Consumer medicine information

Dexmethsone [9749]

Dexamethasone

BRAND INFORMATION

Brand name

Dexmethsone

Active ingredient

Dexamethasone

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Dexmethsone [9749].

What is in this leaflet

This leaflet answers some common questions about DEXMETHSONE. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking DEXMETHSONE against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What DEXMETHSONE is used for

DEXMETHSONE contains dexamethasone as the active ingredient. It belongs to a group of medicines called corticosteroids which are a synthetic version of a naturally occurring body hormone called cortisol.

DEXMETHSONE is used in the treatment of many different conditions including severe allergies, severe or chronic asthma, skin problems, arthritis, inflammatory diseases of the bowel, some types of cancer and "auto-immune" diseases.

It is also used to prevent or reduce the symptoms of inflammation (such as swelling, redness, pain, tenderness or itching) in any part of the body. These symptoms can occur in response to injury or can be caused by many different conditions.

DEXMETHSONE works by acting on the immune system and blocking the production of substances that trigger allergic and inflammatory actions.

Ask your doctor if you have any questions about why DEXMETHSONE has been prescribed for you. Your doctor may have prescribed it for another purpose.

This medicine is only available with a doctor's prescription.

There is no evidence that it is addictive.

Before you take it

When you must not take it

Do not take DEXMETHSONE if you have ever had an allergic reaction to:

  • dexamethasone
  • any of the ingredients listed at the end of this leaflet.

Symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty in breathing; swelling of the face, lips, tongue or any other parts of the body; rash, itching or hives on the skin.

Do not take it if you have a serious or uncontrolled infection. The signs and symptoms of infections such as fever or inflammation may be hidden by the anti-inflammatory action of DEXMETHSONE. You should see your doctor for medical advice for any but the most minor infections.

Do not take DEXMETHSONE after the expiry date (EXP) printed on the label.

Do not take it if the bottle shows signs of having been tampered with.

Do not take this medicine to treat any other complaints unless your doctor has instructed you to do so.

Do not give this medicine to anyone else even if their symptoms seem similar to yours.

Before you start to take it

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

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

  • recent surgery or serious injury
  • a current serious or uncontrolled infection
  • eye problems, such as glaucoma or cataracts
  • liver or kidney disease
  • diabetes mellitus, sugar diabetes
  • osteoporosis, softening of the bone
  • tuberculosis.

Tell your doctor if you are pregnant or intend to become pregnant. Your doctor can discuss the possible risks and benefits of taking high doses of DEXMETHSONE during pregnancy.

Tell your doctor if you are breast-feeding or plan to breast-feed. It is not recommended for use while breastfeeding as it is found in breast milk.

If you have not told your doctor about any of these things, tell them before you start taking DEXMETHSONE.

Taking other medicines

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

Some medicines may interfere with DEXMETHSONE. These include:

  • barbiturates, drugs which cause relaxation and sleepiness
  • phenytoin, a drug used to treat epilepsy
  • fluid or 'water' tablets
  • rifampicin, an antibiotic used to treat tuberculosis
  • oral contraceptives
  • immunisations or vaccines.

These medicines may be affected by DEXMETHSONE or may affect how well it works. You may need to take different amounts of your medicine or you may need to take different medicines. Your doctor or pharmacist will advise you.

Use in children

Take special care when giving DEXMETHSONE to children. It should only be given under your doctor's supervision.

If possible, children should not be exposed to common childhood illnesses such as chicken pox or measles while they are taking DEXMETHSONE. They may suffer from more serious attacks of these illnesses if such exposure occurs.

Children should not be vaccinated with 'live' vaccines against common childhood illnesses while they are taking DEXMETHSONE, as this may result in severe attacks of these illnesses.

Potentially serious side effects may occur in children and growing teenagers who are on long-term treatment of corticosteroids. Some of these include obesity, slowed growth, osteoporosis (softening of the bone) and changes to the adrenal glands.

Use in elderly

Elderly patients may be more sensitive to the effects or side effects of this medicine.

How to take it

How much to take

Your doctor will tell you how many tablets you will need to take each day.

The dose will depend on the condition being treated and your response to the treatment. Your initial dose will be maintained or adjusted until a satisfactory response is noted.

