TOPROL XL- metoprolol succinate tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Aralez Pharmaceuticals US Inc.

INN (International Name):

METOPROLOL SUCCINATE

Composition:

METOPROLOL TARTRATE 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

TOPROL-XL is 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 classes and with different mechanisms

Product summary:

Tablets containing metoprolol succinate equivalent to the indicated weight of metoprolol tartrate, USP, are white, biconvex, film-coated, and scored. Tablet Shape Engraving Bottle of 100 NDC 70347- Bottle of 1000 NDC 70347- 25 mg Oval A/β 025-02 025-03 50 mg Round A/mo 050-02 050-03 100 mg Round A/ms 100-02 100-03 200 mg Oval A/mY 200-02 200-03 Store at 25°C (77°F). Excursions permitted to 15-30°C (59-86°F). (See USP Controlled Room Temperature.)

Authorization status:

New Drug Application

Summary of Product characteristics

TOPROL XL- METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE
ARALEZ PHARMACEUTICALS US INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TOPROL-XL SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TOPROL-XL.
TOPROL-XL (METOPROLOL SUCCINATE) TABLET, EXTENDED-RELEASE FOR ORAL USE
INITIAL U.S. APPROVAL: 1992
INDICATIONS AND USAGE
TOPROL-XL, metoprolol succinate, is 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 TOPROL-XL: use the same
total daily dose of TOPROL-
XL. (2)
DOSAGE FORMS AND STRENGTHS
•TOPROL-XL Extended-Release Tablets (metoprolol succinate): 25 mg,
50 mg, 100 mg, and 200 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: Initiate therapy with an alpha blocker. (5.5)
Major Surgery: Avoid initiation of high-dose extended-release
metoprolol in patients undergoing