Ibuprofen Lysine 10 mg/mL
ibuprofen lysine · SOLUTION · Prasco Laboratories
Ibuprofen Lysine is a solution containing ibuprofen lysine at 10 mg/mL, taken intravenous. Manufactured by Prasco Laboratories.
Key Facts
- Brand Name
- Ibuprofen Lysine
- Generic Name
- ibuprofen lysine
- NDC Code (Product)
66993-490- Manufacturer
- Prasco Laboratories
- Strength
- 10 mg/mL
- Dosage Form
- SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA021903
- Marketing Start
- 04/14/2016
Recall History
X-Gen Pharmaceuticals Inc.
Presence of Particulate Matter
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & 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)
Dosage & Administration
2 DOSAGE AND ADMINISTRATION A course of therapy is three doses administered I.V. (2.1) An initial dose of 10 mg/kg (based on birth weight) is followed by two doses of 5 mg/kg each, after 24 and 48 hours (2.1) Do not administer if anuria or marked oliguria (<0.6 mL/kg/hr) is evident at the scheduled time of the second or third dose (2.1) 2.1 Recommended Dose A course of therapy is three doses of Ibuprofen Lysine 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 Ibuprofen Lysine, 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 Ibuprofen Lysine, no further doses are necessary. If during continued medical management the ductus arteriosus fails to close or reopens, then a second course of Ibu…
Contraindications
4 CONTRAINDICATIONS Ibuprofen Lysine is contraindicated in: Preterm infants with proven or suspected infection that is untreated; Preterm infants with congenital heart disease in whom patency of the PDA is necessary for satisfactory pulmonary or systemic blood flow (e.g., pulmonary atresia, severe tetralogy of Fallot, severe coarctation of the aorta); Preterm infants who are bleeding, especially those with active intracranial hemorrhage or gastrointestinal bleeding; Preterm infants with thrombocytopenia; Preterm infants with coagulation defects; Preterm infants with or who are suspected of having necrotizing enterocolitis; Preterm infants with significant impairment of renal function. Ibuprofen Lysine is contraindicated in preterm infants: With proven or suspected infection that is untreated (4) With congenital heart disease in whom patency of the PDA is necessary for satisfactory pulmonary or systemic blood flow (4) With impaired renal function (4) With thrombocytopenia, coagulation defects or who are bleeding (4) With or who are suspected of having necrotizing enterocolitis (4)
Drug Interactions
7 DRUG INTERACTIONS Diuretics: Ibuprofen may reduce the effect of diuretics; diuretics can increase the risk of nephrotoxicity of NSAIDs in dehydrated patients. Monitor renal function in patients receiving concomitant diuretics. Amikacin: Ibuprofen may decrease the clearance of amikacin. Diuretics: Increased risk of renal dysfunction. (7)
Adverse Reactions
6 ADVERSE REACTIONS Most common adverse reactions (≥10%) are sepsis, anemia, intraventricular bleeding, apnea, gastrointestinal disorders, impaired renal function, respiratory infection, skin lesions, hypoglycemia, hypocalcemia, respiratory failure. (6) To report SUSPECTED ADVERSE REACTIONS, contact Prasco Laboratories at 1-866-525-0688, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience The most frequently reported adverse events with Ibuprofen Lysine were as shown in Table 1. Table 1. Adverse Events within 30 Days of Therapy in the Multicenter Study Within 30 days of therapy, with an event rate greater on Ibuprofen Lysine than on placebo, and greater than 2 events on Ibuprofen Lysine. % Incidence Adverse Event Ibuprofen Lysine Placebo Sepsis 43 37 Anemia 32 25 Total Bleeding A given subject may have experienced more than one specific event within these adverse event categories. Only the most severe grade of IVH counted for a given subject. 32 29 Intraventricular Hemorrhage, Grades 1/2 15 13 Intraventricular Hemorrhage, Grades 3/4 15 10 Other Bleeding 6 13 Intraventricular Hemorrhage, All Grades 29 24 Apnea 28 26 Gastrointestinal Disorders 22 18 non-N…
Frequently Asked Questions
What is Ibuprofen Lysine used for?
Ibuprofen Lysine contains ibuprofen lysine. It is a solution taken intravenous. Consult your doctor for specific uses.
Is Ibuprofen Lysine a controlled substance?
Ibuprofen Lysine is not classified as a controlled substance by the DEA.
What is the generic name for Ibuprofen Lysine?
The generic name for Ibuprofen Lysine is ibuprofen lysine. There are 1 other brand versions of ibuprofen lysine.
What is the NDC code for Ibuprofen Lysine 10 mg/mL?
The NDC (National Drug Code) for Ibuprofen Lysine 10 mg/mL is 66993-490, listed by Prasco Laboratories.