Consumer medicine information

Sone

Prednisone

BRAND INFORMATION

Brand name

Sone Tablets

Active ingredient

Prednisone

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Sone.

What is in this leaflet

This leaflet answers some common questions about SONE (prednisone tablets). It does not contain all the available information about SONE tablets. It does not replace talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you or your child taking SONE against the benefits he or she expects it will have.

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 is SONE

The name of your medicine is SONE and is available in 5 mg and 25 mg tablet strengths.

The active ingredient is called prednisone.

Prednisone belongs to a group of medicines called corticosteroids.

Corticosteroids are used to help reduce inflammation in your body or suppress your immune system, when a disease may be due to an auto-immune reaction (where your body fights against itself).

What SONE is used for

SONE is used to treat a number of medical conditions.

Your doctor will be able to help decide if SONE is suitable for your condition.

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

If you have any concerns, you should discuss this with your doctor.

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

Before you take SONE

When you must not take it

Do not take SONE if you are allergic to:

  • Prednisone or other cortisone type medications, or any of the ingredients listed at the end of this leaflet including lactose.

Some of the symptoms of an allergic reaction to SONE may include urticaria and other skin rashes, difficulty breathing, swelling of the face or throat or faintness.

Do not take SONE if you:

  • have a peptic ulcer
  • suffer from osteoporosis (brittle bones)
  • have severe disturbances in thoughts, feelings and behaviours (psychoneuroses)
  • have tuberculosis.

Do not take SONE if you are breastfeeding or plan to breast-feed.

Do not take SONE if you know you have any infections, including mumps, measles or chickenpox.

Do not use SONE after the expiry date (EXP.) printed on the pack.

If you take it after the expiry date has passed, it may have no effect at all, or worse, there may be an entirely unexpected effect.

Do not use SONE if the packaging is torn or shows any signs of tampering.

Do not give it to children, unless your doctor has prescribed it.

Before you start to take it

You must tell your doctor if:

  1. You are allergic to any other medicines or any foods, dyes or preservatives
  2. You have or have had any other medical conditions or health problems, including:
  • tuberculosis (TB)
  • a stomach ulcer
  • osteoporosis (brittle bone disease)
  • myasthenia gravis
  • congestive heart failure or have any other heart disease
  • diabetes
  • kidney failure
  • an underactive thyroid gland (hypothyroidism)
  • any infection (bacterial or fungal) including viral infections such as chicken pox
  1. Scleroderma (also known as systemic sclerosis, an autoimmune disorder) because daily doses of 15 mg or more may increase the risk of a serious complication called scleroderma renal crisis. Signs of scleroderma renal crisis include increased blood pressure and decreased urine production. The doctor may advise that you have your blood pressure and urine regularly checked.
  2. Take Typhoid Vaccine.
    Live or attenuated vaccines such as oral typhoid vaccine must not be taken with SONE.
  3. You are pregnant or plan to become pregnant.
    SONE like all medicines should not be used during pregnancy, unless your doctor tells you.
  4. You are breastfeeding or plan to breastfeed.
    SONE is expelled in breast milk and therefore should only be taken if your doctor tells you.

If you have not told your doctor about any of the above, tell them before you take any SONE.

Taking other medicines

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

Some medicines may interfere with SONE. These include:

  • medicines used to treat upset stomachs such as antacids
  • medicines used for diabetes including insulin
  • medicines used to treat tuberculosis such as rifampicin
  • medicines used to treat fungal infections such as ketoconazole
  • some medicines which have a high sodium content and also foods with a high sodium content - check with your pharmacist
  • some fluid reducing tablets, also called diuretics
  • barbiturates, medicine used to treat epilepsy
  • high doses of aspirin
  • potassium supplements
  • growth hormones
  • digoxin or digitalis glycosides
  • course of vaccinations

The above medicines may either reduce the effectiveness of SONE, reduce its own effectiveness and/or react with SONE resulting in untoward or sometimes dangerous side effects.

Tell your doctor if you are taking SONE tablets before you undergo any laboratory test. SONE may interfere with laboratory tests to check your thyroid.

Alcohol may interfere whilst you are taking SONE tablets.

This list is not exhaustive. Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking SONE.

How to take SONE

How much to take

Your doctor will decide the right dose for you.

The dose you need depends on your medical condition, the treatment you are undergoing and your response to it.

