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:

Cambridge Therapeutics Technologies, LLC

INN (International Name):

METOPROLOL TARTRATE

Composition:

METOPROLOL TARTRATE 25 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. Oral metoprolol tartrate tablets, USP therapy can be initiated after intravenous metoprolol 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 tablets are contraindicated in sinus bradycardia, heart block greater than first degree, cardiogenic shock, and overt cardiac failure (see WARNINGS ). Hypersensitivity to metoprolol and related derivatives, or to any of the excipients; hyper

Product summary:

Metoprolol Tartrate Tablets, USP are available as follows:   Tablets 25 mg are white round shaped, film coated tablets debossed with ‘C over 73’ on one side and deep break line on other side.                NDC 70882-132-60, Unit of Use Bottles of 60 Tablets                Tablets 50 mg are pink round shaped, film coated tablets debossed with ‘C over 74’ on one side and deep break line on other side.                NDC 70882-133-60, Unit of Use Bottles of 60 Tablets                Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature] . Protect from moisture and heat. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. To report SUSPECTED ADVERSE REACTIONS, contact Cambridge Therapeutic Technologies at 1-844-810-0004 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch   Manufactured by: Aurobindo Pharma Limited Hyderabad-500 090, India Distributed by Cambridge Therapeutic Technologies, LLC Teaneck, NJ 07666 Packaged by Legacy Pharmaceutical Packaging, LLC Earth City, MO 63045 Revised: 10/2017 20733

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METOPROLOL TARTRATE- METOPROLOL TARTRATE TABLET, FILM COATED
CAMBRIDGE THERAPEUTICS TECHNOLOGIES, LLC
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METOPROLOL TARTRATE TABLETS, USP
RX ONLY
DESCRIPTION
Metoprolol tartrate USP is a selective beta -adrenoreceptor blocking
agent, available as 25 and 50
mg tablets for oral administration. Metoprolol tartrate is
(±)-1-(isopropylamino)-3-[_p_-(2-
methoxyethyl)phenoxy]-2-propanol (2:1) _dextro_-tartrate salt. Its
structural formula is:
Metoprolol tartrate USP 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.
Each tablet for oral administration contains 25 mg or 50 mg of
metoprolol tartrate.
The tablets contain the following inactive ingredients:
microcrystalline cellulose, corn starch, sodium
starch glycollate, colloidal silicon dioxide, sodium lauryl sulfate,
talc, magnesium stearate,
hypromellose, titanium dioxide, polyethylene glycol and polysorbate
80. In addition, 50 mg tablet
contains D&C Red #30 Aluminium 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 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.
Hypertension
The mechanism of the antihypertensive effects of beta-blocking agents
has not been fully elucidated.
1
1
2
However, several possible mechanisms have been proposed: (1)
competitive antagonism of
catecholamines at peripheral (especially cardia