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Indomethacin for Injection, USP

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Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

Indomethacin for Injection, USP Quick Finder

INDICATIONS AND USAGE

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...

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DOSAGE AND ADMINISTRATION

FOR INTRAVENOUS ADMINISTRATION ONLY.

Dosage recommendations for closure of the ductus arteriosus depend on the age of the infant at the time of therapy. A course of therapy is defined as...

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CONTRAINDICATIONS

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...

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WARNINGS

Gastrointestinal Effects

In the collaborative study, major gastrointestinal bleeding was no more common in those neonates receiving indomethacin than in...

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ADVERSE REACTIONS

In a double-blind, placebo-controlled trial of 405 premature infants weighing less than or equal to 1750 g with evidence of large ductal shunting, in those neonates treated with indomethacin (n=206),...

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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...

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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....

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HOW SUPPLIED

Sterile Indomethacin for Injection, USP is a lyophilized white to yellow powder or plug supplied as single use vials containing indomethacin sodium, USP equivalent to 1 mg indomethacin; 3 mg sodium citrate...

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