NeoProfen Injection (ibuprofen lysine) is dispensed into a single-use container containing 2 ml of sterile solution (NDC 67386-122-52). The solution is not buffered and contains preservatives. Each milliliter contains 17.1 mg / ml (?) - ibuprofen L-lysine [equivalent to 10 mg / ml (?) - ibuprofen] dissolved in water for injection, USP. NeoProfen comes in a box containing 3 single-use vials.
Pharmacokinetic data were obtained from 54 NeoProfen-treated preterm infants included in a double-blind, placebo-controlled, randomized, multicenter study. The infants were less than 30 weeks of gestational age, weighed between 500 and 1000 g and exhibited asymptomatic PDA with evidence of echocardiographic duct bypass documentation. Dosage was initially 10 mg / kg and then 5 mg / kg for 24 and 48 hours.
NeoProfen? Lysine salt (?) - ibuprofen, which is the active ingredient. (?) - Ibuprofen? It is a non-steroidal anti-inflammatory drug (NSAID). L-lysine is used to create a water-soluble drug salt product for intravenous administration. Each ml of NeoProfen contains 17.1 mg of ibuprofen lysine (equivalent to 10 mg (?) - ibuprofen) in water for injection, USP. PH adjusted to 7.0 with sodium hydroxide gold hydrochloric acid.
In adults, renal elimination of unchanged ibuprofen accounts for only 10-15% of the dose. The excretion of ibuprofen and metabolites rapidly affect both urine and feces. Approximately 80% of the dose is orally recovered in urine as hydroxyl and carboxyl metabolites, respectively, as a mixture of conjugated and unconjugated forms. Ibuprofen is primarily associated with the metabolism of CYP2C9 mediates the 2-and 3-hydroxylations of R-and S-ibuprofen. Ibuprofen and its metabolites are further conjugated to acyl glucuronides.
There are no long-term evaluations of the infants treated with ibuprofen at durations greater than the 36 weeks post-conceptual age observation period. Ibuprofen's effects on neurodevelopmental outcome and growth as well as the impact of prematurity (such as retinopathy of prematurity and chronic lung disease) have not been assessed.
One hundred and thirty-six premature infants received either placebo or NeoProfen (10 mg / kg on the first dose and 5 mg / kg at 24 and 48 hours). Mean age was 1.5 days (range: 4.6 - 73.0 hours), and mean weight was 79 days (range: 530 - 1015 grams). All infants had a document PDA with ev>
NeoProfen, like other non-steroidal anti-inflammatory agents, can inhibit platelet aggregation. Preterm infants should be observed for signs of bleeding. Ibuprofen has been shown to prolong bleeding time in normal adult subjects. This effect may be exaggerated in patients with underlying hemostatic defects (see CONTRAINDICATIONS).
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The ductus arteriosus is a blood vessel that connects the pulmonary artery to the aorta. In utero, blood is shunted away from the lungs due to higher pulmonary resistance. Hence, blood exits the right ventricle, moves through the ductus arteriosus, and enters into the aorta. By 6 weeks' gestation, the amount of blood flowing through the ductus arteriosus is approximately 50% to 60% of total cardiac output. Prostaglandins are potent vasodilators that keep the ductus arteriosus open in utero. Normally, pulmonary resistance begins to drop when oxygenation and ventilation occur after birth. Where they are metabolized and cleared. Oxygenated blood also plays a major role in the closure of the ductus arteriosus. Functional closure occurs in the majority of term neonates by 9 to 12 hours after birth. Risk factors for patent ductus arteriosus (PDA) include prematurity and the presence of respiratory distress syndrome (1). The incidence of PDA is approximately 31% in neonates whose birth weight is between 501 and 1500 g (1, 2). PDA causes left-to-right shunting, which increases the risk of intraventricular hemorrhage (IVH), bronchopulmonary dysplasia, congestive heart failure, and necrotizing enterocolitis (NEC) (1, 3).
A total of 175 patients were enrolled in the study. Eighty-one patients who were assigned to the indomethacin group received three doses of 0.2 mg / kg every 12 hours. Ninety-four patients who were assigned to the ibuprofen group received an initial dose of 10 mg / kg and two doses of 5 mg / kg 24 and 48 hours later. The closure rate was 69% in the indomethacin group vs 73% in the ibuprofen group. For adverse events, 15% of the patients in the indomethacin group experienced oliguria vs 1% in the ibuprofen group (P = 0.017). Posttreatment serum creatinine levels were significantly higher in the indomethacin group than in the ibuprofen group (P = 0.03). These effects have been transient and resolved 24 hours after the end of treatment. The incidence of respiratory complications, NEC, and IVH worsening was not significantly different between the groups.
