previous steroid psychosis).
4. Diabetes mellitus (or a family history of diabetes).
5. History of tuberculosis.
6. Glaucoma (or a family history of glaucoma).
7. Previous corticosteroid-induced myopathy
8. Liver failure or cirrhosis.
9. Renal insufficiency.
10 Epilepsy.
11. Peptic ulceration.
12. Fresh intestinal anastomoses.
13. Predisposition to thrombophlebitis.
14. Abscess or other pyogenic infections.
15. Ulcerative colitis.
16. Diverticulitis.
17. Myasthenia gravis.
18. Ocular herpes simplex, for fear of corneal perforation.
19. Hypothyroidism.
20. Patients and/or carers should be warned that potentially severe
psychiatric adverse reactions may occur with systemic steroids (see
section 4.8). Symptoms typically emerge within a few days or weeks of
starting treatment. Risks may be higher with high doses/systemic
exposure (see also section 4.5 Interaction with Other Medicaments and
Other Forms of Interaction that can increase the risk of side effects),
although dose levels do not allow prediction of the onset, type, severity
or duration of reactions. Most reactions recover after either dose
reduction or withdrawal, although specific treatment may be necessary.
Patients/carers should be encouraged to seek medical advice if worrying
psychological symptoms develop, especially if depressed mood or
suicidal ideation is suspected. Patients/carers should be alert to possible
psychiatric disturbances that may occur either during or immediately after
dose tapering/withdrawal of systemic steroids, although such reactions
have been reported infrequently.

®

Depo-Medrol 40mg/ml suspension for injection

Particular care is required when considering the use of systemic
corticosteroids in patients with existing or previous history of severe affective
disorders in themselves or in their first degree relatives. These would include
depressive or manic-depressive illness and previous steroid psychosis.
Use in Pregnancy and Lactation:
Pregnancy
The ability of corticosteroids to cross the placenta varies between drugs,
however, methylprednisolone does cross the placenta.
Administration of corticosteroids to pregnant animals can cause abnormalities
of foetal development including cleft palate, intra-uterine growth retardation
and affects on brain growth and development. There is no evidence that
corticosteroids result in an increased incidence of congenital abnormalities,
such as cleft palate in man, however, when administered for long periods or
repeatedly during pregnancy, corticosteroids may increase the risk of
intra-uterine growth retardation. Hypoadrenalism may, in theory, occur in the
neonate following prenatal exposure to corticosteroids but usually resolves
spontaneously following birth and is rarely clinically important. As with all
drugs, corticosteroids should only be prescribed when the benefits to the
mother and child outweigh the risks. When corticosteroids are essential,
however, patients with normal pregnancies may be treated as though they
were in the non-gravid state.
Lactation
Corticosteroids are excreted in small amounts in breast milk, however, doses
of up to 40 mg daily of methylprednisolone are unlikely to cause systemic
effects in the infant. Infants of months taking higher doses than this may have
a degree of adrenal suppression, but the benefits of breastfeeding are likely
to outweigh any theoretical risk.
Use in Children: Corticosteroids cause growth retardation in infancy,
childhood and adolescence which may be irreversible. Treatment should be
limited to the minimum dosage for the shortest possible time.
Use in the Elderly: The common adverse effects of systemic corticosteroids
may be associated with more serious consequences in old age, especially
osteoporosis, hypertension, hypokalaemia, diabetes, susceptibility to infection
and thinning of the skin. Close clinical supervision is required to avoid
life-threatening reactions.
Overdosage: There is no clinical syndrome of acute overdosage with
Depo-Medrol. Following overdosage the possibility of adrenal suppression
should be guarded against by gradual diminution of dose levels over a period
of time. In such event the patient may require to be supported during any
further traumatic episode.
Incompatibilities (major):
None stated.
Pharmaceutical precautions: Protect from freezing. Do not store above
25°C. Depo-Medrol should not be mixed with any other fluid. Discard any
remaining suspension after use.
Legal category: POM
Package quantities:1 x 1ml vial pack or 3 x 1ml vials packs.
Manufacturer and Licence Holder
This medicine is manufactured by Pfizer Manufacturing Belgium N.V.,
Rijksweg 12, Puurs, Belgium and procured from within the EU and
repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
Depo-Medrol is a registered trademark of Pharmacia & Upjohn Limited.
Leaflet revision date: 14/11/11

Ref:0927/141111/2P-F

(methylprednisolone acetate)

PHYSICIAN LEAFLET
Presentation
White, sterile aqueous suspension for injection containing 40 mg per ml
methylprednisolone acetate. Also contains macrogol, sodium chloride,
myristyl-gamma-picolinium chloride and sterile water for injections.

