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SOAANZ
(torsemide) Tablets

For patients with 
heart failure and kidney disease

Specially formulated for patients who are taking a loop diuretic and experience:

  • edema

  • worsening symptoms of heart failure

  • Excessive urination

  • hypokalemia

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Duration of action 6-8 hours

decrease the incidences of hypokalemia.p

May help with incidences of hypokalemia

It may reduce drug-induced incontinence.

Prevents excessive urination

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 and 60 mg (3)

CONTRAINDICATIONS

Hypersensitivity to SOAANZ, anuria, and hepatic coma. (4)

WARNINGS AND PRECAUTIONS

  • 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)

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 1-703-627-1934 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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 SOAANZ. (7.3)
     

  • Organic anion drugs: may decrease diuretic activity of SOAANZ. (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)

PATIENT COUNSELING INFORMATION

Symptomatic Hypotension: Advise patients receiving SOAANZ that lightheadedness can occur, especially during the first days of therapy, and that it should be reported to the prescribing physician. Patients should be told that if syncope occurs, SOAANZ 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 (5.1)].

Non-Steroidal Anti-inflammatory Drugs (NSAID): Advise patients to discuss with their physician before taking NSAID medications concomitantly [see Drug Interactions (7.1)].

SARFEZ and SOAANZ are registered trademarks of Sarfez. Any other trademarks are the property of their respective owners.

Manufactured For:
Sarfez Pharmaceuticals Inc.
Vienna, VA 22182