Depo-Medrone 40 mg/ml Suspension for Injection 1 ml vial

Main information

  • Trade name:
  • Depo-Medrone 40 mg/ml Suspension for Injection 1 ml vial
  • Dosage:
  • 40 milligram(s)/millilitre
  • Pharmaceutical form:
  • Suspension for injection
  • Prescription type:
  • Product subject to prescription which may not be renewed (A)
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Depo-Medrone 40 mg/ml Suspension for Injection 1 ml vial
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic area:
  • Glucocorticoids; methylprednisolone

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization status:
  • Marketed
  • Authorization number:
  • PA0822/122/001
  • Authorization date:
  • 01-04-1978
  • Last update:
  • 21-01-2019

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

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Package leaflet: Information for the patient

Depo-Medrone

®

40 mg/ml Suspension for Injection

methylprednisolone acetate

Read all of this leaflet carefully before you start taking this medicine because it contains

important information for you

Depo-Medrone is a steroid medicine, prescribed for many different conditions, including serious

illnesses.

You need to take it regularly to get the maximum benefit.

Don’t stop taking this medicine without talking to your doctor – you may need to reduce the dose

gradually.

Depo-Medrone can cause side effects in some people (read section 4. Possible side effects).

Some problems such as mood changes (feeling depressed, or “high”), or stomach problems can

happen straight away. If you feel unwell in any way, keep taking Depo-Medrone, but see your

doctor straight away.

Some side effects only happen after weeks or months. These include weakness of arms and legs,

or developing a round face (read section 4. Possible side effects for more information).

If you take it for more than 3 weeks, you will get a blue “steroid card”: always keep it with you

and show it to any doctor or nurse treating you.

Keep away from people who have chickenpox or shingles, if you have never had them. They

could affect you severely. If you do come into contact with chickenpox or shingles, see your

doctor straight away.

Now read the rest of this leaflet. It includes other important information on the safe and effective use

of this medicine that might be especially important for you.

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

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

- If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not

listed in this leaflet. See section 4.

What is in this leaflet

What Depo-Medrone is and what it is used for

What you need to know before you take Depo-Medrone

How to take Depo-Medrone

Possible side effects

How to store Depo-Medrone

Contents of the pack and other information

1.

What Depo-Medrone is and what it is used for

Depo-Medrone contains methylprednisolone acetate.

Methylprednisolone belongs to a group of medicines called steroids. Their full name is

corticosteroids. These corticosteroids occur naturally in the body and help to maintain health and

well-being. Boosting your body with extra corticosteroid, such as Depo-Medrone, is an effective

way to treat various illnesses involving inflammation in the body. Depo-Medrone reduces this

inflammation, which could otherwise go on making your condition worse. You must take this

medicine regularly to get maximum benefit from it.

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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.

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 and tenosynovitis: Tennis elbow (epicondylitis) or a tendon's covering sheath

(tenosynovitis). For these conditions this medicine will be injected into the tendon or the

tendon sheath.

Alternatively this medicine may be injected into a muscle to help treat more general (systemic)

problems affecting the whole body (e.g. symptoms caused by a hypersensitivity to a medicine) or

allergic, inflammatory or rheumatic problems affecting the:

brain e.g. meningitis caused by tuberculosis

bowel and gut e.g. Crohn’s disease (inflammation of the gut) or ulcerative colitis

(inflammation of the lower bowel)

joints e.g. rheumatoid arthritis

lungs e.g. asthma, severe hay fever or rhinitis, tuberculosis or inflammation caused by

breathing in (aspirating) vomit or stomach contents

skin e.g. Stevens-Johnson syndrome (an autoimmune disorder in which an immune system

causes the skin to blister and peel) or systemic lupus erythematosus (lupus), an autoimmune

disorder which causes a rash with fever, arthritis, inflammation of the blood vessels, kidney

problems and problems affecting the brain.

Your doctor may use this medicine to treat conditions other than those listed above. Ask your

doctor if you are unsure why you have been given this medicine.

2.

