Indomethacin warnings

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Indomethacin Warnings: Key Considerations and Risks

Central Nervous System (CNS) Effects and Mental Alertness

Indomethacin, a nonsteroidal anti-inflammatory drug (NSAID), has been associated with various central nervous system (CNS) side effects. These include decreased mental alertness and motor coordination, which are critical for activities such as driving. However, a placebo-controlled study found no significant differences in motor coordination, obstacle avoidance, or cognitive task performance between indomethacin and placebo groups, suggesting that the cautionary warnings might not be necessary for all patients.

Gastrointestinal and Dermatological Side Effects

Indomethacin can cause significant gastrointestinal (GI) side effects, such as ulcers and bleeding, which are common among NSAIDs. Additionally, dermatological reactions like rashes, urticaria, and purpura have been reported. These side effects can vary in frequency and severity depending on individual patient factors.

Risks in Neonatal and Preterm Infants

Intraventricular Hemorrhage and Necrotizing Enterocolitis

A systematic review and meta-analysis revealed that antenatal exposure to indomethacin increases the risk of severe intraventricular hemorrhage, necrotizing enterocolitis, and periventricular leukomalacia in preterm infants. These findings highlight the need for careful consideration when using indomethacin as a tocolytic agent in pregnant women.

Prolonged vs. Short Course Treatment for Patent Ductus Arteriosus (PDA)

For the treatment of PDA in preterm infants, prolonged courses of indomethacin have been studied. While a prolonged course may reduce the incidence of severe intraventricular hemorrhage and renal impairment, it also increases the risk of necrotizing enterocolitis. Therefore, the benefits and risks must be weighed carefully, and a prolonged course cannot be universally recommended .

Pharmacokinetics and Drug Interactions

Indomethacin is rapidly absorbed when taken orally, with peak plasma concentrations occurring within 1 to 2 hours. It is extensively metabolized and excreted in both urine and feces. Notably, the drug crosses the placenta and is excreted in breast milk, which necessitates caution in pregnant and breastfeeding women. Additionally, indomethacin's pharmacokinetics can be influenced by other medications, such as probenecid, which increases its plasma concentration and enhances pain relief without increasing side effects.

Conclusion

Indomethacin is a potent NSAID with a range of potential side effects, particularly affecting the CNS, GI system, and skin. While some warnings, such as those related to mental alertness, may not be universally necessary, others, especially those concerning neonatal risks, are critical. Healthcare providers must carefully consider these risks and benefits when prescribing indomethacin, particularly in vulnerable populations such as pregnant women and preterm infants.