CARVEDILOL tablet, film coated

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Blenheim Pharmacal, Inc.

INN (Medzinárodný Name):

CARVEDILOL

Zloženie:

CARVEDILOL 3.125 mg

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Carvedilol tablets, USP 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 (14.2) ]. Carvedilol tablets, USP is indicated for the management of essential hypertension [see Clinical Studies (14.3) ]. It can be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics [see Drug Interactions (7.2) ]. Carvedilol is contraindicated in the following conditions: Pregnancy Category C. Studies performed in pregnant rats and rabbits given carvedilol revealed increased post-implantation loss in rats at doses of 300 mg/kg/day (50 times the maximum recommended human dose [MRHD] as mg/m2 ) and in rabbits at doses of 75 mg/kg/day (25 times the MRHD as mg/m2 ). In the rats, there was also a decrease in fetal body weight at the maternally toxic dose of 300 mg/kg/day (50 times the

Prehľad produktov:

Carvedilol Tablets USP, 3.125 mg  are white to off-white, oval shaped, film-coated tablets debossed with ‘E’ on one side and ‘01’ on the other side.              Bottles of 30               NDC 10544-184-30           Carvedilol Tablets USP, 6.25 mg  are white to off-white, oval shaped, film-coated tablets debossed with ‘E’ on one side and ‘02’ on the other side.               Bottles of 30                NDC 10544-187-30           Bottles of 90        NDC 10544-187-90   Carvedilol Tablets USP, 12.5 mg  are white to off-white, oval shaped, film-coated tablets debossed with ‘E’ on one side and ‘03’ on the other side.              Bottles of 30                NDC 10544-190-30            Bottles of 90               NDC 10544-190-90           Bottles of 181              NDC 10544-190-81  Carvedilol Tablets USP, 25 mg  are white to off-white, oval shaped, film-coated tablets debossed with ‘E’ on one side and ‘04’ on the other side.               Bottles of 30                NDC 10544-191-30           Bottles of 90                NDC 10544-191-30  Store at 20° to 25°C (68° to 77° F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container [see USP]. Manufactured for:  Aurobindo Pharma USA, Inc.   2400 Route 130 North  Dayton, NJ 08810  Manufactured by:  Aurobindo Pharma Limited   Hyderabad–500 072, India Marketed/ Packaged by: Blenheim Pharmacal, Inc. North Blenheim, NY 12131, (USA)     Revised: 10/2011

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

CARVEDILOL- CARVEDILOL TABLET, FILM COATED
BLENHEIM PHARMACAL, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CARVEDILOL SAFELY AND EFFECTIVELY.SEE FULL
PRESCRIBING INFORMATION FOR CARVEDILOL.
CARVEDILOL TABLETS, USP
INITIAL U.S. APPROVAL: 1995
RECENT MAJOR CHANGES
Warnings and Precautions, Major Surgery (5.9) October 2010
Warnings and Precautions, Intraoperative Floppy Iris Syndrome (5.14)
January 2011
INDICATIONS AND USAGE
Carvedilol is an alpha/beta-adrenergic blocking agent indicated for
the treatment of:
•
•
DOSAGE AND ADMINISTRATION
Take with food. Individualize dosage and monitor during up-titration.
(2)
•
•
DOSAGE FORMS AND STRENGTHS
Tablets: 3.125 mg, 6.25 mg, 12.5 mg, or 25 mg (3)
CONTRAINDICATIONS
•
•
•
•
•
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
ADVERSE REACTIONS
Most common adverse events (6.1):
•
•
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT APOTEX AT
1-800-667-4708 OR FDA AT 1-800-FDA-1088
OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Left ventricular dysfunction following myocardial infarction in
clinically stable patients (1.2)
Hypertension (1.3)
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 reaction (e.g., Stevens-Johnson
syndrome, anaphylactic reaction, angioedema) to
any component of this medica