METOPROLOL TARTRATE tablet

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Safecor Health, LLC

INN (nemzetközi neve):

METOPROLOL TARTRATE

Összetétel:

METOPROLOL TARTRATE 25 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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

Termék összefoglaló:

Metoprolol Tartrate Tablets USP, 25 mg - White, circular, film coated tablets debossed with “1” on one side and plain on the other side Boxes of 100 Robot-Rx®1 Unit Dose Pouches                       NDC 48433-313-01 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. Packaging meets USP specifications for light resistance. For institutional use only. To report SUSPECTED ADVERSE REACTIONS, contact Safecor Health, LLC at 1-800-447-1006 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch The product contained in this package is from NDC # 57664-506 Detroit, MI 48202 Packaged and Distributed by: SAFECOR HEALTH, LLC 317 New Boston Street Woburn, MA 01801 SAFECOR HEALTH, LLC 4060 Business Park Drive Columbus, OH 43204 Questions or Comments? Call 1-800-447-1006. Rev: 313-00 08/2014

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

METOPROLOL TARTRATE- METOPROLOL TARTRATE TABLET
SAFECOR HEALTH, LLC
----------
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 beta1-selective (cardioselective) adrenergic
receptor blocker. This
p