METOPROLOL SUCCINATE tablet, film coated, extended release

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

Physicians Total Care, Inc.

INN:

METOPROLOL SUCCINATE

composition:

METOPROLOL TARTRATE 25 mg

administration_route:

ORAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

Metoprolol succinate extended-release tablets USP 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 USP are indicated in the long-term treatment of angina pectoris, to reduce angina attacks and to improve exercise tolerance. Metoprolol succinate extended-release tablets USP 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 USP decreased the rate of mortality plus hospitalization, largely through a reduction in cardiovascular mortality and hospitalizations for heart failure. Metoprolol succinate extended-release is contraindicated in severe bradycardia, second or third degree heart blo

leaflet_short:

Metoprolol Succinate Extended-Release Tablets USP, containing metoprolol succinate equivalent to the indicated weight of metoprolol tartrate USP, are available as: 25 mg: White, oval-shaped, biconvex, film-coated tablet debossed “E” over “ 281” on one side and scored on the other side and supplied as: 50 mg: White, capsule-shaped, biconvex, film-coated tablet debossed “E 282” on one side and scored on the other side and supplied as: 100 mg: White, capsule-shaped, biconvex, film-coated tablet debossed “E 283” on one side and scored on the other side and supplied as: 200 mg: White, oval-shaped, biconvex, film-coated tablet debossed “E 284” on one side and scored on the other side and supplied as: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

authorization_status:

Abbreviated New Drug Application

SPC

METOPROLOL SUCCINATE - METOPROLOL SUCCINATE TABLET, FILM COATED,
EXTENDED RELEASE
PHYSICIANS TOTAL CARE, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
METOPROLOL SUCCINATE EXTENDED-RELEASE
TABLETS USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR METOPROLOL SUCCINATE EXTENDED-
RELEASE TABLETS USP.
METOPROLOL SUCCINATE EXTENDED-RELEASE TABLETS USP
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 extended-release tablets USP, metoprolol
succinate, is a beta -selective adrenoceptor blocking agent.
Metoprolol succinate extended-release tablets USP are indicated for
the treatment of:
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 metopro