What you need to know before you take Depo-Medrone

Do not take Depo-Medrone if:

You think you have ever suffered an allergic reaction, or any other type of reaction after

being given Depo-Medrone, methylprednisolone acetate, another 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 a generalized (systemic) infection that is not being

treated with antibiotics or anti-virals, or if you have a widespread (systemic) fungal infection.

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

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

This medicine should not be injected:

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

directly into a vein (intravenous), the spinal cord (intrathecal), the outer covering of the brain

(extradural), into the nostrils (intranasal), in the eye (intraocular) or by the epidural route.

Warnings and precautions

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Talk to your doctor or nurse before taking Depo-Medrone if you have any of the following

conditions. Your doctor may also have to monitor your treatment more closely, alter your dose or

give you another medicine.

Acute adrenal insufficiency (when your body cannot produce enough corticosteroid due to

problems with your adrenal glands).

Acute pancreatitis (inflammation of the pancreas).

Chickenpox, measles, shingles or a herpes eye infection. If you think you have been in

contact with someone with chickenpox, measles or shingles and you have not already had

these illnesses, or if you are unsure if you have had them.

If you have ever had a severe depression or manic depression (bipolar disorder). This

includes having depression before while taking steroid medicines like Depo-Medrone or if

any of your close family has had these illnesses.

Cushing’s syndrome (a hormone disorder caused by high levels of cortisol in the blood)

Diabetes (or if there is a family history of diabetes).

Epilepsy, fits or seizures.

Glaucoma (increased pressure in the eye) or if there is a family history of glaucoma.

Contact your doctor if you experience blurred vision or other visual disturbances.

You have recently suffered a heart attack.

Heart problems, including heart failure or infections.

Hypertension (high blood pressure).

Hypotension (low blood pressure).

Hypothyroidism (an under-active thyroid).

Joint infection.

Kaposi’s sarcoma (a type of skin cancer).

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 – bones that break easily).

Pheochromocytoma (a rare tumour of adrenal gland tissue. The adrenal glands are located

above the kidneys).

Scleroderma (also known as systemic sclerosis, an autoimmune disorder), because the risk

of a serious complication called scleroderma renal crisis may be increased.

Skin abscess.

Stomach ulcer, diverticulitis (inflammation of the bowel wall) or other serious stomach or

intestinal problems.

Unusual stress.

Thrombophlebitis - vein problems due to thrombosis (clots in the veins) resulting in

phlebitis (red, swollen and tender veins).

Traumatic brain injury.

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.

Other medicines and Depo-Medrone

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

You should tell your doctor if you are taking any of the following medicines which can affect the

way Depo-Medrone or the other medicine works:

Acetazolamide - used to treat glaucoma and epilepsy.

Aminoglutethimide and cyclophosphamide – used for treating cancer.

Antibacterials (such as isoniazid, erythromycin, clarithromycin and troleandomycin).

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Anticoagulants - used to ‘thin’ the blood such as acenocoumarol, phenindione and warfarin.

Anticholinesterases - used to treat myasthenia gravis (a muscle condition) such as distigmine

and neostigmine.

Antidiabetics – medicines used to treat high blood sugar.

Antiemetics (such as aprepitant and fosaprepitant).

Aspirin and non-steroidal anti-inflammatory medicines (also called NSAIDs) such as

ibuprofen used to treat mild to moderate pain.

Barbiturates, carbamazepine, phenytoin and primidone – used to treat epilepsy.

Carbenoxolone - used for heartburn.

Ciclosporin - used to treat conditions such as severe rheumatoid arthritis, severe psoriasis or

following an organ or bone marrow transplant.

Digoxin - used for heart failure and/or an irregular heart beat.

Diltiazem – used for heart problems or high blood pressure.

Ethinylestradiol and norethisterone – an oral contraceptive.

Pharmacokinetic enhancers (such as cobicistat) used to treat HIV infections.

Indinavir and ritonavir – used to treat HIV infections.

Ketoconazole or itraconazole – used to treat fungal infections.

Pancuronium and vecuronium – or other medicines called neuromuscular blocking agents

which are used in some surgical procedures.

Potassium depleting agents – such as diuretics (sometimes called water tablets),

amphotericin B, xanthenes or beta2 agonists (e.g. medicines used to treat asthma).

