Neoprofen (Ibuprofen Lysine) - Summary

NEOPROFEN SUMMARY

NeoProfen^®
(ibuprofen lysine)
Injection

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)

A prospective randomized study to evaluate the antipyretic effect of the combination of acetaminophen and Ibuprofen in neurological ICU patients. [2011.12]
BACKGROUND: To compare the antipyretic effect of simultaneously administered acetaminophen (APAP) plus ibuprofen (IBU) to either APAP or IBU alone in critically ill febrile neurological and neurosurgical patients... CONCLUSION: The combination of IBU and APAP produces significantly greater fever control than APAP alone, with trends favoring the combination over IBU alone and IBU over APAP alone.

A randomised controlled trial of ibuprofen, paracetamol or a combination tablet of ibuprofen/paracetamol in community-derived people with knee pain. [2011.09]
OBJECTIVES: To compare the efficacy and safety of single versus combination non-prescription oral analgesics in community-derived people aged 40 years and older with chronic knee pain... CONCLUSIONS: Ibuprofen/paracetamol combination analgesia, at non-prescription doses, confers modest short-term benefits for knee pain/osteoarthritis. However, in this population, paracetamol 3 g/day may cause similar degrees of blood loss as ibuprofen 1200 mg/day, and the combination of the two appears to be additive. Study no ISRCTN77199439.

Randomized, open-label, 5-way crossover study to evaluate the pharmacokinetic/pharmacodynamic interaction between furosemide and the non-steroidal anti-inflammatory drugs diclofenac and ibuprofen in healthy volunteers. [2011.08]
OBJECTIVE: Nonsteroidal anti-inflammatory drugs (NSAIDs) can induce renal complications in patients taking loop diuretics. This study investigated the pharmacokinetic/pharmacodynamic effects and safety profile of orally administered diclofenac sodium, ibuprofen and diclofenac epolamine topical patch (DETP) on furosemide in healthy adult subjects... CONCLUSIONS: Pharmacodynamic effects were seen with oral diclofenac (urine output) and ibuprofen (urine sodium excretion). Furosemide also affected plasma and urine pharmacokinetic profiles. Pharmacologic effects of DETP on furosemide were not observed under these conditions. Additional research is warranted to delineate the potential interactions of other NSAIDs with furosemide and other loop diuretics.

A randomized controlled trial comparing acetaminophen, acetaminophen and ibuprofen, and acetaminophen and codeine for postoperative pain relief after Mohs surgery and cutaneous reconstruction. [2011.07]
BACKGROUND: There are no population-based data comparing analgesics after Mohs micrographic surgery (MMS) and reconstruction. OBJECTIVE To compare the efficacy in pain management of three analgesic combinations... CONCLUSIONS: The combination of Ac+Ib is superior to Ac alone or Ac+Co in controlling postoperative pain after MMS and cutaneous reconstruction. (c) 2011 by the American Society for Dermatologic Surgery, Inc.

Comparison of pre-emptive ibuprofen, paracetamol, and placebo administration in reducing post-operative pain in primary tooth extraction. [2011.07]
BACKGROUND: This study investigates preliminary investigations that a pre-emptive analgesia administration may reduce post-extraction pain. AIM: This prospective, placebo-controlled, randomized, double-blind trial was planned to compare the efficacy of the pre-emptive administration of ibuprofen, paracetamol, and placebo in reducing post-extraction pain in children... CONCLUSIONS: Preoperative use of ibuprofen and paracetamol may provide a pre-emptive analgesic effect in paediatric patients who receive adequate analgesia during mandibular primary tooth extraction. (c) 2011 The Authors. International Journal of Paediatric Dentistry (c) 2011 BSPD, IAPD and Blackwell Publishing Ltd.

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Clinical Trials Related to Neoprofen (Ibuprofen)

Early Versus Late Use of Ibuprofen for PDA Closure [Recruiting]
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.

Comparison of Oral and Intravenous Ibuprofen for PDA Treatment in Premature Infants [Recruiting]
Background:

Patent ductus arteriosus (PDA) continues to be one of the most common problems in premature infants. Pharmacological closure of PDA with intravenous (IV) indomethacin was first reported in 1976, however, concern remains regarding the safety of indomethacin, which affects renal, GI and cerebral perfusion and may lead to complications such as transient or permanent renal dysfunction, NEC, GI hemorrhage, and reduced cerebral oxygenation. Recently, IV ibuprofen has been shown to be effective for the closure of patent ductus arteriosus in premature infants, without reducing mesenteric, renal, or cerebral blood flow. We have developed the echocardiographic PDA flow pattern as a guide for PDA treatment, fewer doses of drugs were needed to achieve acceptable closing rates. We have also reported that IV ibuprofen is as effective as IV indometacin for the PDA treatment in extremely premature infants, without increasing the incidence of complications in a randomised controlled trial. Several studies reported that oral ibuprofen may be effective for PDA treatment. To date there is no firm conclusion as to the efficacy and safety of oral ibuprofen compared with IV ibuprofen for PDA closure in extremely premature infants.

Objective:

Since the efficacy of pharmacological closure of PDA is related to gestational age, and extremely premature infants carry the highest rate of mortality and morbidity. We intend to conduct a randomized controlled trial to compare oral and intravenous ibuprofen for treatment of PDA in this high-risk population of extremely premature infants.

Methods:

Extremely premature infants (gestational age < 28 weeks) admit to the NICU will be eligible for enrollment. Informed parental consent will be obtained according to the Institutional Review Board's instructions. Extremely premature infants with respiratory distress syndrome (RDS) and PDA confirmed by echocardiography will be randomly assigned to receive either oral or IV ibuprofen. The subsequent doses of ibuprofen are also determined according to our specific echocardiographic PDA flow patterns at intervals of once every 24 hours from the last dose. The dosage of oral or ibuprofen is 10 mg/kg (1 ml) and then 5 mg/kg at 24-hour intervals as indicated by echocardiographic PDA flow pattern.

Sample Size Calculation and Length of the Study Period:

About 50-60 extremely premature infants will be admitted to our NICU each year. To prove with McNemar's Test at a one-sided significance level of 5% and a power of 90% that using oral ibuprofen instead of IV ibuprofen results in comparable PDA closure rates, only 31 extremely premature infants with RDS and PDA have to be enrolled. Allowing for attrition and exclusion from the final study groups, the length of the study period will be safe to set to 2 years.

Expected Results:

We expect to determine whether oral ibuprofen is effective and safe in inducing PDA closure in extremely premature infants and to compare the complications between infants treated with oral ibuprofen and those with IV ibuprofen.

Efficacy and Safety Study to Compare Ibuprofen + Caffeine With Ibuprofen Alone in the Treatment of Headache [Not yet recruiting]
Based on established therapeutic effect of ibuprofen in the treatment of headache attacks, and the action of caffeine in promoting better results when combined with treatments of first choice in the treatment of headache, this study is designed to:

- evaluate the efficacy of therapy with ibuprofen + caffeine in headache patients

compared to ibuprofen alone;

- evaluate the tolerability of the association ibuprofen + caffeine compared to ibuprofen

alone.

The hypothesis is that the association is superior to treatment with ibuprofen alone in terms of efficacy, while maintaining good tolerability.

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.

Study Evaluating A Novel Ibuprofen Formulation In Episodic Tension-Type Headache [Recruiting]
This study will compare the ability of a single-dose of a novel ibuprofen formulation to relieve pain compared to placebo and standard ibuprofen in the treatment of episodic tension-type headache.

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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 >>

PATIENT REVIEWS / RATINGS / COMMENTS

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.

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