INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo PREDNISONE TABLETS

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

PREDNISONE TABLETS

COMPOSITION:
Each tablet contains 5 mg
prednisone.

PHARMACOLOGICAL CLASSIFICATION:
A 21.5.1 Corticosteroids and analogues.

PHARMACOLOGICAL ACTION:
Prednisone is a synthetic glucocorticoid with 5 times the potency mg for mg as cortisone acetate but in equivalent doses causes less sodium and fluid retention although more gastric symptoms.

INDICATIONS:
Prednisone is indicated in all conditions where corticosteroid therapy is likely to be of benefit. These include acute haemolytic disorders, allergic disorders, asthma, leukaemia, thrombocytopenic purpura, coeliac disease, insulin resistance in diabetes mellitus, immunosuppression, liver disorders and ulcerative colitis.

CONTRA-INDICATIONS:
Peptic ulcer, osteoporosis, psychoses or severe psycho-neuroses. They should be used with great caution in the presence of congestive heart failure, in patients with diabetes mellitus, infectious diseases, chronic renal failure, uraemia and in elderly persons. Tuberculosis active or possibly latent is a contra-indication unless adequate amounts of suitable anti-tubercular drugs are simultaneously administered. Simultaneous administration of barbiturates or phenytoin may reduce the effectiveness of prednisone by increasing its metabolism and the action of anticoagulants may be modified.

In many cases of severe illnesses, where prednisone may be lifesaving, they may be administered notwithstanding the above contra-indications –due caution and observation being exercised by the physician.

It should be noted that prednisone has less tendency than many corticosteroids to cause fluid retention and mineral imbalance but it has a somewhat higher incidence of gastric symptoms.

DOSAGE AND DIRECTIONS FOR USE:
This primarily depends on the progress of the case, the presence or absence of contra-indicating factors and the nature of the condition being treated. In rheumatoid arthritis 5 mg may be given at night to ease night and early morning symptoms. Doses of more than 7 mg daily will bring about the long term undesirable effects of corticosteroid therapy. The minimum dosage that will be found beneficial should be administered.
A somewhat higher maintenance dose is needed in asthmatic conditions.
For immunosuppressive therapy 100 - 200 mg daily may be given.
In conditions dangerous to life such as pemphigus vulgaris, systemic lupus erythematosus and acute haemolytic disorders, high dosage up to 100 mg daily may be given. In conditions such as status asthmaticus, up to 60 mg daily may be given.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Care should be taken wherever possible to avoid abrupt cessation of treatment to avoid the possibility of adrenal exhaustion and the sudden return of the disease being treated. During therapy with this drug close observation should be made for signs of bacterial infection as the symptoms normally used for diagnosis may be marked. However should such a condition be observed the treatment can continue provided that a suitable antibiotic is administered. Symptoms of mineral imbalance and fluid retention with consequent effects on the heart and kidneys are less likely to occur with prednisone therapy as are the symptoms of "Cushing's Syndrome". They may however occur particularly if high doses are administered for some time. Protein metabolism may be affected possibly resulting in a negative nitrogen balance. Blood sugar levels may be raised and glycosuria may occur. This could present problems in diabetic or potentially diabetic patients. Dyspepsia is a common side effect with prednisone therapy and gastric ulceration could occur.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
The symptoms listed above under side-effects are more likely to occur and the severity thereof increased if the dosage taken is excessive. Treatment consists of either reducing the dosage or withdrawing the drug, gradually if possible. The level at which a dosage becomes an overdosage is dependent on the conditions being treated and its severity coupled with the needs of the patient in question.

IDENTIFICATION:
Flat white bisected tablets.

PRESENTATION:
Containers of 100, 500, 1000 and 5000.

STORAGE INSTRUCTIONS:
Protect from light. Store below 25°C.
KEEP OUT OF REACH OF CHILDREN

APPLICATION NUMBER:
G 2975 (Act 101/1965)

NAME AND BUSINESS ADDRESS OF APPLICANT:
Lennon Limited
7 Fairclough Road
PORT ELIZABETH
6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
30/8/1976 K191A
  Tradepak PE

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