Indomethacin
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From MedlinePlus, U.S. National Library of Medicine
Nonsteroidal Anti-inflammatory Drug
Dosing in kidney impairment
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, do not give additional doses until laboratory studies indicate that renal function has returned to normal 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, do not give additional doses until laboratory studies indicate that renal function has returned to normal [see Warnings and Precautions] .
Dosage according to age is as follows: [See table below.] 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.
Preparation and administration
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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. 2.1 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, pH 6.0 to 7.5, is clear, slightly yellow and essentially free from visible particles. Prepare the solution 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, do not use diluents that contain preservatives. 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. Discard any unused portion of the solution as it does not contain a preservative.
Prepare a fresh solution 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.
Drug interactions
Check indomethacin against a medication listLabel text (7 paragraphs)
As renal function may be reduced by Indomethacin for Injection, consider reducing the dosage of those medications that rely on adequate renal function for their elimination. • When used concomitantly with digoxin, monitor neonates for the development of digoxin toxicity. ( 7.1 ) • Monitor prothrombin time when indomethacin is added to anticoagulants. ( 7.2 )
7.1 Digoxin Because the half-life of digoxin (given frequently to pre-term infants with patent ductus arteriosus and associated cardiac failure) may be prolonged when given concomitantly with indomethacin, observe neonates receiving concomitant digoxin closely; frequent ECGs and serum digoxin levels may be required to prevent or detect digoxin toxicity early.
7.2 Anticoagulants Indomethacin usually does not influence the hypoprothrombinemia produced by anticoagulants. When indomethacin is added to anticoagulants, monitor prothrombin time closely. In post-marketing experience, bleeding has been reported in patients on concomitant treatment with anticoagulants and Indomethacin for Injection.
7.3 Furosemide Therapy with indomethacin may blunt the natriuretic effect of furosemide. This response has been attributed to inhibition of prostaglandin synthesis by non-steroidal anti-inflammatory drugs. In a study of 19 premature infants with patent ductus arteriosus treated with either Indomethacin for Injection alone or a combination of Indomethacin for Injection and furosemide, results showed that neonates receiving both Indomethacin for Injection and furosemide had significantly higher urinary output, higher levels of sodium and chloride excretion, and higher glomerular filtration rates than did those receiving Indomethacin for Injection alone.
In this study, therapy with furosemide helped to maintain renal function in the premature infant when Indomethacin for Injection was added.
7.4 Aminoglycosides In one study of premature infants treated with Indomethacin for Injection and also receiving either gentamicin or amikacin, both peak and trough levels of these aminoglycosides were significantly elevated.
7.5 Drugs that Act on the Renin-Angiotensin System In some patients with compromised renal function, the co-administration of an NSAID and an ACE inhibitor or angiotensin II antagonist may result in further deterioration of renal function, including possible acute renal failure, which is usually reversible.
Contraindications
Indomethacin for Injection is contraindicated in neonates: • With proven or suspected infection that is untreated • Who are bleeding, especially those with active intracranial hemorrhage or gastrointestinal bleeding • With thrombocytopenia or coagulation defects • With or who are suspected of having necrotizing enterocolitis • With significant impairment of renal function • With congenital heart disease in whom patency of the ductus arteriosus is necessary for satisfactory pulmonary or systemic blood flow (e.g., pulmonary atresia, severe tetralogy of Fallot, severe coarctation of the aorta).
Indomethacin for Injection is contraindicated in neonates: • With proven or suspected infection that is untreated • Who are bleeding, especially those with active intracranial hemorrhage or gastrointestinal bleeding • With thrombocytopenia or coagulation defects • Suspected of having necrotizing enterocolitis • With significant impairment of renal function • With congenital heart disease in whom patency of the ductus arteriosus is necessary for satisfactory pulmonary or systemic blood flow. ( 4 )
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