Undesirable effects may be minimized by using the lowest effective dose for
the minimum period (see special warnings and precautions).

Uses
Depo-Medrol may be used locally or systemically, particularly where oral
therapy is not feasible.

Intramuscular – for sustained systemic effect: Allergic conditions (severe
seasonal and perennial allergic rhinitis, asthma, drug reactions). 80 – 120 mg
(2 – 3 ml).

Depo-Medrol may be used by any of the following routes: intramuscular,
intra-articular, periarticular, intrabursal, intralesional or into the tendon sheath.
It must not be used by the intrathecal or intravenous routes. (See
Contra-indications and Side-effects).

Dermatological conditions, 40 – 120 mg (1 – 3 ml).

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-Medrol 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-Medrol may be used by any of
the following routes: intramuscular, intra-articular, periarticular,
intrabursal, intralesional and into the tendon sheath. It must not be used
by the intrathecal or intravenous routes (see Contra-indications and
Side-effects).

Depo-Medrol vials are intended for single dose use only.

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-Medrol is not intended for the prophylaxis of severe seasonal
and perennial allergic rhinitis or other seasonal allergies and should be
administered only when symptoms are present.
The frequency of intramuscular injections should be determined by the
duration of the clinical response.
In the case of seasonal allergic rhinitis a single injection is frequently
sufficient. If necessary, however, a second injection may be given after two to
three weeks.
On average the effect of a single 2 ml (80 mg) injection may be expected to
last approximately two weeks.
Intra-articular: Rheumatoid arthritis, osteo-arthritis. The dose of
Depo-Medrol depends upon the size of the joint and the severity of the condition. Repeated injections, if needed, may be given at intervals of one to five
or more weeks depending upon the degree of relief obtained from the
initial injection. A suggested dosage guide is: large joint (knee, ankle,
shoulder), 20 – 80mg (0.5 – 2 ml); medium joint (elbow, wrist), 10 – 40 mg
(0.25 – 1 ml); small joint (metacarpophalangeal, interphalangeal,
sternoclavicular, acromioclavicular), 4 – 10 mg (0.1 – 0.25 ml).
Intrabursal: Subdeltoid bursitis, prepatellar bursitis, olecranon bursitis. For
administration directly into bursae, 4 – 30 mg (0.1 – 0.75 ml). In most cases,
repeat injections are not needed.
Intralesional: Keloids, localized lichen planus, localized lichen simplex,
granuloma annulare, alopecia areata, and discoid lupus erythematosus.
For administration directly into the lesion for local effect in dermatological
conditions, 20 – 60 mg (0.5 – 1.5 ml). For large lesions, the dose may be
distributed by repeated local injections of 20 – 40 mg (0.5 – 1 ml). One to
four injections are usually employed. Care should be taken to avoid injection
of sufficient material to cause blanching, since this may be followed by a
small slough.
Periarticular: Epicondylitis. Infiltrate 4 – 30 mg (0.1 – 0.75 ml) into the
affected area.
Into the tendon sheath: Tenosynovitis, epicondylitis. For administration
directly into the tendon sheath, 4 – 30 mg (0.1 – 0.75 ml). In recurrent or
chronic conditions, repeat injections may be necessary.
Special precautions should be observed when administering Depo-Medrol.
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.
Page 1

