Torsemide 10 mg
Torsemide 20 mg
Torsemide 10 mg
Torsemide 20 mg
Torsamolex tablets may be given at any time in relation to a meal, as convenient. Special dosage adjustment in the elderly is not necessary. Because of the high bioavailability of Torsamolex, oral and intravenous doses are therapeutically equivalent, so patients may be switched to and from the intravenous form with no change in dose. Torsamolex intravenous injection should be administered either slowly as a bolus over a period of 2 minutes or administered as a continuous infusion. If Torsamolex is administered through an IV line, it is recommended that, as with other IV injections, the IV line is flushed with Normal Saline (Sodium Chloride Injection, USP) before and after administration. Torsamolex injection is formulated above pH 8.3. Flushing the line is recommended to avoid the potential for incompatibilities caused by differences in pH which could be indicated by colour change, haziness or the formation of a precipitate in the solution. If Torsamolex is administered as a continuous infusion, stability has been demonstrated through 24 hours at room temperature in plastic containers for the following fluids and concentrations:
200 mg Torsamolex (10 mg/mL) added to:
• 250 mL Dextrose 5% in water.
• 250 mL 0.9% Sodium Chloride.
• 500 mL 0.45% Sodium Chloride.
50 mg Torsamolex (10 mg/mL) added to:
• 500 mL Dextrose 5% in water.
• 500 mL 0.9% Sodium Chloride.
• 500 mL 0.45% Sodium Chloride.
Before administration, the solution of Torsamolex should be visually inspected for discoloration and particulate matter. If either is found, the ampoule should not be used.
Congestive Heart Failure
The usual initial dose is 10 mg or 20 mg of once-daily oral or intravenous Torsamolex. If the diuretic response is inadequate, the dose should be titrated upward by approximately doubling until the desired diuretic response is obtained. Single doses higher than 200 mg have not been adequately studied.
Chronic Renal Failure
The usual initial dose of Torsamolex is 20 mg of once-daily oral or intravenous Torsamolex. If the diuretic response is inadequate, the dose should be titrated upward by approximately doubling until the desired diuretic response is obtained. Single doses higher than 200 mg have not been adequately studied.
The usual initial dose is 5 mg or 10 mg of once-daily oral or intravenous Torsamolex, administered together with an aldosterone antagonist or a potassium-sparing diuretic. If the diuretic response is inadequate, the dose should be titrated upward by approximately doubling until the desired diuretic response is obtained. Single doses higher than 40 mg have not been adequately studied.
Chronic use of any diuretic in hepatic disease has not been studied in adequate and well-controlled trials.
The usual 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, the dose may be increased to 10 mg once daily. If the response to 10 mg is insufficient, an additional antihypertensive agent should be added to the treatment regimen.
There is no human experience with overdoses of Torsamolex, but the signs and symptoms of overdosage can be anticipated to be those of excessive pharmacologic effect:
• Hypochloremic alkalosis
Treatment of overdosage should consist of fluid and electrolyte replacement.
Laboratory determinations of serum levels of torsemide and its metabolites are not widely available.
No data are available to suggest physiological maneuvers (eg, maneuvers to change the pH of the urine) that might accelerate elimination of torsemide and its metabolites. Torsemide is not dialyzable, so hemodialysis will not accelerate elimination.
Pregnancy Category B
There was no fetotoxicity or teratogenicity in rats treated with up to 5 mg/kg/day of torsemide (on a mg/kg basis, this is 15 times a human dose of 20 mg/day; on a mg/m2 basis, the animal dose is 10 times the human dose), or in rabbits, treated with 1.6 mg/kg/day (on a mg/kg basis, 5 times the human dose of 20 mg/kg/day; on a mg/m2 basis, 1.7 times this dose). Fetal and maternal toxicity (decrease in average body weight, increase in fetal resorption and delayed fetal ossification) occurred in rabbits and rats given doses 4 (rabbits) and 5 (rats) times larger. Adequate and well-controlled studies have not been carried out in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
It is not known whether Torsamolex is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Torsamolex is administered to a nursing woman.
