METOPROLOL SUCCINATE tablet, extended release

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

NuCare Pharmaceuticals, Inc.

INN (Medzinárodný Name):

METOPROLOL SUCCINATE

Zloženie:

METOPROLOL TARTRATE 25 mg

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Metoprolol succinate extended-release tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including metoprolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic

Prehľad produktov:

Metoprolol succinate extended-release tablets USP, 25 mg are white to off-white, oval shaped, film-coated tablets, debossed with “M” and “1” separated by breakline on one side and breakline on other side. They are supplied in bottles of 30 NDC 68071-2191-3 bottles of 60 NDC 68071-2191-6 bottles of 90 NDC 68071-2191-9 Store at 20°-25°C (68°-77°F); [See USP Controlled Room Temperature.]

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

METOPROLOL SUCCINATE- METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE
NUCARE PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
METOPROLOL SUCCINATE
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)
RECENT MAJOR CHANGES
Indications and Usage: Benefits of lowering blood pressure (1)
10/2012
INDICATIONS AND USAGE
Metoprolol succinate extended-release tablets, metoprolol succinate,
is a beta
-selective adrenoceptor
blocking agent.
Metoprolol succinate extended-release tablets are indicated for the
treatment of:
Hypertension, to lower blood pressure. Lowering blood pressure reduces
the risk of fatal and non-fatal
cardiovascular events, primarily strokes and myocardial infarctions. (
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
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
inte