METOPROLOL TARTRATE tablet

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Contract Pharmacy Services-PA

DCI (Dénomination commune internationale):

METOPROLOL TARTRATE

Composition:

METOPROLOL TARTRATE 50 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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

Descriptif du produit:

Metoprolol Tartrate Tablets USP, 50 mg - 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 Blisterpacks of 30                                                      NDC 67046-474-30 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 the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch Manufactured for: Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32257 USA by: Ipca Laboratories Limited 48, Kandivli Ind. Estate, Mumbai 400 067, India March 2009                                                                              Repackaged by: Contract Pharmacy Services-PA 125 Titus Ave Suite 200 Warrington, PA 18976 USA Original--1/2011--NJW

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

METOPROLOL TARTRATE- METOPROLOL TARTRATE TABLET
CONTRACT PHARMACY SERVICES-PA
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METOPROLOL TARTRATE
_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 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.
_Inactive Ingredients._ Tablets contain anhydrous lactose,
microcrystalline cellulose, croscarmellose
sodium, D&C red No. 30, hypromellose, magnesium stearate, polyethylene
glycol, colloidal silicon
dioxide, sodium starch glycolate, corn starch, talc and titanium
dioxide.
CLINICAL PHARMACOLOGY
Metoprolol tartrate is a beta-adrenergic receptor blocking agent. _In
vitro_ and _in vivo_ animal studies have
shown th