METOPROLOL TARTRATE tablet

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

DIRECT RX

INN (Международно Name):

METOPROLOL TARTRATE

Композиция:

METOPROLOL TARTRATE 100 mg

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

INDICATIONS AND USAGE Hypertension Metoprolol tartrate tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents. Angina Pectoris Metoprolol tartrate tablets are indicated in the long-term treatment of angina pectoris. Myocardial Infarction 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). Hypertension and Angina Metoprolol tartrate is contraindicated in sinus bradycardia, heart block greater than first degree, cardiogenic shock, and overt cardiac failure

Каталог на резюме:

Metoprolol Tartrate Tablets USP, 50 mg - Round, white film coated tablets with “477” debossed on one side and scored on the other side Bottles of 100                                                      NDC 57664-477-52 Bottles of 1000                                                    NDC 57664-477-58 Metoprolol Tartrate Tablets USP, 50 mg - capsule-shaped, biconvex, white, scored (debossed 166) Bottles of 100                                                      NDC 57664-166-52 Bottles of 1000                                                    NDC 57664-166-58 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. Bottles of 90                                                         NDC 57664-162-59 Bottles of 100                                                       NDC 57664-162-52 Bottles of 1000                                                     NDC 57664-162-58 Metoprolol Tartrate Tablets USP, 100 mg - capsule-shaped, biconvex, white, scored (debossed 167) Bottles of 90                                                         NDC 57664-167-59 Bottles of 100                                                       NDC 57664-167-52 Bottles of 1000                                                     NDC 57664-167-58 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.: 5094T86 Detroit, MI 48202                                                                                                    Iss.: 02/13

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

METOPROLOL TARTRATE- METOPROLOL TARTRATE TABLET
DIRECT RX
----------
METOPROLOL TARTRATE
BOXED WARNING SECTION
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 SECTION
Metoprolol tartrate, USP is a selective beta1 -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:
[metoprolol-1]
Metoprolol tartrate 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,monohydrate, magnesium
stearate, microcrystalline cellulose,
polyethylene glycol, polysorbate, povidone, sodium starch glycolate,
talc and titanium dioxide.
CLINICAL PHARMACOLOGY SECTION
Mechanism of Action:
Metoprolol Tartrate is a beta1-selective (cardioselective) adrenergic
receptor blocker. This
preferential ef