METOPROLOL TARTRATE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Rubicon Research Private Limited

INN (International Name):

METOPROLOL TARTRATE

Composition:

METOPROLOL TARTRATE 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 tartrate tablets 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 de

Product summary:

Metoprolol tartrate tablets USP are available containing 25 mg, 50 mg or 100 mg of metoprolol tartrate USP. The 25 mg tablets are film-coated, round, biconvex, pink, scored (debossed with R 25 on one side and scored on the other side). Bottles of 100 ……NDC 49930-001-01 Bottles of 1000 …..NDC 49930-001-02 The 50 mg tablets are film-coated, round, biconvex, pink, scored (debossed with R 50 on one side and scored on the other side). Bottles of 100 ……NDC 49930-002-01 Bottles of 1000 …..NDC 49930-002-02 The 100 mg tablets are film-coated, round, biconvex, pink, scored (debossed with R 100 on one side and scored on the other side). Bottles of 100 ……NDC 49930-003-01 Bottles of 1000 …..NDC 49930-003-02 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. To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured by: Rubicon Research Private Limited Ambernath, Dist: Thane, 421506, INDIA Revised: 11/2014

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METOPROLOL TARTRATE - METOPROLOL TARTRATE TABLET, FILM COATED
RUBICON RESEARCH PRIVATE LIMITED
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METOPROLOL TARTRATE - METOPROLOL TARTRATE TABLET, FILM COATED
RUBICON RESEARCH PRIVATE LIMITED
DESCRIPTION
Metoprolol tartrate is a selective beta -adrenoreceptor blocking
agent, available as 25 mg, 50 mg 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, 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: Lactose Monohydrate; Colloidal Silicon
Dioxide; Hypromellose;
Magnesium Stearate; Microcrystalline Cellulose; Polyethylene glycol;
Titanium Dioxide; Sodium
Starch Glycolate; Talc and D and C Red #30 Aluminium Lake.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Metoprolol 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 (especially cardiac) adrenergic neuron
sites, leading to decreased cardiac