METOPROLOL TARTRATE tablet

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Blenheim Pharmacal, Inc.

INN (الاسم الدولي):

METOPROLOL TARTRATE

تركيب:

METOPROLOL TARTRATE 50 mg

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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 injection and 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 tartrate 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 is 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 (cr

ملخص المنتج:

Metoprolol Tartrate Tablets USP, 50 mg - capsule-shaped, biconvex, white, scored (debossed 166) Bottles of 30   NDC 10544-124-30 Bottles of 90   NDC 10544-124-90 Metoprolol Tartrate Tablets USP, 100 mg - capsule-shaped, biconvex, white, scored (debossed 167) Bottles of 90    NDC 10544-553-90 Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Dispense in tight, light-resistant container (USP). Protect from Moisture. To report SUSPECTED ADVERSE REACTIONS, contact Caraco Pharmaceutical Laboratories, Ltd. at 1-800-818-4555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch Manufactured by: Sun Pharmaceutical Industries Dadra 396 191, India Distributed by: Caraco Pharmaceutical Laboratories, Ltd. 1150 Elijah McCoy Drive                                                                                         Detroit, MI 48202                                                                                                     Marketed/ Packaged by: Blenheim Pharmacal, Inc. North Blenheim, NY 12131, (USA) C.S.No.: 5094T86 Iss.: 02/13

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

METOPROLOL TARTRATE- METOPROLOL TARTRATE TABLET
BLENHEIM PHARMACAL, INC.
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METOPROLOL TARTRATE TABLETS, USP
RX ONLY
_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.
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:
(C
H NO ) • C H O
Metoprolol tartare, USP 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.
_Inactive Ingredients._ Tablets contain colloidal silicon dioxide,
hydroxypropyl methylcellulose, lactose
monohydrate, magnesium stearate, microcrystalline cellulose,
polyethylene glycol, polysorbate,
povidone, sodium starch glycolate, talc and titanium dioxide.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION:
Metoprolol Tartrate is a beta -selective (cardioselective) adrenergic
receptor blocker. Th