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Dose and administration
|1st dose:||200 micrograms/kg as IV infusion by syringe pump over 30 minutes.|
|Subsequent doses:||100 micrograms/kg/dose every 24 hours for a further 5 doses.|
Closure of persistent patent ductus arteriosus.
Contraindications and precautions
- Anuria or oliguria (<0.5-1.0ml/kg/hour).
- Serum creatinine >150 micromol/L.
- Thrombocytopenia <80 x 109/L.
- Bleeding phenomena.
- Necrotising enterocolitis.
Indomethacin, an indole derivative, is one of the most potent inhibitors of the cyclo-oxygenase pathway. Inhibits the action of prostaglandin synthetase, and thus inhibits the synthesis of the prostaglandin E series. Indomethacin is a potent vasoconstrictor and decreases cerebral, gastrointestinal, and renal blood flow.
Very variable absorption from gastrointestinal tract (10-90%). Indomethacin solutions very susceptible to chemical decomposition. High binding (95%) to human plasma protein. No displacement of bilirubin from albumin at usual therapeutic levels. Hepatic metabolism, elimination via biliary tract and kidneys. Elimination half-life is approximately 30 hours (range 15-50 hours). Individual differences in rate of distribution, drug metabolism, rate of renal and biliary excretion, and re-entry of drug into the circulation by enterohepatic recirculation all contribute to the variability in plasma clearance.
Possible adverse effects
- Renal impairment
- Gastrointestinal dysfunction (abdominal distension, gastrointestinal bleeding, necrotising enterocolitis, gastric perforation, gastric ulceration).
- Platelet dysfunction and bleeding tendency.
- Rapid infusions of intravenous indomethacin have been associated with significant reductions in cerebral blood flow.
- Careful monitoring of gastrointestinal and renal status is required during a course of therapy.
Management of Indomethacin administration
Pale yellow powder for reconstitution 1 mg/vial. Reconstituted solution is clear. For IV use only.
Is charted on prescription chart in micrograms/dose.
Slow IV Infusion
- Reconstitution (no powder displacement).
Reconstitute with 2 ml water or 0.9% NaCl to make 1000 micrograms/2ml (=500 micrograms/ml).
This will allow extra volume for ease of administration.
- Do NOT further dilute as indomethacin becomes very unstable.
- Draw up into 1ml syringe.
- Administer by slow IV infusion over 30 minutes using a syringe pump. Filter prior to administration through a 5 micron filter.
- Is compatible with 0.9% NaCl and water only.
- Do NOT mix with other drugs, IV solutions, blood or blood products.
- Ensure the dead space in the IV tubing is considered when administering the very small volumes of indomethacin.
- Flush with 0.9% NaCl before and after administration of indomethacin.
Observation and documentation
- Assess for signs of adverse effects.
- Maintain strict fluid balance. Report urinary output of<1-2 ml/kg/hour to doctor / NS-ANP.
- Perform urinalysis 8 hourly for blood, specific gravity and protein.
- Observe for evidence of bleeding.
- Assess for signs and symptoms of PDA. Auscultate for PDA closure.
- Monitor blood pressure at least 4 hourly.
- At room temperature <30° C until reconstitution.
- Protect from light.
- Reconstituted solution not suitable for storage.
- Douidar SM, Richardson J, Snodgrass WR. Role of indomethacin in ductus closure: An update evaluation. Dev Pharmacol Ther 1988; 11:196-212.
- Hammerman C, Aramburo MJ. Prolonged indomethacin therapy for the prevention of recurrences of patent ductus arteriosus. J Pediatr 1990; 117:771-6.
- Shar N, Lindstrom DP, Cotton RB. Effect of slow infusion of indomethacin on cerebral blood flow in premature infants. Pediatr Res 1990; 27:225A.
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- Date last published: 27 September 2007
- Document type: Drug Dosage Guideline
- Services responsible: ADHB Pharmacy, Neonatology
- Editor: Sarah Bellhouse
- Review frequency: 2 years