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:

McKesson Contract Packaging

INN (International Name):

METOPROLOL TARTRATE

Composition:

METOPROLOL TARTRATE 25 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METOPROLOL TARTRATE- METOPROLOL TARTRATE TABLET, FILM COATED
MCKESSON CONTRACT PACKAGING
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DESCRIPTION
Metoprolol tartrate, USP 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 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: anhydrous lactose, colloidal silicon
dioxide, croscarmellose sodium,
hypromellose, magnesium stearate, microcrystalline cellulose,
polydextrose, polyethylene glycol,
povidone, sodium lauryl sulfate, titanium dioxide and triacetin. In
addition, the 50 mg product contains
FD&C Blue No. 2 Aluminum Lake, D&C Red No. 27 Aluminum Lake and FD&C
Red No. 40 Aluminum
Lake and the 100 mg product contains FD&C Blue No. 2 Aluminum 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