Torsinex 20 Tablets

Torsemide is a loop diuretic indicated for: the treatment of edema associated with heart failure, renal disease or hepatic disease. ( 1.1 ) the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.2 ) 1.1 Edema Torsemide tablets are indicated for the treatment of edema associated with heart failure, renal disease or hepatic disease. 1.2 Hypertension Torsemide tablets are indicated for the treatment of hypertension, to lower blood pressure. …

• 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
• Chronic Renal Failure: Initial dose is 20 mg once daily
• Titrate by factors of two; doses above 200 mg have not been studied
• Hepatic Cirrhosis: Initial dose is 5 or 10 mg once daily
• Titrate by factors of two; doses above 40 mg have not been studied
• 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
• 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

Torsemide tablets 5 mg, USP are available as white to off-white, capsule shaped, uncoated tablets, debossed with bisect between “C” and “40” on one side and plain on other side. Torsemide tablets 10 mg, USP are available as white to off-white, capsule shaped, uncoated tablets, debossed with bisect between “C” and “41” on one side and plain on other side. …

Of the total number of patients who received torsemide in United States clinical studies, 24% were 65 or older while about 4% were 75 or older. No specific age-related differences in effectiveness or safety were observed between younger patients and elderly patients.

In Renal Impairment In single-dose studies in patients with non-anuric renal failure, high doses of torsemide (20 mg to 200 mg) caused marked increases in water and sodium excretion. In patients with non-anuric renal failure, severe enough to require hemodialysis, chronic treatment with up to 200 mg of daily torsemide has not been shown to change steady-state fluid retention. …

• Symptomatic Hypotension: Advise patients receiving torsemide that lightheadedness can occur, especially during the first days of therapy, and that it should be reported to the prescribing physician
• The patients should be told that if syncope occurs, torsemide should be discontinued until the physician has been consulted
• All patients should be cautioned that inadequate fluid intake, excessive perspiration, diarrhea, or vomiting can lead to an excessive fall in blood pressure, with the same consequences of lightheadedness and possible syncope [see Warnings and Precautions ]. …

• 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

Non-steroidal anti-inflammatory drugs (NSAIDs): Reduced diuretic, natriuretic, and antihypertensive effects; risk of renal impairment. ( 7.1 ) CYP2C9: Concomitant use with CYP2C9 inhibitors can decrease torsemide clearance. Torsemide may affect the efficacy and safety of sensitive CYP2C9 substrates or of substrates with a narrow therapeutic range, such as warfarin or phenytoin. ( 7.2 ) Cholestyramine: Decreased exposure of torsemide. ( 7.3 ) Organic anion drugs: may decrease diuretic activity of torsemide. ( 7.4 ) Lithium: Risk of lithium toxicity ( 7.5 ) Renin-angiotensin inhibitors: Increased risk of hypotension and renal impairment. …

Hypotension and worsening renal function: monitor volume status and renal function periodically ( 5.1 ) Electrolyte and metabolic abnormalities: monitor serum electrolytes and blood glucose periodically. ( 5.2 ) Ototoxicity ( 5.3 , 7.6 ) 5.1 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. Worsening of renal function can also occur with concomitant use of nephrotoxic drugs (e.g., aminoglycosides, cisplatin, and NSAIDs). …

The following risks are discussed in more detail in others sections: Hypotension and Worsening Renal Function [see Warnings and Precautions (5.1) ] Electrolyte and Metabolic Abnormalities [see Warnings and Precautions (5.2) ] Ototoxicity [see Warnings and Precautions (5.3) ] The most common adverse reaction is excessive urination (6.7%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Avet Pharmaceuticals Inc. at 1-866-901-DRUG (3784) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …

8.1 Pregnancy Risk Summary There are no available data on use of torsemide in pregnant women and the risk of major birth defects or miscarriage. In pregnant rats and rabbits dosed, on a mg/m 2 basis, with 10 and 1.7 times a human dose of 20 mg/day, respectively, there was no fetotoxicity or teratogenicity. …

The signs and symptoms of overdosage can be anticipated to include those of excessive pharmacologic effect: dehydration, hypovolemia, hypotension, hyponatremia, hypokalemia, hypochloremic alkalosis, and 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 (e.g., maneuvers to change the pH of the urine) that might accelerate elimination of torsemide and its metabolites. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.