CARVEDILOL tablet film coated

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Avera McKennan Hospital

ІПН (Міжнародна Ім'я):

CARVEDILOL

Склад:

CARVEDILOL 12.5 mg

Тип рецепту:

PRESCRIPTION DRUG

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

CARVEDILOL- CARVEDILOL TABLET, FILM COATED
AVERA MCKENNAN HOSPITAL
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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, FOR ORAL USE
INITIAL U.S. APPROVAL: 1995
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 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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DRUG INTERACTIONS
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 of serious hypersensitivity reaction (e.g., Stevens-Johnson
syndrome, anaphylactic reaction, angioedema) to
any component o