CARVEDILOL tablet, film coated

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Major Pharmaceuticals

INN (الاسم الدولي):

CARVEDILOL

تركيب:

CARVEDILOL 3.125 mg

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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 is contraindicated in the following conditions: Risk Summary Available data regarding use of carvedilol in pregnant wo

ملخص المنتج:

Carvedilol tablets, USP are available as follows: 3.125 mg, white, oval shaped, film-coated tablets debossed with SZ on one side and 61 on the other side. NDC 0904-6300-61, unit dose box of 100 tablets 6.25 mg, white, oval shaped, film-coated tablets debossed with SZ on one side and 62 on the other side. NDC 0904-6301-61, unit dose box of 100 tablets 12.5 mg, white, oval shaped, film-coated tablets debossed with SZ on one side and 116 on the other side. NDC 0904-6302-61, unit dose of 100 tablets 25 mg, white, oval shaped, film-coated tablets debossed with SZ on one side and 117 on other side. NDC 0904-6303-61, unit dose box of 100 tablets Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container.

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

CARVEDILOL- CARVEDILOL TABLET, FILM COATED
MAJOR PHARMACEUTICALS
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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.
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:
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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 mg, 6.25 mg, 12.5 mg, 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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TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT SANDOZ INC. AT
1-800-525-8747 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 serious