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

Logo AQUARID 40 mg CAPSULES

SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

AQUARID 40 mg CAPSULES

COMPOSITION:
Each capsule contains 40 mg
Furosemide

PHARMACOLOGICAL CLASSIFICATION:
18.1 Diuretics

PHARMACOLOGICAL ACTION:
Furosemide is a diuretic and is readily absorbed from the gastrointestinal tract. Considerable portions are bound to plasma proteins. It is rapidly excreted in the urine by both glomerular filtration and tubular secretion the latter accounts for roughly two thirds of the ingested dose. The remainder is excreted in the faeces. Furosemide exerts its diuretic action by virtue of its saluretic properties. It acts primarily to inhibit sodium and chloride reabsorption in the ascending limb of the loop of Henle.

INDICATIONS:
Treatment of oedema of cardiac, hepatic or renal origin.
In the management of refractory oedema it may be used in conjunction with other types of diuretics, particularly the potassium-sparing drugs.

CONTRA-INDICATIONS:
Patients who exhibit hypersensitivity to this compound.
Furosemide is contra-indicated if increasing azotaemia and oliguria occur during treatment of severe progressive renal disease - in these cases the medicine should be discontinued.
Drug induced renal failure and renal failure associated with hepatic coma.

WARNINGS:
Not to be used in the first trimester of pregnancy.

DOSAGE AND DIRECTIONS FOR USE:
In most cases 40 mg daily will suffice. If no response is obtained, this dose may be increased after 6 hours to 80 mg and - if necessary - after 6 hours to 120 mg.
Daily doses of more than 120 mg should preferably be distributed over 2 - 3 individual doses. After mobilizing the oedema, maintenance therapy is continued i.e. 20 to 40 mg daily.

Children generally receive daily oral doses of 1 mg/kg body weight. If necessary this dose may be increased step by step to a maximum of 3 mg/kg body weight per day. A dose of 120 mg per day should not be exceeded with children.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Furosemide may cause hyperuricaemia, gout, metabolic alkalosis and potassium depletion. Because of its strong naturetic effect, Aquarid may cause weakness, dizziness, lethargy, leg cramps, anorexia, vomiting and/or mental confusion. Various forms of dermatitis including urticaria and cases of exfoliative dermatitis, pruritus, postural hypotension, nausea, vomiting, diarrhoea, blurring of vision, or paraesthesia may occur. Anaemia, leucopenia, aplastic anaemia, agranulocytosis and thrombocytopenia (with purpura) may occur. Alterations in glucose tolerance tests with abnormalities of the fasting and 2-hour postprandial sugar may occur. Cases of precipitation of diabetes mellitus have been reported. Furosemide may lower the serum calcium levels and cases of tetany have been reported. Excessive diuresis may result in dehydration and reduction in blood volume with circulatory collapse and with the possibility of vascular thrombosis and embolism, particularly in elderly patients. Excessive loss of potassium in patients receiving cardiac glycosides may precipitate digitalis toxicity. Care should be taken in patients receiving potassium-depleting steroids. Deafness can occur especially when the medicine is combined with other ototoxic medicines such as aminoglycosides. In patients with renal insufficiency, tinnitus and deafness may occur. Caution should be exercised in the simultaneous use with cephalosporins as nephrotoxicity associated with the use of cephalosporins may be potentiated.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Fluid and electrolyte depletion is the most serious danger of overdosage. Treatment should therefore be aimed at electrolyte and fluid replacement.

CONDITIONS OF REGISTRATION:
Advertising to the professions only.

IDENTIFICATION:
Blue and white capsules.

PRESENTATION:
Containers of 30, 100 and 1000 capsules.

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

REGISTRATION NUMBER:
R/18.2/5

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Geo Schwulst Laboratories Limited
Co. Reg. No. 77/3056/06
17 Faraday St.,
Village Main, Jhb

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
November 1989

PM 0558/8/94

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