INDOMETHACIN injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

INDOMETHACIN SODIUM (UNII: 0IMX38M2GG) (INDOMETHACIN - UNII:XXE1CET956)

Available from:

Hospira, Inc.

INN (International Name):

INDOMETHACIN SODIUM

Composition:

INDOMETHACIN 1 mg

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Indomethacin for injection is indicated to close a hemodynamically significant patent ductus arteriosus in premature infants weighing between 500 and 1750 g when after 48 hours usual medical management (e.g., fluid restriction, diuretics, digitalis, respiratory support, etc.) is ineffective. Clear-cut clinical evidence of a hemodynamically significant patent ductus arteriosus should be present, such as respiratory distress, a continuous murmur, a hyperactive precordium, cardiomegaly and pulmonary plethora on chest x-ray. Indomethacin for injection is contraindicated in: neonates with proven or suspected infection that is untreated; neonates who are bleeding, especially those with active intracranial hemorrhage or gastrointestinal bleeding; neonates with thrombocytopenia; neonates with coagulation defects; neonates with or who are suspected of having necrotizing enterocolitis; neonates with significant impairment of renal function; neonates with congenital heart disease in whom patency of the ductus arteriosus

Product summary:

Sterile Indomethacin for Injection, USP is a lyophilized white to yellow powder or plug supplied as single-dose vials containing indomethacin sodium, USP equivalent to 1 mg indomethacin; 3 mg sodium citrate dihydrate, USP and 0.13 mg citric acid anhydrous, USP. Storage Store at 20° to 25°C (68° to 77°F). [See USP controlled room temperature.] Protect from light . Store container in carton until contents have been used. Manufactured by: Gland Pharma Limited Hyderabad 500043, India Manufactured for:     Hospira, Inc. Lake Forest, IL  60045 USA LAB-1393-1.0 Revised: 07/2021

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

INDOMETHACIN- INDOMETHACIN INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
HOSPIRA, INC.
----------
STERILE
INDOMETHACIN FOR INJECTION, USP
RX ONLY
DESCRIPTION
Sterile Indomethacin for Injection, USP for intravenous administration
is lyophilized
indomethacin for injection. Each vial of indomethacin for injection
contains indomethacin
sodium, USP equivalent to 1 mg indomethacin; 3 mg sodium citrate
dihydrate, USP and
0.13 mg citric acid anhydrous, USP as a white to yellow lyophilized
powder or plug.
Variations in the size of the lyophilized plug and the intensity of
color have no
relationship to the quality or amount of indomethacin present in the
vial.
Indomethacin for injection is designated chemically as
1-(4-chlorobenzoyl)-5-methoxy-2-
methyl-1_H_-indole-3-acetic acid, sodium salt, trihydrate. Its
molecular weight is 433.82.
Its empirical formula is C
H
ClNNaO •3H O and its structural formula is:
CLINICAL PHARMACOLOGY
Although the exact mechanism of action through which indomethacin
causes closure of
a patent ductus arteriosus is not known, it is believed to be through
inhibition of
prostaglandin synthesis. Indomethacin has been shown to be a potent
inhibitor of
prostaglandin synthesis, both _in vitro_ and _in vivo._ In human
newborns with certain
congenital heart malformations, PGE 1 dilates the ductus arteriosus.
In fetal and
newborn lambs, E type prostaglandins have also been shown to maintain
the patency of
the ductus, and as in human newborns, indomethacin causes its
constriction.
Studies in healthy young animals and in premature infants with patent
ductus arteriosus
indicated that, after the first dose of intravenous indomethacin,
there was a transient
reduction in cerebral blood flow velocity and cerebral blood flow.
Similar decreases in
mesenteric blood flow and velocity have been observed. The clinical
significance of these
effects has not been established.
In double-blind, placebo-controlled studies of indomethacin for
injection in 460 small pre-
term infants, weighing 1750 g or less, the neonates tre