METOPROLOL SUCCINATE tablet, film coated, extended release

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

Cardinal Health

INN（国際名）:

METOPROLOL SUCCINATE

構図:

METOPROLOL TARTRATE 25 mg

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

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

製品概要:

Metoprolol Succinate Extended-Release Tablets, USP are available containing 23.75 mg, 47.5 mg or 95 mg of metoprolol succinate, USP equivalent to 25 mg, 50 mg or 100 mg of metoprolol tartrate, USP, respectively. The 25 mg tablets are white to off-white, film-coated, round, scored tablets debossed with M above the score on one side of the tablet and MT1 on the other side. They are available as follows: Overbagged with 10 tablets per bag, NDC 55154-4388-0 The 50 mg tablets are white to off-white, film-coated, oval, scored tablets debossed with M on one side of the score on one side of the tablet and MT2 on the other side. They are available as follows: Overbagged with 10 tablets per bag, NDC 55154-4385-0 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

認証ステータス:

Abbreviated New Drug Application

製品の特徴

METOPROLOL SUCCINATE- METOPROLOL SUCCINATE TABLET, FILM COATED,
EXTENDED RELEASE
CARDINAL HEALTH
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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, 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:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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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)
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 2 weeks to the highest dose tolerated
or up to 200 mg. ( 2.3)
Hypertension: Usual initial dosage is 25 mg 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 int