METOPROLOL TARTRATE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Hospira, Inc.

INN (International Name):

METOPROLOL TARTRATE

Composition:

METOPROLOL TARTRATE 1 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Metoprolol tartrate injection is 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 tartrate maintenance therapy. Treatment with intravenous metoprolol tartrate can be initiated as soon as the patient's clinical condition allows (see DOSAGE AND ADMINISTRATION,  CONTRAINDICATIONS , and WARNINGS ). 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). Metoprolol tartrate 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 ).

Product summary:

Metoprolol Tartrate Injection, USP is available as: Instructions for Use of the Syringe Systems Instructions for using the Carpuject Syringe are available with the reusable Carpuject Holder, List 2049-02. 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. Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-1112-2.0 Revised: 2/2020

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METOPROLOL TARTRATE- METOPROLOL TARTRATE INJECTION, SOLUTION
HOSPIRA, INC.
----------
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 tartrate 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
1
15
25
3 2
4
6
6
1
2
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 lea