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:

Blenheim Pharmacal, Inc.

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. Treatment with intravenous metoprolol 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 ). Metoprolol tartrate tablets are contraindicated in sinus bradycardia, heart block greater than first degree, cardiogenic shock, and overt cardiac failure (see WARNINGS ). Hypersensitvity

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.                      Bottles of 100         NDC 59762-1300-1 (Child Resistant Closure)                      Bottles of 1000       NDC 59762-1300-3 (Non Child Resistant Closure) 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.                      Bottles of 100         NDC 59762-1301-1 (Child Resistant Closure)                      Bottles of 1000       NDC 59762-1301-3 (Non Child Resistant Closure) Tablets 100 mg are light blue round shaped, film coated tablets debossed with ‘C over 75’ on one side and deep break line on other side.                     Bottles of 100         NDC 59762-1302-1 (Child Resistant Closure)                     Bottles of 1000       NDC 59762-1302-3 (Non Child Resistant Closure) 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. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. To report SUSPECTED ADVERSE REACTIONS, contact Greenstone LLC at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch GREENSTONE® BRAND Distributed by: Greenstone LLC Peacpack, NJ 07977 Code No.: DRUGS/AP/19/1993 Revised: 02/2013

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METOPROLOL TARTRATE- METOPROLOL TARTRATE TABLET, FILM COATED
BLENHEIM PHARMACAL, INC.
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METOPROLOL TARTRATE TABLETS, USP
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.
However, several possible mechanisms have been proposed: (1)
competitive antagonism of
catecholamines at peripheral (especially cardiac) adrenergic neuron
sites, leading to decreased cardiac
output; (2) a central effect leading to reduced sympathetic outflow to
the periphery; and (3) suppression
of renin activity.
Angina Pectoris
By blocking catecholamine-induced increases in heart rate, in velocity
and extent of myocardial
contraction, and in blood pressure, metoprolol reduces the oxygen
requirements of the heart at any
given level of effort, thus making it useful in the long-term
management of angina pectoris.
Myocardial Infarction
The precise mechanism of action of metoprolol in patients with
suspected or definite myocardial
infarction is not known.
PHARMACODYNAMICS
Relative beta
selectivity is demonstrated by the following: (1) In healthy subjects,
metoprolol is unable
to reverse the beta
-mediated vasodilating effects of epinephrine. This contrasts with the
effect of
nonselective (beta
plus beta
) beta-blockers, which completely reverse the vasodilating effects of
epinephrine. (2) In asthmatic patients, metoprolol redu