In the US, intravenous indomethacin is the drug of choice for the treatment of PDA, and it is often prescribed by neonatologists at Baylor University Medical Center. There are safety concerns regarding the use of indomethacin because it affects renal, gastrointestinal, and cerebral perfusion; hence, it can lead to transient renal dysfunction and is associated with the occurrence of NEC. In April 2006, the US Food and Drug Administration approved the use of ibuprofen lysine (NeoProfen) for clinically significant closure PDA in premature neonates 1.6 mg / dL; 7) platelet count.
Thomas and colleagues conducted a meta-analysis to compare the efficacy and safety of indomethacin and ibuprofen for the closure of PDA (8). Nine studies published from 1995 to 2003 were>
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These are not all of the effects that may occur. If you have questions about side effects, call your child's doctor. Call your child's doctor for medical advice.
Give NeoProfen (ibuprofen injection (PDA)) as your child's doctor. Read all information given to you. Follow all instructions closely.
A course of therapy of NeoProfen is three doses administered intravenously. 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. NeoProfen may interact with other drugs. Tell your doctor NeoProfen is usually used in infants and is unlikely to be used in pregnancy or breastfeeding women; consult your doctor if you have questions.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice on side effects. You may report side effects to FDA at 1-800-FDA-1088.
The following adverse reactions have been identified by gastrointestinal perforation, necrotizing enterocolitis, and pulmonary hypertension. Because these reactions are reported voluntarily from a population of certain size, it is not possible to reliably estimate their frequency, or establish a causal relationship to drug exposure..
Indications and Usage NEOPROFEN is a prescribing drug used in the treatment of premature infants weighing between 500 and 1500 grams (1.10 - 3.30 pounds), who are no longer than 32 weeks in gestational age, when usual medical management is ineffective. The clinical trial of NEOPROFEN has been conducted with PDA. However, the consequences of using NEOPROFEN beyond 8 weeks after treatment have not been evaluated; therefore, treatment should be reserved for those with PDA.
Additional Information PDA is a congenital heart defect that occurs soon after birth in some babies. It is typical to see the blood flow between two major arteries connected to the heart: the aorta and the pulmonary artery. Before birth, these two arteries are connected by a blood vessel called the ductus arteriosus, which is necessary for blood circulation in the fetus. Within minutes, the ductus arteriosus is presumed to be part of the normal changes in the baby's circulation. However, in some animals the ductus arteriosus remains open (patent), allowing oxygen-rich blood from the aorta to mix with oxygen-poor blood from the pulmonary artery. The mixture can strain the baby's heart and increase blood pressure in the baby's pulmonary arteries.
Neoprofen should not be used in preterm infants: With a patient with low blood platelet With impaired kidney function With low blood platelet If NEOPROFEN has not been studied for how to grow and develop NEOPROFEN may alter counts, problems with the body's blood clotting process or who are bleeding With or who are suspected of having a premature infants NEOPROFEN can be inhibited by the presence of a carcinoma in the blood, and may be shown in the following table of evidence. Ibuprofen has been shown to displace bilirubin (a liver breakdown product) from binding sites on albumin (a protein in blood serum) NEOPROFEN should be administered carefully to avoid injection of the ven st common adverse reactions (≥10%) are sepsis (bleeding into the fluid-filled areas of the brain), decreased amounts of healthy red blood cells or hemoglobin to the stomach or intestines, impaired kidney function, respiratory infection, abnormal growth or appearance of the skin, low blood sugar, low blood calcium, inability of the lungs to perform their basic task of gas exchange to report SUSPECTED SIDE EFFECTS, contact Recordati Rare Diseases Inc. at 1-888-575-8344, or FDA at 1-800-FDA-1088 or www.fda.gov/Safety/MedWatch/default.htm Drug interaction with diuretics: increased risk of kidney abnormality or impairment.
Give by IV infusion over 15 minutes. Initially 10mg / kg, then two doses of 5mg / kg each, after 24 and 48 hours. Withhold second or third dose if anuria or marked oliguria is evident; do not give additional doses until normal. If ductus arteriosis closes or is significantly reduced in size after completion of the first course, no further doses are necessary. If ductus arteriosis fails to close or reopens, second race, alternative pharmacological therapy, or surgery may be necessary.
Proven or suspected infection that is untreated. Congenital heart disease in which patency of the PDA is necessary for satisfactory pulmonary or systemic blood flow. Bleeding, esp. active intracranial hemorrhage or GI bleeding. Thrombocytopenia. Coagulation defects. Necrotizing enterocolitis. Significant renal impairment.