METOPROLOL TARTRATE- metoprolol tartrate injection, solution

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Cardinal Health

Antoreitti:

INTRAVENOUS

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Myocardial Infarction Metoprolol tartrate injection is 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 ). Hypersensitivity to metoprolol tartrate and related derivatives, or to any of the excipients; hypersensitivity to other beta-blockers (cross sensitivity between beta-blockers can occur). Myocardial Infarction 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 ).

Tuoteyhteenveto:

Metoprolol Tartrate Injection, USP is available as: NDC Container Concentration Fill Quantity 0409-1778-35 CarpujectTM with Luer Lock 1 mg/mL 5 mL 3 cartridges per carton 0409-2285-05 Ampul 1 mg/mL 5 mL 3 ampuls per carton Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Do not freeze. PROTECT FROM LIGHT . Retain in carton until time of use. Discard unused portion. Revised: 05/2013                                                                              EN-3286 Hospira, Inc., Lake Forest, IL 60045 USA Cardinal Health Zanesville, OH 43701 IA6623 0714

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

METOPROLOL TARTRATE- METOPROLOL TARTRATE INJECTION, SOLUTION
CARDINAL HEALTH
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METOPROLOL TARTRATE
Injection, USP
Rx only
PRESCRIBING INFORMATION
DESCRIPTION
Metoprolol tartrate injection, USP is a sterile solution containing
metoprolol tartrate, a selective beta -
adrenoreceptor blocking agent, available in 5 mL ampuls and 5 mL
Carpuject
sterile cartridge units,
for intravenous administration. Each ampul and Carpuject
sterile cartridge unit, contains a sterile
solution of metoprolol tartrate USP, 5 mg and sodium chloride USP, 45
mg. 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
684.83. Its molecular formula is (C
H NO ) • C H O . 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 tartrate 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.
HYPERTENS ION
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 outflo