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-Medrol. 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-Medrol 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-Medrol.
Children: Dosage may be reduced for infants and children but should be
governed more by the severity of the condition and response of the patient,
than by age or size.
Elderly patients: When used according to instructions, there is no information
to suggest that a change in dosage is warranted in the elderly. However,
treatment of elderly patients, particularly if long-term, should be planned
bearing in mind the more serious consequences of the common side-effects
of corticosteroids in old age and close clinical supervision is required (see
Special warnings and precautions).
Contra-indications, warnings, etc.
Contra-indications: Depo-Medrol is contra-indicated where there is known
hypersensitivity to components and in systemic infection unless specific
anti-infective therapy is employed.
Due to its potential for neurotoxicity, Depo-Medrol must not be given by the
intrathecal route. In addition, as the product is a suspension it must not be
given by the intravenous route (see Side-effects).
Interactions:
1. Convulsions have been reported with concurrent use of
methylprednisolone and cyclosporin. Since concurrent administration of
these agents results in a mutual inhibition of metabolism, it is possible
that convulsions and other adverse effects associated with the individual
use of either drug may be more apt to occur.
2. Drugs that induce hepatic enzymes, such as rifampicin, rifabutin,
carbamazepine, phenobarbitone, phenytoin, primidone and
aminoglutethimide enhance the metabolism of corticosteroids and their
therapeutic effect may be reduced.
3. Drugs such as erythromycin and ketoconazole may inhibit the metabolism
of corticosteroids and thus decrease their clearance.
4. Steroids may reduce the effects of anticholinesterases in myasthenia
gravis. The desired effects of hypoglycaemic agents (including insulin),
anti-hypertensives and diuretics are antagonized by corticosteroids, and
the hypokalaemic effects of acetazolamide, loop diuretics, thiazide
diuretics and carbenoxolone are enhanced.
5. The efficacy of coumarin anticoagulants may be enhanced by concurrent
corticosteroid therapy and close monitoring of the INR or prothrombin time
is required to avoid spontaneous bleeding.
Page 2

6. The renal clearance of salicylates is increased by corticosteroids and
steroid withdrawal may result in salicylate intoxication. Salicylates and
non-steroid anti-inflammatory agents should be used cautiously in con
junction with corticosteroids in hypothrombinaemia.
7. Steroids have been reported to interact with neuromuscular blocking
agents such as pancuronium with partial reversal of the neuromuscular
block.
Effects on ability to drive and to use machines: None stated.
Other undesirable effects (frequency and seriousness)
Side-effects: The incidence of predictable undesirable side-effects associated
with the use of corticosteroids, including hypothalamic-pituitary-adrenal
suppression correlates with the relative potency of the drug, dosage, timing
of administration and duration of treatment (see Special warnings and
precautions).

OPHTHALMIC – Increased intra-ocular pressure, glaucoma, papilloedema,
cataracts with possible damage to the optic nerve, corneal or scleral thinning,
exacerbation of ophthalmic viral or fungal disease, exophthalmos.
GENERAL – Leucocytosis, hypersensitivity including anaphylaxis,
thrombo-embolism, nausea, vertigo.
WITHDRAWAL SYMPTOMS – too rapid a reduction of corticosteroid dosage
following prolonged treatment can lead to acute adrenal insufficiency,
hypotension and death. However, this is more applicable to corticosteroids
with an indication where continuous therapy is given (see Special warnings
and precautions).
A ‘withdrawal syndrome’ may also occur including fever, myalgia, arthralgia,
rhinitis, conjunctivitis, painful itchy skin nodules and loss of weight.

PARENTERAL CORTICOSTEROID THERAPY – Anaphylactic reaction or
allergic reactions, hypopigmentation or hyperpigmentation, subcutaneous and
cutaneous atrophy, sterile abscess, post injection flare (following
intra-articular use), Charcot-like arthropathy, rare instances of blindness
associated with intralesional therapy around the face and head.

CERTAIN SIDE-EFFECTS REPORTED WITH SOME NON
RECOMMENDED ROUTES OF ADMINISTRATION
Intrathecal: Usual systemic corticoid adverse reactions, headache,
meningismus, meningitis, paraplegia, spinal fluid abnormalities, nausea,
vomiting, sweating, arachnoiditis, convulsions.

GASTRO-INTESTINAL – Dyspepsia, peptic ulceration with perforation and
haemorrhage, abdominal distension, oesophageal ulceration, oesophageal
candidiasis, acute pancreatitis, perforation of bowel.

