METOPROLOL SUCCINATE tablet, extended release

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Aphena Pharma Solutions - Tennessee, LLC

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Metoprolol succinate is 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 classes and with differe

leaflet_short:

Tablets containing metoprolol succinate equivalent to the indicated weight of metoprolol tartrate, USP, are white, biconvex, film-coated, and scored. Tablet Shape Engraving Bottle of 100 NDC 50816- Bottle of 1000 NDC 50816- 25 mg Oval A/β 025-03 50 mg Round A/mo 050-03 100 mg Round A/ms 100-02 100-03 200 mg Oval A/my 200-02 200-03 Store at 25°C (77°F). Excursions permitted to 15-30°C (59- 86°F). (See USP Controlled Room Temperature.)

מצב אישור:

New Drug Application Authorized Generic

מאפייני מוצר

METOPROLOL SUCCINATE- METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
----------
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.
METOPROLOL SUCCINATE TABLET, EXTENDED-RELEASE FOR ORAL USE
INITIAL U.S. APPROVAL: 2006
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 is indicated for the treatment of:
•
•
•
DOSAGE AND ADMINISTRATION
•
•
•
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
•
•
•
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
1
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 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