CARVEDILOL tablet, film coated

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Mylan Institutional Inc.

INN (nume internaţional):

CARVEDILOL

Compoziție:

CARVEDILOL 3.125 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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), 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 antihypertensive agents, especially thiazide-

Rezumat produs:

Carvedilol Tablets, USP are available containing 3.125 mg, 6.25 mg, 12.5 mg, or 25 mg of carvedilol, USP. The 3.125 mg tablets are blue, film-coated, round, unscored tablets debossed with M on one side of the tablet and C31 on the other side. They are available as follows: NDC 51079-771-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). The 6.25 mg tablets are white, film-coated, round, unscored tablets debossed with M on one side of the tablet and C32 on the other side. They are available as follows: NDC 51079-930-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). The 12.5 mg tablets are white, film-coated, round, unscored tablets debossed with M on one side of the tablet and C33 on the other side. They are available as follows: NDC 51079-931-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). The 25 mg tablets are white, film-coated, round, unscored tablets debossed with M on one side of the tablet and C34 on the other side. They are available as follows: NDC 51079-932-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and moisture. PHARMACIST: Dispense a Patient Information Leaflet with each prescription.

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

CARVEDILOL- CARVEDILOL TABLET, FILM COATED
MYLAN INSTITUTIONAL 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