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Neoprofen (Ibuprofen Lysine) - Summary



NeoProfen® 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.

NeoProfen 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.

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Published Studies Related to Neoprofen (Ibuprofen)

Single dose oral ibuprofen plus codeine for acute postoperative pain in adults. [2015]
CONCLUSIONS: The combination of ibuprofen 400 mg plus codeine 25.6 mg to

Intramuscular ketorolac versus oral ibuprofen for pain relief in first-trimester surgical abortion: a randomized clinical trial. [2014]
ketorolac for pain management during first-trimester surgical abortion... CONCLUSIONS: Intramuscular ketorolac does not offer superior pain control

Randomized clinical trial evaluating transdermal Ibuprofen for moderate to severe knee osteoarthritis. [2013]
pain management practices... CONCLUSIONS: The use of transdermal VALE-ibuprofen has beneficial clinical

Diclofenac with or without an antiemetic for acute migraine headaches in adults. [2013]
CONCLUSIONS: Oral diclofenac potassium 50 mg is an effective treatment

Randomized comparison between the combination of acetaminophen and ibuprofen and each constituent alone for analgesia following tonsillectomy in children. [2013]
individual constituents for analgesia following tonsillectomy in children... CONCLUSION: The combination of ibuprofen and acetaminophen was not superior to

more studies >>

Clinical Trials Related to Neoprofen (Ibuprofen)

Early Versus Late Use of Ibuprofen for PDA Closure [Terminated]
The primary objective is to evaluate the PDA closure rate of early vs. late use of Ibuprofen (Ibu). The investigators believe that early use of Ibu will have a higher PDA closure rate than later use of Ibu. Early use is defined as medication given before the infant reaches 96 hrs old. Late use is defined as medication given when infant is more than 96 hrs old. The secondary objective is to measure the stress hormone and metabolic response (plasma catecholamines, glucose, and lactate) of neonates undergoing Ibu treatment of the PDA. The investigators believe that early ibuprofen will blunt the stress response greater than later use.

Efficacy Study of IV Ibuprofen vs IV Acetaminophen Post Surgical Extraction [Recruiting]
This study will compare how effective a single dose of an intravenous (IV) ibuprofen is when compared to single dose of IV acetaminophen in reducing pain. We will administer this study medication thirty minutes prior to removal of wisdom teeth. We want to see if administering these drugs prior to surgery may reduce post-operative pain. Administration of nonsteroidal anti-inflammatory drug before the onset of inflammation during surgery will reduce postoperative pain following third molar extraction when compared to the acetaminophen group. Subjects receiving nonsteroidal anti-inflammatory drug will consume less opioid medications compared to those receiving preemptive acetaminophen.

Oral Ibuprofen Prophylaxis for Patent Ductus Arterioses in Very Extremely Low Birth Weight Infants [Recruiting]
Patent ductus arterioses (PDA) is a major morbidity in preterm infants, especially in extremely premature infants less than 28 weeks. The clinical signs and symptoms of PDA in preterm infants are non specific and insensitive for making an early diagnosis of significant ductal shunting. Functional echocardiography is emerging as a new valuable bedside tool for early diagnosis of hemodynamically significant ductus, even though there are no universally accepted criteria for grading the hemodynamic significance. Echocardiography has also been used for early targeted treatment of ductus arterioses, though the long term benefits of such strategy are debatable. The biomarkers like BNP and N- terminal pro-BNP are currently under research as diagnostic marker of PDA. The primary mode of treatment for PDA is pharmacological closure using cyclo-oxygenase inhibitors with closure rate of 70-80%. Oral ibuprofen is emerging as a better alternative especially in Indian scenario where parenteral preparations of indomethacin are unavailable and side effects are comparatively lesser. Though pharmacological closure of PDA is an established treatment modality, there is still lack of evidence for long term benefits of such therapy as well as there is some evidence for the possible adverse effects like increased ROP and BPD rates, especially if treated prophylactically. The aim of this study is to investigate the effect of oral ibuprofen prophylaxis administrated on the first 24 hours of life and the following two days on hemodynamically significant patent ductus arterioses and its long term effects such as ROP and BPD.

Effect of Ibuprofen, Paracetamol and Their Combination on Radical Oxygen Species (ROS) Production [Completed]
The purpose of this study is to determine whether paracetamol, ibuprofen or their combination can modify generation of radical oxygen species (ROS) from stimulated neutrophils.

Safety Study of Ibuprofen to Treat Acute Traumatic Spinal Cord Injury [Recruiting]

The Ibuprofen - Spinal Cord Injury (SCI) - Safety trial investigates tolerability and

feasibility of "small molecule" (Ibuprofen) mediated Rho-inhibition as putative neuroprotective, plasticity-enhancing and neurorestaurative intervention. The primary safety analysis is based on the incidence of severe gastrointestinal bleedings. In addition, the feasibility of recruitment procedure, and oral administration of the compound within the multidisciplinary setting of acute intensive medical care will be explored. Furthermore, the pharmacokinetics of Ibuprofen under the condition of acute motor complete SCI will be investigated. Secondary endpoints will permit preliminary statements about effects on neuropathic pain, spasticity, and neurological function.

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Reports of Suspected Neoprofen (Ibuprofen) Side Effects

Bronchopulmonary Dysplasia (96)Pulmonary Hypertension (14)Haemorrhage Intracranial (4)Retinopathy of Prematurity (3)Neonatal Hypotension (2)Death Neonatal (2)Ventricular Hypokinesia (1)Dilatation Ventricular (1)Tricuspid Valve Incompetence (1)Failure TO Thrive (1)more >>


Based on a total of 2 ratings/reviews, Neoprofen has an overall score of 10. The effectiveness score is 10 and the side effect score is 10. The scores are on ten point scale: 10 - best, 1 - worst.

Neoprofen review by 31 year old female patient

Overall rating:  
Effectiveness:   Highly Effective
Side effects:   No Side Effects
Treatment Info
Condition / reason:   headaches, menstrual aches/cramps, fever
Dosage & duration:   depends, between 200-400 mg taken when needed for the period of 3 years off and on
Other conditions:   None
Other drugs taken:   None
Reported Results
Benefits:   THE BEST painkillers ever! Quite low dosage when it comes to the active substance used but it does work perfect. I like the fact that they come in two different dosages 200mg and 400mg. When taking this medicine I think that one should take ones weight and the severity of the condition that one wants to treat.
Side effects:   None that I have experienced. These are supposedly one of the least invasive painkillers on the market.
Comments:   I have used it to take down, fever, headaches, PMS cramps, lumbago, the pain just vanishes.


Neoprofen review by 30 year old female patient

Overall rating:  
Effectiveness:   Highly Effective
Side effects:   No Side Effects
Treatment Info
Condition / reason:   Earache
Dosage & duration:   600mg taken 3 times per day for the period of 3 weeks
Other conditions:   none
Other drugs taken:   none
Reported Results
Benefits:   I had very stron earache, which made me unable to work. High-dose Aspirin did not help, nor did Paracetamol. However, Ibuprofen worked perfectly: my pain was letely compgone as long as the tablet taken twas effective. Only about half an hour before I was allowed to take the next tablet did my earache start again. I was very happy!!
Side effects:   none
Comments:   3 tablets per day

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Page last updated: 2015-08-10

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