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Torsamolex

Torsemide 10 mg
Torsemide 20 mg

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Active ingredient

Torsemide 10 mg
Torsemide 20 mg
 

Indications

  • Torsamolex is indicated for the treatment of edema associated with congestive heart failure, renal disease, or hepatic disease.
  • Use of torsemide has been found to be effective for the treatment of edema associated with chronic renal failure.
  • Chronic use of any diuretic in hepatic disease has not been studied in adequate and well-controlled trials.
  • Torsamolex intravenous injection is indicated when a rapid onset of dieresis is desired or when oral administration is impractical.
  • Torsamolex is indicated for the treatment of hypertension alone or in combination with other antihypertensive agents.

Dosage and Administration

General
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.
Hepatic Cirrhosis
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.
Hypertension
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.

Contraindication

  • Torsamolex is contraindicated in patients with known hypersensitivity to Torsamolex or to sulfonylureas.
  • Torsamolex is contraindicated in patients who are anuric.

Side effects

Overdose:
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:
• Dehydration.
• Hypovolemia.
• Hypotension
• Hyponatremia
• Hypokalemia
• Hypochloremic alkalosis
• Hemoconcentration.
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.

Drug Interaction

  • In patients with essential hypertension, Torsamolex has been administered together with beta-blockers, ACE inhibitors, and calcium-channel blockers. In patients with congestive heart failure, Torsamolex has been administered together with digitalis glycosides, ACE inhibitors, and organic nitrates. None of these combined uses was associated with new or unexpected adverse events.
  • Torsemide does not affect the protein binding of glyburide or of warfarin, the anticoagulant effect of phenprocoumon (a related coumarin derivative), or the pharmacokinetics of digoxin or carvedilol (a vasodilator/beta-blocker).
  • In healthy subjects, coadministration of Torsamolex was associated with significant reduction in the renal clearance of spironolactone, with corresponding increases in the AUC. However, clinical experience indicates that dosage adjustment of either agent is not required.
  • Because Torsamolex and salicylates compete for secretion by renal tubules, patients receiving high doses of salicylates may experience salicylate toxicity when Torsamolex is concomitantly administered.
  • Also, although possible interactions between torsemide and nonsteroidal anti-inflammatory agents (including aspirin) have not been studied, coadministration of these agents with another loop diuretic (furosemide) has occasionally been associated with renal dysfunction.
  • The natriuretic effect of Torsamolex (like that of many other diuretics) is partially inhibited by the concomitant administration of indomethacin. This effect has been demonstrated for Torsamolex under conditions of dietary sodium restriction (50 mEq/day) but not in the presence of normal sodium intake (150 mEq/day).
  • The pharmacokinetic profile and diuretic activity of torsemide are not altered by cimetidine or spironolactone. Coadministration of digoxin is reported to increase the area under the curve for torsemide by 50%, but dose adjustment of Torsamolex is not necessary.
  • Concomitant use of torsemide and cholestyramine has not been studied in humans but, in a study in animals, coadministration of cholestyramine decreased the absorption of orally administered torsemide. If Torsamolex and cholestyramine are used concomitantly, simultaneous administration is not recommended.
  • Coadministration of probenecid reduces secretion of Torsamolex into the proximal tubule and thereby decreases the diuretic activity of Torsamolex.
  • Other diuretics are known to reduce the renal clearance of lithium, inducing a high risk of lithium toxicity, so coadministration of lithium and diuretics should be undertaken with great caution, if at all. Coadministration of lithium and Torsamolex has not been studied.
  • Other diuretics have been reported to increase the ototoxic potential of aminoglycoside antibiotics and of ethacrynic acid, especially in the presence of impaired renal function. These potential interactions with Torsamolex have not been studied.

Pregnancy and Lactation

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.
Lactation:
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.
Pediatric Use:
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.

Warning and Precaution

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.
Ototoxicity
• 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 and Storage

• Package: Carton box containing 1,2,3 & 4 strips each of 10 tablets & insert leaflet.
• â€‹Storage: Store at temperature not exceeding 30 ºC in a dry place.

Mother Company

Manufactured by Marcyrl