METOPROLOL SUCCINATE tablet, film coated, extended release

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

METOPROLOL SUCCINATE (UNII: TH25PD4CCB) (METOPROLOL - UNII:GEB06NHM23)

Sẵn có từ:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (Tên quốc tế):

METOPROLOL SUCCINATE

Thành phần:

METOPROLOL TARTRATE 25 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Metoprolol succinate extended-release tablets are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents [see Dosage and Administration (2)]. Metoprolol succinate extended-release tablets are indicated in the long-term treatment of angina pectoris, to reduce angina attacks and to improve exercise tolerance. Metoprolol succinate extended-release tablets are indicated for the treatment of stable, symptomatic (NYHA Class II or III) heart failure of ischemic, hypertensive, or cardiomyopathic origin. It was studied in patients already receiving ACE inhibitors, diuretics, and, in the majority of cases, digitalis. In this population, metoprolol succinate extended-release tablets decreased the rate of mortality plus hospitalization, largely through a reduction in cardiovascular mortality and hospitalizations for heart failure. Metoprolol succinate extended-release tablets are contraindicated in severe bradycardia, second or third degree heart block, card

Tóm tắt sản phẩm:

Tablets containing metoprolol succinate equivalent to the indicated weight of metoprolol tartrate, USP, are white, biconvex, film-coated, and scored.  *The 25 mg tablet is scored on both sides. Store at 20°-25°C (68°-77°F); [see USP Controlled Room Temperature].

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

METOPROLOL SUCCINATE- METOPROLOL SUCCINATE TABLET, FILM COATED,
EXTENDED RELEASE
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
METOPROLOL SUCCINATE EXTENDED-RELEASE
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
METOPROLOL SUCCINATE EXTENDED-RELEASE
TABLETS. METOPROLOL SUCCINATE EXTENDED-RELEASE TABLETS, USP FOR ORAL
USE. "INITIAL U.S. APPROVAL:1992
WARNING: ISCHEMIC HEART DISEASE
_(SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING)_
FOLLOWING ABRUPT CESSATION OF THERAPY WITH BETA-BLOCKING AGENTS,
EXACERBATIONS OF ANGINA PECTORIS AND
MYOCARDIAL INFARCTION HAVE OCCURRED. WARN PATIENTS AGAINST
INTERRUPTION OR DISCONTINUATION OF THERAPY
WITHOUT THE PHYSICIAN’S ADVICE. (5.1)
INDICATIONS AND USAGE
Metoprolol succinate, is a beta -selective adrenoceptor blocking
agent.
Metoprolol succinate extended-release tablets are indicated for the
treatment of: (1)
Hypertension (1.1)
Angina Pectoris (1.2)
Heart Failure - for the treatment of stable, symptomatic (NYHA Class
II or III) heart failure of ischemic, hypertensive,
or cardiomyopathic origin.(1.3)
DOSAGE AND ADMINISTRATION
Administer once daily. Dosing of metoprolol succinate extended-release
tablets should be individualized. (2)
Heart Failure: Recommended starting dose is 12.5 mg or 25 mg doubled
every two weeks to the highest dose tolerated
or up to 200 mg. (2.3)
Hypertension: Usual initial dosage is 25 to 100 mg once daily. The
dosage may be increased at weekly (or longer)
intervals until optimum blood pressure reduction is achieved. Dosages
above 400 mg per day have not been studied.
(2.1)
Angina Pectoris: Usual initial dosage is 100 mg once daily. Gradually
increase the dosage at weekly intervals until
optimum clinical response has been obtained or there is an
unacceptable bradycardia. Dosages above 400 mg per day
have not been studied. (2.2)
Switching from immediate release metoprolol to metoprolol succinate
extended-releas