INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
BE-TABS PREDNISONE 5 mg TABLETS

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

BE-TABS PREDNISONE 5 mg TABLETS

COMPOSITION:
Each tablet contains: Prednisone 5 mg

PHARMACOLOGICAL CLASSIFICATION:
21.5.1 Corticosteroids and analogues

PHARMACOLOGICAL ACTION:
Prednisone is a synthetic glucocorticoid which produces various metabolic effects and in addition modifies the immune reaction of the body to diverse stimuli. It has properties qualitatively similar to those of cortisone acetate but causes less sodium and fluid retention and is therefore preferred in the treatment of such conditions as asthma, psoriasis, rheumatoid arthritis, thrombocytopenia and ulcerative colitis. Prednisone is not used for adrenal deficiency states. It is useful in the treatment of the nephrotic syndrome. Prednisone is inactive until converted to prednisolone in the liver.

INDICATIONS:
Suppressive and palliative therapy in rheumatoid arthritis which is progressive despite intensive conventional treatment.
The nephrotic syndrome attributable to systemic lupus erythematosus or to primary renal disease, except renal amyloidosis, may be benefited by corticosteroid therapy.
Collagen diseases. Manifestations of most of these diseases, except scleroderma, are controlled. Morbidity is decreased and the survival times of patients with polyarteritis nodosa and Wegener's granulomatosis is prolonged.
Fulminating systemic lupus erythematosus is a life-threatening condition the manifestations of which should be promptly suppressed with large doses.
Manifestations of allergic conditions which do not react to antihistaminic treatment may be suppressed by adequate doses or as a supplement to primary therapy. However, severe reactions such as anaphylaxis require immediate adrenaline subcutaneously.
Bronchial asthma. Acute, or severe chronic asthma, uncontrolled by other measures.
Acute skin diseases and exacerbations of chronic skin diseases. Severely ill patients with chronic ulcerative colitis.
Thrombocytopenia: To decrease the bleeding tendency.
Organ transplantation.

CONTRA-INDICATIONS:
Liver disease, peptic ulcer, osteoporosis, psychosis or severe psychoneurosis. Because of interference with antibody formation, systemic administration is usually contraindicated in the presence of acute bacterial and viral infections.

INTERACTIONS:
Concurrent administration of barbiturates, phenylbutazone, phenytoin, or rifampicin may enhance the metabolism and reduce the effects of corticosteroids. response to anticoagulants may also be reduced by corticosteroids.
Immunisation procedures should not be undertaken in patients receiving corticosteroids.

PREGNANCY AND LACTATION
Babies born of mothers who received large doses corticosteroids during pregnancy should be watched carefully for signs of hypoadrenalism. Corticosteroids appear in breast milk and mothers receiving corticosteroids should be advised not to breast feed.

DOSAGE AND DIRECTIONS FOR USE:

1.	The dose must be determined individually by the seriousness of the disease and the reaction of the patient.
2.	Administration of large doses for short courses cause less side effects than long-term therapy with small doses. Long courses of therapy at high dosage should be reserved for life-threatening disease.
3.	In long-term therapy the dose must be the smallest one to achieve a desired effect. Complete relief is not sought.

Rheumatoid arthritis:
The initial dose should be small, usually about 10 mg and increase slowly until the desired degree of control is attained.
Nephrotic syndrome:
60 mg daily in divided doses (2 mg/kg oedema-free body mass in children) for 3 to 4 weeks. If a remission with a diuresis and decreased proteinuria occurs during this period, maintenance treatment is continued for as long as a year. For this the daily dose of prednisone is given only for the first 3 days of each week.
Collagen diseases:
1 mg/kg daily until remission is induced. The dose is then reduced to minimally effective level.
Fulminating systemic lupus erythematosus:
1 mg/kg daily which may be increased in 20 mg increments daily until a favourable response occurs. After control has been obtained, dosage should be reduced by small steps of 5 mg prednisone per week until further reductions elucidate symptoms.
Bronchial asthma:
In status asthmaticus the attack is brought under control by intravenous cortisol whereafter 10 mg prednisone is given for 4 to 5 days. The dose is then reduced in steps to be withdrawn 10 days after initiation of prednisone therapy.
Severe chronic bronchial asthma:
To reduce severity without eliminating the manifestations of the disease, 5 to 10 mg daily in divided doses in combination with the usual medication.
Skin diseases:
40 mg per day. Up to 120 mg per day may be life-saving in pemphigus.
Chronic ulcerative colitis:
60 to 120 mg per day.
Thrombocytopenia:
0,5 mg/kg
Organ transplantation:
50 to 100 mg at the time of surgery. Maintenance doses of 10 to 20 mg per day are continued indefinitely and the dosage increased if rejection is threatened.
The dosage should be reduced and therapy discontinued gradually if therapy continued for more than a few days.
Abrupt cessation of prolonged, high dosage therapy may produce adrenal insufficiency or sufficient severity to be threatening to life.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Side effects which results from use of large doses are:
Retention of sodium and water, with oedema and hypertension; increased excretion of potassium with the possibility of hypokalaemic alkalosis, and in extreme cases cardiac failure may be induced. Patients receiving diuretics which causes potassium depletion should be watched carefully for signs of hypokalaemia.
Excessive metabolic effects which lead to mobilisation of calcium and phosphorous, with osteoporosis and spontaneous fractures, nitrogen depletion, and hyperglycaemia with accentuation or precipitation of the diabetic state. Insulin requirements of diabetic patients are increased. Increased appetite.
An effect on tissue repair which is manifest in delayed wound healing and increased liability to infection. There may be peptic ulceration with haemorrhage and perforation.
Other toxic effects include 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 arterioles similar to polyarteritis. An increase in the coagulability of the blood may lead to thrombo-embolic complications.
PRECAUTIONS:
Corticosteroids should be used only with great caution in the presence of congestive heart failure, in patients with 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. Patients with quiescent tuberculosis should be observed closely and should receive chemoprophylaxis if corticosteroid therapy is prolonged.
Acute adrenal insufficiency may occur during prolonged treatment or on cessation of treatment and may be precipitated by an infection or stressful situation such as anaesthesia, surgery or trauma.
Patients under stress should therefore received supplementary corticosteroids if they were given corticosteroids in the previous 3 months or high or prolonged doses in the previous year.
Infections may be masked. A reduction in the number of circulating lymphocytes may occur.
Caution must be observed in ulcerative colitis if a possibility exists of intestinal perforation and peritonitis.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
The same as for Side-effects.

IDENTIFICATION:
White tablet 6,4 mm in diameter, biconvex with a score mark on one side.

PRESENTATION:
100, 500, 1000 and 5000 tablets in an amber PVC bottle. Also includes 100’s in asecuritainer, 1000’s in awhite HDPE bottle and 50000’s in a white HDPE jar. Patient ready packs of different pack sizes.

STORAGE DIRECTIONS:
Store in a cool dry place below 25°C. Protect from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
G 3004 (Act 101 1965) (S.A)
B9315040 (Botswana)
POM 168/001 (Zambia)

NAME AND BUSINESS ADRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION:
BE-TABS PHARMACEUTICALS (PTY) LTD.
14 LAUTRE ROAD
STORMILL, EXT. 1
ROODEPOORT
1724
SOUTH AFRICA

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
June 1992

CODE: IPDS/8        JET PRINTERS 5/05(S)

New addition to this site: October 2005
Source: Community Pharmacy
SAEPI HOME PAGE      TRADE NAME INDEX      GENERIC NAME INDEX      FEEDBACK
Information presented by Malahyde Information Systems © Copyright 1996-2005