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Basic Drug Info
Drug Name:Metoprolol Tartrate
Manufacturer:Sandoz Inc.
Other Info:

10-2008MD1006951Manufactured in Canada bySandoz Canada Inc.

forSandoz Inc., Princeton, NJ 08540



Clinical Trials:


Indications and Usage

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).
Acute myocardial infarction --

Contraindications
Metoprolol tartrate is contraindicated in sinus bradycardia, heart block greater than first degree, cardiogenic shock, and overt cardiac failure (see WARNINGS).Hypersensitivity to metoprolol tartrate 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.Pheochromocytoma (see WARNINGS).
Sinus bradycardia -- A heart rate of less than 60 beats per minute, with its origin in the sinus node. (NCI)

Heart Block -- Impaired conduction of cardiac impulse that can occur anywhere along the conduction pathway, such as between the SINOATRIAL NODE and the right atrium (SA block) or between atria and ventricles (AV block). Heart blocks can be classified by the duration, frequency, or completeness of conduction block. Reversibility depends on the degree of structural or functional defects.

Cardiogenic shock -- Shock resulting from diminution of cardiac output in heart disease.

Heart failure -- inability of the heart to pump blood at an adequate rate to fill tissue metabolic requirements or the ability to do so only at an elevated filling pressure.

Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Sick Sinus Syndrome -- A condition caused by dysfunctions related to the SINOATRIAL NODE including impulse generation (CARDIAC SINUS ARREST) and impulse conduction (SINOATRIAL EXIT BLOCK). It is characterized by persistent BRADYCARDIA, chronic ATRIAL FIBRILLATION, and failure to resume sinus rhythm following CARDIOVERSION. This syndrome can be congenital or acquired, particularly after surgical correction for heart defects.

Unspecified circulatory system disorder --

Pheochromocytoma -- A usually benign, well-encapsulated, lobular, vascular tumor of chromaffin tissue of the ADRENAL MEDULLA or sympathetic paraganglia. The cardinal symptom, reflecting the increased secretion of EPINEPHRINE and NOREPINEPHRINE, is HYPERTENSION, which may be persistent or intermittent. During severe attacks, there may be HEADACHE; SWEATING, palpitation, apprehension, TREMOR; PALLOR or FLUSHING of the face, NAUSEA and VOMITING, pain in the CHEST and ABDOMEN, and paresthesias of the extremities. The incidence of malignancy is as low as 5% but the pathologic distinction between benign and malignant pheochromocytomas is not clear. (Dorland, 27th ed; DeVita Jr et al., Cancer: Principles & Practice of Oncology, 3d ed, p1298)

Warnings

Sympathetic stimulation is a vital component supporting circulatory function in congestive heart failure, and beta blockade carries the potential hazard of further depressing myocardial contractility and precipitating more severe failure.

In hypertensive and angina patients who have congestive heart failure controlled by digitalis and diuretics, metoprolol tartrate should be administered cautiously.
Branded Drugs
The following US Branded drugs contain Metoprolol Tartrate


LOPRESSIDONE -- NOVARTIS PHARMACEUTICALS CORP

LOPRESSOR HCT -- NOVARTIS PHARMACEUTICALS CORP

METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE -- MYLAN PHARMACEUTICALS INC

LOPRESSOR -- NOVARTIS PHARMACEUTICALS CORP


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