CARVEDILOL- 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:

H.J. Harkins Company, Inc.

INN (nume internaţional):

CARVEDILOL

Compoziție:

CARVEDILOL 6.25 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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 ≤40% (with or without symptomatic heart failure) [see Clinical Studies (14.1)]. Carvedilol tablets are indicated for the management of essential hypertension [see Clinical Studies (14.2)]. It can be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics [see Drug Interactions (7.2)]. Carvedilol tablets are contraindicated in the following conditions: - Bronchial asthma or related bronchospastic conditions. Deaths from status asthmaticus have been reported following single doses of carvedilol tablets. - Second- or third-degree AV block - Sick sinus syndrome - Severe bradycardia (unless a permanent pacemaker is in place) - Patients with cardiogenic shock or who have decompensated heart failure requiring the use of intravenous inotropic therapy. Such patients sho

Rezumat produs:

Carvedilol Tablets, 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-68382-092-17 in bottles of 28 tablets NDC-68382-092-01 in bottles of 100 tablets NDC-68382-092-05 in bottles of 500 tablets Carvedilol Tablets, 6.25 mg are white to off-white, round, biconvex, beveled edge, film-coated tablets debossed with ‘ZC40’ on one side and plain on other side and are supplied as follows: NDC-68382-093-17 in bottles of 28 tablets NDC-68382-093-01 in bottles of 100 tablets NDC-68382-093-05 in bottles of 500 tablets Carvedilol Tablets, 12.5 mg are white to off-white, round, biconvex, beveled edge, film-coated tablets debossed with ‘ZC41’ on one side and plain on other side and are supplied as follows: NDC-68382-094-17 in bottles of 28 tablets NDC-68382-094-01 in bottles of 100 tablets NDC-68382-094-05 in bottles of 500 tablets Carvedilol Tablets, 25 mg are white to off-white, round, biconvex, beveled edge, film-coated tablets debossed with ‘ZC42’ on one side and plain on other side and are supplied as follows: NDC-68382-095-17 in bottles of 28 tablets NDC-68382-095-01 in bottles of 100 tablets NDC-68382-095-05 in bottles of 500 tablets 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.

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

CARVEDILOL - CARVEDILOL TABLET, FILM COATED
H.J. HARKINS COMPANY, 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.
INITIAL U.S. APPROVAL: 1995
RECENT MAJOR CHANGES
Drug Interactions (7) December 2008
Contraindications (4) April 2008
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)
Hype rte nsion(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 permanent pacemaker in place) (4)
Patients in cardiogenic shock or decompensated heart failure requiring
the use of IV inotropic therapy. (4)
Severe hepatic impairment (2.3, 4)
History of serious hypersensitivity reaction (e.g., Stevens-Johnson
syndrome, anaphylactic reaction, angioedema) to
carvedilol, any of the components of carvedilol (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