Ibuprofen Lysine 10 mg/mL Solution
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Nonsteroidal Anti-inflammatory Drug class.
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🏭 Manufacturer & labeler
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🩺 Clinical
- It does a lot more than just kill pain. Ibuprofen is an anti-inflammatory drug, so it relieves pain, reduces swelling and inflammation, and brings down fever. Over-the-counter prod...
- What's ibuprofen actually used for — is it just a painkiller?
- Yes, it really does help. Ibuprofen can irritate the stomach lining, so taking it with food or a glass of milk significantly reduces the chance of nausea or stomach upset. You don'...
- Should I take ibuprofen with food? Does it really matter?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Ibuprofen lysine — tap one for details:
Ibuprofen lysine may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
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Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
1 inactive ingredient listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Ibuprofen Lysine 10 mg/mLthis 39822-1030-02 | XGen | 3 vials | — | AP | FDA listed | — |
| Neoprofen 10 mg/mL 55292-0122-52 | Recordati | 3 vials | — | AP | FDA listed | — |
| Ibuprofen Lysine 10 mg/mL 66993-0490-36 | Prasco | 3 vials | — | AP | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 39822-1030-02 You're viewing this | 3 VIAL in 1 CARTON (39822-1030-2) / 2 mL in 1 VIAL (39822-1030-1) | 2016-04-08 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Ibuprofen Lysine Injection 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.
Ibuprofen Lysine Injection is a nonsteroidal anti-inflammatory drug 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 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.
(1)
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION 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)
2.1Recommended Dose A course of therapy is three doses of Ibuprofen Lysine Injection 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 Injection, 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 Injection, 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 Injection, alternative pharmacological therapy, or surgery may be necessary.
2.2Directions for Use For intravenous administration only. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Do not use Ibuprofen Lysine Injection if particulate matter is observed.
After the first withdrawal from the vial, any solution remaining must be discarded because Ibuprofen Lysine Injection contains no preservative. For administration, Ibuprofen Lysine Injection should be diluted to an appropriate volume with dextrose or saline. Ibuprofen Lysine Injection should be prepared for infusion and administered within 30 minutes of preparation and infused continuously over a period of 15 minutes.
The drug should be administered via the IV port that is nearest the insertion site. After the first withdrawal from the vial, any solution remaining must be discarded because Ibuprofen Lysine Injection contains no preservative. Since Ibuprofen Lysine Injection is potentially irritating to tissues, it should be administered carefully to avoid extravasation.
Ibuprofen Lysine Injection should not be simultaneously administered in the same intravenous line with Total Parenteral Nutrition (TPN). If necessary, TPN should be interrupted for a 15-minute period prior to and after drug administration. Line patency should be maintained by using dextrose or saline.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS 20 mg/2 mL (10 mg/mL) as a clear sterile preservative-free solution of the L-lysine salt of ibuprofen in a 2 mL single-use vial. 20 mg/2 mL (10 mg/mL) as a clear sterile preservative-free solution of the L-lysine salt of ibuprofen in a 2 mL single-use vial (3)
⛔ Contraindications ▾
4 CONTRAINDICATIONS Ibuprofen Lysine Injection 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 Injection 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)
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Ibuprofen Lysine Injection has not been assessed for neurodevelopmental outcome and growth (5.1) Ibuprofen Lysine Injection may alter the usual signs of infection (5.2) Ibuprofen Lysine Injection 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 Injection should be administered carefully to avoid extravascular injection or leakage (5.5) Ibuprofen Lysine Injection may cause serious skin reactions ( 5.6 )
5.1General 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.
5.2Infection Ibuprofen Lysine Injection 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.
5.3Platelet Aggregation Ibuprofen Lysine Injection, 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 ).
5.4Bilirubin 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.
5.5Administration Ibuprofen Lysine Injection should be administered carefully to avoid extravascular injection or leakage, as solution may be irritating to tissue.
5.6Serious 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.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS 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 XGen Pharmaceuticals DJB Inc. at 1-866-390-4411, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience The most frequently reported adverse events with Ibuprofen Lysine Injection were as shown in Table 1. Table 1. Adverse Events within 30 Days of Therapy in the Multicenter Study* % Incidence Adverse Event Ibuprofen Lysine Injection Placebo Sepsis 43 37 Anemia 32 25 Total Bleeding** 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 non-Necrotizing Enterocolitis 22 18 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 Increased 7 4 Respiratory Infection 19 13 Skin Lesion/Irritation 16 6 Hypoglycemia 12 6 Hypocalcemia 12 9 Respiratory Failure 10 4 Urinary Tract Infection 9 4 Adrenal Insufficiency 7 1 Hypernatremia 7 4 Edema 4 0 Atelectasis 4 1 * Within 30 days of therapy, with an event rate greater on Ibuprofen Lysine Injection than on placebo, and greater than 2 events on Ibuprofen Lysine Injection. ** 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.
