METOPROLOL SUCCINATE tablet, extended release

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

PD-Rx Pharmaceuticals, Inc.

INN (Algemene Internationale Benaming):

METOPROLOL SUCCINATE

Samenstelling:

METOPROLOL TARTRATE 25 mg

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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

Product samenvatting:

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: Bottles of 30    NDC 43063-624-30 Bottles of 60    NDC 43063-624-60 Bottles of 90    NDC 43063-624-90 Store at 20°-25°C (68°-77°F); [See USP Controlled Room Temperature.]

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

METOPROLOL SUCCINATE- METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE
PD-RX PHARMACEUTICALS, INC.
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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
INDICATIONS AND USAGE
Metoprolol succinate extended-release tablets are a beta-adrenergic
blocker 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, to reduce the risk of cardiovascular mortality and
heart failure hospitalizations in patients
with heart failure. ( 1.3)
DOSAGE AND ADMINISTRATION
Administer once daily. Titrate at weekly or longer intervals as needed
and tolerated. ( 2)
Hypertension: Starting dose is 25 to 100 mg. ( 2.1)
Angina Pectoris: Starting dose is 100 mg. ( 2.2)
Heart Failure: Starting dose is 12.5 or 25 mg. ( 2.3)
Switching from immediate-release metoprolol to metoprolol succinate
extended-release tablets: use
the same total daily dose of metoprolol succinate extended-release
tablets. ( 2)
DOSAGE FORMS AND STRENGTHS
• Metoprolol succinate extended-release tablets: 25 mg and 50 mg.
(3)
CONTRAINDICATIONS
Known hypersensitivity to product components. (4)
Severe bradycardia: Greater than first degree heart block, or sick
sinus syndrome without a pacemaker.
(4)
Cardiogenic shock or decompensated heart failure (4)
WARNINGS AND PRECAUTIONS
Abrupt cessation may exacerbate myocardial ischemia. ( 5.1)
Heart Failure: Worsening cardiac failure may occur. (5.2)
Bronchospastic Disease: Avoid beta-blockers. (5.3)
Concomitant use of glycosides, clonidine, diltiazem and verapamil with
beta-blockers can increase the
risk of bradycardia. ( 5.4)
Pheochromocytoma: Initia