neoprofen
Neoprofen (Ibuprofen Lysine) is a medication used to treat Juvenile Arthritis, Rheumatoid Arthritis, Bursitis, Dysmenorrhea.
Ibuprofen Lysine · by Recordati Rare
Key facts
- Active ingredient
- Ibuprofen Lysine
- Form
- Solution
- Strength
- Ibuprofen Lysine EQ 20MG BASE/2ML (EQ 10MG BASE/ML)
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- juvenile arthritis, rheumatoid arthritis, bursitis
- Manufacturer
- Recordati Rare
- Half-life
- about 1.8 to 2.0 hours (how long it stays in your system)
- FDA application
- NDA021903
What is Neoprofen?
From the FDA label:Ibuprofen Lysine 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 Ibuprofen Lysine 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. The structural formula is: Ibuprofen Lysine is designated chemically as α-methyl-4-(2-methyl propyl) benzeneacetic acid lysine salt. Its molecular weight is 352.48. Its empirical formula is C 19 H 32 N 2 O 4 . It occurs as a white crystalline solid which is soluble in water and slightly soluble in ethanol. Chemical Structure
How to use
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 Ibuprofen Lysine, alternative pharmacological therapy, or surgery may be necessary. 2.2 Directions for Use For intravenous administration only. Parenteral drug products should be inspected visually for particulate matter and…
Side effects
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-Necrotizing Enterocolitis Total Renal Events 21 15 Renal Failure 1 3 Renal Insufficiency, Impairment 6 4 Urine Output Reduced 3 1 Blood Creatinine Increased 3 1 Blood Urea Increased with Hematuria 1 1 Blood Urea…
Warnings
Important safety information
Ibuprofen Lysine has not been assessed for neurodevelopmental outcome and growth (5.1) Ibuprofen Lysine may alter the usual signs of infection (5.2) Ibuprofen Lysine can inhibit platelet aggregation, and has been shown to prolong bleeding time in normal adult subjects (5.3) Ibuprofen has been shown to displace bilirubin from albumin binding-sites (5.4) Ibuprofen Lysine should be administered carefully to avoid extravascular injection or leakage (5.5) Ibuprofen Lysine may cause serious skin reactions ( 5.6 ) 5.1 General 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 disease processes associated with prematurity (such as retinopathy of prematurity and chronic lung disease) have not been assessed. 5.2 Infection Ibuprofen Lysine may alter the usual signs of infection. The physician must be continually on the alert and should use the drug with extra care in the presence of controlled infection and in infants at risk of infection. 5.3 Platelet Aggregation Ibuprofen Lysine, 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 (but within the normal range) in normal adult subjects. This effect may be exaggerated in patients with underlying hemostatic defects (see CONTRAINDICATIONS ). 5.4 Bilirubin Displacement Ibuprofen has been shown to displace bilirubin from albumin binding-sites; therefore, it should be used with caution in patients with elevated total bilirubin. 5.5 Administration Ibuprofen Lysine should be administered carefully to avoid extravascular injection or leakage, as solution may be irritating to tissue. 5.6 Serious Skin Reactions NSAIDS, including ibuprofen, can cause serious skin reactions such as exfoliative dermatitis, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP), which can be fatal. Ibuprofen should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.
Who should not take Neoprofen
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)
Overdose — what happens if you take too much
The following signs and symptoms have occurred in individuals (not necessarily in premature infants) following an overdose of oral ibuprofen: breathing difficulties, coma, drowsiness, irregular heartbeat, kidney failure, low blood pressure, seizures, and vomiting. There are no specific measures to treat acute overdosage with Ibuprofen Lysine. The patient should be followed for several days because gastrointestinal ulceration and hemorrhage may occur.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
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)
How long does Ibuprofen Lysine stay in your body?
The elimination half-life of ibuprofen lysine is about 1.8 to 2.0 hours — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. The label states a single serum half-life of 1.8 to 2.0 hours — it does not split the curve into a distribution and a terminal phase, so this is the elimination figure. Ibuprofen is not a prodrug, and the label names no active metabolite that outlasts the parent: the two major urinary metabolites (metabolite A, a hydroxymethyl-propyl derivative, and metabolite B, a carboxypropyl derivative) are described only as excretion products, and the label notes that excretion is virtually complete 24 hours after the last dose. This label does not report a different half-life for older adults or for people with kidney or liver impairment; it only advises caution in patients 65 and older and in those with impaired renal or hepatic function, so any change in clearance in those groups is not quantified here. This is a pharmacokinetic figure about how fast the drug leaves the blood — it is not a dosing instruction and not a drug-test detection window.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: Ibuprofen tablets USP — FDA label, Clinical Pharmacology (DailyMed).
May treat (source: NIH RxClass)
Dosage forms
Solution
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
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Frequently asked questions
- What does Neoprofen treat?
- Neoprofen (Ibuprofen Lysine) may be used to treat juvenile arthritis, rheumatoid arthritis, bursitis, dysmenorrhea, fever, gout, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- Is there a coupon or discount for Neoprofen?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Neoprofen. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Neoprofen?
- Neoprofen is marketed by Recordati Rare. You can see Recordati Rare's full profile, rating, and other products on pharmaranks.
- Is Neoprofen a brand-name or generic drug?
- Neoprofen is a brand-name product with the active ingredient Ibuprofen Lysine.
- Is Neoprofen available over the counter?
- No. Neoprofen is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Neoprofen come in?
- Neoprofen is currently marketed as solution, per the FDA's National Drug Code Directory.
- Is Neoprofen FDA-registered?
- Neoprofen is on record with the U.S. FDA under application number NDA021903. You can verify this on its official FDA label.
- Is Neoprofen safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Neoprofen. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Neoprofen?
- Neoprofen's side effects are taken directly from its FDA label. From the label: 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,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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