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:

Aphena Pharma Solutions - Tennessee, LLC

INN (International Name):

METOPROLOL SUCCINATE

Composition:

METOPROLOL TARTRATE 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Metoprolol succinate extended-release tablets USP are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents [see Dosage and Administration (2) ] . Metoprolol succinate extended-release tablets USP are indicated in the long-term treatment of angina pectoris, to reduce angina attacks and to improve exercise tolerance. Metoprolol succinate extended-release tablets USP are indicated for the treatment of stable, symptomatic (NYHA Class II or III) heart failure of ischemic, hypertensive, or cardiomyopathic origin. It was studied in patients already receiving ACE inhibitors, diuretics, and, in the majority of cases, digitalis. In this population, metoprolol succinate extended-release tablets decreased the rate of mortality plus hospitalization, largely through a reduction in cardiovascular mortality and hospitalizations for heart failure. Metoprolol succinate extended-release is contraindicated in severe bradycardia, second or third degree heart block

Product summary:

Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. Tablets containing metoprolol succinate equivalent to the indicated weight of metoprolol tartrate, USP, are white, coated, and scored. a The 25 mg tablet is debossed with  and M on one side and scored on both sides. b The 50 mg tablet is debossed with 831 on one side and scored on the other side. c The 100 mg tablet is debossed with 832 on one side and scored on the other side. d The 200 mg tablet is debossed with 833 on the score side and plain on the other side. 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
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
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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
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 (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
unacceptable bradycardia. Dosages above 400 mg per day
have not been studied. (2.2)
Switching from immediate release metoprolol to metoprolol succinate
extended-release tablets: