Description
DESCRIPTION
Ibuprofen lysine is a clear sterile preservative-free solution of the L-lysine salt of (±)-ibuprofen which is the active ingredient. (±)-Ibuprofen is a nonsteroidal anti-inflammatory agent (NSAID). L-lysine is used to create a water-soluble drug product salt suitable for intravenous administration. Each mL of NeoProfen contains 17.1 mg of ibuprofen lysine (equivalent to 10 mg of (±)-ibuprofen) in Water for Injection, USP. The pH is adjusted to 7.0 with sodium hydroxide or hydrochloric acid.
INDICATIONS
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.
Medical uses
Ibuprofen lysine is used primarily for fever (including postimmunisation fever), mild-to-moderate pain (including pain relief after surgery), painful menstruation, osteoarthritis, dental pain, headaches and pain from kidney stones. It is used for inflammatory diseases such as juvenile idiopathic arthritis and rheumatoid arthritis.It is also used for pericarditis and patent ductus arteriosus.
Ibuprofen lysine is a clear sterile preservative-free solution of the L-lysine salt of (±)-ibuprofen which is the active ingredient. (±)-Ibuprofen is a nonsteroidal anti-inflammatory agent (NSAID). L-lysine is used to create a water-soluble drug product salt suitable for intravenous administration. Each mL of NeoProfen contains 17.1 mg of ibuprofen lysine (equivalent to 10 mg of (±)-ibuprofen) in Water for Injection, USP. The pH is adjusted to 7.0 with sodium hydroxide or hydrochloric acid.
INDICATIONS
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.
Medical uses
Ibuprofen lysine is used primarily for fever (including postimmunisation fever), mild-to-moderate pain (including pain relief after surgery), painful menstruation, osteoarthritis, dental pain, headaches and pain from kidney stones. It is used for inflammatory diseases such as juvenile idiopathic arthritis and rheumatoid arthritis.It is also used for pericarditis and patent ductus arteriosus.
is a clear sterile preservative-free solution of the L-lysine salt of (±)-ibuprofen which is the active ingredient. (±)-Ibuprofen is a nonsteroidal anti-inflammatory agent (NSAID). L-lysine is used to create a water-soluble drug product salt suitable for intravenous administration. Each mL of Ibuprofen contains 17.1 mg of ibuprofen lysine (equivalent to 10 mg of (±)-ibuprofen) in Water for Injection, USP. The pH is adjusted to 7.0 with sodium hydroxide or hydrochloric acid.
| Product Name | Ibuprofen Lysine | |
| Eest Basis | Interior Standard | |
| Tests | Specifications | Results |
| Characteristics | White or almost white Crystalline powder | Almost white crystalline powder |
| Optical Rotation | -0.10º- +0.10º | +0.00º |
| Identification | HPLC | Conforms |
| Melting point | 178~182ºC | 180ºC |
| PH | 6.0~8.0 | 7.2 |
| Clarity and color of solution | Conforms | Conforms |
| Related substances | ≤1.0% | 0.30% |
| Loss on drying | ≤1.0% | 0.20% |
| Residue on ignition | ≤0.2% | <0.1% |
| Heavy metals | ≤20PPM | <20PPM |
| Assay | 57.00%~60.00% | 58.64% |
| Ibuprofen Lysine | 40.000%~43.00% | 42.37% |
| Conclusion | Confrom to Interior Quality Standard | |
