DEMADEX- torsemide tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

TORSEMIDE (UNII: W31X2H97FB) (TORSEMIDE - UNII:W31X2H97FB)

Disponível em:

Meda Pharmaceuticals

DCI (Denominação Comum Internacional):

TORSEMIDE

Composição:

TORSEMIDE 5 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

DEMADEX is indicated for the treatment of edema associated with heart failure, renal disease or hepatic disease. DEMADEX is 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 DEMADEX. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Educ

Resumo do produto:

DEMADEX for oral administration is available as white, scored tablets as follows: Dose Shape Debossing NDC 0037-xxxx-xx Side 1 Side 2 Bottle/100 5 mg elliptical 5 5005 3505-01 10 mg elliptical 10 5010 3510-01 20 mg elliptical 20 5020 3520-01 100 mg capsule shaped 100 5001 3500-01 Store at 15° to 30°C (59° to 86°F).

Status de autorização:

New Drug Application

Características técnicas

DEMADEX- TORSEMIDE TABLET
MEDA PHARMACEUTICALS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DEMADEX® SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR DEMADEX
DEMADEX (TORSEMIDE) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1993
INDICATIONS AND USAGE
DEMADEX is a loop diuretic indicated for:
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DOSAGE AND ADMINISTRATION
Edema associated with:
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Hype rte nsion:
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DOSAGE FORMS AND STRENGTHS
Tablets: 5 mg, 10 mg, 20 mg and 100 mg (3)
CONTRAINDICATIONS
Hypersensitivity to DEMADEX or povidone, anuria, and hepatic coma. (4)
WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
The most common adverse reaction is excessive urination (6.7%). (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MEDA PHARMACEUTICALS
INC. AT 1-800-526-3840 OR FDA
AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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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)
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)
The recommended initial dose is 5 mg once daily. After 4-6 weeks,
increase to 10 mg once daily, if needed. If 10 mg
is insufficient, consider adding another agent. (2.2)
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)
Non-steroidal anti-inflamm