torsemide tablets
approved for the treatment of edema
associated with heart failure and
kidney disease
√ A novel slow release formulation
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Important Corrective Communication Regarding SOAANZ® (torsemide) Tablets
The FDA Office of Prescription Drug Promotion (OPDP) determined that certain promotional claims about SOAANZ® (torsemide) tablets made on this webpage were misleading because they (1) minimized risks by suggesting that SOAANZ does not cause excessive urination or hypokalemia and (2) overstated benefits by implying that SOAANZ is superior to generic loop diuretics for treating refractory edema or could benefit patients with worsening heart failure and bladder problems. These claims are not supported by the FDA-approved Prescribing Information.
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Corrective Information
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SOAANZ is indicated in adults for the treatment of edema associated with heart failure or renal disease.
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The cited materials are no longer in use. The webpage has been revised to comply with FDA requirements.
For complete safety and efficacy information, please see the Full Prescribing Information for SOAANZ
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Formulated to treat edema associated with ​
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worsening symptoms of heart failure
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chronic kidney disease
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volume overload
Duration of action 6-8 hours
May help reduce edema
Induces sustained diuresis
Benefits of SOAANZ®
Highlights Of Prescribing Information
These highlights do not include all the information needed to use SOAANZ® safely and effectively. See full prescribing information for SOAANZ.
SOAANZ (torsemide) tablets, for oral use
INDICATIONS AND USAGE
SOAANZ is a loop diuretic indicated in adults for the treatment of edema associated with heart failure or renal disease. (1)
DOSAGE AND ADMINISTRATION
The recommended initial dose is 20 mg orally once daily. Titrate dose by approximately doubling until desired diuretic response is obtained. Doses above 200 mg have not been studied.(2)
DOSAGE FORMS AND STRENGTHS
Tablets: 20 mg, 40 mg and 60 mg (3)
CONTRAINDICATIONS
Hypersensitivity to SOAANZ, anuria, and hepatic coma. (4)
WARNINGS AND PRECAUTIONS
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Hypotension and worsening renal function: monitor volume status and renal function periodically (5.1)
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Electrolyte and metabolic abnormalities: monitor serum electrolytes and blood glucose periodically. (5.2)
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Ototoxicity (5.3, 7.6)
ADVERSE REACTIONS
Discontinuation of therapy due to adverse reactions occurred in 6% of patients treated with SOAANZ (6.1).
To report SUSPECTED ADVERSE REACTIONS, contact Sarfez Pharmaceuticals Inc. at 1-877-8-SARFEZ or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
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Non-steroidal anti-inflammatory drugs (NSAIDs): Reduced diuretic, natriuretic, and antihypertensive effects; risk of renal impairment. (7.1)
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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)
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Cholestyramine: Decreased exposure of SOAANZ. (7.3)
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Organic anion drugs: may decrease diuretic activity of SOAANZ. (7.4)
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Lithium: Risk of lithium toxicity. (7.5)
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Renin-angiotensin inhibitors: Increased risk of hypotension and renal impairment. (7.7)
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Radiocontrast agents: Increased risk of renal toxicity. (7.8)
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Corticosteroids and ACTH: Increased risk of hypokalemia. (7.9)