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LOPRESSOR (METOPROLOL TARTRATE) TABLETS AND INJECTIONS: PRESCRIBING INFORMATION

DESCRIPTION

Lopressor (metoprolol tartrate) is a selective beta1-adrenoreceptor blocking agent, available as 50 mg and 100 mg tablets for oral administration and in 5 ml ampuls for intravenous administration. Each ampul contains a sterile solution of metoprolol tartrate 5 mg, sodium chloride 45 mg, and water for injection.

Metoprolol tartrate is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether.

Inactive Ingredients: Tablets contain cellulose compounds, colloidal silicon dioxide, D&C Red No. 30 aluminum lake (50-mg tablets), FD&C Blue No. 2 aluminum lake (100-mg tablets), lactose, magnesium stearate, polyethylene glycol, propylene glycol, povidone, sodium starch glycolate, talc, and titanium dioxide.


CLINICAL PHARMACOLOGY

Lopressor clinical pharmacology


PHARMACOKINETICS

Lopressor pharmacokinetics


INDICATIONS AND USAGE

Hypertension

Lopressor tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents.

Angina Pectoris

Lopressor is indicated in the long-term treatment of angina pectoris.

Myocardial Infarction

Lopressor tablets and injections are indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality.

Treatment with intravenous Lopressor can be initiated as soon as the patient's clinical condition allows. Alternatively, treatment can begin within 3 to 10 days of the acute event.


CONTRAINDICATIONS

Hypertension and Angina

Lopressor is contraindicated in sinus bradycardia, heart block greater than first degree, cardiogenic shock, and overt cardiac failure.

Hypersensitivity to Lopressor and related derivatives, or to any of the excipients; hypersensitivity to other beta blockers (cross sensitivity between beta blockers can occur).
Sick-sinus syndrome.
Severe peripheral arterial circulatory disorders.

Myocardial Infarction

Lopressor is contraindicated in patients with a heart rate < 45 beats/min; second- and third-degree heart block; significant first-degree heart block (P-R interval .0.24 sec); systolic blood pressure < 100 mmHg; or moderate-to-severe cardiac failure.


WARNINGS

Lopressor warnings


PRECAUTIONS

Lopressor precautions


DRUG INTERACTIONS

Lopressor drug interactions


USE IN SPECIAL POPULATIONS

Lopressor use in special populations


ADVERSE REACTIONS

Lopressor adverse reactions


OVERDOSAGE

Lopressor overdosage


DOSAGE AND ADMINISTRATION

Lopressor dosage and administration


HOW SUPPLIED

Lopressor Tablets
Metoprolol Tartrate tablets, USP

Tablets 50 mg capsule-shaped, biconvex, pink, scored (imprinted GEIGY on one side and 51 twice on the scored side).
Tablets 100 mg capsule-shaped, biconvex, light blue, scored (imprinted GEIGY on one side and 71 twice on the scored side).
Store at 25C (77F); excursions permitted to 15-30C (59-86F) [see USP Controlled Room Temperature]. Protect from moisture.
Dispense in tight, light-resistant container (USP).

Lopressor Injection
Metoprolol Tartrate injection, USP

Ampuls 5 ml each containing 5 mg of metoprolol tartrate.
Store at 25C (77F); excursions permitted to 15-30C (59-86F) [see USP Controlled Room Temperature]. Protect from light.

Lopressor tablets and injections are manufactured and distributed by Novartis pharmaceutical company.

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