Rifampicin and rifabutin – antibiotics used to treat tuberculosis (TB).

Tacrolimus – used following an organ transplant to prevent rejection of the organ.

Vaccines - tell your doctor or nurse if you have recently had, or are about to have any

vaccination. You must not have ‘live’ vaccines while using this medicine. Other vaccines

may be less effective.

If you are taking long term medication(s)

If you are being treated for diabetes, high blood pressure or water retention (oedema) tell your

doctor as he/she may need to adjust the dose of the medicines used to treat these conditions.

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

medicine.

If you 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.

Depo-Medrone with drink

Do not drink grapefruit juice while taking this medicine.

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. Depo-Medrone should be used

during pregnancy only if clearly needed.

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

during pregnancy.

If you are breast-feeding, ask your doctor or nurse for advice before taking this medicine, as

methylprednisolone is excreted into breast milk.

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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.

Ask your doctor or nurse for advice before taking any medicine.

Driving and using machines

Undesirable effects, such as dizziness, a feeling of spinning (vertigo), visual disturbances and

fatigue are possible after treatment with corticosteroids. If you are affected do not drive or operate

machinery.

Depo-Medrone contains sodium

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

‘sodium-free’.

3.

How to take Depo-Medrone

Steroid Cards

Remember to always carry a Steroid Treatment Card. Make sure your doctor or nurse 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 or 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 an injection into a 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, epicondylitis (tennis elbow) and tendonitis – the usual dose is between 4-30 mg (0.1 -

0.75 ml). In most cases repeat injections will not be needed for bursitis and epicondylitis. Repeat

injections may be necessary to treat long standing tendonitis.

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.

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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 take 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 medicine must not be stopped suddenly. 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 a long time

have been given high doses of Depo-Medrone, or 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 taking 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.

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

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Your

doctor will have given you this medicine for a condition which if not treated properly could

become serious.

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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 attention. Your

doctor will then decide whether you should continue taking your medicine.

Allergic reactions such as skin rash, swelling of the face or wheezing and difficulty

breathing. This type of side effect is rare, but can be serious.

Pancreatitis, stomach pain spreading to your back, possibly accompanied by vomiting, shock

and loss of consciousness.

Ulcers or bleeding ulcers, symptoms of which are severe stomach pain which may go

through to the back and could be associated with bleeding from the back passage, black or

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.

Peritonitis, an inflammation (irritation) of the peritoneum, the thin tissue that lines the inner

wall of the abdomen and covers most of the abdominal organs. Symptoms are, the stomach

(abdomen) being very painful or tender, the pain may become worse when the stomach is

touched or when you move.

Pulmonary embolus (blood clot in the lung) symptoms include sudden sharp chest pain,

breathlessness and coughing up blood.

Raised pressure within the skull of children (pseudotumour cerebri) symptoms of which are

headaches with vomiting, lack of energy and drowsiness. This side effect usually occurs after

treatment is stopped.

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 if you notice any other unusual effects

not listed in this leaflet, tell your doctor immediately.

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

not known: frequency cannot be estimated from the available data.

Blood, heart and circulation

not known

High blood pressure, symptoms of which are headaches, or generally feeling

unwell.Problems with the pumping of your heart (heart failure) symptoms of which are

swollen ankles, difficulty in breathing and palpitations (awareness of heart beat) or irregular

beating of the heart, irregular or very fast or slow pulse.

Low blood pressure, symptoms may include dizziness, fainting, lightheadedness, blurred

vision, a rapid or irregular heartbeat (palpitations).

Increase of white blood cells (leukocytosis).

Body water and salts

not known

Swelling and high blood pressure, caused by increased levels of water and salt content.

Cramps and spasms, due to the loss of potassium from your body. In rare cases this can lead

to congestive heart failure (when the heart cannot pump properly).

Digestive system

not known

Ulcers.

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

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Thrush in the gullet (discomfort on swallowing).

Indigestion.

Diarrhoea.

Bloated stomach.

Abdominal pain.

Persistent hiccups, especially when high doses are taken.

Ears

not known

A feeling of dizziness or spinning (vertigo).

