NEOPROFEN 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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NEWS HIGHLIGHTS
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
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.
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 >>
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PATIENT REVIEWS / RATINGS / COMMENTSBased 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 | | Rating |
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. |
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| Neoprofen review by 30 year old female patient | | Rating |
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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