Consumer medicine information

Methylprednisolone Alphapharm Powder for injection

Methylprednisolone sodium succinate

BRAND INFORMATION

Brand name

Methylprednisolone Alphapharm Powder for injection

Active ingredient

Methylprednisolone sodium succinate

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Methylprednisolone Alphapharm Powder for injection.

What is in this leaflet

This leaflet answers some common questions about Methylprednisolone Alphapharm.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have benefits and risks. Your doctor has weighed the risks of you being treated with Methylprednisolone Alphapharm against the benefits it is expected to have for you.

Follow the instructions given to you by your doctor and the advice contained in this leaflet.

If you have any concerns about being treated with this medicine, ask your doctor or pharmacist.

Keep this leaflet with your medicine.

You may need to read it again.

What Methylprednisolone Alphapharm is used for

Your doctor has prescribed Methylprednisolone Alphapharm for the treatment of one or more of the following:

  • skin diseases
  • allergic reactions
  • inflammation of the eyes
  • respiratory diseases and certain respiratory infections
  • diseases of the gut (gastrointestinal tract)
  • multiple sclerosis
  • rheumatic disorders
  • diseases of the blood
  • treatment of certain glandular conditions

Your doctor may have prescribed Methylprednisolone Alphapharm for another reason.

How your medicine works

Methylprednisolone sodium succinate, the active ingredient in Methylprednisolone Alphapharm, belongs to a group of medicines called corticosteroids.

Methylprednisolone Alphapharm acts in the body by reducing inflammation (pain, swelling, redness and heat), which is one of the body's reactions to injury, and by reducing the body's reaction to infection.

Ask your doctor if you have any questions about why Methylprednisolone Alphapharm has been prescribed for you.

Methylprednisolone Alphapharm is available only with a doctor's prescription.

There is no evidence that Methylprednisolone Alphapharm is addictive.

Before you start treatment with Methylprednisolone Alphapharm

When Methylprednisolone Alphapharm must not be used

Methylprednisolone Alphapharm must not be used if you have an allergy to:

  • methylprednisolone sodium succinate
  • any of the ingredients listed at the end of this leaflet

Some symptoms of an allergic reaction (anaphylactic reactions) may include

  • skin rash
  • itching or hives on the skin
  • difficulty breathing
  • wheezing or coughing
  • swelling of the face, lips, tongue or other parts of the body

If you are not sure if you have or have had an allergic reaction to Methylprednisolone Alphapharm, check with your doctor.

Do not start treatment with Methylprednisolone Alphapharm, if you have a severe fungal infection.

Your doctor will advise whether use of Methylprednisolone Alphapharm is appropriate in those particular circumstances.

Methylprednisolone Alphapharm must not be used with certain types of vaccines.

Tell your doctor if you have recently been vaccinated or immunised.

Your doctor will advise you whether use of Methylprednisolone is appropriate in those particular circumstances.

Methylprednisolone Alphapharm must be administered by intravenous or intramuscular injection.

Do not administer Methylprednisolone Alphapharm in the spinal cord (intrathecal or epidural) or by local injection due to the risk of serious side effects.

Do not administer this medicine to yourself.

Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.

If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure if you should start treatment with this medicine, talk to your doctor.

Before treatment with Methylprednisolone Alphapharm

Tell your doctor if you are allergic to any other medicines or any other substances such as foods, preservatives or dyes.

Tell your doctor if you have or have had any of the following medical conditions:

  • disease of the heart, e.g., high blood pressure (hypertension) or congestive heart failure
  • condition or tumour of the adrenal and/or pituitary glands
  • stomach ulcers
  • thin or weak bones, or bones that tend to break easily (osteoporosis)
  • kidney or liver disease
  • underactive thyroid gland
  • emotional and mental disorder
  • myasthenia gravis (ongoing chronic fatigue and muscle weakness)
  • tuberculosis (TB)
  • herpes simplex of the eye
  • any pus producing infections
  • disease of the bowel, e.g., ulcerative colitis or diverticulitis
  • recent head injuries
  • fits or convulsions
  • diabetes or increased sugar in your blood
  • blood clots.

If you are scheduled to have any laboratory tests, e.g., blood or urine, tell your doctor that you are being treated with Methylprednisolone Alphapharm.

The use of Methylprednisolone Alphapharm may disguise the signs of infections due to a decrease in the body's response to the infection. If you are in any doubt please consult your doctor.

Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding.

Your doctor can discuss with you the risks and benefits involved.

Children

Long term treatment with corticosteroids can affect growth and development in children. It can also increase the risk of high pressure in the brain. Your doctor will monitor your child closely if your child needs long term treatment with Methylprednisolone Alphapharm.

Elderly

If you are over 65 years old, you may have an increased chance of side effects such as bone weakness possibly leading to fractures. You may also experience fluid retention which may lead to increased blood pressure.

If you have not told your doctor about any of the above, tell them before you start treatment with Methylprednisolone Alphapharm.

Taking other medicines

Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from a pharmacy, supermarket or health food shop.

Some medicines and food and Methylprednisolone Alphapharm may interfere with each other. These include:

  • nonsteroidal anti-inflammatory such as salicylates or aspirin, medicines used to relieve pain, swelling and other symptoms of inflammation including arthritis.
  • neuromuscular blocking drugs, e.g., pancuronium
  • some antibiotics, e.g., erythromycin
  • medicines used to treat TB, e.g. isoniazid
  • some anti-fungal agents, e.g., ketoconazole, amphotericin
  • medicines to treat HIV, e.g., indinavir, ritonavir
  • some medicines to treat blood pressure, heart conditions and stroke, e.g., digoxin and diltiazem
  • some diuretics e.g., frusemide, a medicine to help kidneys get rid of salt and water by increasing the amount of urine produced
  • medicine for nausea, e.g., aprepitant, fosaprepitant
  • oral contraceptives
  • medicines used for myasthenia gravis , glaucoma , Alzheimer's disease
  • medicines for psychiatric disorders
  • medicines to treat anxiety
  • bronchodilators (a type of medicine that opens up the airways in the lungs) used to treat asthma, bronchitis, emphysema, and other lung diseases, e.g., salbutamol
  • medicines to treat breast cancer or hormone disorder
  • anticonvulsants e.g., phenytoin, phenobarbitone
  • anticoagulants e.g., heparin, warfarin
  • antidiabetic medicines e.g., insulin, glibenclamide and metformin
  • immunosuppressants e.g., methotrexate and cyclosporin (a medicine used in kidney transplant patients)
  • some immunisations, inoculations or vaccinations
  • grapefruit juice.

