METOPROLOL TARTRATE tablet, film coated

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

NuCare Pharmaceuticals, Inc.

INN (Международно Name):

METOPROLOL TARTRATE

Композиция:

METOPROLOL TARTRATE 25 mg

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

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

Каталог на резюме:

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 30 NDC 68071-1288-3 Bottles of 60 NDC 68071-1288-6 Bottles of 90 NDC 68071-1288-9 Bottles of 180 NDC 68071-1288-8 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 Citron Pharma LLC. at 1-855-5-CITRON (1-855-524-8766) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch Distributed by: Citron Pharma LLC Suite - 1101 2 Tower Center Blvd East Brunswick NJ 08816 Code No.: DRUGS/AP/19/1993 Made in India Revised: 12/2015

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

METOPROLOL TARTRATE- METOPROLOL TARTRATE TABLET, FILM COATED
NUCARE PHARMACEUTICALS, INC.
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METOPROLOL TARTRATE TABLETS, USP
RX ONLY
DESCRIPTION
Metoprolol tartrate USP is a selective beta
-adrenoreceptor blocking agent, available as
25, 50 and 100 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, 50 mg or 100 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 and
100 mg tablet contains FD&C Blue #2 Aluminium Lake as coloring agents.
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.
1
1
2
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