When to take it

How often you take DEXMETHSONE depends on what condition is being treated.

Do not miss any doses and do not stop taking this medicine even if you feel better. Missing doses may make your symptoms worse.

How long to take it

Continue taking your medicine for as long as your doctor tells you.

This will depend on your condition and your response to the treatment. Some people will need to take DEXMETHSONE for short periods of time, whereas, other people may require long term therapy.

Ask your doctor when and how you should stop taking DEXMETHSONE.

If you have been taking it for a long time, your doctor may gradually reduce the amount you are taking over a period of several days, weeks or months before stopping completely.

If you have been taking it for a short period of time, this may not apply.

If you forget to take it

If you miss a dose of this medicine, the decision of whether you should take it or not will depend on how many times a day your doctor has told you to take DEXMETHSONE.

If you are taking DEXMETHSONE:

*once a day -

Take the missed dose as soon as possible, then go back to your regular dosing schedule. If you do not remember until the next day, skip the missed dose and do not double the next one.

*several times a day -

Take the missed dose as soon as possible, then go back to your regular dosing schedule.

*on alternate days -

If you miss a dose and remember it the same morning, take it straight away, then continue as you normally would. If you do not remember the missed dose until later in the day, wait and take it the following morning. Then skip a day before continuing your regular dosage schedule.

Do not take a double dose to make up for any missed dose. This may increase the chance of you getting an unwanted side effect.

If you are not sure what to do, ask your doctor or pharmacist.

If you take too much (overdose)

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

While you are taking it

Things you must do

Take DEXMETHSONE exactly as directed by your doctor. If you do not follow your doctor's instructions, you may not get improvement in the symptoms of your condition. Try not to miss any doses and take the medicine even if you feel well.

Ask your doctor when and how you should stop taking DEXMETHSONE. If you have been taking it for a long time, your doctor may gradually reduce the amount you are taking over a period of several days, weeks or months before stopping completely.

If you have been taking it for a short period of time, this may not apply.

Keep all of your doctor's appointments. If you are taking DEXMETHSONE for a long period of time, you must have regular checkups with your doctor. This is especially important for children who are taking DEXMETHSONE.

Tell your doctor if you get a serious infection or injury whilst taking DEXMETHSONE.

Tell any other doctors, dentists, and pharmacists who are treating you that you are taking DEXMETHSONE, especially if you are being started on any new medicines.

If you plan to have surgery that needs a general anaesthetic, tell your doctor, surgeon or dentist that you are taking DEXMETHSONE. The trauma of the operation or surgery may mean that your dose of this medicine needs to be adjusted to cover this stressful time.

Tell your doctor immediately if you are diabetic and if you notice any change in your blood or urine sugar readings. DEXMETHSONE may affect your blood sugar levels as it can affect the body's ability to handle glucose. For diabetics, this means that your diabetes may become more severe.

For others, diabetes may develop for the first time while taking corticosteroids such as DEXMETHSONE.

Tell your doctor if you become pregnant while taking DEXMETHSONE.

Things you must not do

Do not stop taking DEXMETHSONE or lower the dosage without checking with your doctor. If you stop taking it suddenly, the symptoms of your condition may return or you may develop symptoms of certain hormone deficiencies such as fainting, weakness, restless-ness, nausea, vomiting, headache, dizziness, muscle weakness or joint pain.

Do not have any immunisations while you are taking DEXMETHSONE. Immunisation with 'live' vaccines may interfere with DEXMETHSONE or not work at all.

Things to be careful of

Avoid close contact with anyone who has a contagious disease such as chicken pox or measles. Exposure to such diseases while you are taking DEXMETHSONE can put you at greater risk of developing these diseases if you have not had them before.

Tell your doctor immediately if you think you have been exposed to chickenpox or measles.

Things to be aware of

As with any new medicine, you should take care when driving, operating machinery or drinking alcohol until you know how DEXMETHSONE affects you.

The signs and symptoms of infections such as fever or inflammation may be hidden by the anti-inflammatory action of DEXMETHSONE. You should see your doctor for medical advice for any but the most minor infections.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking DEXMETHSONE.

