METOPROLOL TARTRATE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

METOPROLOL TARTRATE (UNII: W5S57Y3A5L) (METOPROLOL - UNII:GEB06NHM23)

Available from:

Legacy Pharmaceutical Packaging, LLC

INN (International Name):

METOPROLOL TARTRATE

Composition:

METOPROLOL TARTRATE 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Metoprolol tartrate tablets are indicated for the treatment of hypertension in adult patients, 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 summary:

Metoprolol Tartrate Tablets, USP are available as follows: Tablets 50 mg are pink round shaped, film coated tablets debossed with ‘C over 74’ on one side and deep break line on other side. Unit of Use Bottles of 60: 50mg (NDC 68645-190-59) Tablets 100 mg are light blue round shaped, film coated tablets debossed with ‘C over 75’ on one side and deep break line on other side. Unit of Use Bottles of 60: 100mg (NDC 68645-191-59) Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture and heat. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METOPROLOL TARTRATE- METOPROLOL TARTRATE TABLET, FILM COATED
LEGACY PHARMACEUTICAL PACKAGING, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
METOPROLOL TARTRATE
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
METOPROLOL TARTRATE
TABLETS.
METOPROLOL TARTRATE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1992
INDICATIONS AND USAGE
Metoprolol tartrate tablets are a beta-adrenergic blocker indicated
for the treatment of: (1)
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)
Myocardial Infarction, to reduce the risk of cardiovascular mortality
when used in conjunction with
intravenous metoprolol therapy in patients with definite or suspected
acute myocardial infarction in
hemodynamically stable patients (1.3)
DOSAGE AND ADMINISTRATION
Administer once daily with food or after a meal. Titrate at weekly or
longer intervals as needed and
tolerated. (2)
Hypertension: Recommended starting dosage is 100 mg daily, in single
or divided doses. (2.1)
Angina Pectoris: Recommended starting dosage is 100 mg daily, given as
two divided doses. (2.2)
Myocardial Infarction: The starting dosage depends upon tolerance of
intravenous metoprolol, see full
prescribing information. (2.3)
DOSAGE FORMS AND STRENGTHS
Metoprolol tartrate tablets, USP: 25 mg, 50 mg and 100 mg. (3) (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)
Pheochromocytoma: Initiate therapy with an alpha blocker. (5.4)
Major Sur