The recommended doses are for:

Adults: 10 mg to 100 mg daily in divided doses.

Children: 1 to 5 years: 2.5 mg to 10 mg twice daily.

Children: 6 to 12 years: 5 mg to 20 mg twice daily.

Follow your doctor's instructions carefully, if you need to reduce your dose of SONE.

High doses of SONE should be reduced gradually.

How to take it

Swallow the medicine with water. If the dose is one-half tablet, there is a break-line on the tablet to help you divide it.

When to take it

Take SONE after meals at the time directed by your doctor.

How long to take it

Continue taking SONE as long as your doctor recommends it.

If you forget to take it

If your dosing schedule is one dose a day, take the missed dose as soon as possible, but not later than 4 hours before your next dose. If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Otherwise, take it as soon as you remember, and then go back to taking it as you would normally.

Do not take a double dose to make up for the dose that you missed.

If you are unsure about whether to take your next dose, speak to your doctor or pharmacist.

Do not try to make up for missed doses by taking more than one dose at a time.

This may increase the chance of you getting an unwanted side effect.

If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.

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 the nearest hospital, if you think that you or anyone else may have taken too much SONE. Do this even if there are no signs of discomfort or poisoning. Also report any other medicine or alcohol which has been taken. You may need urgent medical attention.

Keep telephone numbers for these places handy.

If you take too much SONE you may have the following symptoms: weakness, convulsions, dizziness, headache, nausea, vomiting, blurred vision, menstrual irregularities, and symptoms associated with electrolyte and fluid depletion and high blood pressure (hypertension).

While you are using SONE

Things you must do

Use SONE exactly as your doctor has prescribed.

Tell all doctors, dentists and pharmacists who are treating you that you are taking SONE.

Tell your doctor promptly if you become pregnant while you are taking SONE.

Tell your doctor if you feel SONE is not helping your condition.

Visit your doctor regularly.

Your doctor needs to check your progress and see whether you need to keep taking SONE.

Always discuss with your doctor any problems or difficulties during or after taking SONE.

Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed.

Otherwise your doctor may think that it was not effective and change your treatment unnecessarily.

Keep enough SONE to last weekends and holidays.

Things you must not do

Do not take any other medicines while you are taking SONE without first telling your doctor.

Do not drive or operate machinery until you know how SONE affects you.

SONE may cause dizziness in some people and therefore may affect alertness.

Make sure you know how you react to SONE before you drive a car, operate machinery, or do anything else that could be dangerous if you are dizzy or have blurred vision.

Do not take SONE for a longer time than your doctor has prescribed.

Do not change your dose without first checking with your doctor.

Do not stop taking SONE or lower the dose, without first checking with your doctor.

Stopping this medicine suddenly on your own accord may cause some unwanted and dangerous effects, or your condition may reappear. Your doctor will advise you when you can stop taking SONE completely.

Do not use this medicine to treat any other complaints unless your doctor says to.

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

Side effects

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

SONE helps most people with medical conditions listed in the beginning of this leaflet, but it may have unwanted side effects in some people.

All medicines have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Ask your doctor or pharmacist any questions you may have.

Short term use

When Sone is taken for short periods of time it is unlikely to cause any problems.

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

  • mood changes
  • nausea (feeling sick)
  • vomiting
  • increased appetite (which may result in weight gain)
  • stomach bloating or irritation
  • diarrhoea or constipation.

Long term use

When Sone 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 the body:

  • bloating and rounding of the face (moon face)
  • headache
  • dizziness
  • high blood pressure
  • weight gain
  • redistribution of body fat
  • water retention leading to swollen legs and feet, high blood pressure or an irregular heart beat
  • cramps or weakness in the muscles of the arms and legs
  • slowed growth in children
  • irregular menstrual periods.

Changes to the skin:

  • acne
  • red or flushed face
  • red or purple streaks
  • easy bruising
  • skin thinning
  • increased sweating
  • poor wound healing
  • skin rashes.

Changes to the immune system:

  • an increased seriousness or frequency of infections.

Changes in behaviour:

  • excessive mood swings (such as changes in personality and loss of contact with reality)
  • anxiety or nervousness
  • depression
  • euphoria
  • restlessness
  • trouble sleeping.

