METOPROLOL TARTRATE tablet, film coated METOPROLOL TARTRATE- 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:

Ranbaxy Pharmaceuticals Inc.

INN (International Name):

METOPROLOL TARTRATE

Composition:

METOPROLOL TARTRATE 25 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 is 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 tartrate. Oral metoprolol tartrate therapy can be initiated after intravenous metoprolol tartrate 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 is contraindicated in sinus bradycardia, heart block greater than first degree, cardiogenic shock, and overt cardiac failure (see WARNINGS). Hypersensitivity to metoprolol tartrate and related d

Product summary:

Metoprolol tartrate tablets, USP 25 mg are available as white to off-white, round, film-coated tablets, debossed with "RE " above the bisect and "79 " below the bisect on one side and plain on the other side. Bottles of 10                           NDC 63304-579-03 Bottles of 100                         NDC 63304-579-01 Bottles of 1000                       NDC 63304-579-10 Metoprolol tartrate tablets, USP 50 mg are available as pink colored, round, film-coated tablets debossed with "RE " above the bisect and "75 " below the bisect on one side and plain on the other side. Bottles of 10                           NDC 63304-580-03 Bottles of 100                         NDC 63304-580-01 Bottles of 1000                       NDC 63304-580-10 Metoprolol tartrate tablets, USP 100 mg are available as white to off-white, round, film-coated tablets, debossed with "RE " above the bisect and "76 " below the bisect on one side and plain on the other side. Bottles of 10                           NDC 63304-581-03 Bottles of 100                         NDC 63304-581-01 Bottles of 1000                       NDC 63304-581-10 Store at 20 - 25°C (68 - 77°F) [See USP Controlled Room Temperature]. Protect from moisture and heat. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. You may report side effects to FDA at 1-800-FDA 1088.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METOPROLOL TARTRATE- METOPROLOL TARTRATE TABLET, FILM COATED
RANBAXY PHARMACEUTICALS INC.
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METOPROLOL TARTRATE TABLETS,USP
RX ONLY
PRESCRIBING INFORMATION
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, and its
structural formula is
Metoprolol tartrate, USP is a white, practically odorless, crystalline
powder with a molecular weight
of 684.81. 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 USP and the
following inactive ingredients: colloidal silicon dioxide,
croscarmellose sodium, hypromellose,
lactose anhydrous, magnesium stearate, microcrystalline cellulose,
sodium starch glycolate,
polyethylene glycol, pregelatinized starch, titanium dioxide. In
addition the 25 MG and 100 MG tablet
contain propylene glycol and sodium lauryl sulfate; the 50 MG tablet
contains D&C Red #30 and talc.
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 tartrate 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 mecha