METOPROLOL TARTRATE tablet, film coated

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

METOPROLOL TARTRATE (UNII: W5S57Y3A5L) (METOPROLOL - UNII:GEB06NHM23)

Dostupno od:

Actavis Pharma, Inc.

INN (International ime):

METOPROLOL TARTRATE

Sastav:

METOPROLOL TARTRATE 50 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

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 tartrate can be initiated as soon as the patient’s clinical condition allows (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 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 circulato

Proizvod sažetak:

Metoprolol Tartrate Tablets, USP 50 mg - round, scored pink tablets embossed with Watson 462 , supplied in bottles of 100 and 1000. Metoprolol Tartrate Tablets, USP 100 mg - round, scored light blue tablets embossed with Watson 463 , supplied in bottles of 100 and 1000. Store at 20° to 25°C (68° to  77°F) [See USP Controlled Room Temperature]. Protect from moisture. Do not store above 30°C (86°F). Dispense in a tight, light-resistant container (USP).                                              To report SUSPECTED ADVERSE REACTIONS, contact Actavis at 1-800-272-5525 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch Manufactured by: Watson Pharma Private Limited Verna, Salcette Goa 403 722 INDIA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Revised:  October 2014

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

METOPROLOL TARTRATE- METOPROLOL TARTRATE TABLET, FILM COATED
ACTAVIS PHARMA, INC.
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METOPROLOL TARTRATE TABLETS A074217
METOPROLOL TARTRATE TABLETS, USP
Revised: October 2014
RX ONLY
DESCRIPTION
Metoprolol tartrate, USP, is a selective beta -adrenoreceptor blocking
agent, available as 50 mg and
100 mg tablets for oral administration. Metoprolol tartrate, USP is
(±)-1-(Isopropylamino)-3-[_p_-(2-
methoxyethyl)phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and 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.
_Inactive Ingredients:_ Tablets contain lactose anhydrous,
microcrystalline cellulose, sodium starch
glycolate, talc, povidone, magnesium stearate, hydroxypropyl
methylcellulose, titanium dioxide,
polyethylene glycol, and polysorbate 80. The 50 mg dosage strength
also contains D&C Red No. 30
aluminum lake and the 100 mg dosage strength also contains 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 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 (espe