METOPROLOL TARTRATE tablet

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Quality Care Products, LLC

INN (Kansainvälinen yleisnimi):

METOPROLOL TARTRATE

Koostumus:

METOPROLOL TARTRATE 100 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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

Tuoteyhteenveto:

Metoprolol Tartrate Tablets USP, 50 mg - Round, white film coated tablets with “477” debossed on one side and scored on the other side Metoprolol Tartrate Tablets USP, 50 mg - capsule-shaped, biconvex, white, scored (debossed 166) Metoprolol Tartrate Tablets USP, 100 mg - round-shaped, film coated, white colored tablets debossed with ‘162’ on one side and ‘scored’ on the other side. Metoprolol Tartrate Tablets USP, 100 mg - capsule-shaped, biconvex, white, scored (debossed 167) 35356-782-90 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.: 5094T86 Detroit, MI 48202                                                                                                    Iss.: 02/13

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

METOPROLOL TARTRATE- METOPROLOL TARTRATE TABLET
QUALITY CARE PRODUCTS, 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
1
15
25
3 2
4
6
6
dioxide.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION:
Metoprolol Tartrate is a beta -selective (cardioselective) adrenergic