DEXMETHSONE helps most people, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

If you are elderly you may have an increased chance of getting side effects.

Short term use

When DEXMETHSONE is taken for short periods of time, even at high doses, it is unlikely to cause any problems.

Long term use

When DEXMETHSONE is taken for long periods of time and in high doses the risk of side effects is greater.

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

general changes to your body:

  • headache
  • nausea, feeling sick
  • vomiting
  • dizziness
  • indigestion, stomach pain or discomfort
  • diarrhoea or constipation
  • increased or reduced appetite
  • weight gain
  • slowed growth in children
  • bloating or rounding of the face
  • cramps or weakness in the muscles of the arms and legs
  • water retention leading to swollen legs and feet
  • irregular heart beat
  • irregular menstrual periods.

changes to the immune system:

  • an increased seriousness or frequency of infections.

changes in behaviour:

  • mood changes
  • anxiety or nervousness
  • restlessness
  • difficulty sleeping (insomnia).

changes to the skin:

  • poor wound healing
  • red or flushed face
  • increased sweating
  • extra hair growth
  • acne
  • red or purple streaks on skin
  • skin thinning
  • itchy rash
  • unusual bleeding or bruising under the skin.

changes in eyes:

  • cataracts
  • eyes sticking out too far
  • decreased or blurred vision.

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

  • severe stomach or intestinal pain
  • sudden changes in your vision
  • fits
  • major psychiatric or personality changes
  • symptoms such as severe dizziness, fainting, weakness, chest pain or irregular heart beat
  • swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing.

These are serious side effects. You may need urgent medical attention or hospitalisation. Serious side effects are rare.

Some side effects can only be detected by your doctor. So it is important to visit your doctor for regular check-ups when DEXMETHSONE is taken for long periods of time.

Such side effects can include changes in:

  • osteoporosis, softening of the bone
  • blood sugar level (diabetes)
  • eye pressure (glaucoma)
  • cholesterol levels
  • hormone levels
  • sperm count
  • high blood pressure (hypertension)
  • certain blood cells
  • the way nerves work
  • heart beat and rhythm.

Tell your doctor or pharmacist if you notice anything else that is making you feel unwell. Some people may get other side effects while using DEXMETHSONE.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

After taking it

Storage

Keep DEXMETHSONE tablets in a cool dry place where the temperature stays below 30°C.

Do not store it or any other medicine in the bathroom or near a sink. Do not leave it on a windowsill or in the car on hot days. Heat and dampness can destroy some medicines.

Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

Dispose of the tablets where children cannot reach them.

If your doctor or pharmacist tells you to stop taking DEXMETHSONE or the tablets have passed their expiry date, ask your pharmacist what to do with any tablets you may have left.

Product description

What it looks like

DEXMETHSONE tablets are available in two strengths; 0.5 mg or 4 mg.

The 0.5 mg tablets are round, slightly biconvex and white with a breakline and "DS/0.5" on one side and plain on the other side.

Available in bottles of 30 tablets.

The 4 mg tablets are round and white with a breakline and "DS/4" on one side and plain on the other side.

Available in bottles of 30 tablets.

Ingredients

Active ingredient:

DEXMETHSONE 0.5 mg - 0.5 mg dexamethasone per tablet.

DEXMETHSONE 4 mg - 4 mg dexamethasone per tablet.

Inactive ingredients:

  • lactose monohydrate
  • povidone
  • magnesium stearate
  • wheat starch (0.5 mg only)
  • maize starch (4 mg only).

DEXMETHSONE tablets do not contain sucrose, tartrazine or any other azo dyes. In addition, DEXMETHSONE 4 mg tablets do not contain gluten.

Sponsor

Aspen Pharmacare Australia. Pty Ltd
34-36 Chandos St
St Leonards NSW 2065 Australia

Australian Registration Numbers:

0.5 mg tablet: AUST R 27917

4 mg tablet: AUST R 27915

This leaflet was revised in October 2018.

Published by MIMS January 2019

BRAND INFORMATION

Brand name

Dexmethsone

Active ingredient

Dexamethasone

Schedule

S4

 

1 Name of Medicine

Dexamethasone.

