CARVEDILOL tablet, film coated

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Proficient Rx LP

INN (Mezinárodní Name):

CARVEDILOL

Složení:

CARVEDILOL 3.125 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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 (14.1)]. Carvedilol tablets, USP 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: 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

Přehled produktů:

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-63187-570-30 in bottles of 30 tablets NDC-63187-570-60 in bottles of 60 tablets NDC-63187-570-90 in bottles of 90 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.

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

CARVEDILOL- CARVEDILOL TABLET, FILM COATED
PROFICIENT RX LP
----------
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
WARNINGS AND PRECAUTIONS, MAJOR SURGERY (5.9) OCTOBER 2010
WARNINGS AND PRECAUTIONS, INTRAOPERATIVE FLOPPY IRIS SYNDROME JANUARY
2011
(5.14 )
INDICATIONS AND USAGE
Carvedilol tablets, USP 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, 6.25, 12.5, 25 mg (3)
CONTRAINDICATIONS
•
•
•
•
•
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
ADVERSE REACTIONS
Most common adverse events (6.1):
•
•
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ZYDUS PHARMACEUTICALS
USA INC. AT 1-877-993-8779 OR
FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Left ventricular dysfunction following myocardial infarction in
clinically stable patients(1.1)
Hype rte nsion(1.2)
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)
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