SPIRONOLACTONE tablet

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

PharmPak, Inc.

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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

Ringkasan produk:

Spironolactone Tablets USP, 50 mg are yellow, film-coated, round tablets, debossed “AN” bisect “514” on one side and plain on other side. They are available as follows: Bottles of 90:                                      NDC 54348-340-90 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

SPIRONOLACTONE- SPIRONOLACTONE TABLET
PHARMPAK, INC.
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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 TABLETS FOR ORAL USE
INITIAL U.S. APPROVAL: 1960
INDICATIONS AND USAGE
Spironolactone tablets are 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 mg 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 ( 2.3).
Primary hyperaldosteronism: Initiate treatment at 100 mg to 400 mg in
preparation for surgery. In
patients unsuitable for surgery use the lowest effective dosage
determined for the individual patient (
2.4).
DOSAGE FORMS AND STRENGTHS
Tablets: 25 mg, 50 mg, and 100 mg ( 3)
CONTRAIND