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:

REMEDYREPACK INC.

INN (International Name):

CARVEDILOL

Composition:

CARVEDILOL 3.125 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Carvedilol tablets 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) and Clinical Studies ( 14.1) ]. Carvedilol tablets 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 tablets are indicated for the management of essential hypertension [ see   Clinical Studies ( 14.3, 14.4)] . It can be used alone or in combination with other antihyper

Product summary:

Carvedilol Tablets USP, 3.125 mg are white to off-white, round, biconvex, film-coated tablets debossed with 'Z' on one side and '1' on other side and are supplied as follows: NDC: 70518-0582-00 NDC: 70518-0582-01 PACKAGING: 360 in 1 BOTTLE PLASTIC PACKAGING: 30 in 1 BLISTER PACK Storage: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

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:
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 abruptl