Changes in eyes:

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

Side effects where the frequency is not known:
Scleroderma renal crisis in patients already suffering from scleroderma (an autoimmune disorder). Signs of scleroderma renal crisis include increased blood pressure and decreased urine production.

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
  • epileptic fits
  • sudden changes in your vision
  • symptoms such as severe dizziness, fainting, weakness, chest pain or irregular heart beat
  • psychiatric (mental) disturbances.

These are all serious side effects of Sone. You may need urgent medical attention or hospitalisation.

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

Such side effects can include:

  • osteoporosis or other changes in bone which can result in an increased chance of fractures due to brittleness or softening of the bone
  • changes in other hormone levels in your body
  • changes in the body's ability to handle glucose (steroid diabetes)
  • effects on the parathyroid and thyroid glands which control calcium and body metabolism
  • increased amounts of cholesterol in the blood
  • changes to your white blood cells
  • changes to your nervous system which may affect the way your nerves work
  • increased blood pressure
  • increased pressure in the skull
  • increased pressure in the eye (glaucoma).

Tell your doctor if you notice anything else that is making you feel unwell.

Some people may get other side effects while using SONE.

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

Your doctor may lower the dose to help control serious side effects and decide on necessary tests to monitor any of the above problems.

Check with your doctor as soon as possible if you have any problems while taking SONE, even if you do not think the problems are connected with the medicine or are not listed in this leaflet.

After using SONE

Storage

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.

Keep SONE in a cool dry place where the temperature stays below 30°C and protect from light.

Do not store it, or any other medicines, in a bathroom or near a sink.

Do not leave it in the car or on windowsills.

Heat and dampness can destroy some medicines.

Do not take SONE if the tablets do not look quite right.

Keep your tablets in the bottle they were provided in until it is time to take them.

Disposal

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

Product description

What it looks like

SONE 5 mg tablet is a white round plain uncoated tablet, one side plain and the other scored. It comes in a bottle of 60 tablets.

SONE 25 mg tablet is a white round plain uncoated tablet, one side plain and the other scored. It comes in a bottle of 30 tablets.

Ingredients

Each SONE 5 mg tablet contains 5 mg of the active ingredient, prednisone.

The other ingredients are:

  • lactose
  • propyl hydroxybenzoate
  • starch-maize
  • starch-wheat
  • gelatin
  • magnesium stearate

Each SONE 25 mg tablet contains 25 mg of the active ingredient, prednisone.

The other ingredients are:

  • lactose
  • propyl hydroxybenzoate
  • starch-maize
  • starch-wheat
  • gelatin
  • magnesium stearate

SONE contains lactose and gluten but does not contain sucrose.

Sponsor

iNova Pharmaceuticals (Australia) Pty Limited
ABN: 13 617 871 539
Level 10, 12 Help Street
Chatswood NSW 2067
Telephone: 1800 630 056

The Australian Registration Number for SONE 5 mg tablet is
AUST R 56129.

The Australian Registration Number for SONE 25 mg tablet is
AUST R 13470.

This leaflet was prepared in November 2017.

BRAND INFORMATION

Brand name

Sone Tablets

Active ingredient

Prednisone

Schedule

S4

 

1 Name of Medicine

Prednisone.

6.7 Physicochemical Properties

Chemical name: 17α,21-Dihydroxypregna-1, 4-diene-3,11,20-trione.

Chemical structure.


CAS number.

53-03-2.

2 Qualitative and Quantitative Composition

Prednisone occurs as white to practically white, odourless, crystalline powder. Prednisone is very slightly soluble in water, slightly soluble in alcohol, in chloroform, in dioxane, and in methanol. Prednisolone is very slightly soluble in water and sparingly soluble in alcohol.
Sone tablets contain the following excipients: Lactose monohydrate, propyl hydroxybenzoate, gelatin, maize starch, wheat starch and magnesium stearate.

Excipients with known effect.

Lactose monohydrate, hydroxybenzoates.

3 Pharmaceutical Form

Tablet, uncoated.

Prednisone (Sone) 5 mg tablet.

White round biconvex tablet, uncoated, one face plain, and other face scored.

Prednisone (Sone) 25 mg tablet.

