CARVEDILOL tablet, film coated

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

MedVantx, Inc.

INN (Nome Internazionale):

CARVEDILOL

Composizione:

CARVEDILOL 12.5 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Carvedilol tablets USP 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) and Clinical Studies (14.1) ]. Carvedilol tablets USP 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 ≤ 40% (with or without symptomatic heart failure) [see Clinical Studies (14.2) ]. Carvedilol tablets USP are indicated for the management of essential hypertension [see Clinical Studies (14.3, 14.4) ]. They can be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics [see Drug Interactions (7.2) ]. Carvedilol tablets are contraindicated in the following conditions: Teratogenic Effects Pregnancy category C Studies performed in pregnan

Dettagli prodotto:

Carvedilol tablets USP, 3.125 mg, are available as white, film-coated, elliptical-shaped tablets, debossed with "TV" on one side and "51" on the other. They are available in bottles of 100 and 500. Carvedilol tablets USP, 6.25 mg, are available as white, film-coated, elliptical-shaped tablets, debossed with "TV" on one side and "135" on the other. They are available in bottles of 100 and 500. Carvedilol tablets USP, 12.5 mg, are available as white, film-coated, elliptical-shaped tablets, debossed with "TV" on one side and "7295" on the other. They are available in bottles of 100 and 500. Carvedilol tablets USP, 25 mg, are available as white, film-coated, elliptical-shaped tablets, debossed with "TV" on one side and "7296" on the other. They are available in bottles of 100 and 500. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

CARVEDILOL- CARVEDILOL TABLET, FILM COATED
MEDVANTX, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CARVEDILOL TABLETS USP SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR CARVEDILOL TABLETS USP.
CARVEDILOL TABLETS USP FOR ORAL USE
INITIAL U.S. APPROVAL: 1995
RECENT MAJOR CHANGES
Warnings and Precautions, Major Surgery (5.9) October 2010
Warnings and Precautions, Intraoperative Floppy Iris Syndrome (5.14)
January 2011
INDICATIONS AND USAGE
Carvedilol tablets USP 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, 6.25, 12.5, 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 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