Torsemide 10 mg/1
Torsemide · TABLET · Camber Pharmaceuticals, Inc.
Torsemide is a loop diuretic taken by mouth that helps remove excess fluid from your body by increasing urine production. It is commonly used to treat swelling and fluid buildup caused by heart failure, liver disease, or kidney disease, and may also be used to help manage high blood pressure.
Key Facts
- Brand Name
- Torsemide
- Generic Name
- Torsemide
- NDC Code (Product)
31722-530- Manufacturer
- Camber Pharmaceuticals, Inc.
- Strength
- 10 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA079234
- Drug Class
- Loop Diuretic [EPC]
- Marketing Start
- 01/01/2011
Recall History
Apotex Corp.
CGMP Deviations
Apotex Corp.
CGMP Deviations
Aidapak Services, LLC
Labeling: Label Mixup; TORSEMIDE, Tablet, 10 mg may be potentially mislabeled as PYRIDOXINE HCL, Tablet, 50 mg, NDC 00536440801, Pedigree: AD30197_22, EXP: 5/9/2014.
Aidapak Services, LLC
Labeling: Label Mixup; TORSEMIDE Tablet, 10 mg may be potentially mislabeled as MEXILETINE HCL, Capsule, 200 mg, NDC 00093874001, Pedigree: AD25264_7, EXP: 5/3/2014.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 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. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with torsemide. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exerci…
Dosage & Administration
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. ( 2.1 ) Chronic Renal Failure: Initial dose is 20 mg once daily. Titrate by factors of two; doses above 200 mg have not been studied. ( 2.1 ) Hepatic Cirrhosis: Initial dose is 5 or 10 mg once daily. Titrate by factors of two; doses above 40 mg have not been studied. ( 2.1 ) 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. ( 2.2 ) 2.1 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.…
Contraindications
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 )
Drug Interactions
7 DRUG INTERACTIONS 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. ( 7.7 ) Radiocontrast agents: Increased risk of renal toxicity. ( 7.8 ) Corticosteroids and ACTH: Increased risk of hypokalemia. ( 7.9 ) 7.1 Nonsteroidal Anti-inflammatory Drugs Because torsemide and salicylates compete for secretion by renal tubules, patients receiving high doses of salicylates may experience salicylate toxicity when torsemide is concomitantly administered. Concomitant use of nonsteroidal anti-inflammatory drugs (NSAIDs) and torsemide has been associated with the development of acute renal failure. The antihypert…
Adverse Reactions
6 ADVERSE REACTIONS 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. 6.1 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. Discontinuation of therapy due to adverse…
Frequently Asked Questions
What is Torsemide used for?
Torsemide is a loop diuretic taken by mouth that helps remove excess fluid from your body by increasing urine production. It is commonly used to treat swelling and fluid buildup caused by heart failure, liver disease, or kidney disease, and may also be used to help manage high blood pressure.
Is Torsemide a controlled substance?
Torsemide is not classified as a controlled substance by the DEA.
What is the generic name for Torsemide?
The generic name for Torsemide is Torsemide. There are 1 other brand versions of Torsemide.
What is the NDC code for Torsemide 10 mg/1?
The NDC (National Drug Code) for Torsemide 10 mg/1 is 31722-530, listed by Camber Pharmaceuticals, Inc..