ACU-PREDNISOLONE Tablets
SCHEDULING STATUS:
S4
PROPRIETARY NAME
(and dosage form):
ACU-PREDNISOLONE Tablets
COMPOSITION:
Each tablet contains 5mg of Prednisolone.
PHARMACOLOGICAL CLASSIFICATION:
A 21.5.1 Corticosteroids and analogues.
PHARMACOLOGICAL ACTION:
Prednisolone is a gluco-corticosteroid which has potent anti-inflammatory and immunosuppressive properties.
INDICATIONS:
ACU-PREDNISOLONE is indicated for the treatment of diseases responsive to glucocorticosteroid therapy.
CONTRA-INDICATIONS:
Hypersensitivity to prednisolone.
ACU-PREDNISOLONE is contra-indicated in patients with systemic fungal infections. Unless considered life-saving, systemic administration of corticosteroids is contra-indicated in patients with peptic ulcer, osteoporosis, psychoses and psychoneuroses, active or doubtfully quiescent tuberculosis and acute infections.
Immunizations using live vaccines are contra-indicated in patients on corticosteroid therapy.
DOSAGE AND DIRECTIONS FOR USE:
DOSING REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALISED ON THE BASIS OF THE SPECIFIC DISEASE, THE SEVERITY OF THE DISEASE AND THE RESPONSE OF THE PATIENT.
Adults: 10mg to 100mg daily in divided doses.
Infants and children: 1mg to 20mg twice daily.
The daily dosage may either be given in divided doses, as a single daily dose after breakfast or as a double dose on alternate days.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects include fluid and electrolyte imbalance, musculoskeletal, gastro-intestinal, dermatological, neurological, endocrine, ophthalmic, metabolic and psychiatric disturbances, inhibition of growth and immunosuppression.
Corticosteroids are to be used with caution in the presence of congestive heart failure or hypertension, diabetes mellitus, epilepsy, glaucoma, infectious diseases, chronic renal failure, uremia and in the elderly.
To be used with caution in ocular herpes simplex.
Corticosteroids may mask the signs of infection.
Prolonged use may cause ocular disturbances which may require further eva luation.
Electrolyte imbalance may occur and should be monitored at regular intervals.
Growth retardation may occur and paediatric patients should be closely monitored.
The immune response may be limited when vaccines are given.
Care should be exercised when ACU-PREDNISOLONE is given with the following medicines: barbiturates, carbamazepine, phenytoin, primidone and rifampicin may enhance the metabolism and reduce the effects of corticosteroids; concurrent administration with potassium-depleting diuretics such as thiazides or frusemide may cause excessive potassium loss; increased gastro-intestinal bleeding and ulceration with the non-steroidal anti-inflammatory agents; response to anticoagulants may be altered and requirements of antidiabetics and antihypertensives may be increased.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Gastric lavage and emesis if indicated. Treatment is symptomatic and supportive.
IDENTIFICATION:
White scored tablets, slightly convex, bitter taste.
PRESENTATION:
Glass bottles containing 1000 tablets.
STORAGE INSTRUCTIONS:
Store below 25°C, protected from light.
KEEP OUT OF REACH OF CHILDREN.
REGISTRATION NUMBER:
G3094 (Act 101/1965)
NAME AND BUSINESS ADDRESS OF THE APPLICANT:
PHARMAKON MANUFACTURING LABORATORIES CC.
PO Box 47021
Parklands 2121
MARKETED AND DISTRIBUTED BY:
ACUPHARM (PTY) LTD
43 Richards Drive
Halfway House
1685
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
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