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Indomethacin for Injection, USP Dosage and Administration

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 three intravenous doses of indomethacin for injection given at 12 to 24 hour intervals, with careful attention to urinary output. If anuria or marked oliguria (urinary output <0.6 mL/kg/hr) is evident at the scheduled time of the second or third dose of indomethacin for injection, no additional doses should be given until laboratory studies indicate that renal function has returned to normal (see WARNINGS, Renal Effects).

Dosage according to age is as follows:

AGE at 1st dose

DOSAGE (mg/kg)

 
Less than 48 hours

1st
0.2

2nd
0.1

3rd
0.1

2 to 7 days

0.2

0.2

0.2

Over 7 days

0.2

0.25

0.25

If the ductus arteriosus closes or is significantly reduced in size after an interval of 48 hours or more from completion of the first course of indomethacin for injection, no further doses are necessary. If the ductus arteriosus re-opens, a second course of 1 to 3 doses may be given, each dose separated by a 12 to 24 hour interval as described above.

If the neonate remains unresponsive to therapy with indomethacin for injection after 2 courses, surgery may be necessary for closure of the ductus arteriosus. If severe adverse reactions occur, STOP THE DRUG.

Directions For Use

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

The reconstituted solution is clear, slightly yellow and essentially free from visible particles.

The solution should be prepared only with 1 to 2 mL of preservative-free Sterile Sodium Chloride Injection, 0.9 percent or preservative-free Sterile Water for Injection. Benzyl alcohol as a preservative has been associated with toxicity in neonates. Therefore, all diluents should be preservative-free. If 1 mL of diluent is used, the concentration of indomethacin in the solution will equal approximately 0.1 mg/0.1 mL; if 2 mL of diluent are used, the concentration of the solution will equal approximately 0.05 mg/0.1 mL. Any unused portion of the solution should be discarded because there is no preservative contained in the vial. A fresh solution should be prepared just prior to each administration. Once reconstituted, the indomethacin solution may be injected intravenously. While the optimal rate of injection has not been established, published literature suggests an infusion rate over 20 to 30 minutes.

Further dilution with intravenous infusion solutions is not recommended.

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