METOPROLOL SUCCINATE tablet, extended release

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Major Pharmaceuticals

INN (Nama Internasional):

METOPROLOL SUCCINATE

Komposisi:

METOPROLOL TARTRATE 100 mg

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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

Ringkasan produk:

Metoprolol succinate extended-release tablets USP, 100 mg are white to off-white, round shaped, film-coated tablets, debossed with “M” and “3” 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). Cartons of 100 tablets (10 tablets each blister pack x 10), NDC 0904-6324-61  Store at 20°-25°C (68°-77°F); [See USP Controlled Room Temperature.]

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

METOPROLOL SUCCINATE- METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE
MAJOR PHARMACEUTICALS
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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, metoprolol succinate,
is a beta-adrenergic blocker
indicated for the treatment of:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
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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)
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 mg 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)
Metoprolol succinate extended-release tablets: 100 mg and 200 mg. (3)
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)
Abrupt cessation may exacerbate myocardial ischemia. (5)
Heart Failure: Worsening cardiac failure may occur. (5.2)
Bronchospastic Disease: Avoid beta-blockers. (5.3)
Concomitant use of glycosides, clonidine, and diltia