White flat round, bevelled edges tablet, uncoated, one face plain and other face scored.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Prednisone is a synthetic corticosteroid with glucocorticoid and anti-inflammatory effects. Prednisone has the same chemical relationship to prednisolone as cortisone has to hydrocortisone. Prednisolone exceeds hydrocortisone in glucocorticoid and anti-inflammatory activity, being about three times more potent on a weight basis than the parent hormone, but is considerably less active than hydrocortisone in mineralocorticoid activity.
Prednisolone like hydrocortisone is a potent therapeutic agent influencing the biochemical behaviour of most tissues of the body.
The mechanism of action of corticosteroids is thought to be by control of protein synthesis. Corticosteroids react with receptor proteins in the cytoplasm of sensitive cells in many tissues to form a steroid-receptor complex.
Corticosteroids are palliative symptomatic treatment by virtue of their anti-inflammatory effects; they are never curative.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Prednisone is readily absorbed from the gastrointestinal tract, but must be converted in the liver to its active metabolite, prednisolone.
The plasma half-life after oral administration of prednisone ranges from 3 to 4 hours. Oral bioavailability varies widely between subjects. With the active metabolite prednisolone, peak plasma concentrations are obtained 1 or 2 hours after oral administration and prednisolone has a usual plasma half-life of 2 to 4 hours. Its initial absorption, but not its overall bioavailability, is affected by food.

Distribution.

Prednisolone is 90 to 95% bound to plasma proteins.

Metabolism.

The conversion from prednisone into prednisolone is rapid so that prednisone has a pre-conversion biological half-life of only about 60 minutes. Prednisolone is conjugated in the liver and to some extent in the kidney.

Excretion.

Little prednisone is excreted unchanged in the urine, however prednisolone is excreted in the urine as free and conjugated metabolites, together with an appreciable proportion of unchanged prednisolone. Prednisolone crosses the placenta and small amounts are excreted in breast milk.

5.3 Preclinical Safety Data

Genotoxicity.

In male rats, administration of prednisolone in the drinking water at a daily dose level of 0.4 mg/kg for two years caused an increased incidence of hepatocellular tumours. Similar results were obtained with triamcinolone acetonide and budesonide, indicating a class effect of glucocorticosteroids. The hepatocarcinogenic response to these drugs does not appear to be related to genotoxic activity.

Carcinogenicity.

The carcinogenic potential of prednisone has been evaluated in mice at oral doses up to 5 mg/kg/day for 18 months. No carcinogenic effect was noted in the mouse.

4 Clinical Particulars

4.1 Therapeutic Indications

Wherever corticosteroid therapy is indicated.

4.3 Contraindications

Systemic fungal infections and known hypersensitivity to prednisone or any of the excipients.
Peptic ulcer, osteoporosis, psychoses or severe psychoneuroses. Patients with active or doubtfully quiescent tuberculosis should not be given these hormones except as adjuncts to treatment with tuberculostatic drugs.

4.4 Special Warnings and Precautions for Use

Corticosteroids should be used with caution in the presence of diminished cardiac reserve or congestive heart failure, in patients with diabetes mellitus, infectious diseases, chronic renal failure, uraemia and in elderly persons.
In patients on corticosteroid therapy subjected to unusual stress, increased dosage of rapidly acting corticosteroids before, during, and after the stressful situation is indicated.
Corticosteroids may mask some signs of infection, and new infections may appear during their use. Infections with any pathogen including viral, bacterial, fungal, protozoan or helminthic infections, in any location of 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. There may be decreased resistance and inability to localize infection when corticosteroids are used.
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.
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 non-immune children or adults on corticosteroids. In such children or adults who have not had these diseases, particular care should be taken to avoid exposure. How the dose, route and duration of corticosteroid administration affects the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known.

Scleroderma renal crisis.

Caution is required in patients with systemic sclerosis because of an increased incidence of (possibly fatal) scleroderma renal crisis with hypertension and decreased urinary output observed with a daily dose of 15 mg or more prednisolone. Blood pressure and renal function (s-creatinine) should therefore be routinely checked. When renal crisis is suspected, blood pressure should be carefully controlled.

Withdrawal symptoms.