You may need different amounts of Methylprednisolone Alphapharm or you may need to take different medicines.

Your doctor or pharmacist can tell you what to do if you are taking any of these medicines. They also have a more complete list of medicines to be careful with or avoid while being treated with Methylprednisolone Alphapharm.

Ask your doctor or pharmacist if you are not sure if you are taking any of these medicines.

How to use Methylprednisolone Alphapharm

This medicine will be administered under medical supervision.

Methylprednisolone Alphapharm must be administered by intravenous or intramuscular injection. It must not be given in the spinal cord (intrathecal or epidural) or by local injection due to the risk of serious side effects.

You must not administer this medicine to yourself.

Methylprednisolone Alphapharm powder is reconstituted with Sterile Water for Injections by your doctor or pharmacist.

How much you should be given

The dose and how often you are treated with will depend on your medical condition and also on your weight. Your doctor may change the dose and how many times a day you have it, as your condition changes.

How long you should be given Methylprednisolone Alphapharm

Your doctor will continue giving you Methylprednisolone Alphapharm for as long as your condition requires.

If you are given too much (overdose)

Methylprednisolone Alphapharm will be administered under medical supervision so an overdose is unlikely.

However, repeated frequent doses over a long period of time may cause an increase in side effects.

Immediately telephone your doctor, or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think you or anyone else may have taken too much Methylprednisolone Alphapharm. Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

Keep the telephone numbers for these services handy.

While being treated with Methylprednisolone Alphapharm

Things you must do

Tell your doctor immediately if you notice any unusual symptoms.

If you are about to start taking any new medicines, tell your doctor or pharmacist that you are being treated with Methylprednisolone Alphapharm.

Tell any doctor, dentist or pharmacist who treats you that you are being treated with Methylprednisolone Alphapharm.

Tell your doctor immediately if you become pregnant while taking this medicine.

If you are about to have any blood test, tell your doctor that you are taking Methylprednisolone Alphapharm.

It may interfere with some of the results.

Keep all your doctor's appointments so that your progress can be checked.

Things to be careful of

Avoid drinking grapefruit juice while you are being treated with Methylprednisolone Alphapharm.

Grapefruit may interact with Methylprednisolone Alphapharm and affect the way your body uses the medicine.

Be careful when driving or operating machinery until you know how Methylprednisolone Alphapharm affects you.

Methylprednisolone Alphapharm may cause dizziness, light headedness, visual disturbances, and fatigue in some patients.

Do not drive or operate machinery or do anything else that could be dangerous, if you have any of these symptoms.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are being treated with Methylprednisolone Alphapharm.

All medicines can have side effects and Methylprednisolone Alphapharm may have unwanted side effects in a few people. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Do not be alarmed by this list of possible side effects.

You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you notice any of the following and they worry you:

  • weight gain as a result of fluid retention or increased appetite
  • muscle weakness or loss of muscle mass
  • loss of ability to feel pain in the joint and instability of the joint
  • pain when putting weight or pressure on a joint
  • increased sweating
  • headache or dizziness
  • light headedness
  • changes in your menstrual periods
  • mood changes and other mental disorders such as memory loss, reduced perception and problem solving abilities
  • nausea
  • vomiting
  • itchy or peeling skin
  • loss of appetite or weight loss
  • thin fragile skin or bruising
  • acne
  • facial redness or bands, stripes or lines on the skin
  • excessive hairiness, particularly in women
  • benign tumour like lumps as a result of fat deposits in the tissues
  • persistent hiccups
  • stomach pain or discomfort
  • diarrhoea
  • fatigue or generally feeling unwell
  • pain, redness at the injection site.

If these effects do not go away, or they are worrying to you, tell your doctor.

Tell your doctor immediately if you experience any of the following:

  • bone weakness possibly leading to fractures
  • wounds that will not heal
  • red, purple or brown patches on your skin
  • loss of sensation or problems with your reflexes (slow or too fast).

Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you experience any of the following:

  • signs of increased pressure in the skull, including drowsiness, vomiting, headache, weakness, numbness and/or eye problems such as double vision
  • signs of frequent infections such as fever, severe chills, sore throat or mouth ulcers
  • allergic-type reactions, e.g., skin rash, itching and difficulty breathing, wheezing or coughing (anaphylactic reactions)
  • swelling of hands, ankles or feet
  • swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing
  • inflammation of the food pipe. You may experience difficulty or pain when swallowing or heartburn
  • poor appetite, fever, chills, nausea and a persistent stomach ache that becomes worse with movement
  • uncomfortable or severe stomach pains or belching after eating
  • convulsions or fits
  • blurred or loss of vision, distorted vision or a blind spot in your central vision, pressure in the eye.
  • pain and tenderness in the leg, pain on extending the foot, swelling of the lower leg, ankle and foot
  • chest pain and breathlessness.

Methylprednisolone Alphapharm can also cause: chemical imbalances in the blood and urine, swelling of the pancreas (pancreatitis), bleeding in the stomach, masking of infections, increased risk of infection, hormone changes, metabolic changes, changes in liver enzymes, increased blood pressure or increased number of white blood cells (leucocytosis).

Some of these side effects can only be found when your doctor does tests from time to time to check on your progress.

This is not a complete list of all possible side effects. Some people may get other side effects while being treated with Methylprednisolone Alphapharm.

It is very important to tell your doctor if you notice any side effects during a course of treatment with Methylprednisolone Alphapharm.