6.7 Physicochemical Properties

Chemical formula: C22H29FO5, molecular weight: 392.5.

Chemical structure.

The structure of dexamethasone is:

CAS number.

50-02-2.

2 Qualitative and Quantitative Composition

Dexamethasone is a white or almost white, crystalline powder. It is practically insoluble in water, sparingly soluble in anhydrous ethanol, slightly soluble in methylene chloride.
Each Dexmethsone tablet contains either 0.5 mg or 4 mg of dexamethasone as the active ingredient.
Excipients include lactose monohydrate and wheat starch (0.5 mg tablet). For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

0.5 mg.

Round, slightly biconvex, white tablets plain on one side and 'DS/0.5' with breakline on the other side.

4 mg.

Round, white tablets plain on one side and 'DS/4' with breakline on the other side.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Dexamethasone is a glucocorticoid.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption, distribution, metabolism and excretion.

No data available.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

4 Clinical Particulars

4.1 Therapeutic Indications

Wherever corticosteroid therapy is indicated such as: pemphigus vulgaris, allergic dermatitis, eczema, exfoliative dermatitis, dermatitis herpetiformis, dermatitis medicamentosa, erythema multiforme; disseminated lupus erythematosus, dermatomyositis, polyarteritis nodosa; severe bronchial asthma and status asthmaticus, emphysema, pulmonary fibrosis; adrenal hyperplasia (adrenogenital syndrome); idiopathic thrombocytopenic purpura, acquired haemolytic anaemia, acute leukaemia; nephrotic syndrome; iridochoroiditis; ulcerative colitis; rheumatoid arthritis; ankylosing spondylitis, rheumatic fever, gout, periarthritis of the shoulder.

4.3 Contraindications

Uncontrolled infections. Known hypersensitivity to dexamethasone.

4.4 Special Warnings and Precautions for Use

Stress and intercurrent illness.

In patients on corticosteroid therapy subjected to unusual stress (from trauma or infection), increased dosage of rapidly acting corticosteroids before, during and after the stressful situation is indicated.

Adrenocortical insufficiency.

Drug induced secondary adrenocortical insufficiency may result from too rapid withdrawal of corticosteroids and 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 may need to be reinstituted. If the patient is receiving steroids already, dosage may have to be increased.
During prolonged corticosteroid therapy, adrenal suppression and atrophy may occur and secretion of corticotrophin may be suppressed. Abrupt withdrawal of corticosteroid therapy may precipitate acute adrenal insufficiency with muscle weakness, hypotension, hypoglycaemia, headache, nausea, vomiting, restlessness, and muscle and joint pain. Muscle weakness and stiff joints may persist for three to six months after discontinuation of treatment. In some cases, withdrawal symptoms may simulate a clinical relapse of the disease for which the patient has been under treatment.
Duration of treatment and dosage appear to be important factors in determining suppression of the pituitary-adrenal axis and response to stress on cessation of steroid treatment. The patient's liability to suppression is also variable. Some patients may recover normal function rapidly. In others, the production of hydrocortisone in response to the stress of infections, surgical operations or accident may be insufficient, and death results. Therefore, withdrawal of corticosteroids should always be gradual. If sudden withdrawal is necessary, corticotrophin (20 units) given daily by IV infusion during 8 hours for three to five successive days is usually sufficient to prevent withdrawal symptoms.

Infection.

Corticosteroids may mask some signs of infection (such as fever and inflammation), and new infections may appear during their use. There may be decreased resistance and inability to localise infection when corticosteroids are used. Susceptibility to infection is not specific for any particular bacterial or fungal pathogen.
Children who are on immunosuppressant drugs are more susceptible to infections than healthy children. Chickenpox and measles, for example, can have a more serious or even fatal course in children on immunosuppressant corticosteroids. In such children, or in adults who have not had these diseases, particular care should be taken to avoid exposure. If exposed, therapy with varicella zoster immune globulin (VZIG) or pooled intravenous immunoglobulin (IVIG), as appropriate, may be indicated. If chickenpox develops, treatment with antiviral agents may be considered.

