CARVEDILOL- carvedilol tablet, film coated

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Sun Pharmaceutical Industries, Inc.

INN (שם בינלאומי):

CARVEDILOL

הרכב:

CARVEDILOL 3.125 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Carvedilol is 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) and Clinical Studies (14.1)] . Carvedilol is 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 is 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: - Bronchial asthma or related bronchospastic conditions. Deaths from status asthmaticus have been reported follo

leaflet_short:

Carvedilol Tablets USP, 3.125 mg are available in the following form: White colored, film coated, oval, biconvex tablets, debossed with “242” on one side and plain on the other side. Bottle of 100 NDC 57664-242-88 Bottle of 500 NDC 57664-242-13 Bottle of 1000 NDC 57664-242-18 Carvedilol Tablets USP, 6.25 mg are available in the following form: White colored, film coated, oval, biconvex tablets, debossed with “244” on one side and plain on the other side. Bottle of 100 NDC 57664-244-88 Bottle of 500 NDC 57664-244-13 Bottle of 1000 NDC 57664-244-18 Carvedilol Tablets USP, 12.5 mg are available in the following form: White colored, film coated, oval, biconvex tablets, debossed with “245” on one side and plain on the other side. Bottle of 100 NDC 57664-245-88 Bottle of 500 NDC 57664-245-13 Bottle of 1000 NDC 57664-245-18 Carvedilol Tablets USP, 25 mg are available in the following form: White colored, film coated, oval, biconvex tablets, debossed with “247” on one side and plain on the other side. Bottle of 100 NDC 57664-247-88 Bottle of 500 NDC 57664-247-13 Bottle of 1000 NDC 57664-247-18 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.

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

CARVEDILOL- CARVEDILOL TABLET, FILM COATED
SUN PHARMACEUTICAL INDUSTRIES, INC.
REFERENCE LABEL SET ID: CEE9BCE2-ADD0-48E8-80C6-EA2183EE7698
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
CARVEDILOL - CARVEDILOL TABLET
SUN PHARMACEUTICAL INDUSTRIES, INC.
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CARVEDILOL TABLETS SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR CARVEDILOL TABLETS, USP.
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: ( 1)
• Mild to severe chronic heart failure ( 1.1)
• Left ventricular dysfunction following myocardial infarction in
clinically stable patients ( 1.2)
• Hypertension ( 1.3)
DOSAGE AND ADMINISTRATION
Take with food. Individualize dosage and monitor during up-titration.
( 2)
• Heart failure: Start at 3.125 mg twice daily and increase to 6.25,
12.5, 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)
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 hep