After treatment with Methylprednisolone Alphapharm

Storage

Normally your doctor will get Methylprednisolone Alphapharm from the hospital pharmacy or their consulting rooms. If you do take your Methylprednisolone Alphapharm from the pharmacy to your doctor, it is important to store it in a safe place away from heat (below 25°C).

Do not leave Methylprednisolone Alphapharm in a car or on window sills.

Heat can destroy some medicines.

If for any reason you take your Methylprednisolone Alphapharm home, always ensure that it is stored in a place where children cannot reach it.

Keep Methylprednisolone Alphapharm in a cool dry place where the temperature stays below 25°C.

Disposal

If your doctor stops treating you with Methylprednisolone Alphapharm, your hospital pharmacist will dispose of any unused medicine.

The expiry date is printed on the labels. Methylprednisolone Alphapharm should not be used after this date has passed.

Product description

What it looks like

Methylprednisolone Alphapharm is a white powder, which has to be reconstituted with water for injection, before being injected into the vein.

Methylprednisolone Alphapharm 500 mg and 1 g are available in packs of 1 vial.

Ingredients

Each vial of Methylprednisolone Alphapharm contains 500 mg and 1 g of methylprednisolone sodium succinate.

Methylprednisolone Alphapharm 500 mg and 1 g also contain the following inactive ingredients:

  • sodium phosphate monobasic anhydrous
  • sodium phosphate dibasic anhydrous
  • sodium hydroxide

Methylprednisolone Alphapharm 500 mg and 1 g do not contain gluten, lactose, sucrose, tartrazine or any other azo dyes.

Supplier

Methylprednisolone Alphapharm is supplied by:

Alphapharm Pty Limited
(ABN 93 002 359 739)
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: (02) 9298 3999
www.mylan.com.au

Australian registration numbers:

Methylprednisolone Alphapharm
500 mg - AUST R 166624

Methylprednisolone Alphapharm
1 g - AUST R 166625

This leaflet was prepared on 11 December 2017.

Methylprednisolone Alphapharm_cmi\Dec17/00

BRAND INFORMATION

Brand name

Methylprednisolone Alphapharm Powder for injection

Active ingredient

Methylprednisolone sodium succinate

Schedule

S4

 

Name of the medicine

Methylprednisolone sodium succinate.

Excipients.

40 mg.

Anhydrous monobasic sodium phosphate, anhydrous dibasic sodium phosphate, sodium hydroxide and anhydrous lactose.

500 mg and 1 g.

Anhydrous monobasic sodium phosphate, anhydrous dibasic sodium phosphate and sodium hydroxide.

Description

Chemical name: pregna-1,4-diene-3,20-dione,21- (3-carboxy-1-oxopropoxy)- 11,17-dihydroxy-6-methyl-,monosodium salt,(6α,11β). Molecular formula: C26H33NaO8. MW: 496.53. CAS: 2375-03-3. Methylprednisolone Alphapharm contains methylprednisolone sodium succinate, a synthetic glucocorticoid. It occurs as a white or nearly white, odourless, hygroscopic, amorphous solid. It is very soluble in water and in alcohol; it is insoluble in chloroform and is very slightly soluble in acetone.
Methylprednisolone sodium succinate is so extremely soluble in water that it may be administered in a small volume of diluent and is especially well suited for intravenous use in situations in which high blood levels of methylprednisolone are required rapidly.
Methylprednisolone Alphapharm 40 mg, powder for injection (IM-IV) contains the active ingredient, methylprednisolone. It also contains the following excipients: sodium phosphate monobasic anhydrous, sodium phosphate dibasic anhydrous, sodium hydroxide and lactose anhydrous. It is intended for intramuscular or intravenous administration.
Methylprednisolone Alphapharm 500 mg and 1 g, powder for injection (IV) contain the active ingredient, methylprednisolone. They also contain the following excipients: sodium phosphate monobasic anhydrous, sodium phosphate dibasic anhydrous and sodium hydroxide, and are indicated for intravenous administration only.

Pharmacology

Pharmacodynamics.

Methylprednisolone is a potent anti-inflammatory steroid, with greater anti-inflammatory potency and even less sodium and water retention inducing tendency than prednisolone.
Methylprednisolone sodium succinate has the same metabolic and anti-inflammatory actions as methylprednisolone. When given parenterally and in equimolar quantities, the two compounds are equivalent biologically. The relative potency of methylprednisolone sodium succinate and hydrocortisone sodium succinate, as indicated by depression of eosinophil count, following intravenous administration, is at least four to one. This has shown to be consistent with the relative oral potency of methylprednisolone and hydrocortisone.

Pharmacokinetics.

In vivo, cholinesterases rapidly hydrolyse methylprednisolone sodium succinate to free methylprednisolone. In man, methylprednisolone forms a weak dissociable bond with albumin and transcortin; approximately 40 to 90% of the drug is bound.
Metabolism of methylprednisolone occurs via the hepatic route and is qualitatively similar to metabolism of cortisol. The major metabolites are 20-beta-hydroxymethylprednisolone and 20-beta-hydroxy-6-alpha-methylprednisolone. The metabolites are mainly excreted in the urine as glucuronides, sulphates and unconjugated compounds. Following intravenous (IV) administration of 14C labelled methylprednisolone, 75% of the total radioactivity was recovered in the urine in 96 hours, 9% in faeces after 5 days and 20% in the bile.
Peak methylprednisolone plasma levels of approximately 20 microgram/mL are reached after IV infusions of 30 mg/kg bodyweight administered over 20 minutes, or 1 g over 30 to 60 minutes, whilst levels of 42-47 microgram/mL are measured after an IV bolus injection of 40 mg. Peak methylprednisolone plasma levels of 34 microgram/100 mL are measured after 120 minutes following a 40 mg intramuscular (IM) injection. Lower peak methylprednisolone plasma levels are achieved following IM injection than IV administration. However, the peak plasma value persists for a longer period following IM administration resulting in equivalent quantities of methylprednisolone reaching the plasma independent of the route of administration.
The plasma half-life of methylprednisolone is 2.3 to 4 hours and appears to be independent of the route/ pattern of administration. The biological half-life is 12 to 36 hours. The intracellular activity of glucocorticoids results in the marked variation in the plasma and pharmacological half-lives. Pharmacological activity persists after plasma levels are no longer measurable.
The duration of the anti-inflammatory action of glucocorticoids approximately equals the duration of the hypothalmic pituitary adrenal (HPA) axis suppression.