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, 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.
If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes.
During long courses of treatment, laboratory and metabolic studies should be made. Fluid retention should be watched for via a fluid balance chart and daily weighing. Sodium intake may need to be reduced to less than 1 g daily and potassium supplements may be necessary.
The possibility of development of osteoporosis should be an important consideration in initiating and managing corticosteroid therapy, especially in postmenopausal women (see Section 4.8 Adverse Effects (Undesirable Effects)).
Caution should be taken in patients with diabetes mellitus (see Section 4.8 Adverse Effects (Undesirable Effects)).
Patients should not be vaccinated with live vaccines while on corticosteroid therapy. Other immunisation procedures should not be undertaken in patients on corticosteroid therapy, especially on high doses, because of possible hazards of neurological complications and lack of antibody response. Immunisation procedures may be undertaken in patients receiving corticosteroids as replacement therapy.
Close observation is necessary in patients with latent tuberculosis or tuberculin reactivity, as reactivation of the disease may occur. Chemoprophylaxis is indicated during prolonged corticosteroid therapy.

Use in hepatic impairment.

Use with caution in patients with impaired hepatic function. A reduction of dosage may be necessary. In treating chronic active liver disease with the drug, major adverse reactions such as vertebral collapse, diabetes, hypertension, cataracts and Cushing's syndrome occur in about 30% of patients.

Use in the elderly.

Caution is recommended for elderly patients as they are more susceptible to adverse reactions.

Paediatric use.

Children on long-term steroids must be carefully observed for potential serious adverse reactions such as obesity, growth retardation, osteoporosis and adrenal suppression.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Drugs which induce hepatic microsomal enzymes, such as barbiturates, phenytoin and rifampicin, administered before or during treatment may shorten the elimination half-life of the drug. Long-term corticosteroid therapy may also reduce the half-life. Oral contraceptives have been reported to increase the volume of distribution.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category A)
In animal experiments, corticosteroids have been found to cause malformations of various kinds (cleft palate, skeletal malformations) and abortion. These findings do not seem to be relevant to humans. Reduced placental and birth weight have been recorded in animals and humans after long-term treatment. Since the possibility of suppression of the adrenal cortex in the newborn baby after long-term treatment must be considered, the needs of the mother must be carefully weighed against the risk to the foetus when prescribing corticosteroids. The short-term use of corticosteroids antepartum for the prevention of respiratory distress syndrome does not seem to pose a risk to the fetus or the newborn infant. Maternal pulmonary oedema has been reported with tocolysis and fluid overload.
Glucocorticoids appear in breast milk in small quantities. Mothers taking high doses of glucocorticoids should be advised against breast feeding.

4.8 Adverse Effects (Undesirable Effects)

Reporting suspected adverse events.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.
Adverse reactions from corticosteroids are those resulting from withdrawal or from prolonged use of high doses.

More common reactions.

Cardiovascular.

The mineralocorticoid activity of a steroid may lead to salt and water retention, which can also result in hypertension. Hypokalaemia can lead to arrhythmias and cardiac arrest.

Central nervous system.

Large doses can cause behavioural and personality changes ranging from nervousness, insomnia, euphoria, or mood swings to psychotic episodes which can include both manic and depressive states, paranoid states and acute toxic psychoses.
It is no longer believed that previous psychiatric problems predispose to behavioural disturbances during therapy with glucocorticoids. Conversely, the absence of a history of psychiatric illness is no guarantee against the occurrence of psychosis during hormonal therapy.

Dermatologic.

Impaired wound healing. Facial plethora. An acneiform eruption on the face, chest and back, red striae on the thighs, buttocks and shoulders. Several months of high dose therapy often result in thinning of skin.
Corticosteroid induced purpura resembles senile purpura. This purpura usually occurs on extensor surfaces, dorsum of the hand, and radial aspect of the forearm.

Endocrine.

The endocrine effects of the glucocorticoids involve variously the hypothalamic-pituitary-adrenal axis; the genitals, the parathyroid and thyroid; there are also metabolic effects, primarily involving the carbohydrates. Suppression of growth may occur in children.
Cushing's syndrome may result from prolonged elevation of plasma glucocorticoid levels.
Disorders of menstruation are common.
Antagonism occurs between the parathyroids and hypercorticism. The phosphate retention occurring in renal failure caused by adrenal insufficiency may also make hypoparathyroidism manifest.

