METOPROLOL SUCCINATE tablet, film coated, extended release

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Mylan Institutional Inc.

INN (Διεθνής Όνομα):

METOPROLOL SUCCINATE

Σύνθεση:

METOPROLOL TARTRATE 25 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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

Περίληψη προϊόντος:

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: NDC 51079-169-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). 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: NDC 51079-170-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). The 100 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 MT3 on the other side. They are available as follows: NDC 51079-171-03 – Unit dose blister packages of 30 (5 cards of 6 tablets each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

METOPROLOL SUCCINATE- METOPROLOL SUCCINATE TABLET, FILM COATED,
EXTENDED
RELEASE
MYLAN INSTITUTIONAL INC.
----------
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:
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 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
intervals until optimum clinical response has been obtained or there
is an unacceptable bradycardia.
D