Indications

When oral therapy is not feasible and the strength, dosage form and route of administration of the drug reasonably lend the preparation to the treatment of the condition, Methylprednisolone Alphapharm is indicated only for intravenous or intramuscular use in the following conditions.

1. Endocrine disorders.

Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogues may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance).
Acute adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; mineralocorticoid supplementation may be necessary, particularly when synthetic analogues are used).
Preoperatively and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful.
Shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspected.
Congenital adrenal hyperplasia.
Nonsuppurative thyroiditis.
Hypercalcaemia associated with cancer.

2. Rheumatic disorders.

As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: ankylosing spondylitis; psoriatic arthritis; acute and subacute bursitis; epicondylitis; synovitis of osteoarthritis; acute gouty arthritis; acute nonspecific tenosynovitis; post-traumatic osteoarthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low dose maintenance therapy).

3. Collagen disease.

During an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus; systemic dermatomyositis (polymyositis); acute rheumatic carditis.

4. Dermatological diseases.

Bullous dermatitis herpetiformis; pemphigus; severe psoriasis; severe seborrhoeic dermatitis; exfoliative dermatitis; mycosis fungoides; severe erythema multiforme (Stevens-Johnson syndrome).

5. Allergic states.

Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in: bronchial asthma; drug hypersensitivity reactions; contact dermatitis; urticarial transfusion reactions; atopic dermatitis; serum sickness; seasonal or perennial allergic rhinitis; acute noninfectious laryngeal oedema (adrenaline is the drug of first choice).

6. Ophthalmic diseases.

Severe acute and chronic allergic and inflammatory processes involving the eye, such as: allergic corneal marginal ulcers; allergic conjunctivitis; chorioretinitis; anterior segment inflammation; herpes zoster ophthalmicus; iritis, iridocyclitis; diffuse posterior uveitis and choroiditis; keratitis; optic neuritis; sympathetic ophthalmia.

7. Gastrointestinal diseases.

To tide the patient over a critical period of the disease in: ulcerative colitis (systemic therapy); regional enteritis (systemic therapy).

8. Respiratory diseases.

Symptomatic sarcoidosis; berylliosis; aspiration pneumonitis; Loeffler's syndrome not manageable by other means; fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy.

9. Haematologic disorders.

Idiopathic thrombocytopenic purpura in adults (IV only; IM administration is contraindicated); secondary thrombocytopenia in adults; acquired (autoimmune) haemolytic anaemia; erythroblastopenia (RBC anaemia); congenital (erythroid) hypoplastic anaemia.

10. Neoplastic diseases.

For palliative management of: leukaemias and lymphomas in adults, acute leukaemia of childhood.

11. Oedematous states.

To induce diuresis or remission of proteinuria in the nephrotic syndrome, without uraemia, of the idiopathic type or that due to lupus erythematosus.

12. Nervous system.

Acute exacerbations of multiple sclerosis.

13. Miscellaneous.

Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy.
Trichinosis with neurologic or myocardial involvement.
As adjunctive therapy in the treatment of AIDS patients with moderate to severe Pneumocystis jiroveci pneumonia (PCP) when given within the first 72 hours of initial antipneumocystis treatment.

Contraindications

Methylprednisolone is contraindicated in patients with systemic fungal infections; known hypersensitivity to methylprednisolone or any of the excipients used in the formulation. The 40 mg strength presentation includes lactose produced from cow’s milk. This presentation may contain trace amounts of milk ingredients and is therefore contraindicated in patients with a known hypersensitivity to cow’s milk or its components, or to other dairy products.
Methylprednisolone Alphapharm is not indicated for intrathecal, epidural or local injection or any other unspecified route of administration.
Administration of live or live, attenuated vaccines is contraindicated in patients receiving doses of corticosteroids (see Precautions, Immunosuppressant effects/ increased susceptibility to infections).

Precautions

The lowest possible dose of corticosteroid should be used to control the condition under treatment, and when reduction in dosage is possible, the reduction should be gradual. Since complications of treatment with glucocorticoids are dependent on the size of the dose and the duration of treatment, a risk/ benefit decision must be made in each individual case as to dose and duration of treatment and as to whether daily or intermittent therapy should be used.

Immunosuppressant effects/ increased susceptibility to infections.

Corticosteroids increase susceptibility to infection, may mask some signs of infection, and new infections may appear during their use. There may be decreased resistance and inability to localise infection when corticosteroids are used. Infections with any pathogen including viral, bacterial, fungal, protozoan or helminthic infections, in any location in the body, may be associated with the use of corticosteroids alone or in combination with other immunosuppressive agents that affect cellular immunity, humoral immunity, or neutrophil function. These infections may be mild, but can be severe and at times fatal. With increasing doses of corticosteroids, the rate of occurrence of infectious complications increases.
Persons who are on drugs which suppress the immune system are more susceptible to infections than healthy individuals. Chicken pox and measles, for example, can have a more serious or even fatal course in nonimmune children or adults on corticosteroids.
Similarly, corticosteroids should be used with great care in patients with known or suspected parasitic infections such as Strongyloides (threadworm) infestation, which may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicaemia.
Administration of live or live attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids. Killed or inactivated vaccines may be administered to patients receiving immuno-suppressive doses of corticosteroids; however, the response to such vaccines may be diminished. Indicated immunisation procedures may be undertaken in patients receiving nonimmuno-suppressive doses of corticosteroids.
The use of methylprednisolone 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 appropriate anti-tuberculous 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 chemophylaxis.
The use of methylprednisolone in patients with AIDS (as in the adjunctive treatment of Pneumocystis jiroveci pneumonia) may be associated with an increased rate of reactivation of tuberculosis. Consideration should therefore be given to the administration of antimycobacterial therapy if corticosteroids are used in this high risk group. Such patients should also be observed for the activation of other latent infectious, and judicious examinations of sputum/ bronchoalveolar fluid should be made for the presence of other infectious agents.
Kaposi's sarcoma has been reported to occur in patients receiving corticosteroid therapy. Discontinuation of corticosteroids may result in clinical remission.
A study has failed to establish the efficacy of methylprednisolone sodium succinate in the treatment of sepsis syndrome and septic shock. Thus, routine use in septic shock is not recommended. The study also suggests that treatment of these conditions with methylprednisolone may increase the risk of mortality in certain patients (i.e. patients with elevated serum creatinine levels or patients who develop secondary infections after methylprednisolone).

