METOPROLOL TARTRATE tablet, film coated

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

PD-Rx Pharmaceuticals, Inc.

INN (Jina la Kimataifa):

METOPROLOL TARTRATE

Tungo:

METOPROLOL TARTRATE 50 mg

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

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

Bidhaa muhtasari:

Metoprolol Tartrate Tablets, USP 50 mg - round, scored pink tablets embossed with Watson 462 , supplied in bottles of 6 tablets. 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  FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

METOPROLOL TARTRATE- METOPROLOL TARTRATE TABLET, FILM COATED
PD-RX PHARMACEUTICALS, INC.
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METOPROLOL TARTRATE TABS
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 (especia