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What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
NeoProfen (ibuprofen lysine injection) is indicated to close a clinically significant patent ductus arteriosus (PDA) in premature infants weighing between 500 and 1500 g, who are no more than 32 weeks gestational age when usual medical management (e.g., fluid restriction, diuretics, respiratory support, etc.) is ineffective. The clinical trial was conducted among infants with an asymptomatic PDA. However, the consequences beyond 8 weeks after treatment have not been evaluated; therefore, treatment should be reserved for infants with clear evidence of a clinically significant PDA.
Read the complete drug monograph for NeoProfen »
Drug Description - Indications & Dosage - Side Effects & Drug Interactions - Warnings & Precautions - Contraindications - Medication Guide and More
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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