Immune system effects.

Allergic reactions may occur. Because rare instances of skin reactions and anaphylactic/ anaphylactoid reactions (e.g. bronchospasm) 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 allergy to any drug.
In patients receiving the 40 mg presentation of methylprednisolone sodium succinate during the treatment for acute allergic conditions and where these symptoms worsen or any new allergic symptoms occur, consideration should be given to the potential for hypersensitivity reactions to cow’s milk ingredients (see Contraindications). If appropriate, administration of methylprednisolone sodium succinate should be stopped, and the patient’s condition should be treated accordingly. Alternative treatments, including the use of corticosteroid formulations that do not contain ingredients produced from cow’s milk, should be considered for acute allergy management, where appropriate.

Cardiac effects.

There are reports of cardiac arrhythmias and/or circulatory collapse and/or cardiac arrest following the rapid administration of large IV doses of methylprednisolone (greater than 0.5 g administered over a period of less than 10 minutes). Bradycardia has been reported during or after the administration of large doses of methylprednisolone sodium succinate, and may be unrelated to the speed or duration of infusion (see Dosage and Administration, Adverse Effects and Overdosage).
Adverse effects of glucocorticoids on the cardiovascular system, such as dyslipidemia and hypertension, may predispose treated patients with existing cardiovascular risk factors to additional cardiovascular effects, if high doses and prolonged courses are used. Accordingly, corticosteroids should be employed judiciously in such patients and risk modification and additional cardiac monitoring may need to be considered. Low dose and alternate day therapy may reduce the incidence of complications in corticosteroid therapy.
Use of systemic corticosteroid is not recommended in patients with congestive heart failure.

Vascular effects.

Thrombosis including venous thromboembolism has been reported to occur with corticosteroids. As a result corticosteroids should be used with caution in patients who have or may be predisposed to thromboembolic disorders.
Corticosteroids should be used with caution in patients with hypertension.

Endocrine effects.

In patients on corticosteroid therapy subjected to any unusual stress, increased dosage of rapidly acting corticosteroids before, during and after the stressful situation is indicated.
Pharmacologic doses of corticosteroids administered for prolonged periods may result in hypothalamic pituitary adrenal (HPA) suppression (secondary adrenocortical insufficiency). The degree and duration of adrenocortical insufficiency produced is variable among patients and depends on the dose, frequency, time of administration, and duration of glucocorticoid therapy. This effect may be minimised by use of alternate day therapy.
In addition, acute adrenal insufficiency leading to a fatal outcome may occur if glucocorticoids are withdrawn abruptly.
Drug induced secondary adrenocortical insufficiency may be minimised by gradual reduction of dosage. This type of relative insufficiency may persist for months after discontinuation of therapy, therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted.
A steroid withdrawal syndrome, seemingly unrelated to adrenocortical insufficiency, may also occur following abrupt discontinuance of glucocorticoids. This syndrome includes symptoms such as anorexia, nausea, vomiting, lethargy, headache, fever, joint pain, desquamation, myalgia, weight loss, and/or hypotension. These effects are thought to be due to the sudden change in glucocorticoid concentration rather than to low corticosteroid levels.
Because glucocorticoids can produce or aggravate Cushing's syndrome, glucocorticoids should be avoided in patients with Cushing's disease.
There is an enhanced effect of corticosteroids in patients with hypothyroidism.
Pheochromocytoma crisis, which can be fatal, has been reported after administration of systemic corticosteroids. Corticosteroids should only be administered to patients with suspected or identified pheochromocytoma after an appropriate risk/ benefit evaluation.

Hepatobiliary effects.

Drug-induced liver injury such as acute hepatitis can result from cyclical pulsed IV methylprednisolone (usually at doses of 1 g/day). The time to onset of acute hepatitis can be several weeks or longer. Resolution of the adverse event has been observed after treatment was discontinued. Serious hepatotoxicity has been reported.
There is an enhanced effect of corticosteroids in patients with cirrhosis.

Ocular effects.

Corticosteroids should be used cautiously in patients with ocular herpes simplex because of possible corneal perforation.
Prolonged use of corticosteroids may produce posterior subcapsular cataracts and nuclear cataracts (particularly in children), exopthalmos or increase intraocular pressure which may result in glaucoma with possible damage to the optic nerves and may enhance the establishment of secondary ocular infections due to fungi or viruses.
Corticosteroid therapy has been associated with central serous chorioretinopathy, which may lead to retinal detachment.

Psychiatric effects.

Psychic derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes and severe depression to frank psychotic manifestations. Also, existing emotional instability or psychotic tendencies may be aggravated by corticosteroids.
Potentially severe psychiatric adverse reactions may occur with systemic steroids (see Adverse Effects). Symptoms typically emerge within a few days or weeks of starting treatment. Most reactions recover after either dose reduction or withdrawal, although specific treatment may be necessary.
Psychological effects have been reported upon withdrawal of corticosteroids; the frequency is unknown. Patients/ caregivers should be encouraged to seek medical attention if psychological symptoms develop in the patient, especially if depressed mood or suicidal ideation is suspected. Patients/ caregivers should be alert to possible psychiatric disturbances that may occur either during or immediately after dose tapering/ withdrawal of systemic steroids.

Gastrointestinal effects.