During prolonged treatment with corticosteroids, adrenal suppression and atrophy may occur and secretion of corticotrophin may be suppressed. Sudden withdrawal of the hormone treatment may then 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 treatment has been discontinued. In some instances, withdrawal symptoms may stimulate 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. Individual liability to depression 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. Withdrawal of corticosteroids should therefore always be gradual but if sudden withdrawal is necessary, corticotrophin (20 units) given daily by intravenous infusion over eight hours for three to five successive days is usually sufficient to prevent withdrawal symptoms.
There is an enhanced effect of corticosteroids on patients with hypothyroidism and in those with cirrhosis.
Corticosteroids should be used cautiously in patients with ocular herpes simplex because of possible corneal perforation.
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.
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.
Steroids should be used with caution in non-specific ulcerative colitis, if there is a probability of impending perforation, abscess or other pyogenic infection; diverticulitis; fresh intestinal anastomoses; active or latent peptic ulcer; renal insufficiency; hypertension; osteoporosis; and myasthenia gravis.
Kaposi's sarcoma has been reported to occur in patients receiving corticosteroid therapy. Discontinuation of corticosteroids may result in clinical remission.
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.
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.
Convulsions have been reported with concurrent use of methylprednisolone and cyclosporin. Since concurrent use of these agents results in a mutual inhibition of metabolism, it is possible that adverse events associated with the individual use of either drug may be more apt to occur.

Visual disturbance.

Visual disturbance may be reported with systemic and topical corticosteroid use. 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 which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

Use in the elderly.

Corticosteroids should be used with caution in elderly persons.

Paediatric use.

Growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed.

Effects on laboratory tests.

Glucocorticoids may decrease I131 uptake and protein- bound iodine concentrations, making it difficult to monitor the therapeutic response of patients receiving the drugs for thyroiditis. Glucocorticoids may produce false-negative results in the nitroblue tetrazolium test for systemic bacterial infection. Glucocorticoids may suppress reactions to skin tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

The following drug interactions with corticosteroids have been selected on the basis of their potential clinical significance: antacids, antidiabetic agents (oral or insulin), digitalis glycosides, diuretics, drugs which induce hepatic microsomal enzymes such as barbiturates, phenytoin and rifampicin; potassium supplements, ritodrine, sodium-containing medications or foods, somatrem or somatropin, vaccines, live viruses or other immunizations.
Drugs that induce hepatic enzymes such as phenobarbital, phenytoin and rifampin may increase the clearance of corticosteroids and may require increases in corticosteroid dose to achieve the desired response.
Drugs such as troleandomycin and ketoconazole may inhibit the metabolism of corticosteroids and thus decrease their clearance. Therefore, the dose of corticosteroid should be titrated to avoid steroid toxicity. Corticosteroids may increase the clearance of chronic high dose aspirin. This could lead to decreased salicylate serum levels or increase the risk of salicylate toxicity when corticosteroid is withdrawn. Aspirin should be used cautiously in conjunction with corticosteroids in patients suffering from hypoprothrombinemia.
The effect of corticosteroids on oral anticoagulants is variable. There are reports of enhanced as well as diminished effects of anticoagulants when given concurrently with corticosteroids. Therefore, coagulation indices should be monitored to maintain the desired anticoagulant effect.

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 infant after long-term treatment must be considered, the needs of the mother must be carefully weighed against the risk to the fetus when prescribing these drugs. 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.
The drug is excreted in breast milk; therefore, administration to nursing mothers is not recommended.