Extradural: Wound dehiscence, loss of sphincter control.
Intranasal: Permanent/temporary

Increases in alanine transaminase (ALT, SGPT) aspartate transaminase
(AST, SGOT) and alkaline phosphatase have been observed following
corticosteroid treatment. These changes are usually small, not associated
with any clinical syndrome and are reversible upon discontinuation.
ANTI-INFLAMMATORY AND IMMUNOSUPPRESSIVE EFFECTS –
Increased susceptibility and severity of infections with suppression of clinical
symptoms and signs, opportunistic infections, may suppress reactions to skin
tests, recurrence of dormant tuberculosis (see Special warnings and
precautions).
MUSCULOSKELETAL – Proximal myopathy, osteoporosis, vertebral and long
bone fractures, avascular osteonecrosis, tendon rupture, aseptic necrosis,
muscle weakness.
FLUID AND ELECTROLYTE DISTURBANCE – Sodium and water retention,
potassium loss, hypertension, hypokalaemic alkalosis, congestive heart
failure in susceptible patients.
DERMATOLOGICAL – Impaired healing, petechiae and ecchymosis, thin
fragile skin, skin atrophy, bruising, striae, telangiectasia, acne.
ENDOCRINE/METABOLIC – Suppression of the hypothalamo-pituitaryadrenal axis, growth suppression in infancy, childhood and adolescence,
menstrual irregularity and amenorrhoea. Cushingoid facies, hirsutism, weight
gain, impaired carbohydrate tolerance with increased requirement for
antidiabetic therapy, negative nitrogen and calcium balance, increased
appetite.
NEUROPSYCHIATRIC – A wide range of psychiatric reactions including
affective disorders (such as irritable, euphoric, depressed and labile mood
psychological dependence and suicidal thoughts), psychotic reactions
(including mania, delusions, hallucinations and aggravation of schizophrenia),
behavioural disturbances, irritability, anxiety, sleep disturbances, and
cognitive dysfunction including confusion and amnesia have been reported
for all corticosteroids. Reactions are common and may occur in both adults
and children. In adults, the frequency of severe reactions was estimated to
be 5-6%. Psychological effects have been reported on withdrawal of
corticosteroids; the frequency is unknown. Increased intra-cranial pressure
with papilloedema in children (pseudotumour cerebri) has been reported,
usually after treatment withdrawal of methylprednisolone.

Ophthalmic: (Subconjunctival) – Redness and itching, abscess, slough at
injection site, residue at injection site, increased intra-ocular pressure,
decreased vision – blindness, infection.
Miscellaneous injection sites – Scalp, tonsillar fauces, sphenopalatine
ganglion: blindness.
Special warnings and precautions
Warnings and Precautions:
1. A Patient Information Leaflet is provided in the pack by the manufacturer.
2. Undesirable effects may be minimized by using the lowest effect dose for
the minimum period. Frequent patient review is required to appropriately
titrate the dose against disease activity (see Dosage and administration).
3. Patients should carry ‘Steroid Treatment’ cards which give clear guidance
on the precautions to be taken to minimize risk and which provide details
of prescriber, drug, dosage and the duration of treatment.
4. Depo-Medrol vials are intended for single dose use only. Any multidose
use of the product may lead to contamination.
5. Depo-Medrol is not recommended for epidural, intranasal, intra-ocular, or
any other unapproved route of administration. See Side-effects section for
details of side-effects reported from some non-recommended routes of
administration.
6. Due to the absence of a true tendon sheath, the Achilles tendon should
not be injected with Depo-Medrol.
7. While crystals of adrenal steroids in the dermis suppress inflammatory
reactions, their presence may cause disintegration of the cellular elements
and physiochemical changes in the ground substance of the connective
tissue. The resultant infrequently occurring dermal and/or subdermal
changes may form depressions in the skin at the injection site. The degree
to which this reaction occurs will vary with the amount of adrenal steroid
injected. Regeneration is usually complete within a few months or after all
crystals of the adrenal steroid have been absorbed. In order to minimize
the incidence of dermal and subdermal atrophy, care must be exercised
not to exceed recommended doses in injections. Multiple small injections
into the area of the lesion should be made whenever possible. The
technique of intra-articular and intramuscular injection should include
precautions against injection or leakage into the dermis. Injection into the
deltoid muscle should be avoided because of a high incidence of
subcutaneous atrophy.
8. Intralesional doses should not be placed too superficially, particularly in
easily visible sites in patients with deeply pigmented skins, since there
have been rare reports of subcutaneous atrophy and depigmentation.
9. Systemic absorption of methylprednisolone occurs following intra-articular
injection of Depo-Medrol. Systemic as well as local effects can therefore
be expected.

