Comment
Author: Admin | 2025-04-28
Delayed parturition and increased stillbirths.LactationLimited data indicate ibuprofen distributes into milk, resulting in infant doses of 0.06–0.6% of the maternal weight-adjusted daily dosage. Adverse effects on breast-fed infants or effects on milk production not reported to date.Consider the developmental and health benefits of breast-feeding along with the mother's clinical need for ibuprofen and any potential adverse effects on the breast-fed infant from the drug or underlying maternal condition.FertilityNSAIAs may be associated with reversible infertility in some women. Reversible delays in ovulation observed in limited studies in women receiving NSAIAs; animal studies indicate that inhibitors of prostaglandin synthesis can disrupt prostaglandin-mediated follicular rupture required for ovulation.Consider withdrawal of NSAIAs in women experiencing difficulty conceiving or undergoing evaluation of infertility.Pediatric UseSafety and efficacy of ibuprofen lysine established only in premature neonates receiving the drug for PDA. Long-term follow-up (>36 weeks postconception age) of these neonates has not been conducted. Effects of ibuprofen on neurodevelopmental outcome, growth, and other complications of prematurity (e.g., retinopathy of prematurity, chronic lung disease) not assessed. (See Contraindications under Cautions.)Safety and efficacy of oral ibuprofen not established in infants Carefully monitor pediatric patients receiving dosages >30 mg/kg daily and those who had abnormal liver function test results associated with prior NSAIA therapy for signs and symptoms of early liver dysfunction.Safety and efficacy of IV ibuprofen for pain relief and antipyresis in pediatric patients ≥6 months of age supported by evidence of fever reduction in an open-label study in hospitalized febrile pediatric patients, safety data from 3 studies in 143 pediatric patients ≥6 months of age receiving IV ibuprofen for pain relief or antipyresis, supportive data for other ibuprofen preparations labeled for use in pediatric patients, and evidence from adequate and well-controlled studies in adults. Efficacy of IV ibuprofen for pain relief or antipyresis not established in infants Risk of overdosage and toxicity (including death) in children Such preparations also may contain analgesics and antipyretics. Limited evidence of efficacy for these preparations in this age group; appropriate dosages not established. Therefore, FDA recommends not to use such preparations in children safety and efficacy in older children currently under evaluation.
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