Eyes

not known

Cataracts (indicated by failing eyesight).

Glaucoma (raised pressure within the eye, causing pain in the eyes and headaches).Swollen

optic nerve (causing a condition called papilloedema, and which may cause sight

disturbance).

Increased intra-ocular pressure, with possible damage to the optic nerve 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).

Disease of the retina and choroid membrane, symptoms of which are blurred or distorted

vision (due to a disease called chorioretinopathy).

Blurred vision.

General disorders

not known

Poor wound healing.

Irritability in children.

Feeling tired or unwell.

Skin reactions at the site of injection.

Irritability in adults.

Hepatobiliary disorders

not known

Methylprednisolone can damage your liver, hepatitis and increase of liver enzymes have been

reported.

Hormones and metabolic system

not known

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

Round or moon-shaped face (Cushingoid facies).

Diabetes or worsening of existing diabetes.

Irregular or no periods in women.

Abnormal localized or tumour-like accumulations of fat in the tissues.

Increased appetite and weight gain.

Prolonged therapy can lead to lower levels of some hormones which in turn can cause low

blood pressure and dizziness. This effect may persist for months.

The amount of certain chemicals (enzymes) called alanine transaminase, aspartate

transaminase and alkaline phosphatase that help the body digest drugs and other substances in

your body may be raised after treatment with a corticosteroid. The change is usually small

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and the enzyme levels return to normal after your medicine has cleared naturally from your

system. You will not notice any symptoms if this happens, but it will show up if you have a

blood test.

Immune system

not known

Increased susceptibility to infections which can hide or change normal reactions to skin tests,

such as that for tuberculosis.

Metabolism and nutrition disorders

not known

Accumulation of fat tissue on localized parts of the body

Muscles, bones and joints

not known

Muscle weakness.

Brittle bones (bones that break easily).

Muscle wasting.

Broken bones or fractures.

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

Joint pain.

Torn muscle tendons causing pain and/or swelling.

Muscle cramps or spasms.

Swollen or painful joints due to infection.

Nerves and mood issues

not known

Steroids, including Depo-Medrone, can cause serious mental health problems.

Feeling depressed, including thinking about suicide.

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

Feeling anxious, having problems sleeping, difficulty in thinking or being confused.

Feeling, seeing or hearing things which do not exist. Having strange and frightening thoughts,

changing how you act or having feelings of being alone.

If you notice any of these problems talk to a doctor straight away.

Other nervous system side effects may include convulsions (seizures), amnesia (loss of memory),

cognitive disorder (mental changes), dizziness and headache.

Back pain or weakness (due to Epidural Lipomatosis, a rare disorder in which an abnormal

amount of fat is deposited on or outside the lining of the spine).

Skin

not known

Acne.

Bruising.

Poor wound healing.

Abscess, especially near injection sites.

Thinning of skin, stretch marks.

Small purple/red patches on the skin.

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

Increased hair on the body and face (hirsutism).

Rash, itching, hives.

Increased sweating.

Vascular disorders

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not known

Increased clotting of the blood.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet.

Reporting of side effects

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not

listed in this leaflet. You can also report side effects directly via HPRA Pharmacovigilence,

Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website:

www.hpra.ie; e-mail: medsafety@hpra.ie. By reporting side effects, you can help provide more

information on the safety of this medicine.

5.

How to store Depo-Medrone

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and carton after EXP.

The expiry date refers to the last day of that month.

Do not store this medicine above 25°C. Do not freeze.

Keep the vial in the outer carton.

6.

Contents of the pack and other information

What Depo-Medrone contains

The active substance is methylprednisolone acetate. Each millilitre contains 40 mg of

methylprednisolone acetate.

The other ingredients are sodium chloride, macrogol 3350, miripirium chloride, sodium hydroxide,

hydrochloric acid and water for injections.

What Depo-Medrone looks like and contents of the pack

Depo-Medrone is a sterile, white suspension (liquid) for injection contained in a glass vial fitted with a rubber

cap and metal seal.