High doses of corticosteroids may produce acute pancreatitis.
Corticosteroid therapy may mask the symptoms of peptic ulcer so that perforation or haemorrhage may occur without significant pain. Glucocorticoid therapy may mask peritonitis or other signs or symptoms associated with gastrointestinal disorders such as perforation, obstruction or pancreatitis. In combination with NSAIDs, the risk of developing gastrointestinal ulcers is increased.
Corticosteroids should be used with caution in nonspecific ulcerative colitis if there is a probability of impending perforation, abscess or other pyogenic infection, diverculitis, fresh intestinal anastomoses, or active or latent peptic ulcer.

Nervous system effects.

Use of corticosteroids is not recommended in patients with seizure disorders.
Corticosteroids should be used with caution in patients with myasthenia gravis (see Precautions, Musculoskeletal effects).
Although controlled clinical trials have shown corticosteroids to be effective in speeding the resolution of acute exacerbations of multiple sclerosis, they do not show that corticosteroids affect the ultimate outcome or natural history of the disease. The studies do show that relatively high doses of corticosteroids are necessary to demonstrate a significant effect (see Dosage and Administration).
Severe medical events have been reported in association with the intrathecal/ epidural routes of administration (see Adverse Effects).
There have been reports of epidural lipomatosis in patients taking corticosteroids, typically with long-term use at high doses.

Musculoskeletal effects.

An acute myopathy has been described with the use of high doses of corticosteroids, most often occurring in patients with disorders of neuromuscular transmission (e.g. myasthenia gravis), or in patients receiving concomitant therapy with anticholinergics, such as neuromuscular blocking drugs (e.g. pancuronium). This acute myopathy is generalised, may involve ocular and respiratory muscles, and may result in quadriparesis. Elevations of creatine kinase may occur. Clinical improvement or recovery after stopping corticosteroids may require weeks to years.
Corticosteroids should be used with caution in osteoporosis. Osteoporosis is a common but infrequently recognised adverse effect associated with a long-term use of large doses of glucocorticoid.

Metabolism and nutrition.

Corticosteroids, including methylprednisolone, can increase blood glucose, worsen pre-existing diabetes, and predispose those on long-term corticosteroid therapy to diabetes mellitus.

Investigations.

Average and large doses of cortisone or hydrocortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. These effects are less likely to occur with the synthetic derivatives except when used in large doses. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion.

Injury, poisoning and procedural complications.

Systemic corticosteroids are not indicated for, and should therefore not be used to treat traumatic brain injury. A large multicentre randomised study in patients administered corticosteroid therapy after significant head injury revealed an increased risk of mortality in the corticosteroid group compared to the placebo group.

Other.

Aspirin and nonsteroidal anti-inflammatory agents should be used cautiously in conjunction with corticosteroids (see Interactions with Other Medicines, Table 2, NSAIDs).

Effects on fertility.

Animal studies on the effects of methylprednisolone did not show an adverse impact on fertility in male and female rats treated with methylprednisolone aceponate at subcutaneous doses up to 0.1 mg/kg/day, although there was an increase in the number of non-viable fetuses. Other corticosteroids have been shown to impair fertility and reduce embryonic viability in studies in mice and rats.

Use in pregnancy.

(Category A)
Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. In animal reproduction studies, glucocorticoids such as methylprednisolone have been shown to increase the incidence of malformations (cleft palate, skeletal malformations), embryofetal lethality (e.g. increase in resorptions), and intrauterine growth retardation. There is limited data on the use of methylprednisolone sodium succinate in human pregnancies, and animal reproduction studies have not been done. Methylprednisolone sodium succinate should be used in pregnancy only after a careful assessment of the benefit-risk ratio to the mother and fetus.
Some corticosteroids readily cross the placenta. An increased incidence of low birthweights in infants born of mothers receiving corticosteroids has been reported.
Infants exposed in utero to substantial doses of corticosteroids must be carefully observed and evaluated for signs of adrenal insufficiency.
Cataracts have been observed in infants born to mothers treated with long-term corticosteroids during pregnancy.

Use in lactation.

Corticosteroids are excreted in breast milk.
Corticosteroids distributed into breast milk may suppress growth and interfere with endogenous glucocorticoid production in nursing infants. This medicinal product should be used during breastfeeding only after careful assessment of the benefit-risk ratio to the mother and infant.

Paediatric use.

Growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed. Growth may be suppressed in children receiving long-term, daily, divided dose glucocorticoid therapy and use of such a regimen should be restricted to the most urgent indications. Alternate day glucocorticoid therapy usually avoids or minimises this side effect.
Infants and children on prolonged corticosteroid therapy are at special risk from raised intracranial pressure.
High doses of corticosteroids may produce pancreatitis in children.

Use in the elderly.

Caution is recommended with prolonged corticosteroid treatment in the elderly due to a potential increased risk for osteoporosis, as well as increased risk for fluid retention with possible resultant hypertension.

Use in renal impairment.

Corticosteroids should be used with caution in patients with renal insufficiency.

Effects on ability to drive and use of machines.

The effect of corticosteroids on the ability to drive or use machinery has not been systematically evaluated. Undesirable effects, such as dizziness, vertigo, visual disturbances, and fatigue are possible after treatment with corticosteroids. If affected, patients should not drive or operate machinery.

Interactions

Methylprednisolone has a wide spectrum of clinical use and is therefore used with numerous concurrent drugs. The interactions listed below are of known or likely clinical significance. The need for dosage adjustment of either medication will depend on the clinical situation, the dose regimen prescribed and the observed clinical response. The interactions listed have either pharmacokinetic or pharmacodynamic basis.
Methylprednisolone is a cytochrome P450 enzyme (CYP) substrate and is mainly metabolised by the CYP3A4 enzyme. CYP3A4 catalyses 6β-hydroxylation of steroids, the essential phase I metabolic step for both endogenous and synthetic corticosteroids. Many other compounds are also substrates of CYP3A4, some of which (as well as other drugs) have been shown to alter glucocorticoid metabolism by induction (upregulation) or inhibition of the CYP3A4 enzyme.

CYP3A4 inhibitors.

