METOPROLOL TARTRATE- metoprolol tartrate tablet

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Preferred Pharmaceuticals, Inc.

INN (Medzinárodný Name):

METOPROLOL TARTRATE

Zloženie:

METOPROLOL TARTRATE 25 mg

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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 tartrate. Oral metoprolol tartrate therapy can be initiated after intravenous metoprolol tartrate therapy, or alternatively, oral treatment can begin within 3 to 10 days of acute event( see DOSAGE AND ADMINISTRATION, CONTRAINDICATIONS, and WARNINGS) . Hypertension and Angina 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

Prehľad produktov:

Metoprolol Tartrate Tablets USP, 25 mg - White, circular, film coated tablets debossed with "1" on one side and plain on the other side; Bottle of 30 – 68788-9286-3 Bottle of 60 – 68788-9286-6 Bottle of 90 – 68788-9286-9 Bottle of 100 - 68788-9286-1 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 Sun Pharmaceutical Industries, Inc. at 1-800-818-4555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India. 5094T89 Iss: 07/15 Repackaged By: Preferred Pharmaceuticals Inc.

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

METOPROLOL TARTRATE- METOPROLOL TARTRATE TABLET
PREFERRED PHARMACEUTICALS, INC.
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METOPROLOL TARTRATE TABLETS, USP
RX ONLY
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:
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, 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
preferential effect is not absolute, however, and at higher plasma
concentrations, Metoprolol Tartrate
also inhibits beta2-adrenoreceptors, chiefly located in the bronchial
and vascular musculature.
Clinical pharmacology studies have demonstrated the beta-blocking
activity of 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 decreased cardiac
output; (2) a central effect leading to reduced sympathetic outflow to
the periphery; and (3) suppressio