SPIRONOLACTONE- spironolactone tablet, film coated

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

SPIRONOLACTONE (UNII: 27O7W4T232) (SPIRONOLACTONE - UNII:27O7W4T232)

Dostępny od:

Bryant Ranch Prepack

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Spironolactone tablets are indicated for treatment of NYHA Class III–IV heart failure and reduced ejection fraction to increase survival, manage edema, and reduce the need for hospitalization for heart failure. Spironolactone tablets are usually administered in conjunction with other heart failure therapies. Spironolactone tablets are indicated as add-on therapy for the treatment of hypertension, to lower blood pressure in patients who are not adequately controlled on other agents. 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. 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 dru

Podsumowanie produktu:

Product: 63629-8132 NDC: 63629-8132-1 30 TABLET, FILM COATED in a BOTTLE Product: 63629-8133 NDC: 63629-8133-1 30 TABLET, FILM COATED in a BOTTLE

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

SPIRONOLACTONE- SPIRONOLACTONE TABLET, FILM COATED
BRYANT RANCH PREPACK
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SPIRONOLACTONE TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SPIRONOLACTONE
TABLETS.
SPIRONOLACTONE (SPIRONOLACTONE) TABLETS FOR ORAL USE
INITIAL U.S. APPROVAL: 1960
INDICATIONS AND USAGE
Spironolactone is an aldosterone antagonist indicated for:
The treatment of NYHA Class III–IV heart failure and reduced
ejection fraction to increase survival, manage edema,
and to reduce the need for hospitalization for heart failure ( 1.1)
Use as an add-on therapy 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 ( 1.2)
The management of edema in adult patients who are cirrhotic when edema
is not responsive to fluid and sodium
restrictions and in the setting of nephrotic syndrome when treatment
of the underlying disease, restriction of fluid and
sodium intake, and the use of other diuretics produce an inadequate
response ( 1.3).
Treatment of primary hyperaldosternism for: ( 1.4)
Short-term preoperative treatment
Long-term maintenance for patients with discrete aldosterone-producing
adrenal adenomas who are not candidates
for surgery and patients with bilateral micro or macronodular adrenal
hyperplasia
DOSAGE AND ADMINISTRATION
Heart Failure: Initiate treatment at 25 mg once daily ( 2.2).
Hypertension: Initiate treatment at 25 to 100 mg daily in either
single or divided doses ( 2.3).
Edema: Initiate therapy in a hospital setting and titrate slowly. The
recommended initial daily dose is 100 mg in single
or divided doses ( 2.4).
Primary hyperaldosteronism: Initiate treatment at 100 to 400 mg in
preparation for surgery. In patients unsuitable for
surgery use the lowest effective dosage determined for the individual
patient ( 2.5).
DOSAGE FORMS AND STRENGTHS
Tablets: 25 mg, 50 mg, and