CARVEDILOL- carvedilol tablet, film coated

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

NCS HealthCare of KY, Inc dba Vangard Labs

INN（国际名称）:

CARVEDILOL

组成:

CARVEDILOL 3.125 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

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(14.1) ] . Carvedilol is indicated for the management of essential hypertension [ see CLINICAL STUDIES (14.2, 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: - Bronchial asthma or related bronchospastic conditions. Deaths from status asthmaticus have been reported following single doses of carvedilol - Second- or third-degree AV block - Sick sinus syndrome - Severe bradycardia (unless a permanent pacemaker is in place) - Patients with cardiogenic shock or who have decompensated heart failure requiring the use of intravenous inotropic therapy. Such patients should first be weaned fro

產品總結:

Carvedilol tablets 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 0615-6583-39, blisterpacks of 30 tablets NDC 0615-6583-30, boxes of 30 tablets for unit-dose dispensing. 6.25 mg, white, oval shaped, film-coated tablets debossed with SZ on one side and 62 on the other side. NDC 0615-6584-39, blisterpacks of 30 tablets NDC 0615-6584-30, unit-dose boxes of 30 tablets 12.5 mg, white, oval shaped, film-coated tablets debossed with SZ on one side and 116 on the other side. NDC 0615-6585-39, blisterpacks of 30 tablets NDC 0615-6585-30, boxes of 30 tablets for unit-dose dispensing. 25 mg, white, oval shaped, film-coated tablets debossed with SZ on one side and 117 on other side. NDC 0615-6586-39, blisterpacks of 30 tablets NDC 0615-6586-30, boxes of 30 tablets for unit-dose dispensing. Store at 20º-25ºC (68º-77ºF) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container.

授权状态:

Abbreviated New Drug Application

产品特点

CARVEDILOL- CARVEDILOL TABLET, FILM COATED
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
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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 TABLETS, USP.
CARVEDILOL TABLETS, USP FILM COATED FOR ORAL USE
INITIAL U.S. APPROVAL: 1995
RECENT MAJOR CHANGES
Warnings and Precautions, Major Surgery (5.9) Oct 2010
Warnings and Precautions, Intraoperative Floppy Iris Syndrome (5.14)
Jan 2011
INDICATIONS AND USAGE
Carvedilol is an alpha/beta-adrenergic blocking agent indicated for
the treatment of:
Left ventricular dysfunction following myocardial infarction in
clinically stable patients (1.1)
Hypertension (1.2)
DOSAGE AND ADMINISTRATION
Take with food. Individualize dosage and monitor during up-titration.
(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)
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 a permanent pacemaker is 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
any component of this medication or other medications containing
carvedilol. (4)
WARNINGS AND PRECAUTIONS
Acute exacerbation of coronary artery disease upon cessation of
therapy: Do not abruptly discontinue. (5.1 )
Bradycardia, hypotension, worsening heart failure/flui