METOPROLOL TARTRATE tablet, film coated

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Contract Pharmacy Services-PA

INN (International ime):

METOPROLOL TARTRATE

Sastav:

METOPROLOL TARTRATE 50 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Metoprolol tartrate tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents. Metoprolol tartrate is 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 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 ). 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 derivatives, or to

Proizvod sažetak:

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. NDC 67046-473-07 blisterpacks of 7 NDC 67046-473-14 blisterpacks of 14 NDC 67046-473-15 blisterpacks of 15 NDC 67046-473-20 blisterpacks of 20 NDC 67046-473-21 blisterpacks of 21 NDC 67046-473-28 blisterpacks of 28 NDC 67046-473-30 blisterpacks of 30 NDC 67046-473-60 blisterpacks of 60 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. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Manufactured for: Ingenus Pharmaceuticals, LLC 4190 Millenia Boulevard Orlando, FL 32839-6408 Customer complaint toll free number : 877-748-1970 by: Ipca Laboratories Limited 48, Kandivli Ind. Estate, Mumbai 400 067, India July 2013

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

METOPROLOL TARTRATE- METOPROLOL TARTRATE TABLET, FILM COATED
CONTRACT PHARMACY SERVICES-PA
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473 METOPROLOL 50 MG
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. 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, and 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 beta1-selective (cardioselective) adrenergic
receptor blocker. This preferential
effect is not absolute, however, and at higher plasma concentrations,
metaprolol tartrate also inhibits
beta2-adrenorecepttors, chiefly located in the bronchial and vascular
musculature.
Clinical pharmacology studies have confirmed 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