CARVEDILOL tablet film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

McKesson Contract Packaging

INN (International Name):

CARVEDILOL

Composition:

CARVEDILOL 3.125 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CARVEDILOL- CARVEDILOL TABLET, FILM COATED
MCKESSON CONTRACT PACKAGING
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CARVEDILOL SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR CARVEDILOL.
CARVEDILOL TABLET, FILM COATED FOR ORAL USE
INITIAL U.S. APPROVAL: 2007
INDICATIONS AND USAGE
Carvedilol is an alpha/beta-adrenergic blocking agent indicated for
the treatment of:
Left ventricular dysfunction following myocardial infarction in
clinically stable patients (1.1)
Hypertension (1.2)
DOSAGE AND ADMINISTRATION
Take with food. Individualize dosage and monitor during up-titration.
(2)
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. (2.1)
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. (2.2)
DOSAGE FORMS AND STRENGTHS
Tablets: 3.125, 6.25, 12.5, 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 a permanent pacemaker is in place). (4)
Patients in cardiogenic shock or decompensated heart failure requiring
the use of IV inotropic therapy. (4)
Severe hepatic impairment (2.3, 4)
Hypersensitivity to carvedilol (e.g. Stevens- Johnson syndrome). (4)
WARNINGS AND PRECAUTIONS
Acute exacerbation of coronary artery disease upon cessation of
therapy: Do not abruptly discontinue. (5.1 )
Bradycardia, hypotension, worsening heart failure/fluid retention may
occur. Reduce the dose as needed. (5.2 , 5.3, 5.4 )
Non-allergic bronchospasm (e.g., chronic bronchitis and emphysema):
Avoid β-blockers. (4) However, if deemed
necessary, use with caution and at lowest effective dose. (5.5 )
Diabetes: Monitor glucose as β-blockers may mask symptoms of
hypoglycem