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Logo PREDELTIN TABLETS

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

PREDELTIN TABLETS

COMPOSITION:
Per tablet:
Prednisone         5 mg

PHARMACOLOGICAL CLASSIFICATION:
A 21.5 Corticosteroids.

PHARMACOLOGICAL ACTION:
Prednisone, or 17alpha , 21-dihydroxypregna-1,4-diene-3, 11, 20-trione, is a synthetic analogue of cortisone and has increased glucocorticoid activity without a corresponding increase in mineralocorticoid activity.
Its principal action is upon gluconeogenesis, glycogen deposition and calcium and protein metabolism, with a correspondingly lesser action on electrolyte and water metabolism. The drug has potent anti-inflammatory, anti-allergic and anti-rheumatic properties.
In rheumatoid arthritis, the effect of prednisone is suppressive and palliative, affording prompt symptomatic relief with diminution of joint-swelling, effusion and pain.
Corticosteroids improve ventilation and relieve symptoms in patients with bronchial asthma and are used when bronchodilators, such as adrenaline, ephedrine, theophylline, ethylenediamine and isoprenaline are ineffective. In the presence of infection, however, antibiotics must be given.

INDICATIONS:
PREDELTIN is used for three main purposes.
1. as replacement therapy in adrenal insufficiency, as in Addison's disease, after adrenalectomy, or secondary to hypopituitarism;
2. for the treatment of some blood disorders, e.g. auto-immune haemolytic anaemia, idiopathic thrombocytic purpura, acute leukemia in children and chronic lymphocytic leukemia;
3. for its anti-inflammatory action to suppress the chemical manifestations of disease in selected cases of rheumatoid arthritis, acute rheumatic fever, allergic disorders such as serum sickness, angioneurotic oedema, asthma, status asthmaticus and inflammatory skin disorders, e.g. acute exacerbations of generalised eczema and exfoliative dermatitis.
Other indications include:
Control of the acute symptoms of fulminating systemic lupus erythematosus.
Ulcerative colitis.
Collagen diseases.
Nephrotic oedema.

CONTRA-INDICATIONS:
Systemic administration of corticosteroids is contra-indicated in patients with peptic ulcer, osteoporosis and psychoses or severe psychoneuroses.
Patients with active or doubtfully quiescent tuberculosis should not be given corticosteroids except as adjunct to treatment with tuberculostatics.

DOSAGE AND DIRECTIONS FOR USE:
5 to 60 mg daily in divided doses.
In long-term therapy, dosage should be maintained at not more than 7,5 mg (one and a half tablet) daily, as side-effects inevitably occur on higher doses.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The side-effects of prednisone are, in general, those associated with cortisone and may include the following:
Sodium and water retention due to electrolyte balance disturbance, with resultant oedema and hypertension.
Increased potassium excretion, with a possibility of hypokalaemic alkalosis.
In extreme cases, cardiac failure may be included.
Retention is, however, less likely to occur with prednisone than with cortisone.
Other 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 of tissue repair is manifest in peptic ulceration with haemorrhage and perforation, delayed wound healing and increased liability to infection. Increased susceptibility to all kinds of infection, including sepsis, fungus infections and viral infections, has been reported in patients on corticosteroid therapy.
Large doses of corticosteroids may produce symptoms typical of over-activity of the adrenal cortex, with moon face, buffalo hump, flushing, striae, acne and, sometimes, a fully developed Cushing's syndrome.
Prednisone and prednisolone may cause growth retardation in children.
Other toxic effects include mental and neurological disturbances and intracranial hypertension.
Infections may be masked, since corticosteroids have marked anti-inflammatory and antipyretic properties and may produce a feeling of well-being. They may also cause a reduction in the number of circulating lymphocytes.
Corticosteroids should be used with great caution in the presence of diminished cardiac reserve or congestive cardiac failure, in patients with diabetes mellitus, infectious diseases, chronic renal failure uraemia and in elderly patients.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
The incidence of toxic effects rises steeply in high dosages and acute overdosage, per se, has not been the subject of documentation. A danger situation lies rather in the sudden withdrawal than in acute overdosage.
Treatment of toxicity.
There is no antidote for the corticosteroids and treatment is symptomatic, together with either dosage reduction or careful withdrawal of the drug.

IDENTIFICATION:
While, biconvex tablet, scored on one side.

PRESENTATION:
100's or 1000’s in securitainers.

STORAGE INSTRUCTIONS:
Store below 25°C, well closed and protect from light.
KEEP OUT OF REACH OF CHILDREN.

REFERENCE NUMBER:
G 3097 (Act 101/1965)

NAME AND BUSINESS ADDRRESS OF THE APPLICANT:
QUATROMED LIMITED
10 Lindley Street
BETHLEHEM
9701

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
6 December 1974

PPR 005-28/01-99

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