ibuprofen lysine
ibuprofen lysine is listed in the FDA National Drug Code directory with 2 NDC codes, marketed under brand names including NEOPROFEN, Ibuprofen Lysine. Available dosage form: solution.
Drug Details
- Generic Name
- ibuprofen lysine
- Brand Names
- NEOPROFEN, Ibuprofen Lysine
- Application Number
- NDA021903
- Sponsor
- Recordati Rare Diseases Inc.
- NDC Codes
- 2
- Dosage Forms
- SOLUTION
- Routes
- INTRAVENOUS
- Active Ingredients
- IBUPROFEN LYSINE
Indications and Usage
1 INDICATIONS AND USAGE Ibuprofen Lysine 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. Ibuprofen Lysine is a nonsteroidal anti-inflammatory drug 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 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. (1)