METOPROLOL TARTRATE tablet, film coated

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

STAT RX USA LLC

ИНН (Международная Имя):

METOPROLOL TARTRATE

состав:

METOPROLOL TARTRATE 50 mg

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Metoprolol tartrate tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents. Metoprolol tartrate tablets are indicated in the long-term treatment of angina pectoris. Metoprolol tartrate tablets and injection 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 (seeDOSAGE AND ADMINISTRATION ,CONTRAINDICATIONS , andWARNINGS ). Alternatively, treatment can begin within 3 to 10 days of the acute event (seeDOSAGE AND ADMINISTRATION ). Metoprolol tartrate is contraindicated in sinus bradycardia, heart block greater than first degree, cardiogenic shock, and overt cardiac failure (seeWARNINGS ). Hypersensitivity to metoprolol and related derivatives, or to any of the excipients; hypersensitivity to other beta-blockers (cross s

Обзор продуктов:

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°-25°C (68°-77°F). [See USP controlled room temperature.] Do not store above 30°C (86°F). Dispense in a tight, light-resistant container (USP). Protect from moisture. Manufactured By: Watson Pharma Private Limited Verna, Salcette Goa 403 722 INDIA Distributed By: Watson Pharma, Inc. Corona, CA 92880 USA Revised: December 2008                        1208B                                                                  174366

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

METOPROLOL TARTRATE - METOPROLOL TARTRATE TABLET, FILM COATED
STAT RX USA LLC
----------
METOPROLOL TARTRATE TABLETS USP
REVISED: DECEMBER 2008
RX ONLY
174366
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:
(C
H NO ) •C H 0
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
Metoprolol tartrate is a beta-adrenergic receptor blocking agent. _In
vitro _and _in vivo _animal studies have
shown that it has a preferential effect on beta adrenoreceptors,
chiefly located in cardiac muscle. This
preferential effect is not absolute, however, and at higher doses,
metoprolol also inhibits beta
adrenoreceptors, chiefly located in the bronchial and vascular
musculature.
Clinical pharmacology studies have confirmed the beta-blocking
activity of metoprolol in man, 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.
Relative beta selectivity has been confirmed by the following: (1) In
normal subjects, metoprolol is
unable to reverse the beta -mediated vasodilating effects