Drugs that inhibit CYP3A4 activity generally decrease hepatic clearance, resulting in increased plasma concentrations of corticosteroids. Co-administration of these substances may require titration of corticosteroid dosage to reduce the risk of adverse effects and avoid steroid toxicity.

CYP3A4 inducers.

Drugs that induce CYP3A4 activity generally increase hepatic clearance, resulting in decreased plasma concentrations of corticosteroids. Co-administration of these substances may require an increase in corticosteroid dosage to achieve the desired result.

CYP3A4 substrates.

In the presence of another CYP3A4 substrate, the hepatic clearance of methylprednisolone may be inhibited or induced, with corresponding dosage adjustments required. It is possible that adverse events associated with the use of either drug alone may be more likely to occur with co-administration.
The most common and/or clinically important drug interactions or effects resulting from co-administration of methylprednisolone and examples of CYP3A4 inhibitors, inducers and substrates are provided in Table 1 and 2. Table 1 and 2 should be used in conjunction with the detailed information provided above.

Adverse Effects

Serious undesirable adverse events are also mentioned under the subheading Precautions.
The following adverse reactions have been reported with the following contraindicated routes of administration.
Intrathecal/ epidural: arachnoiditis, functional gastrointestinal disorder/ bladder dysfunction, headache, meningitis, parapareisis/ paraplegia, convulsions, and sensory disturbances. The frequency of these adverse reactions is not known.
The adverse effects are listed below by system organ class.

Infections and infestations.

Opportunistic infection, infectiona, peritonitisg.

Blood and lymphatic system disorders.

Leucocytosis.

Immune system disorders.

Drug hypersensitivityb (including anaphylactic reaction and anaphylactoid reaction).

Endocrine disorders.

Cushingoid, hypopituitarism, steroid withdrawal syndrome, adrenal insufficiency, secondary adrenocortical and pituitary unresponsivenessc.

Metabolism and nutrition disorders.

Metabolic acidosis, sodium retention, fluid retention, alkalosis hypokalaemic, dyslipidaemia, glucose tolerance impairedd, increased insulin requirement (or oral hypoglycaemic agents in diabetics), lipomatosis, increased appetite (which may result in weight increased).

Psychiatric disorders.

Psychotic disorder (including mania, delusion, hallucination and schizophrenia), affective disorder (including affect lability, drug dependence, suicidal ideation, depressed mood, euphoric mood), mental disorder, personality change, confusional state, anxiety, irritability, mood swings, abnormal behaviour, insomnia.

Nervous system disorders.

Epidural lipomatosis, intracranial pressure increased (with papilloedema [benign intracranial hypertension]), convulsion, amnesia, cognitive disorder, dizziness, headache.

Eye disorders.

Central serous chorioretinopathy, cataract, glaucoma, exophthalmos.

Ear and labyrinth disorders.

Vertigo.

Cardiac disorders.

Cardiac failure congestive (in susceptible patients), myocardial rupturee, arrhythmia.

Vascular disorders.

Thrombosis, hypertension, hypotension.

Respiratory, thoracic and mediastinal disorders.

Pulmonary embolism, hiccups.

Gastrointestinal disorders.

Peptic ulcer (with possible peptic ulcer perforation and peptic ulcer haemorrhage), intestinal perforation, gastric haemorrhage, pancreatitis, oesophagitis ulcerative, oesophagitis, vomiting, abdominal distention, abdominal pain, diarrhoea, dyspepsia, nausea.

Hepatobiliary disorders.

Hepatitisf.

Skin and subcutaneous tissue disorders.

Angioedema, hirsutism, subcutaneous atrophy, skin atrophy, petechiae, ecchymosis, erythema, hyperhidrosis, pruritus, rash, urticaria, skin striae, skin hyperpigmentation, skin hypopigmentation, acne.

Musculoskeletal and connective tissue disorders.

Muscular weakness, myalgia, myopathy, muscle atrophy, osteoporosis, osteonecrosis, pathological fracture, neuropathic arthropathy, arthralgia, growth retardation.

Reproductive system and breast disorders.

Menstruation irregular.

General disorders and administration site conditions.

Abscess sterile, impaired healing, oedema peripheral, fatigue, malaise, injection site reaction.

Investigations.

Intraocular pressure increased, carbohydrate tolerance decreased, blood potassium decreased, urine calcium increased, alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, blood urea increased, suppression of reactions to skin testsh.

Injury, poisoning and procedural complications.

Spinal compression fracture, tendon rupture.
aIncluding masking of infections and latent infections becoming active.
bWith or without circulatory collapse, cardiac arrest, bronchospasm, or hypertension.
cParticularly in times of stress, as in trauma, surgery or illness.
dManifestations of latent diabetes mellitus.
eFollowing a myocardial infarction.
fHepatitis has been reported with IV administration (see Precautions).
gPeritonitis may be the primary presenting sign or symptom of a gastrointestinal disorder such as perforation, obstruction or pancreatitis (see Precautions).
hNot a MedDRA preferred term.

Dosage and Administration

Methylprednisolone Alphapharm may be administered by intravenous or intramuscular injection or by intravenous infusion. The preferred method for initial emergency use is intravenous injection. Prepare solution as directed for intravenous (or intramuscular) administration (see Reconstitution). The desired dose, if 250 mg or less, may be administered intravenously over at least 5 minutes. Intramuscular injections (250 mg or less) should be injected slowly into a large muscle.
When high dose therapy is indicated (i.e. greater than 250 mg), the recommended dose of Methylprednisolone Alphapharm is 30 mg/kg administered intravenously over at least 30 minutes (see Precautions, Adverse Effects and Overdosage). This dose may be repeated every 4 to 6 hours for up to 48 hours.
In general, high dose corticosteroid therapy should be continued only until the patient's condition has stabilised; usually not beyond 48 to 72 hours.
Although the adverse effects associated with high dose short-term corticoid therapy are uncommon, peptic ulceration may occur. Prophylactic antacid therapy may be indicated.
In other indications, initial dosage will vary from 10 to 500 mg of methylprednisolone depending on the clinical problem being treated. The larger doses may be required for short-term management of severe, acute conditions. The initial dose, up to 250 mg, should be given intravenously over a period of at least 5 minutes, and if greater than 250 mg then over at least 30 minutes. Subsequent doses may be given intravenously or intramuscularly at intervals dictated by the patient's response and clinical condition. Corticoid therapy is an adjunct to, and not replacement for conventional therapy.
Dosage may be reduced for infants but should be governed more by the severity of the condition and response of the patient than by age or size. It should not be less than 0.5 mg per kg every 24 hours.
Dosage must be decreased or discontinued gradually when the drug has been administered for more than a few days. If a period of spontaneous remission occurs in a chronic condition, treatment should be discontinued. Routine laboratory studies, such as urinalysis, two hour postprandial blood glucose, determination of blood pressure and bodyweight, and a chest X-ray should be made at regular intervals during prolonged therapy. The state of the upper GI tract should be monitored in patients with a history of ulceration or significant dyspepsia.