Biochemical.

All glucocorticoids increase gluconeogenesis. Glucose tolerance and sensitivity to insulin are decreased but, provided pancreatic islet function is normal, carbohydrate metabolism will not be noticeably deranged. Steroid diabetes has been reported to develop in one-fifth of patients treated with high glucocorticoid dosage.
High dose corticosteroid therapy may induce marked hypertriglyceridaemia with milky plasma.

General.

Retardation of growth by long-term corticosteroid treatment in children.

Haematological.

Corticosteroids will increase the total white blood cell count, with an increase in neutrophils and a decrease in monocytes, lymphocytes and eosinophils.

Immunological.

The frequency and severity of clinical infections increase during glucocorticoid therapy.

Musculoskeletal.

Osteoporosis and vertebral compression fractures in patients of all ages. Osteoporosis is an indication for withdrawal of therapy.
Myopathy, characterised by weakness of the proximal musculature of arms and legs of their associated shoulder and pelvic muscles, is occasionally reported in patients taking large doses of corticosteroids. It may occur soon after treatment is begun and be sufficiently severe to prevent ambulation. It is an indication for withdrawal of therapy.
Avascular aseptic necrosis of bone has often been described and preferentially involves the femoral and humeral head.

Ocular.

The incidence of posterior subcapsular cataract in patients undergoing long-term therapy with corticosteroids is approximately 10%. A correlation with duration of treatment and the total dose is clear.

Less common reactions.

Gastrointestinal.

Pancreatitis. Peptic ulceration is an occasional complication. The high incidence of haemorrhage and perforation in these ulcers and the insidious nature of their development make them severe therapeutic problems. Some investigators believe the available evidence does not support the conclusion that steroids cause ulcers. Others feel that only patients with rheumatoid arthritis have an increased incidence of ulcers. It has been proposed that the glucocorticoids alter the mucosal defense mechanism.

Neurological.

Latent epilepsy can be rendered manifest by corticosteroid treatment. Long-term treatment may result in benign intracranial hypertension.

Ophthalmological.

Increased intraocular pressure and glaucoma may occur with corticosteroid treatment. The rise in intraocular pressure may lead to blindness.

Severe or life-threatening reactions.

Suppression of the hypothalamic-pituitary-adrenal axis is one of the consequences of repeated administration of glucocorticoids; after termination of treatment a withdrawal syndrome may be experienced (see Section 4.4 Special Warnings and Precautions for Use).
In some cases, acute adrenal insufficiency after a period of glucocorticoid treatment has proved fatal.

Post marketing.

Eye disorders.

Blurred vision.

4.2 Dose and Method of Administration

Adults.

0.5 to 10 mg daily in divided doses, gradually reduced after good effect is achieved to a maintenance dosage of 0.5 to 1 mg daily. In potentially fatal conditions, much larger doses may be given for acute rheumatic carditis, acute leukaemia, the nephrotic syndrome and pemphigus.

Instructions to patients.

Patients should be warned of the long-term adverse effects of corticosteroids.
The necessity for increasing dosage in situations of intercurrent stress or infection should be advised. The patient should seek medical advice for any but the most minor infections. The danger of interrupting steroid therapy should be explained and the need to inform medical personnel that corticosteroid medication is being taken.
Patients on a dose reduction regime should be advised of the symptoms of acute glucocorticoid deficiency (faintness, weakness, vomiting).
Patients who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles and, if exposed, to obtain medical advice.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.9 Overdose

Treatment is symptomatic with the dosage being reduced or the drug withdrawn.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

7 Medicine Schedule (Poisons Standard)

S4.

6 Pharmaceutical Particulars

6.1 List of Excipients

Excipients include lactose monohydrate, magnesium stearate, povidone and wheat starch (0.5 mg tablet) or maize starch (4 mg tablet).

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 30°C. Protect from light.

6.5 Nature and Contents of Container

0.5 mg.

HDPE bottles. Pack sizes of 30's, 100's* and 1000's*.

4 mg.

HDPE bottles. Pack sizes of 30's, 100's* and 1000's*.
*Not currently distributed in Australia.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

Summary Table of Changes