CARVEDILOL tablet, film coated

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

CARVEDILOL (UNII: 0K47UL67F2) (CARVEDILOL - UNII:0K47UL67F2)

Disponível em:

Glenmark Pharmaceuticals Inc., USA

DCI (Denominação Comum Internacional):

CARVEDILOL

Composição:

CARVEDILOL 3.125 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Carvedilol tablets are indicated for the treatment of mild-to-severe chronic heart failure of ischemic or cardiomyopathic origin, usually in addition to diuretics, ACE inhibitors, and digitalis, to increase survival and, also, to reduce the risk of hospitalization [see Drug Interactions (7.4), Clinical Studies (14.1)]. Carvedilol tablets are indicated to reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of a myocardial infarction and have a left ventricular ejection fraction of less than or equal to 40% (with or without symptomatic heart failure) [see Clinical Studies (14.2)]. Carvedilol tablets are indicated for the management of essential hypertension [see Clinical Studies (14.3, 14.4)]. It can be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics [see Drug Interactions (7.2)]. Carvedilol is contraindicated in the following conditions: Risk Summary Available data regarding use of carvedilol in pregnant women are

Resumo do produto:

Carvedilol Tablets, USP are available in the following strengths: 3.125 mg – White, film-coated circular shaped tablets with ‘G’ engraved on one side and plain on the other side, 6.25 mg – White, film-coated circular shaped tablets with ‘G’ engraved on one side and ‘41’ engraved on the other side, 12.5 mg – White, film-coated capsule shaped tablets with ‘G’ engraved on one side and ‘164’ engraved on the other side, 25 mg – White, film-coated circular shaped tablets with ‘G41’ engraved on one side and ‘25’ engraved on the other side. Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight container.

Status de autorização:

Abbreviated New Drug Application

Características técnicas

CARVEDILOL- CARVEDILOL TABLET, FILM COATED
GLENMARK PHARMACEUTICALS INC., USA
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CARVEDILOL TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
CARVEDILOL TABLETS.
CARVEDILOL TABLETS FOR ORAL USE
INITIAL U.S. APPROVAL: 1995
INDICATIONS AND USAGE
Carvedilol tablets are an alpha-/beta-adrenergic blocking agent
indicated for the treatment of:
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DOSAGE AND ADMINISTRATION
Take with food. Individualize dosage and monitor during up-titration.
(2)
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DOSAGE FORMS AND STRENGTHS
Tablets: 3.125 mg, 6.25 mg, 12.5 mg, 25 mg (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Most common adverse events (6.1):
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mild to severe chronic heart failure (1.1)
left ventricular dysfunction following myocardial infarction in
clinically stable patients (1.2)
hypertension (1.3)
Heart failure: Start at 3.125 mg twice daily and increase to 6.25,
12.5, and then 25 mg twice daily
over intervals of at least 2 weeks. Maintain lower doses if higher
doses are not tolerated. (2.1)
Left ventricular dysfunction following myocardial infarction: Start at
6.25 mg twice daily and increase
to 12.5 mg then 25 mg twice daily after intervals of 3 to 10 days. A
lower starting dose or slower
titration may be used. (2.2)
Hypertension: Start at 6.25 mg twice daily and increase if needed for
blood pressure control to 12.5
mg and then 25 mg twice daily over intervals of 1 to 2 weeks. (2.3)
Bronchial asthma or related bronchospastic conditions. (4)
Second- or third-degree AV block. (4)
Sick sinus syndrome. (4)
Severe bradycardia (unless permanent pacemaker in place). (4)
Patients in cardiogenic shock or decompensated heart failure requiring
the use of IV inotropic therapy.
(4)
Severe hepatic impairment. (2.4, 4)
History of serious hypersensitivity reaction (e.g., Stevens-Johnson
syndrome, anaphylactic reaction,
angioedema) to any component of this medi