CARVEDILOL tablet film coated

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Apotex Corp.

ІПН (Міжнародна Ім'я):

CARVEDILOL

Склад:

CARVEDILOL 3.125 mg

Тип рецепту:

PRESCRIPTION DRUG

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

CARVEDILOL- CARVEDILOL TABLET, FILM COATED
APOTEX CORP.
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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 is 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. Individualize dosage and monitor during up-titration.
(2)
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)
DOSAGE FORMS AND STRENGTHS
Tablets: 3.125 mg, 6.25 mg, 12.5 mg, 25 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 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 medication or other medications containing
carvedilol. (4)
WARNINGS AND PRECAUTIONS
Acute exacerbation of coronary artery disease upon cessation of
therapy: Do not abruptly discontinue. (5.1)
Brad