10. Intra-articular corticosteroids are associated with a substantially
increased risk of inflammatory response in the joint, particularly bacterial
infection introduced with the injection. Charcot-like arthropathies have
been reported particularly after repeated injections. Appropriate
examination of any joint fluid present is necessary to exclude any
bacterial infection, prior to injection.
11. Following a single dose of Depo-Medrol, plasma cortisol levels are
reduced and there is evidence of hypothalamic-pituitary-adrenal (HPA)
axis suppression. This suppression lasts for a variable period of up to 4
weeks. The usual dynamic tests of HPA axis function can be used to
diagnose evidence of impaired activity (e.g. Synacthen test).
12. Adrenal cortical atrophy develops during prolonged therapy and may
persist for months after stopping treatment. In patients who have
received more than physiological doses of systemic corticosteroids
(approximately 6 mg methylprednisolone) for greater than 3 weeks,
withdrawal should not be abrupt. How dose reduction should be carried
out depends largely on whether the disease is likely to relapse as the
dose of systemic corticosteroids is reduced. Clinical assessment of
disease activity may be needed during withdrawal. If the disease is
unlikely to relapse on withdrawal of systemic corticosteroids, but there is
uncertainty about HPA suppression, the dose of systemic corticosteroid
may be reduced rapidly to physiological doses. Once a daily dose of
6 mg methylprednisolone is reached, dose reduction should be slower to
allow the HPA-axis to recover.
Abrupt withdrawal of systemic corticosteroid treatment, which has continued
up to 3 weeks is appropriate if it is considered that the disease is unlikely to
relapse. Abrupt withdrawal of doses up to 32 mg daily of methylprednisolone
for 3 weeks is unlikely to lead to clinically relevant HPA-axis, in the majority
of patients. In the following patient groups, gradual withdrawal of systemic
corticosteroid therapy should be considered even after courses lasting 3
weeks or less:
• Patients who have had repeated courses of systemic corticosteroids,
particularly if taken for greater than 3 weeks.
• When a short course has been prescribed within one year of
cessation of long-term therapy (months or years).
• Patients who may have reasons for adrenocortical insufficiency other
than exogenous corticosteroid therapy.
• Patients receiving doses of corticosteroid greater than 32 mg daily of
methylprednisolone.
• Patients repeatedly taking doses in the evening.
13. Since mineralocorticoid secretion may be impaired, salt and/or a miner
alocorticoid should be administered concurrently.
14. Because rare instances of anaphylactic reactions have occurred in
patients receiving parenteral corticosteroid therapy, appropriate
precautionary measures should be taken prior to administration,
especially when the patient has a history of drug allergy.
15. Corticosteroids may mask some signs of infection, and new infections
may appear during their use. Suppression of the inflammatory response
and immune function increases the susceptibility to fungal, viral and
bacterial infections and their severity. The clinical presentation may often
be atypical and may reach an advanced stage before being recognised.
16. Chickenpox is of serious concern since this normally minor illness may
be fatal in immunosuppressed patients. Patients (or parents of children)
without a definite history of chickenpox should be advised to avoid close
personal contact with chickenpox or herpes zoster and if exposed they
should seek urgent medical attention. Passive immunisation with
varicella/zoster immunoglobulin (VZIG) is needed by exposed
non-immune patients who are receiving systemic corticosteroids or who
have used them within the previous 3 months; this should be given within
10 days of exposure to chickenpox. If a diagnosis of chickenpox is
confirmed, the illness warrants specialist care and urgent treatment.
Corticosteroids should not be stopped and the dose may need to be
increased.
17. Live vaccines should not be given to individuals with impaired immune
responsiveness. The antibody response to other vaccines may be
diminished.
Ref:0927/1411112P-B

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Source: Medicines and Healthcare Products Regulatory Agency

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

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