SPIRONOLACTONE tablet, film coated

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Preferred Pharmaceuticals Inc.

INN (Mezinárodní Name):

SPIRONOLACTONE

Složení:

SPIRONOLACTONE 100 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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

Přehled produktů:

Spironolactone tablets USP 100 mg tablets are Light peach to peach colored, round, biconvex, film coated tablets with inscription “AF” on one side and breakline on the other side having faint odour of peppermint, supplied as: 68788-7019-3 bottle of 30 68788-7019-6 68788-7019-9 bottle of 60 bottle of 90

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

SPIRONOLACTONE- SPIRONOLACTONE TABLET, FILM COATED
PREFERRED PHARMACEUTICALS 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 is an aldosterone antagonist indicated for:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Tablets: 25 mg, 50 mg, and 100 mg ( 3)
CONTRAINDICATIONS
Spironolactone tablets are contraindicated in patients with ( 4):
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WARNINGS AND PRECAUTIONS
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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)
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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
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 hyperaldosteronis