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Metoprolol (Metoprolol Tartrate) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Myocardial Infarction

Metoprolol tartrate injection USP is indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality. Treatment with intravenous metoprolol tartrate injection USP can be initiated as soon as the patient’s clinical condition allows (see DOSAGE AND ADMINISTRATION, CONTRAINDICATIONS, and WARNINGS). Alternatively, treatment can begin within 3 to 10 days of the acute event (see DOSAGE AND ADMINISTRATION).

DOSAGE AND ADMINISTRATION

Myocardial Infarction

Early Treatment

During the early phase of definite or suspected acute myocardial infarction, treatment with metoprolol tartrate can be initiated as soon as possible after the patient’s arrival in the hospital. Such treatment should be initiated in a coronary care or similar unit immediately after the patient’s hemodynamic condition has stabilized.

Treatment in this early phase should begin with the intravenous administration of three bolus injections of 5 mg of metoprolol tartrate each; the injections should be given at approximately 2-minute intervals. During the intravenous administration of metoprolol tartrate, blood pressure, heart rate, and electrocardiogram should be carefully monitored.

In patients who tolerate the full intravenous dose (15 mg), metoprolol tartrate tablets, 50 mg every 6 hours, should be initiated 15 minutes after the last intravenous dose and continued for 48 hours. Thereafter, patients should receive a maintenance dosage of 100 mg twice daily (see Late Treatment below).

Patients who appear not to tolerate the full intravenous dose should be started on metoprolol tartrate tablets either 25 mg or 50 mg every 6 hours (depending on the degree of intolerance) 15 minutes after the last intravenous dose or as soon as their clinical condition allows. In patients with severe intolerance, treatment with metoprolol tartrate should be discontinued (see WARNINGS).


Late Treatment

Patients with contraindications to treatment during the early phase of suspected or definite myocardial infarction, patients who appear not to tolerate the full early treatment, and patients in whom the physician wishes to delay therapy for any other reason should be started on metoprolol tartrate tablets, 100 mg twice daily, as soon as their clinical condition allows. Therapy should be continued for at least 3 months. Although the efficacy of metoprolol tartrate beyond 3 months has not been conclusively established, data from studies with other beta-blockers suggest that treatment should be continued for 1 to 3 years.

Note 1

For further information on oral therapy continuation, please refer to the package insert of metoprolol tartrate tablets.

Note 2

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

HOW SUPPLIED

Metoprolol tartrate injection USP, 5 mg/5 mL (1 mg/mL)

NDC 0781-3071-95, 5 mL single use vials (each containing 5 mg of metoprolol tartrate), boxes of 10

Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature). Do not freeze. Protect from light. Retain in carton until time of use. DISCARD UNUSED PORTION.

10-2008M

D1006951

Manufactured in Canada by

Sandoz Canada Inc. for

Sandoz Inc., Princeton, NJ 08540

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