CARVEDILOL tablet, film coated

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Solco Healthcare US LLC

INN (International ime):

CARVEDILOL

Sastav:

CARVEDILOL 3.125 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Carvedilol Tablets is 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 Clinical Studies (14.1)]. Carvedilol Tablet is 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 Tablet is 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-type diuretics [see Drug Interactions (7.2) ]. Carvedilol Tablet is contraindicated in the following conditions: Studies performed in pregnant rats and rabbits given Carvedilol Tablet revealed increased post-impl

Proizvod sažetak:

Carvedilol Tablets are available as follows: 3.125 mg- Each white, oval shaped, biconvex, film-coated tablet engraved with 254 on one side and plain on the other side contains 3.125 mg of Carvedilol. Tablets are supplied as follows: NDC 43547-254-10 in bottles of 100 tablets NDC 43547-254-50 in bottles of 500 tablets NDC 43547-254-11 in bottles of 1000 tablets 6.25 mg- Each white, oval shaped, biconvex, film-coated tablet engraved with 255 on one side and plain on the other side contains 6.25 mg of Carvedilol. Tablets are supplied as follows: NDC 43547-255-10 in bottles of 100 tablets NDC 43547-255-50 in bottles of 500 tablets NDC43547-255-11 in bottles of 1000 tablets 12.5 mg- Each white, oval shaped, biconvex, film-coated tablet engraved with 256 on one side and plain on the other side, and contains 12.5 mg of Carvedilol. Tablets are supplied as follows: NDC 43547-256-10 in bottles of 100 tablets NDC 43547-256-50 in bottles of 500 tablets NDC 43547-256-11 in bottles of 1000 tablets 25 mg- Each white, oval shaped, biconvex, film-coated tablet engraved with 257 on one side and plain on the otherside contains 25 mg of Carvedilol. Tablets are supplied as follows: NDC 43547-257-10 in bottles of 100 bottles NDC 43547-257-50 in bottles of 500 tablets NDC 43547-257-11 in bottles of 1000 tablets Store below 30°C (86°F). Protect from moisture. Dispense in a tight, light-resistant container.

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

CARVEDILOL- CARVEDILOL TABLET, FILM COATED
SOLCO HEALTHCARE US LLC
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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, FILM COATED FOR ORAL USE
INITIAL U.S. APPROVAL: 1995
RECENT MAJOR CHANGES
Warnings and Precautions, Major Surgery (5.9)
Warnings and Precautions, Intraoperative Floppy Iris Syndrome (5.14)
INDICATIONS AND USAGE
Carvedilol Tablet is 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, 6.25, 12.5, 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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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 rea