(and dosage form):
Each tablet contains 250 mg Acetazolamide with 0,199% Nipastat as preservative.
A.15.4 Ophthalmic Preparations - others.
Acetazolamide is an inhibitor of carbonic anhydrase. By inhibiting the reaction catalysed by carbonic anhydrase in the renal tubules, acetazolamide increases the excretion of bicarbonates and of cations, chiefly sodium and potassium, and so promotes an alkaline diuresis.
By inhibiting carbonic anhydrase in the eye, acetazolamide reduces the rate of aqueous humour formation and thus decreases intra-ocular pressure. A mild degree of metabolic acidosis persists for as long as the medicine is given.
Acute primary and secondary glaucoma.
Acetazolamide is contra-indicated in the presence of sodium or potassium depletion, in idiopathic renal hyperchloraemic acidosis, in conditions such as Addison's disease and adrenal failure, and in marked hepatic or renal failure. It should not be used in chronic non-congested closed-angle glaucoma as the condition may deteriorate. The use of Acetazolamide should be avoided in the first trimester of pregnancy.
DOSAGE AND DIRECTIONS FOR USE:
In glaucoma: 500 mg initially, then 250 mg every 6-8 hours.
SIDE EFFECTS AND SPECIAL PRECAUTIONS:
The most common side effects of acetazolamide are drowsiness and numbness and tingling of the face and extremities. Fatigue, excitement, thirst, headache, dizziness, ataxia, hyperpnoea, tinnitus, hearing loss and gastro-intestinal disturbances occasionally occur. Rarely, in patients with hepatic cirrhosis it may cause disorientation. Fever and skin rashes of an allergic type have been reported. Isolated cases, some fatal, of agranulocytosis, aplastic anaemia, thrombocytopenia and renal lesions have occurred. Appreciable loss of sodium and potassium during prolonged therapy with acetazolamide may result in a tendency towards hypokalaemic acidosis.
By rendering the urine alkaline, acetazolamide enhances the effect of amphetamines and reduces the effect of hexamine and its compounds; it may enhance the effect of quinidine. The diuretic effect of acetazolamide is diminished if ammonium chloride is taken concomitantly.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
White normal biconvex tablet with quadrisected top, measuring 12,7 mm in diameter.
Securitainers of 100.
Store at room temperature (below 30 °C). Keep out of reach of children.
H1805 (Act 101/1965).
NAME AND BUSINESS ADDRESS OF THE APPLICANT:
The Premier Pharmaceutical Co. Ltd.
Adcock Ingram Park
17 Harrison Avenue, Bryanston Ext. 77
Private Bag X69, Bryanston, 2021
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
Current: May 2005
Source: Hospital Pharmacy
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