METOPROLOL TARTRATE- metoprolol tartrate tablet, film coated

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Aurolife Pharma LLC

INN (Међународно име):

METOPROLOL TARTRATE

Састав:

METOPROLOL TARTRATE 25 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Metoprolol tartrate tablets are indicated in the long-term treatment of angina pectoris. Metoprolol tartrate tablets 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). Hypersensitvity 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 circulatory disorders. Metoprolol tartrate tablets are contraindicated in patients with a heart rate < 45 beats/min; second- and third-degree heart block; significant first-degree heart block (P-R interval ≥ 0.24 sec); systolic blood pressure <

Резиме производа:

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. 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. 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. 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. Issued: 07/2010

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

METOPROLOL TARTRATE - METOPROLOL TARTRATE TABLET, FILM COATED
AUROLIFE PHARMA LLC
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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 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 glycolate, 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
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 vasodi