METOPROLOL TARTRATE- 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:

Safecor Health, LLC

INN (International Name):

METOPROLOL TARTRATE

Composition:

METOPROLOL TARTRATE 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Metoprolol Tartrate Tablets USP are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents. Metoprolol Tartrate Tablets USP are indicated in the long-term treatment of angina pectoris. Metoprolol Tartrate Tablets USP are indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality when used alone or in conjunction with intravenous metoprolol tartrate. Oral metoprolol tartrate therapy can be initiated after intravenous metoprolol tartrate therapy or, alternatively, oral treatment can begin within 3 to 10 days of the acute event (see DOSAGE AND ADMINISTRATION , CONTRAINDICATIONS , and WARNINGS ). 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; hypersens

Product summary:

Metoprolol Tartrate Tablets USP are available as follows: 50 mg: Pink, round, biconvex, film coated tablets, scored in half on one side with the numbers "93" and "733" on each side of the score. Plain on the other side. Store at 20o to 25o C (68o to 77o F) [See USP Controlled Room Temperature]. Protect from moisture and heat. For Institutional Use Only KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. The drug product contained in this package is from NDC # 0093-0733 TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Packaged and Distributed by: SAFECOR HEALTH, LLC 317 New Boston Street Woburn, MA 01801 SAFECOR HEALTH, LLC 4060 Business Park Drive Columbus, OH 43204 Questions or Comments? Call 1-800-447-1006 Rev. 312-00 08/2014

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METOPROLOL TARTRATE- METOPROLOL TARTRATE TABLET, FILM COATED
SAFECOR HEALTH, LLC
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METOPROLOL TARTRATE TABLETS USP
RX ONLY
DESCRIPTION
Metoprolol tartrate, USP is a selective beta -adrenoreceptor blocking
agent, available as 50 and 100 mg
tablets for oral administration. Metoprolol tartrate, USP is
1-(isopropylamino)-3-[_p_-(2-methoxyethyl)
phenoxy]-2-propanol (2:1) _dextro_-tartrate salt, and its structural
formula is:
(C
H NO ) •C H O M.W. 684.82
Metoprolol tartrate, USP is a white, practically odorless, crystalline
powder. It is very soluble in water;
freely soluble in methylene chloride, in chloroform, and in alcohol;
slightly soluble in acetone; and
insoluble in ether.
Metoprolol Tartrate Tablets USP, for oral administration, contain 50
mg or 100 mg of metoprolol
tartrate, USP. In addition, each tablet contains the inactive
ingredients: colloidal silicon dioxide,
hypromellose, lactose monohydrate, magnesium stearate, polyethylene
glycol, povidone, propylene
glycol, sodium starch glycolate, talc, and titanium dioxide. The 50 mg
tablets contain D&C Red No. 30
Aluminum Lake, and the 100 mg tablets contain FD&C Blue No. 1 Lake and
FD&C Blue No. 2
Aluminum Lake.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Metoprolol tartrate is a beta -selective (cardioselective) adrenergic
receptor blocker. This preferential
effect is not absolute, however, and at higher plasma concentrations,
metoprolol tartrate also inhibits
beta -adrenoreceptors, chiefly located in the bronchial and vascular
musculature.
Clinical pharmacology studies have demonstrated the beta-blocking
activity of metoprolol, as shown by
(1) reduction in heart rate and cardiac output at rest and upon
exercise, (2) reduction of systolic blood
pressure upon exercise, (3) inhibition of isoproterenol-induced
tachycardia, and (4) reduction of reflex
orthostatic tachycardia.
HYPERTENS ION
The mechanism of the antihypertensive effects of beta-blocking agents
has not been fully elucidated.
However, several possible mechanisms have been proposed: (1)
competit