G-TORZ® 20
  • Torsemide is anilinopyridine sulfonylurea belonging to the class of loop diuretic, used as antihypertention agent .
  • Torsemide acts from within the lumen of the thick ascending portion of the loop of Henle, where it inhibits the Na+/K+/2Cl- carrier system.
  • Torsemide increases the urinary excretion of sodium, chloride, and water,but it does not significantly alter glomerular fltration rate, renal plasma flow, or acid-base balance.
  • With oral dosing, the onset of diuresis occurs within 1 hour and the peak effect occurs during the first or second hour and diuresis lasts about 6 to 8 hours.
  • Torsemide tablets bioavailability is approximately 80%. The drug is absorbed with little first-pass metabolism, and the serum concenteration reaches its peak (cmax)  within 1 hour after oral administration. Simultaneous food intake delays the time to cmax by about 30 minutes, but overall bioavailability (AUC) and diuretic activity are unchanged. 
  • Absorption is essentially unaffected by renal or hepatic dysfunction.
  • The volume of distribution of torsemide is 12 liters to 15 liters in normal adults or in patients with mild to moderate renal failure or congestive heart failure. In patients with hepatic cirrhosis, the volume of distribution is approximately doubled.
  • The elimination half-life of torsemide is approximately 3.5 hours.
  • Torsemide is cleared from the circulation by both hepatic metabolism (approximately 80% of total clearance) and excretion into the urine (approximately 20% of total clearance in patients with normal renal function).The major metabolite in humans is the carboxylic acid derivative,which is biologically inactive. Two of the lesser metabolites possess some diuretic activity, but for practical purposes, 
    metabolism terminates the action of the drug.
  • Excretion: Because torsemide is extensively bound to plasma protein (more than 99%), very little enters tubular urine via glomerular filtration. Most renal clearance of torsemide occurs via active secretion of the drug by the proximal tubules into tubular urine.

Each  tablet of G-TORZ® 20 contains:   

  • Torsemide         20 mg

G -TORZ® is indicated for :

  • Treatment of Edema associated with congestive heart failure, renal disease, or hepatic disease.
  • Treatment of Edema associated with chronic renal failure. 
  • Treatment of Hypertension alone or in combination with other antihypertensive agents

G -TORZ® is contraindicated in

  • patients with known hypersensitivity to torsemide or sulfonylureas .
  • patients who are anuric.
  • In patients with essential hypertension,G -TORZ® has been administered together with beta-blockers, ACE inhibitors, and calcium-channel blockers.
  • In patients with congestive heart failure,G -TORZ® 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.
  • In healthy subjects, coadministration of G -TORZ® was associated with significant reduction in the renal clearance of spironolactone, with corresponding increase in the AUC. However, clinical experience indicates that dosage adjustment of either agent is not required.
  • G-TORZ® and salicylates compete for secretion by renal tubules, patients receiving high doses of salicylates may experience salicylate toxicity when G-TORZ® is concomitantly administered.
  • Also, although possible interactions between torsemide and nonsteroidal antiinflammatory 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 G -TORZ® (like that of many other diuretics) is partially inhibited by the concomitant administration of indomethacin.
  • Coadministration of probenecid reduces secretion of G -TORZ® into the 
    proximal tubule and thereby decreases the diuretic activity of 
    G -TORZ®
  • Coadministration of lithium and G -TORZ® 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 
    G -TORZ®  have not been studied.
  • Pregnancy Category B.
  • This drug should be used during pregnancy only if clearly needed.
  • Nursing Mothers: It is not known whether G -TORZ® is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when G -TORZ® is administered to a nursing woman.
  • The reported side effects of G -TORZ® were generally transient and there was no relationship between side effects and age, sex , race or duration of therapy. The most common reasons for discontinuation (in descending order of frequency) are ( dizziness, headache, nausea, weakness, vomiting, hyperglycemia, excessive urination, hyperuricemia, hypokalemia, excessive thirst, hypovolemia, impotence, esophageal hemorrhage, and dyspepsia ) .
  • Serious adverse events reported in the clinical studies for which a drug 
    relationship could not be excluded were atrial fibrillation, chest pain, diarrhea, digitalis intoxication, gastrointestinal hemorrhage, hyperglycemia, hyperuricemia, hypokalemia, hypotension, hypovolemia, shunt thrombosis, rash, rectal bleeding, syncope, and ventricular tachycardia) . Serious skin reactions i.e., Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported in association with torsemide use.
  • G -TORZ® tablets may be given at any time in relation to a meal.
  • Special dosage adjustment in the elderly is not necessary.
  • Congestive Heart Failure: The usual initial dose is 10 mg or 20 mg once a day, if diuretic response is inadequate, the dose should be titrated upward by approximately doubling until the desired response is obtained.
  • Chronic Renal Failure:The usual initial dose is 20 mg  once daily, if diuretic response is inadequate, the dose should be titrated upward by approximately doubling until the desired response is obtained.
  • Hepatic Cirrhosis:The usual initial dose is 5 mg or 10 mg of once-daily oral G -TORZ® administered together with an aldosterone antagonist or a potassium-sparing diuretic, if diuretic response is inadequate,the dose should be titrated upward by approximately doubling until the desired response is obtained.
  • 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.
  • The signs and symptoms of overdosage can be anticipated to be those of 
    excessive pharmacologic effect: dehydration, hypovolemia, hypotension, 
    hyponatremia, hypokalemia, hypochloremic alkalosis, and hemoconcentration. Treatment of overdosage should consist of fluid and electrolyte replacement.

G -TORZ® 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 torsemide (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 torsemide.
  • Ototoxicity:Tinnitus and hearing loss (usually reversible) have been observed after oral dose of G -TORZ® . It is not certain that these events were attributable to torsemide.
  • Volume and Electrolyte Depletion: patients receiving diuretic 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. If any of these occur, 
    G -TORZ® should be discontinued until the situation is corrected; G -TORZ® may be restarted at a lower dose.
  • 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 adrenocorticotropic hormone (ACTH).
  • Labratory Values: single doses of G -TORZ® increase the urinary excretion of calcium and magnesium.
  • An increase in serum glucose concentration, total plasma cholesterol, blood urea nitrogen (BUN), serum creatinine, and serum uric acid have been observed. 
  • G -TORZ® 20 pack of 2 blisters , Blister of 10 tablets.
  • Store below 25° C.