4.8 Adverse Effects (Undesirable Effects)

The side effects associated with the use of corticosteroids in the large doses necessary to produce a therapeutic response result from excessive action on electrolyte balance; excessive action on other aspects of metabolism including gluconeogenesis; the action on tissue repair and healing; and an inhibitory effect on the secretion of cortico-trophin by the anterior pituitary gland. Disturbance of electrolyte and water balance is manifest in sodium retention with oedema and hypertension, and in the increased excretion of potassium with the development of hypokalaemic alkalosis. In extreme cases, cardiac failure may be induced. Disturbances of electrolyte balance are common with the naturally occurring corticotrophins, cortisone, deoxycortone and hydrocortisone but are less frequent with the synthetic derivatives, prednisone and prednisolone. Other metabolic effects include mobilisation of calcium and phosphorus with osteoporosis and spontaneous fractures; nitrogen depletion; and hyperglycaemia with accentuation or precipitation of the diabetic state. The insulin requirements of diabetic patients are increased and appetite is often increased.
The effect on tissue repair manifests as peptic ulceration with haemorrhage and perforation, delayed wound healing and increased liability to infection. Increased susceptibility to all kinds of infection, including sepsis, fungal and viral infection, has been reported.
Large doses of corticosteroids or corticotrophins may produce symptoms typical of hyperactivity of the adrenal cortex, with moonface, buffalo hump, flushing, striae and acne, sometimes leading to a fully developed Cushing's syndrome. If administration of the hormone is discontinued immediately on the appearance of these symptoms, they are usually reversed, but such sudden cessation may be dangerous. The dose of corticosteroid required to cause a decrease or absence of corticotrophin in the blood with consequent atrophy of the adrenal cortex and the time required for its occurrence are very variable. Acute adrenal insufficiency with loss of consciousness may occur during prolonged treatment or on cessation of treatment and may be precipitated by an infection or trauma.
Growth retardation in children has been reported and in this respect cortisone is only one-tenth as potent as prednisone and prednisolone. Other toxic effects include mental and neurological disturbances, intracranial hypertension and, on sudden reduction of dosage during the treatment of rheumatoid arthritis, fatalities attributed to lesions of small arteries and arterioles similar to polyarteritis.
Infections may be masked since corticosteroids have marked anti-inflammatory and antipyretic properties and may produce a feeling of well-being. The administration of corticosteroids may also cause a reduction in the number of circulating lymphocytes.
Muscular weakness is an occasional side effect of most corticosteroids, particularly when they are taken in large doses.
Toxic effects occur with all corticosteroid preparations and their incidence rises steeply if dosage increases much above 8 mg daily of prednisolone or its equivalent.

Scleroderma renal crisis.

Frequency 'unknown'.
Amongst the different subpopulations the occurrence of scleroderma renal crisis varies. The highest risk has been reported in patients with diffuse systemic sclerosis. The lowest risk has been reported in patients with limited systemic sclerosis (2%) and juvenile onset systemic sclerosis (1%).

Fluid and electrolyte disturbances.

Sodium retention, fluid retention, congestive heart failure in susceptible patients, potassium loss, hypokalemic alkalosis, hypertension.

Musculoskeletal.

Muscle weakness, steroid myopathy, loss of muscle mass, osteoporosis, tendon rupture (particularly of the Achilles tendon), vertebral compression fractures, aseptic necrosis of femoral and humeral heads, pathologic fracture of long bones.

Gastrointestinal.

Peptic ulcer with possible perforation and haemorrhage, pancreatitis, abdominal distention, ulcerative oesophagitis.
Increases in alanine transaminase (ALT), aspartate transaminase (AST) and alkaline phosphatase have been observed following corticosteroid treatment. These changes are usually small, not associated with any clinical syndrome and are reversible upon discontinuation.

Dermatologic.

Impaired wound healing, thin fragile skin, petechiae and ecchymoses, facial erythema, increased sweating. May suppress reactions to skin tests.

Metabolic.

Negative nitrogen balance due to protein catabolism.

Neurological.

Increased intracranial pressure with papilloedema (pseudo-tumour cerebri) usually after treatment, convulsions, vertigo, headache.

Endocrine.

Menstrual irregularities, development of Cushingoid state, secondary adrenocortical and pituitary unresponsiveness (particularly in times of stress, as in trauma, surgery or illness), suppression of growth in children, decreased carbohydrate tolerance, manifestations of latent diabetes mellitus, increased requirements for insulin or oral hypoglycaemic agents in diabetics.

Ophthalmic (eye disorders).

Posterior sub-capsular cataracts, increased intraocular pressure, glaucoma, exophthalmos, vision blurred.

Additional reactions.

Urticaria and other allergic, anaphylactic or hypersensitivity reactions.

Reporting suspected adverse effects.

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.

4.2 Dose and Method of Administration

Adults.

10 to 100 mg daily in divided doses.

Children.

1 to 5 years.

2.5 to 10 mg twice daily.

6 to 12 years.

5 to 20 mg twice daily.

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

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

Treatment.

There is no specific antidote. Toxic effects are signs of overdosage, and should be treated symptomatically and the dosage reduced or the drug withdrawn. 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.

7 Medicine Schedule (Poisons Standard)

S4.

6 Pharmaceutical Particulars

6.1 List of Excipients

See Section 2 Qualitative and Quantitative Composition.

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

Supplied in HDPE bottles.

5 mg tablet.

60's, 90's# and 1000's# packs.

25 mg tablet.

30's pack.
#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