CARVEDILOL PHOSPHATE capsule, extended release

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

CARVEDILOL PHOSPHATE (UNII: EQT531S367) (CARVEDILOL - UNII:0K47UL67F2)

Disponible depuis:

Bryant Ranch Prepack

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Carvedilol Phosphate extended-release capsules 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 Phosphate extended-release capsules 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 Phosphate extended-release capsules 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 Phosphate extended-release capsules a

Descriptif du produit:

NDC: 63629-9632-1: 30 EXTENDED RELEASE CAPSULEs in a BOTTLE, PLASTIC NDC: 63629-9632-2: 90 EXTENDED RELEASE CAPSULEs in a BOTTLE, PLASTIC

Statut de autorisation:

New Drug Application Authorized Generic

Résumé des caractéristiques du produit

CARVEDILOL PHOSPHATE- CARVEDILOL PHOSPHATE CAPSULE, EXTENDED RELEASE
BRYANT RANCH PREPACK
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CARVEDILOL PHOSPHATE
EXTENDED-RELEASE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
CARVEDILOL PHOSPHATE EXTENDED-RELEASE CAPSULES.
CARVEDILOL PHOSPHATE EXTENDED-RELEASE CAPSULES FOR ORAL USE
INITIAL U.S. APPROVAL: 1995
INDICATIONS AND USAGE
Carvedilol Phosphate extended-release capsules are an
alpha-/beta-adrenergic blocking agent indicated
for the treatment of:
mild to severe chronic heart failure. (1.1)
left ventricular dysfunction following myocardial infarction in
clinically stable patients. (1.2)
hypertension. (1.3)
DOSAGE AND ADMINISTRATION
Take with food. Do not crush or chew capsules. Individualize dosage
and monitor during up-titration. (2)
Heart failure: Start at 10 mg once daily and increase to 20, 40, and
then 80 mg once 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
20 mg once daily and increase to 40
mg then 80 mg once daily after intervals of 3 to 10 days. A lower
starting dose or slower titration may
be used. (2.2)
Hypertension: Start at 20 mg once daily and increase if needed for
blood pressure control to 40 mg
then 80 mg once daily over intervals of 1 to 2 weeks. (2.3)
Elderly patients (> 65 years of age): When switching from higher doses
of immediate-release carvedilol
tablets to Carvedilol Phosphate extended-release capsules, a lower
starting dose should be considered
to reduce the risk of hypotension and syncope. (2.5)
DOSAGE FORMS AND STRENGTHS
Capsules: 10 mg, 20 mg, 40 mg, 80 mg (3)
CONTRAINDICATIONS
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 failu