METOPROLOL TARTRATE tablet, film coated

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

Physicians Total Care, Inc.

INN (Միջազգային անվանումը):

METOPROLOL TARTRATE

Կազմը:

METOPROLOL TARTRATE 25 mg

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

Metoprolol tartrate, USP is a selective beta1 -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 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.   The tablets contain the following inactive ingredients: microcrystalline cellulose, corn starch, sodium starch glycollate, colloidal silicon dioxide, sodium lauryl sulfate, talc, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol and polysorbate 80. In addition, 50 mg tablet contains D&C Red #30 Aluminium Lake and 100 mg tablet contains FD&C Blu

Ապրանքի ամփոփագիր:

Metoprolol Tartrate Tablets, USP are available as follows:   Tablets 25 mg are white round shaped, film coated tablets debossed with ‘C over 73’ on one side and deep break line on other side. Tablets 50 mg are pink round shaped, film coated tablets debossed with ‘C over 74’ on one side and deep break line on other side.   Tablets 100 mg are light blue round shaped, film coated tablets debossed with ‘C over 75’ on one side and deep break line on other side.   Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°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.   Manufactured for: Aurobindo Pharma USA, Inc. 2400 Route 130 North Dayton, NJ 08810 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 072, India Revised: 01/2009 Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, OK     74146

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Ապրանքի հատկությունները

METOPROLOL TARTRATE - METOPROLOL TARTRATE TABLET, FILM COATED
PHYSICIANS TOTAL CARE, INC.
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Ischemic Heart Disease
Following abrupt cessation of therapy with certain beta-blocking
agents, exacerbations of angina
pectoris and, in some cases, myocardial infarction have occurred. When
discontinuing
chronically administered metoprolol, particularly in patients with
ischemic heart disease, the
dosage should be gradually reduced over a period of 1 to 2 weeks and
the patient should be
carefully monitored. If angina markedly worsens or acute coronary
insufficiency develops,
metoprolol administration should be reinstated promptly, at least
temporarily, and other measures
appropriate for the management of unstable angina should be taken.
Patients should be warned
against interruption or discontinuation of therapy without the
physician's advice. Because
coronary artery disease is common and may be unrecognized, it may be
prudent not to discontinue
metoprolol therapy abruptly even in patients treated only for
hypertension.
Bronchospastic Diseases
PATIENTS WITH BRONCHOSPASTIC DISEASES SHOULD, IN GENERAL, NOT
RECEIVE BETA-BLOCKERS, including metoprolol. Because of its relative
beta1 selectivity,
however, metoprolol may be used with caution in patients with
bronchospastic disease who do
not respond to, or cannot tolerate, other antihypertensive treatment.
Since beta1 selectivity is not
absolute, a beta2-stimulating agent should be administered
concomitantly, and the lowest possible
dose of metoprolol tartrate should be used. In these circumstances it
would be prudent initially to
administer metoprolol in smaller doses three times daily, instead of
larger doses two times daily,
to avoid the higher plasma levels associated with the longer dosing
interval. (See DOSAGE
AND ADMINISTRATION.)
Major Surgery
The necessity or desirability of withdrawing beta-blocking therapy,
including metoprolol, prior
to major surgery is controversial; the impaired ability of the heart
to respond to reflex adrenergic
stimuli may augment the ri