TROLIC 5 mg (TABLETS)
(and dosage form):
TROLIC 5 mg (TABLETS)
Each tablet contains 5 mg of Prednisone.
A. 21.5.1 Corticosteroids and analogues
Prednisone is a glucocorticosteroid, which undergoes conversion in the liver to prednisolone, which has potent anti-inflammatory and immunosuppressive properties.
Trolic 5 mg is indicated for the treatment of diseases responsive to glucocorticosteroid therapy.
Hypersensitivity to Prednisone.
Trolic 5 mg 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
Immunization using live vaccines is contra-indicated in patients on corticosteroid therapy.
DOSAGE AND DIRECTIONS FOR USE:
Dosage requirements are variable and must be individualized based on the specific disease, the severity of the disease and the response of the patient.
Adults: 10 mg to 100 mg daily in divided doses.
Infants and children: 1 mg to 20 mg twice daily.
The daily dosage may either be given in divided dosage, 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, uraemia and in the elderly.
To be used with caution in ocular herpes simplex. Corticosteroids may mask the signs of infections. Prolonged use may cause ocular disturbances, which may require further evaluation. 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 TROLIC 5 mg 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 Furosemide 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 OVER DOSAGE AND PARTICULARS OF ITS TREATMENT:
Gastric lavage and emesis if indicated. Treatment is symptomatic and supportive.
White scored flat tablets, bitter taste.
Containers containing 30, 100, 500, 1000, 5000 tablets.
Store below 25ºC and protect from light.
KEEP OUT OF REACH OF CHILDREN
G 3093 (Act 101 of 1965)
NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION:
Gulf Drug Company (PTY) LTD.
22 Burnside Drive
Old Mill Industrial Park
Mount Edgecombe, 4300
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
New addition to this site: July 2010
Source: Pharmaceutical Industry
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