Torsemide

2 DOSAGE AND ADMINISTRATION Edema associated with: Heart failure: Initial dose is 10 or 20 mg once daily. Titrate by factors of two; doses above 200 mg have not been studied. 1 ) Chronic Renal Failure: Initial dose is 20 mg once daily.

Titrate by factors of two; doses above 200 mg have not been studied. 1 ) Hepatic Cirrhosis: Initial dose is 5 or 10 mg once daily. Titrate by factors of two; doses above 40 mg have not been studied. 1 ) Hypertension: The recommended initial dose is 5 mg once daily.

After 4 to 6 weeks, increase to 10 mg once daily, if needed. If 10 mg is insufficient, consider adding another agent. 1 Treatment of Edema Edema associated with heart failure The recommended initial dose is 10 mg or 20 mg oral torsemide once daily.

If the diuretic response is inadequate, titrate upward by approximately doubling until the desired diuretic response is obtained. Doses higher than 200 mg have not been adequately studied. Edema associated with chronic renal failure The recommended initial dose is 20 mg oral torsemide once daily.

If the diuretic response is inadequate, titrate upward by approximately doubling until the desired diuretic response is obtained. Doses higher than 200 mg have not been adequately studied. Edema associated with hepatic cirrhosis The recommended initial dose is 5 mg or 10 mg oral torsemide once daily, administered together with an aldosterone antagonist or a potassium-sparing diuretic.

If the diuretic response is inadequate, titrate upward by approximately doubling until the desired diuretic response is obtained. Doses higher than 40 mg have not been adequately studied in this population. 2 Treatment of Hypertension The recommended initial dose is 5 mg once daily.

If the 5 mg dose does not provide adequate reduction in blood pressure within 4 to 6 weeks, increase to 10 mg once daily. If the response to 10 mg is insufficient, add another antihypertensive agent to the treatment regimen.

7%). 1 ) To report SUSPECTED ADVERSE REACTIONS, contact Avet Pharmaceuticals Inc. gov/medwatch. 1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In pre-approval studies, torsemide has been evaluated for safety in approximately 4,000 subjects; over 800 of these subjects received torsemide for at least 6 months, and over 380 were treated for more than 1 year. Among these subjects were 564 who received torsemide during United States-based trials in which 274 other subjects received placebo.

4% of patients treated with placebo. 2% of patients receiving placebo. 25 mg to 20 mg, with most patients receiving 5 mg to 10 mg; the duration of treatment ranged from 1 to 52 days, with a median of 41 days. In the placebo-controlled hypertension studies excessive urination was dose related; 1% of patients receiving placebo, 4% of those treated with 5 mg of daily torsemide, and 15% of those treated with 10 mg.

Excessive urination was generally not reported as an adverse event among patients who received torsemide for cardiac, renal, or hepatic failure. There was no effect of age or sex on the incidence of adverse reactions. Laboratory Parameters Potassium In controlled studies in the United States, torsemide was administered to hypertensive patients at doses of 5 mg or 10 mg daily.

1 mEq/L. 5% on torsemide and 3% on placebo. In patients followed for 1 year, there was no progressive change in mean serum potassium levels. In patients with congestive heart failure, hepatic cirrhosis, or renal disease treated with torsemide at doses higher than those studied in United States antihypertensive trials, hypokalemia was observed with greater frequency, in a dose-related manner.

1 ) Electrolyte and metabolic abnormalities: monitor serum electrolytes and blood glucose periodically. 1 Hypotension and Worsening Renal Function Excessive diuresis may cause potentially symptomatic dehydration, blood volume reduction and hypotension and worsening renal function, including acute renal failure particularly in salt-depleted patients or those taking renin-angiotensin aldosterone inhibitors.

, aminoglycosides, cisplatin, and NSAIDs). Monitor volume status and renal function periodically. 2 Electrolyte and Metabolic Abnormalities Torsemide can cause potentially symptomatic hypokalemia, hyponatremia, hypomagnesemia, hypocalcemia, and hypochloremic alkalosis.

Treatment with torsemide can cause an increase in blood glucose levels and hyperglycemia. Asymptomatic hyperuricemia can occur and gout may rarely be precipitated. Monitor serum electrolytes and blood glucose periodically. 3 Ototoxicity Tinnitus and hearing loss (usually reversible) have been observed with loop diuretics, including torsemide.

Higher than recommended doses, severe renal impairment, and hypoproteinemia, appear to increase the risk of ototoxicity.

4 CONTRAINDICATIONS Torsemide is contraindicated in patients with known hypersensitivity to torsemide or to povidone. Torsemide is contraindicated in patients who are anuric. Torsemide is contraindicated in patients with hepatic coma.

Hypersensitivity to torsemide or povidone, anuria, and hepatic coma. ( 4 )