METOPROLOL TARTRATE - metoprolol tartrate tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Bryant Ranch Prepack

INN (International Name):

METOPROLOL TARTRATE

Composition:

METOPROLOL TARTRATE 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Metoprolol Tartrate Tablets USP, 25 mg - White, circular, film coated tablets debossed with “1” on one side and plain on the other side Bottles of 30                                                       NDC 57664-506-54 Bottles of 90                                                       NDC 57664-506-59 Bottles of 100                                                     NDC 57664-506-52 Bottles of 1000                                                   NDC 57664-506-58 Samples, when available, are identified by the word SAMPLE appearing on each bottle. 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                                                                                                          C.S. No.: 5094T84 Detroit, MI 48202                                                                                                                        Iss.: 04/11

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METOPROLOL TARTRATE - METOPROLOL TARTRATE TABLET
BRYANT RANCH PREPACK
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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.
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 colloidal silicon dioxide,
hydroxypropyl methylcellulose, lactose
monohydrate, magnesium stearate, microcrystalline cellulose,
polyethylene glycol, polysorbate,
povidone, sodium starch glycolate, talc and titanium dioxide.
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