CARVEDILOL tablet film coated

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

REMEDYREPACK INC.

INN (nemzetközi neve):

CARVEDILOL

Összetétel:

CARVEDILOL 6.25 mg

Recept típusa:

PRESCRIPTION DRUG

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

CARVEDILOL- CARVEDILOL TABLET, FILM COATED
REMEDYREPACK INC.
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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 tablets are an alpha/beta-adrenergic blocking agent
indicated for the treatment of:
1. mild to severe chronic heart failure ( 1.1)
2. left ventricular dysfunction following myocardial infarction in
clinically stable patients ( 1.2)
3. hypertension ( 1.3)
DOSAGE AND ADMINISTRATION
Take with food. Individualize dosage and monitor during up-titration.
( 2)
1. 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)
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. ( 2.2)
3. 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
1. Bronchial asthma or related bronchospastic conditions. ( 4)
2. Second- or third-degree AV block. ( 4)
3. Sick sinus syndrome. ( 4)
4. Severe bradycardia (unless permanent pacemaker in place). ( 4)
5. Patients in cardiogenic shock or decompensated heart failure
requiring the use of IV inotropic therapy. ( 4)
6. Severe hepatic impairment. ( 2.4, 4)
7. 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
1. Acute exacerbation of coronary artery dis