"The U.S. Food and Drug Administration today approved Dotarem (gadoterate meglumine) for use in magnetic resonance imaging (MRI) of the brain, spine and associated tissues of patients ages 2 years and older.
Dotarem is a gadolinium-based"...
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.
DOSAGE AND ADMINISTRATION
A course of therapy is three doses of NeoProfen (ibuprofen lysine injection) administered intravenously (administration via an umbilical arterial line has not been evaluated). An initial dose of 10 mg per kilogram is followed by two doses of 5 mg per kilogram each, after 24 and 48 hours. All doses should be based on birth weight. If anuria or marked oliguria (urinary output < 0.6 mL/kg/hr) is evident at the scheduled time of the second or third dose of NeoProfen (ibuprofen lysine injection) , no additional dosage should be given until laboratory studies indicate that renal function has returned to normal. If the ductus arteriosus closes or is significantly reduced in size after completion of the first course of NeoProfen (ibuprofen lysine injection) , no further doses are necessary. If during continued medical management the ductus arteriosus fails to close or reopens, then a second course of NeoProfen (ibuprofen lysine injection) , alternative pharmacological therapy, or surgery may be necessary.
Directions for Use
For intravenous administration only. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
For administration, NeoProfen (ibuprofen lysine injection) should be diluted to an appropriate volume with dextrose or saline. NeoProfen (ibuprofen lysine injection) should be prepared for infusion and administered within 30 minutes of preparation and infused continuously over a period of 15 minutes. The drug should be administered via the IV port that is nearest the insertion site. After the first withdrawal from the vial, any solution remaining must be discarded because NeoProfen (ibuprofen lysine injection) contains no preservative.
Since NeoProfen (ibuprofen lysine injection) is potentially irritating to tissues, it should be administered carefully to avoid extravasation.
NeoProfen (ibuprofen lysine injection) should not be simultaneously administered in the same intravenous line with Total Parenteral Nutrition (TPN). If necessary, TPN should be interrupted for a 15-minute period prior to and after drug administration. Line patency should be maintained by using dextrose or saline.
Dosage Forms And Strengths
10 mg/mL as a clear sterile preservative-free solution of the L-lysine salt of ibuprofen in a 2 mL single-use vial
NeoProfen (ibuprofen lysine) Injection is dispensed in clear glass single-use vials, each containing 2 mL of sterile solution (NDC 67386-122-52). The solution is not buffered and contains no preservatives. Each milliliter contains 17.1 mg/mL (±)-ibuprofen L-lysine [equivalent to 10 mg/mL (±)-ibuprofen] dissolved in Water for Injection, USP. NeoProfen (ibuprofen lysine injection) is supplied in a carton containing 3 single-use vials.
Storage and Handling
Store at 20 - 25oC (68 - 77oF); excursions permitted 15 - 30oC (59 - 86oF) [see USP Controlled Room Temperature]. Protect from light. Store vials in carton until contents have been used.
Manufactured for: Lundbeck Inc., Deerfield, IL 60015, U.S.A.
Last reviewed on RxList: 1/20/2010
This monograph has been modified to include the generic and brand name in many instances.
Additional NeoProfen Information
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.
Find out what women really need.