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:

Proficient Rx LP

INN (Medzinárodný Name):

CARVEDILOL

Zloženie:

CARVEDILOL 3.125 mg

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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-type diuretics [see Drug Interactions (7.2)] . Carvedilol tablets are contraindicated in the following conditions: Risk Summary Available data regarding use of carvedilol in pregna

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 63187-941-30          Bottles of 60               NDC 63187-941-60          Bottles of 90             NDC 63187-941-90 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 Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

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.
CARVEDILOL TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1995
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, 25 mg (3)
CONTRAINDICATIONS
•
•
•
•
•
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
ADVERSE REACTIONS
Most common adverse events (6.1):
•
•
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT AUROBINDO PHARMA USA,
INC. AT 1-866-850-2876 OR
FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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 mg,
12.5 mg 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