6.2Renal Function Compared to placebo, there was a small decrease in urinary output in the ibuprofen group on days 2-6 of life, with a compensatory increase in urine output on day 9. In other studies, adverse events classified as renal insufficiency including oliguria, elevated BUN, elevated creatinine, or renal failure were reported in ibuprofen treated infants.
6.3Additional Adverse Events The adverse events reported in the multicenter study and of unknown association include tachycardia, cardiac failure, abdominal distension, gastroesophageal reflux, gastritis, ileus, inguinal hernia, injection site reactions, cholestasis, various infections, feeding problems, convulsions, jaundice, hypotension, and various laboratory abnormalities including neutropenia, thrombocytopenia, and hyperglycemia.
6.4Postmarketing Experience Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency, or establish a causal relationship to drug exposure. The following adverse reactions have been identified from spontaneous post-marketing reports or published literature: gastrointestinal perforation, necrotizing enterocolitis, drug reaction with eosinophilia and systemic symptoms (DRESS), and pulmonary hypertension.
🔄 Drug Interactions ▾
7 DRUG 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 )
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.4Pediatric Use Safety and effectiveness have only been established in premature infants.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness have only been established in premature infants.
🆘 Overdosage ▾
10 OVERDOSAGE 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 Injection. The patient should be followed for several days because gastrointestinal ulceration and hemorrhage may occur.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action The mechanism of action through which ibuprofen causes closure of a patent ductus arteriosus (PDA) in neonates is not known. In adults, ibuprofen is an inhibitor of prostaglandin synthesis.
12.2Pharmacokinetics and Bioavailability Studies The pharmacokinetic data were obtained from 54 Ibuprofen Lysine Injection-treated premature infants included in a double-blind, placebo-controlled, randomized, multicenter study. Infants were less than 30 weeks gestational age, weighed between 500 and 1000 g, and exhibited asymptomatic PDA with evidence of echocardiographic documentation of ductal shunting. Dosing was initially 10 mg/kg followed by 5 mg/kg at 24 and 48 hours.
The population average clearance and volume of distribution values of racemic ibuprofen for premature infants at birth were 3 mL/kg/h and 320 mL/kg, respectively. Clearance increased rapidly with post-natal age (an average increase of approximately 0.5 mL/kg/h per day). Inter-individual variability in clearance and volume of distribution were 55% and 14%, respectively.
In general, the half-life in infants is more than 10 times longer than in adults. The metabolism and excretion of ibuprofen in premature infants have not been studied. In adults, renal elimination of unchanged ibuprofen accounts for only 10-15% of the dose.
The excretion of ibuprofen and metabolites occurs rapidly in both urine and feces. Approximately 80% of the dose administered orally is recovered in urine as hydroxyl and carboxyl metabolites, respectively, as a mixture of conjugated and unconjugated forms. Ibuprofen is eliminated primarily by metabolism in the liver where CYP2C9 mediates the 2- and 3-hydroxylations of R- and S-ibuprofen.
Ibuprofen and its metabolites are further conjugated to acyl glucuronides. In neonates, renal function and the enzymes associated with drug metabolism are underdeveloped at birth and substantially increase in the days after birth.
🧬 Mechanism of Action ▾
12.1Mechanism of Action The mechanism of action through which ibuprofen causes closure of a patent ductus arteriosus (PDA) in neonates is not known. In adults, ibuprofen is an inhibitor of prostaglandin synthesis.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Ibuprofen Lysine Injection is dispensed in clear plastic single-use vials, each containing 2 mL of sterile solution (NDC 39822-1030-1). The solution is not buffered and contains no preservatives. Each milliliter contains 17.1 mg/mL (±)-ibuprofen L-lysine [equivalent to 10 mg/mL (±)-ibuprofen] dissolved in Water for Injection, USP.
Ibuprofen Lysine Injection is supplied in a carton containing 3 single-use vials (NDC 39822-1030-2). Storage and Handling Store at 20 to 25°C (68 to 77°F); excursions permitted 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Protect from light.
Store vials in carton until contents have been used.
📋 Description ▾
11 DESCRIPTION Ibuprofen Lysine Injection 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 Injection 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 Injection 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.
Structural Formula