Safety and effectiveness in pediatric patients have not been established. Administration of another loop diuretic to severely premature infants with edema due to patent ductus arteriosus and hyaline membrane disease has occasionally been associated with renal calcifications, sometimes barely visible on X-ray but sometimes in staghorn form, filling the renal pelves. Some of these calculi have been dissolved, and hypercalciuria has been reported to have decreased, when chlorothiazide has been coadministered along with the loop diuretic. In other premature neonates with hyaline membrane disease, another loop diuretic has been reported to increase the risk of persistent patent ductus arteriosus, possibly through a prostaglandin-Emediated process. The use of Torsamolex in such patients has not been studied.
Hepatic Disease with Cirrhosis and Ascites
• Torsamolex should be used with caution in patients with hepatic disease with cirrhosis and ascites, since sudden alterations of fluid and electrolyte balance may precipitate hepatic coma. In these patients, diuresis with Torsamolex (or any other diuretic) is best initiated in the hospital.
• To prevent hypokalemia and metabolic alkalosis, an aldosterone antagonist or potassium-sparing drug should be used concomitantly with Torsamolex.
• Tinnitus and hearing loss (usually reversible) have been observed after rapid intravenous injection of other loop diuretics and have also been observed after oral Torsamolex. It is not certain that these events were attributable to Torsamolex.
• Ototoxicity has also been seen in animal studies when very high plasma levels of torsemide were induced. Administered intravenously, Torsamolex should be injected slowly over 2 minutes, and single doses should not exceed 200 mg.
Volume and Electrolyte Depletion
• Patients receiving diuretics should be observed for clinical evidence of electrolyte imbalance, hypovolemia, or prerenal azotemia. Symptoms of these disturbances may include one or more of the following: dryness of the mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pains or cramps, muscular fatigue, hypotension, oliguria, tachycardia, nausea, and vomiting.
• Excessive diuresis may cause dehydration, blood-volume reduction, and possibly thrombosis and embolism, especially in elderly patients. In patients who develop fluid and electrolyte imbalances, hypovolemia, or prerenal azotemia, the observed laboratory changes may include hyper- or hyponatremia, hyper- or hypochloremia, hyper- or hypokalemia, acid-base abnormalities, and increased blood urea nitrogen (BUN). If any of these occur, Torsamolex should be discontinued until the situation is corrected; Torsamolex may be restarted at a lower dose.
• In controlled studies in the United States, Torsamolex was administered to hypertensive patients at doses of 5 mg or 10 mg daily. After 6 weeks at these doses, the mean decrease in serum potassium was approximately 0.1 mEq/L.
• The percentage of patients who had a serum potassium level below 3.5 mEq/L at any time during the studies was essentially the same in patients who received Torsamolex (1.5%) as in those who received placebo (3%). In patients followed for 1 year, there was no further change in mean serum potassium levels. In patients with congestive heart failure, hepatic cirrhosis, or renal disease treated with Torsamolex at doses higher than those studied in United States antihypertensive trials, hypokalemia was observed with greater frequency, in a dose-related manner.
• In patients with cardiovascular disease, especially those receiving digitalis glycosides, diuretic-induced hypokalemia may be a risk factor for the development of arrhythmias. The risk of hypokalemia is greatest in patients with cirrhosis of the liver, in patients experiencing a brisk diuresis, in patients who are receiving inadequate oral intake of electrolytes, and in patients receiving concomitant therapy with corticosteroids or ACTH.
• Periodic monitoring of serum potassium and other electrolytes is advised in patients treated with Torsamolex.
• Package: Carton box containing 1,2,3 & 4 strips each of 10 tablets & insert leaflet.
• Storage: Store at temperature not exceeding 30 ºC in a dry place.
Manufactured by Marcyrl