METOPROLOL TARTRATE injection, solution

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

metoprolol tartrate (UNII: W5S57Y3A5L) (metoprolol - UNII:GEB06NHM23)

Fáanlegur frá:

Alvogen Inc.

INN (Alþjóðlegt nafn):

metoprolol tartrate

Samsetning:

metoprolol tartrate 5 mg in 5 mL

Stjórnsýsluleið:

INTRAVENOUS

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Metoprolol tartrate injection, USP vials are indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality when used in conjunction with oral metoprolol maintenance therapy. Treatment with intravenous metoprolol can be initiated as soon as the patient's clinical condition allows (see DOSAGE AND ADMINISTRATION, CONTRAINDICATIONS , and WARNINGS ). Hypersensitivity to metoprolol and related derivatives, or to any of the excipients; hypersensitivity to other beta blockers (cross sensitivity between beta blockers can occur). Metoprolol is contraindicated in patients with a heart rate <45 beats/min; second- and third-degree heart block; significant first-degree heart block (P-R interval ≥0.24 sec); systolic blood pressure <100 mmHg; or moderate-to-severe cardiac failure (see WARNINGS ).

Vörulýsing:

Metoprolol Tartrate Injection, USP is supplied as follows: Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] Protect from light and heat. Do not freeze. Retain in carton until time of use. To report SUSPECTED ADVERSE REACTIONS, contact Alvogen, Inc. at 1-866-770-3024 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch Product of Spain Manufactured by: Gland Pharma Limited D.P.Pally, Dundigal Post, Hyderabad-500 043, INDIA Distributed by: Alvogen, Inc. Pine Brook, NJ 07058 USA Revised: August 2017 PI587-00

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

METOPROLOL TARTRATE- METOPROLOL TARTRATE INJECTION, SOLUTION
ALVOGEN INC.
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METOPROLOL TARTRATE INJECTION, USP
DESCRIPTION
Metoprolol tartrate USP, is a selective beta -adrenoreceptor blocking
agent, available in 5-mL vials for
intravenous administration. Each vial contains a sterile solution of
metoprolol tartrate USP, 5 mg, and
sodium chloride USP, 45 mg, and water for injection USP.
Metoprolol tartrate USP is
(±)-1-(Isopropylamino)-3-[_p_-(2-methoxyethyl)phenoxy]-2-propanol L-
(+)-
tartrate (2:1) 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.
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 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) suppression
of renin activity.
Angina Pectoris
By blocking catecholamine-induced increases in heart rate, in velocity
and extent of myocardial
1
1
2
contraction, and in blood pres