METOPROLOL TARTRATE- metoprolol tartrate tablet, film coated

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

NuCare Pharmaceuticals, Inc.

DCI (Dénomination commune internationale):

METOPROLOL TARTRATE

Composition:

METOPROLOL TARTRATE 50 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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 tablets are indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality when used alone or in conjunction with intravenous metoprolol. Oral Metoprolol tartrate tablets therapy can be initiated after intravenous metoprolol therapy or, alternatively, oral treatment can begin within 3 to 10 days of the acute event. (See DOSAGE AND ADMINISTRATION,  CONTRAINDICATIONS, and WARNINGS). Hypertension and Angina Metoprolol tartrate tablets are contraindicated in sinus bradycardia, heart block greater than first degree, cardiogenic shock, and over

Descriptif du produit:

The 50 mg tablets are film-coated, pink colored, round, biconvex tablets debossed with R 50 on one side and scored on the other side. NDC 68071-4307-3 Bottles of 30 NDC 68071-4307-6 Bottles of 60 NDC 68071-4307-9 Bottles of 90 NDC 68071-4307-2 Bottles of 120 NDC 68071-4307-8 Bottles of 180 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. To report SUSPECTED ADVERSE REACTIONS, contact Vensun Pharmaceuticals, Inc. at 1-800-385-1540 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured for: Vensun Pharmaceuticals, Inc. Yardley, PA 19067 Manufactured by: Rubicon Research Private Limited Ambernath, Dist: Thane, 421506, INDIA Rev. 01, January 2017

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

METOPROLOL TARTRATE - METOPROLOL TARTRATE TABLET, FILM COATED
NUCARE PHARMACEUTICALS, INC.
----------
METOPROLOL TARTRATE - METOPROLOL TARTRATE TABLET, FILM COATED
VENSUN PHARMACEUTICALS, INC.
R ONLY
DESCRIPTION
Metoprolol tartrate is a selective beta
-adrenoreceptor blocking agent, available as 25
mg, 50 mg, and 100 mg tablets for oral administration. Metoprolol
tartrate is (±)-1-
(isopropylamino)-3-[ _p_-2-methoxyethyl)phenoxy]-2-propanol (2:1)
_dextro_-tartrate salt.
Its structural formula is:
Metoprolol tartrate, USP is a white, 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.
Each tablet for oral administration contains 25 mg, 50 mg, or 100 mg
of metoprolol
tartrate and the following inactive ingredients: lactose monohydrate,
colloidal silicon
dioxide, hypromellose, magnesium stearate, microcrystalline cellulose,
polyethylene
glycol, titanium dioxide, sodium starch glycolate, talc and D & C Red
#30 Aluminium
Lake.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Metoprolol is a beta
-selective (cardioselective) adrenergic receptor blocker. This
preferential effect is not absolute, however, and at higher plasma
concentrations,
metoprolol also inhibits beta
adrenoreceptors, chiefly located in the bronchial and
vascular musculature.
Clinical pharmacology studies have demonstrated the beta-blocking
activity of
X
1
1
2
metoprolol, as shown by (1) reduction in heart rate and cardiac output
at rest and upon
exercise, (2) reduction of systolic blood pressure upon exercise, (3)
inhibition of
isoproterenol-induced tachycardia, and (4) reduction of reflex
orthostatic tachycardia.
_HYPERTENSION_
The mechanism of the antihypertensive effects of beta-blocking agents
has not been
fully elucidated. However, several possible mechanisms have been
proposed: (1)
competitive antagonism of catecholamines at peripheral (especially
cardiac) adrenergic
neuron sites, leading to decrease