Puresis 40 mg Tablet

(a) Ascites due to cirrhosis of the liver, mechanical obstruction or cardiac failure.

(b) To prevent oliguria from progressing to complete anuria.

(c) Cardiac oedema.

(d) Hypertension of mild to moderate degree.

(e) Oedema occurring during the last three months of pregnancy - pre-eclamptic toxaemia and eclampsia (see WARNINGS AND SPECIAL PRECAUTIONS).

Adults Initial dose: One to three tablets.

Maintenance dose: Half to one tablet daily. Or: As prescribed by the physician.

Patients who exhibit hypersensitivity to furosemide. In hepatic coma and in states of electrolyte depletion. PURESIS is contraindicated if increasing azotaemia and oliguria treatment of severe progressive renal disease. Lactating women (see HUMAN REPRODUCTION).

In pregnancy, PURESIS should be administered with great caution and only in carefully selected cases, for short periods of time (see HUMAN REPRODUCTION). PURESIS should be used with care in patients with prostatic hypertrophy or impairment of micturition. PURESIS should be used with caution in patients with impaired hepatic function since it may increase the risk of hepatic encephalopathy. It should be used with caution in patients with renal impairment. The use of PURESIS in patients suffering from acute forms of porphyria, especially variegate porphyria, and to a lesser extent acute intermittent porphyria and hereditary coproporphyria is contentious, and PURESIS should thus be used with caution in these patients. Excessive diuresis may result in dehydration and reduction in blood volume, with circulatory collapse and the possibility of vascular thrombosis and embolism, particularly in elderly patients. The excessive loss of potassium in patients receiving cardiac glycosides may precipitate digitalis toxicity. Care should be taken in patients receiving potassium depleting steroids.

Electrolyte disturbance - Hypokalaemia may be reduced with a potassium-rich diet. If it already exists before the commencement of treatment - which is particularly likely to occur in cases of cirrhosis - the serum potassium should be restored to normal by potassium supplements and, if necessary, by the administration of sodium and chloride. Because of its strong natriuretic effect, PURESIS may cause a decrease in the sodium levels, particularly when the oedema is corrected rapidly. Electrolyte depletion may manifest itself by weakness, dizziness, lethargy, leg cramps, anorexia, vomiting and/or mental confusion.

Concomitant therapy with cephaloridine may result in nephrotoxicity. PURESIS may enhance the nephrotoxicity of cephalosporin antibiotics such as cephalothin and of aminoglycoside antibiotics. It can also enhance the ototoxicity of aminoglycoside antibiotics. Concurrent administration of phenytoin or indomethacin may reduce the clinical effects of PURESIS. PURESIS may enhance the toxicity of digitalis glycosides by depleting serum-potassium concentrations. It may enhance the neuromuscular blocking action of competitive muscle relaxants, such as tubocurarine. It may enhance the effects of antihypertensive agents. The potassium-depleting effect of furosemide may be enhanced by corticosteroids, corticotrophin, or carbenoxolone. Concomitant administration of PURESIS and lithium is generally not recommended since the association may lead to toxic blood concentrations of lithium. Blood-glucose concentrations should be monitored in patients taking antidiabetic agents as requirements may change.

In pregnancy, PURESIS should be administered with great caution and only in carefully selected cases, for short periods of time. Lactating women should not use PURESIS (see CONTRAINDICATIONS and WARNINGS AND SPECIAL PRECAUTIONS).

Not known.

(i) Various forms of dermatitis including urticaria and exfoliative dermatitis, pruritus, paraesthesia, blurring of vision, yellow vision, dizziness, pancreatitis, photosensitivity, postural hypotension, headache, nausea, vomiting or diarrhoea may occur.

(ii) Anaemia, leucopenia, aplastic anaemia and thrombocytopenia (with purpura) may occur. Agranulocytosis has occurred.

(iii) Asymptomatic hyperuricaemia can occur and gout may be precipitated.

(iv) Alterations in glucose tolerance tests with abnormalities of the fasting and 2-hour post-prandial sugar has been observed, and cases of precipitation of diabetes mellitus have been reported.

(v) PURESIS may lower the serum calcium levels and cases of tetany have been reported. Hepatic dysfunction, cholestatic jaundice and paraesthesia have been reported. Tinnitus and deafness may occur in particular during rapid high-dose parenteral furosemide therapy. Deafness may be permanent particularly if furosemide has been given to patients taking ototoxic medication. PURESIS increases the urinary excretion of calcium. Renal stone formation has been reported when PURESIS has been used to treat preterm infants.

Symptoms See SIDE EFFECTS above.

Treatment Treatment is symptomatic and supportive.