Pneumocystis jiroveci pneumonia.

For patients diagnosed with Pneumocystis jiroveci pneumonia (PCP), presenting with a PaO2 (arterial oxygen pressure) under 55 mmHg on room air, or where respiratory failure is considered likely, the following regimen should be administered.
Administer 40 mg of Methylprednisolone Alphapharm powder for solution for injection intravenously every six hours for 5 to 7 days. Upon improvement, oral prednisolone should be instituted with the following tapering regimen: 60 mg (divided four times daily) for 2 days; 50 mg (divided twice daily) for 2 days; 40 mg (divided twice daily) for 2 days; 30 mg (divided twice daily) for 2 days; 20 mg (divided twice daily) for 2 days; 15 mg (divided twice daily) for 2 days; 10 mg (divided twice daily) for 2 days; 5 mg (divided twice daily) for 2 days then cease.
Treatment with prednisolone should last a maximum of 21 days or until the end of antipneumocystis therapy.
The following four clinical points should be considered when using adjunctive corticosteroid therapy for AIDS related PCP.
1. Adjunctive corticosteroid therapy should be initiated early (within 72 hours of starting antipneumocystis therapy).
2. The diagnosis of PCP must be confirmed and other pulmonary pathogens ruled out because of the potential for masking symptoms of untreated infections.
3. Antimycobacterial therapy should be initiated along with antipneumocystis therapy in patients with a current positive PPD test or in other high risk patients.
4. Adjunctive corticosteroid therapy should be commenced with the maximum recommended dose. The duration of treatment at this dose should be dependent upon both the severity of the disease and the clinical response to therapy. Following a satisfactory clinical response a tapering regimen should be instituted. The use of a tapering regimen decreases the potential for relapse upon the discontinuation of corticosteroid therapy.

Multiple sclerosis.

In treatment of acute exacerbations of multiple sclerosis, daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day for 1 month have been shown to be effective (4 mg of methylprednisolone is equivalent to 5 mg of prednisolone).

Summary of dosage and administration recommendations.

For intravenous use.

(See Table 3.)

For intramuscular use.

Intramuscular injections (250 mg or less) should be injected slowly into a large muscle.

Reconstitution.

Methylprednisolone Alphapharm should be reconstituted with sterile water for injections. Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration whenever solution and container permit.
It is recommended that the reconstituted solution of Methylprednisolone Alphapharm be used immediately upon preparation.
The volume of diluent recommended and the resulting concentration is stated in Table 4.

Preparation of solutions for intravenous infusion.

To prepare an intravenous solution, first reconstitute powder for injection as directed in the reconstitution section. The reconstituted solution may then be added to glucose intravenous infusion 5%, sodium chloride intravenous infusion 0.9% or sodium chloride 0.9% and glucose 5% intravenous infusion; the resulting admixtures should be used immediately and is for single use only.

Compatibility and stability.

It is recommended to administer Methylprednisolone Alphapharm separately from other drugs and as either IV injection, through an IV medication chamber, microburette, or as an IV piggyback solution, whenever possible, to avoid compatibility and stability problems. The IV compatibility and stability of methylprednisolone sodium succinate, either alone in solution or in admixtures with other drugs, is dependent on pH, concentration, time, temperature, and the ability of methylprednisolone to solubilise itself.
Drugs that are physically incompatible in solution with methylprednisolone sodium succinate include, but are not limited to: allopurinol sodium, doxapram hydrochloride, tigecycline, diltiazem hydrochloride, calcium gluconate, vecuronium bromide, rocuronium bromide, cisatracurium besylate, glycopyrrolate, propofol.

Overdosage

Symptoms.

Reports of acute toxicity and metabolic disturbances with glucocorticoids are rare but do occur. There is no clinical syndrome of acute overdosage with Methylprednisolone Alphapharm Powder for Injection. Acute overdose may possibly aggravate pre-existing disease states such as ulceration of the gastrointestinal tract, electrolyte disturbances, infections, diabetes and oedema.
High doses of methylprednisolone, when given repeatedly, have caused hepatic necrosis and an increase in amylase. Bradyarrhythmias, ventricular arrhythmias and cardiac arrest have been observed in cases of intravenous administration of high doses of methylprednisolone.
Repeated frequent doses (daily or several times per week) over a protracted period may result in Cushingoid state. The possibility of adrenal suppression should be guarded against by gradual diminution of dose levels over a period of time.

Treatment.

In the event of an overdose, treatment is symptomatic and supportive, including respiratory and cardiovascular function. In chronic toxicity, fluids and electrolytes should be monitored closely. Serum levels are not clinically useful.
Contact the Poisons Information Centre on 131 126 (Australia) for advice on management of overdosage.

Presentation

Powder for injection (sterile, white), 40 mg*, 500 mg, 1 g: 1's, 5's* (vial).
*Not currently marketed in Australia.

Storage

Store below 25°C. Protect from light.
When reconstituted using sterile water for injections, the resulting solution should be used immediately. Discard any unused portion.
Product is for single use in one patient only. Discard any residue.

Poison Schedule

S4.