(and dosage form):
Each tablet contains:
A 21.5.1 Hormones and antihormones and oral hypoglycaemia. Corticosteroids and analogues.
Prednisone is a synthetic glycocorticoid. It has anti-inflammatory actions.
Severe or acute rheumatic dermatological and allergic conditions, collagen diseases, musculo-skeletal conditions.
Peptic ulcer, osteoporosis, psychosis or severe psychoneuroses, acute bacterial infections, herpes zoster, herpes simplex, ulceration of the eye and other viral infections.
Vaccination against smallpox and other infections.
DOSAGE AND DIRECTIONS FOR USE:
Take with or after food, 2 20 tablets daily in divided doses.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Disturbance of electrolyte balance is manifest in the retention of sodium and water, oedema, hypertension and with the increased excretion of potassium with the possibility of hypokalaemic alkalosis. In extreme cases cardiac failure may be induced.
Excessive metabolic effects lead to 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. Increased appetite is often reported.
The effect on tissue repair is manifest in delayed wound healing and increased liability to infection. There may be peptic ulceration with haemorrhage and perforation.
Increased susceptibility to all kinds of infection, including sepsis, fungous infections and viral infections, e.g. Candida infections of the mouth especially if given concomitantly with antibiotics.
Acute adrenal insufficiency may occur during prolonged treatment or on cessation of treatment and may be precipitated by an infection or trauma. Large doses may produce symptoms typical of hyperactivity of the adrenal cortex, with moon-face, sometimes with hirsutism, buffalo hump, flushing, increased bruising, striae and acne, sometimes leading to a fully developed Cushings syndrome.
Amenorrhoea, mental and neurological disturbances, intracranial hypertension and on sudden reduction of dosage during the treatment of rheumatoid arthritis, fatalities have been attributed to lesions of small arteries and arterioles similar to polyarteritis, an increase in the coagulability of the blood may lead to thrombo-embolic complications. Infections may be masked since steroids have marked anti-inflammatory properties with analgesic and antipyretic effects and may produce a feeling of well-being.
The administration of prednisone may also cause a reduction in the number of circulating lymphocytes.
Use with caution in the presence of congestive heart failure, diabetes mellitus, infectious diseases, chronic renal failure and uraemia and in elderly persons.
Patients with active or doubtfully quiescent tuberculosis should not be given these hormones except as adjuncts to treatment with tuberculostatic drugs.
There is normally an increased secretion of corticosteroids by the adrenals in response to stress caused by anaesthesia, surgery or trauma; patients receiving corticosteroids or who have been given corticosteroids in the previous 3 months may have insufficient adrenal reserve and should be given supplementary corticosteroids.
Concurrent administration of barbiturates, phenylbutazone, phenytoin or rifampicin may enhance the metabolism and reduce the effects of prednisone. Response to anticoagulants may also be reduced.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
As under side-effects.
White, round, normal, convex tablet.
1000s packed into white PP securitainer with a white LDPE snap-on cap or round, amber glass bottle with a PP screwcap. 5000s packed into 1L white HDPE bucket with handle, with a HDPE closure.
Store in airtight container and protect from light, below 25ºC.
KEEP OUT OF REACH OF CHILDREN
G3054 (Act 101/1965)
NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Adcock Ingram Limited
Adcock Ingram Park
17 Harrison Avenue, Bryanston Ext. 77
Private Bag X69, Bryanston, 2021
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
December 1974 15623-12/2001
Updated on this site: December 2006
Source: Community Pharmacy
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