METOPROLOL SUCCINATE- metoprolol succinate tablet, film coated, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NuCare Pharmaceuticals, Inc.

INN (International Name):

METOPROLOL SUCCINATE

Composition:

METOPROLOL TARTRATE 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Tablets containing metoprolol succinate equivalent to the indicated weight of metoprolol tartrate, USP, are white, coated, and scored. The 25 mg tablet is debossed with logo and M on one side and scored on both sides. Store at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature.]

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METOPROLOL SUCCINATE- METOPROLOL SUCCINATE TABLET, FILM COATED,
EXTENDED RELEASE
NUCARE PHARMACEUTICALS, 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, 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 beta1-selective adrenoceptor blocking agent.
Metoprolol succinate extended-release tablets USP 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
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
unaccept