METOPROLOL TARTRATE tablet, film coated

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

State of Florida DOH Central Pharmacy

INN (Algemene Internationale Benaming):

METOPROLOL TARTRATE

Samenstelling:

METOPROLOL TARTRATE 25 mg

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Metoprolol tartrate tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents. Metoprolol tartrate tablets are indicated in the long-term treatment of angina pectoris. Metoprolol tartrate tablets are indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality. Treatment with intravenous metoprolol can be initiated as soon as the patient’s clinical condition allows (see DOSAGE AND ADMINISTRATION, CONTRAINDICATIONS, and WARNINGS). Alternatively, treatment can begin within 3 to 10 days of the acute event (see DOSAGE AND ADMINISTRATION). 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 derivatives, or to any of the excipients; hypersensitivity to other beta-blockers (cross-sensitivity bet

Product samenvatting:

Metoprolol Tartrate Tablets, USP are available containing 25 mg, 50 mg or 100 mg of metoprolol tartrate, USP. The 25 mg tablets are white film-coated, round, scored tablets debossed with M over 18 on one side of the tablet and scored on the other side. The 50 mg tablets are pink film-coated, round, scored tablets debossed with M over 32 on one side of the tablet and scored on the other side. The 100 mg tablets are light blue film-coated, round, scored tablets debossed with M over 47 on one side of the tablet and scored on the other side. They are supplied by State of Florida DOH Central Pharmacy as follows: 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 Mylan Pharmaceuticals Inc. Toll free at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . Mylan Pharmaceuticals Inc. Morgantown, WV 26505 This Product was Repackaged By: State of Florida DOH Central Pharmacy 104-2 Hamilton Park Drive Tallahassee, FL 32304 United States

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

METOPROLOL TARTRATE - METOPROLOL TARTRATE TABLET, FILM COATED
STATE OF FLORIDA DOH CENTRAL PHARMACY
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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 confir