Depo-Medrone is available in packs containing 1 or 10 vials, containing 1 ml, 2 ml or 3ml of suspension.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Pfizer Healthcare Ireland

9, Riverwalk

National Digital Park

Citywest Business Campus

Dublin 24

Manufacturer

Pharmacia NV/SA

Rijksweg 12

B-2870, Puurs

Belgium

Company contact address:

For further information on your medicine contact Medical Information at the following address:

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Pfizer Healthcare Ireland

9 Riverwalk

National Digital Park

Citywest Business Campus

Dublin 24

Telephone: 1800 633 363.

This leaflet was last revised in: MM/YYYY

Ref: DM 20_0 IE

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The following information is intended for healthcare professionals only.

PHYSICIAN LEAFLET

Depo-Medrone® 40 mg/ml Suspension for Injection

methylprednisolone acetate

FOR FURTHER INFORMATION PLEASE REFER TO THE SUMMARY OF PRODUCT

CHARACTERISTICS.

Posology and method of administration

Depo-Medrone may be used by any of the following routes: intramuscular, intra-articular,

intralesional, intrarectal, intrabursal, periarticular, or into the tendon sheath. It must not be used

by the intrathecal, epidural or intravenous routes.

Undesirable effects may be minimised by using the lowest effective dose for the minimum

period.

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

The following may serve as a guide:

Adults

The usual dose is 20 to 120 mg daily or weekly, with adjustment on the basis of the individual

requirements of the patient.

Elderly patients

When used according to instructions, there is no information to suggest that a change in dosage is

warranted in the elderly. Treatment of elderly patients, however, 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.

Paediatric population

Dosage depends principally on the condition and to a lesser extent on body weight and age of the

patient.

Intramuscular (for sustained systemic effect):

Allergic conditions (hay fever, asthma, rhinitis, drug reactions), 80 - 120 mg (2 - 3 ml).

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

Rheumatic disorders, collagen disease, SLE, 40 - 120 mg (1 - 3 ml) per week.

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Adrenogenital syndrome, 40 mg (1 ml) every two weeks.

On average the effect of a single 2 ml (80 mg) injection may be expected to last approximately

two weeks.

In the case of seasonal allergic rhinitis a single injection is frequently sufficient. If necessary,

however, a second injection may be given after 2 to 3 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 - 80 mg (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 and 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.

Rectal:

Ulcerative colitis, 40 - 120 mg (1 - 3 ml). Administer in retention enemas or by continuous drip in

30 - 300 ml of water, three to seven times weekly for two or more weeks.

Periarticular:

Epicondylitis. Infiltrate 4 - 30 mg (0.1 - 0.75 ml) into the affected area.

Into the tendon sheath:

Tendonitis, tenosynovitis, epicondylitis. For administration directly into the tendon sheath, 4 - 30

mg (0.1 - 0.75 ml). In recurrent or chronic conditions, repeat injections may be necessary.

Special precautions should be observed when administering Depo-Medrone. Intramuscular

injections should be made deeply into the gluteal muscles. The usual technique of aspirating prior

to injection should be employed to avoid intravascular administration. Doses recommended for

intramuscular injection must not be administered superficially or subcutaneously.

Intra-articular injections should be made using precise, anatomical localisation into the synovial

space of the joint involved. The injection site for each joint is determined by that location where

the synovial cavity is most superficial and most free of large vessels and nerves. Suitable sites for

intra-articular injection are the knee, ankle, wrist, elbow, shoulder, phalangeal and hip joints. The

spinal joints, unstable joints and those devoid of synovial space are not suitable. Treatment

failures are 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

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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 percent 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 and tendinitis care should be taken to inject Depo-Medrone into

the tendon sheath rather than into the substance of the tendon. Due to the absence of a true tendon

sheath, the Achilles tendon should not be injected with Depo-Medrone.

The usual sterile precautions should be observed, with each injection.

Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other

medicinal products.

Special precautions for storage

Do not store above 25

Do not freeze.

Keep the vial in the outer carton.

Special precautions for disposal and other handling

Depo-Medrone should not be mixed with any other fluid. Parenteral drug products should be

inspected visually for particulate matter and discoloration prior to administration whenever

suspension and container permit. Shake well before use.

Discard any remaining suspension after use.

HCP leaflet was last revised in: MM/YYYY

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