METOPROLOL TARTRATE- metoprolol tablet

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Alembic Pharmaceuticals Limited

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

Hypertension Metoprolol tartrate tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents. Angina Pectoris Metoprolol tartrate tablets are indicated in the long-term treatment of angina pectoris. Myocardial Infarction Metoprolol tartrate tablets 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 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. Hypertension and Angina Metoprolol tartrate tablets are contraindicated in sinus bradycardia, heart block greater than first degree, cardiogenic shock, and overt cardiac failure (see WARNINGS). Hypersensitivity to metoprolol and related deriv

Ringkasan produk:

Metoprolol Tartrate Tablets, USP are available containing 25 mg, 50 mg or 100 mg of metoprolol tartrate, USP. The 25 mg tablets are white to off white film coated, round, biconvex tablets debossed with ‘L150’ on one side and breakline on other side. They are available as follows:   NDC 46708-290-30      bottles of 30 tablets NDC 46708-290-31      bottles of 100 tablets NDC 46708-290-71      bottles of 500 tablets NDC 46708-290-91      bottles of 1000 tablets NDC 46708-290-10      100 (10 x 10) Tablets Unit-dose blisters   The 50 mg tablets are pink, film coated, round, biconvex tablets debossed with ‘L151’ on one side and breakline on other side. They are available as follows: NDC 46708-291-30      bottles of 30 tablets NDC 46708-291-31      bottles of 100 tablets NDC 46708-291-91      bottles of 1000 tablets NDC 46708-291-10      100 (10 x 10) Tablets Unit-dose blisters   The 100 mg tablets are blue, film coated, round, biconvex tablets debossed with ‘L152’ on one side and breakline on other side. They are available as follows: NDC 46708-292-30      bottles of 30 tablets NDC 46708-292-31      bottles of 100 tablets NDC 46708-292-91      bottles of 1000 tablets NDC 46708-292-10      100 (10 x 10) Tablets Unit-dose blisters   Store at 20° to 25°C (68° to 77°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. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Alembic Pharmaceuticals Limited Manufactured in India Revised: 03/2023

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

METOPROLOL TARTRATE - METOPROLOL TABLET
ALEMBIC PHARMACEUTICALS LIMITED
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METOPROLOL TARTRATE TABLETS USP
RX ONLY
PRESCRIBING INFORMATION
DESCRIPTION
Metoprolol tartrate, USP is a selective beta1-adrenoreceptor blocking
agent, available as
25 mg, 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,
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 and the following inactive ingredients: microcrystalline
cellulose, lactose
monohydrate, povidone, croscarmellose sodium, colloidal silicon
dioxide, magnesium
stearate hypromellose, titanium dioxide and polyethylene glycol. In
addition, the 50 mg
product contains D&C Red No. 30 Aluminum Lake and the 100 mg product
contains
FD&C Blue No. 2 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake as
coloring
agents.
CLINICAL PHARMACOLOGY
_MECHANISM OF ACTION:_
Metoprolol tartrate is a beta1- selective (cardioselective) adrenergic
receptor blocker.
This preferential effect is not absolute, however, and at higher
plasma concentrations,
metoprolol also inhibits beta2- 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.
_Hypertension_
The mechanism of the antihypertensive effects of beta-blocking agents
has not been
fully elucidated.However, several possible mechanisms have been