METOPROLOL SUCCINATE tablet, extended release

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Medsource Pharmaceuticals

INN (الاسم الدولي):

METOPROLOL SUCCINATE

تركيب:

METOPROLOL TARTRATE 50 mg

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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

ملخص المنتج:

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, 60, 100, 500 and unit dose packages of 100 (10x10). Bottles of 30                                                                              NDC 55111-466-30 Bottles of 60                                                                              NDC 55111-466-60 Bottles of 100                                                                            NDC 55111-466-01 Bottles of 500                                                                            NDC 55111-466-05 Unit dose packages of 100 (10x10)                                            NDC 55111-466-78 Metoprolol succinate extended-release tablets USP, 50 mg are white to off-white, round shaped, film-coated tablets, debossed with  “M” and “2” separated by breakline on one side and plain on other side. They are supplied in bottles of 30, 60, 100, 500 and unit dose packages of 100 (10x10). Bottles of 30                                                                              NDC 55111-467-30 Bottles of 60                                                                              NDC 55111-467-60 Bottles of 100                                                                            NDC 55111-467-01 Bottles of 500                                                                            NDC 55111-467-05 Unit dose packages of 100 (10x10)                                            NDC 55111-467-78   Store at 20°-25°C (68°-77°F); [See USP Controlled Room Temperature.]

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

METOPROLOL SUCCINATE- METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE
MEDSOURCE PHARMACEUTICALS
----------
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 interval