Neoprofen

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• 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 NeoProfen 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 NeoProfen, 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 NeoProfen, no further doses are necessary.
• If during continued medical management the ductus arteriosus fails to close or reopens, then a second course of NeoProfen, 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 discoloration prior to administration whenever solution and container permit.
• Do not use NeoProfen if particulate matter is observed.
• After the first withdrawal from the vial, any solution remaining must be discarded because NeoProfen contains no preservative.
• For administration, NeoProfen should be diluted to an appropriate volume with dextrose or saline.
• NeoProfen 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 NeoProfen contains no preservative.
• Since NeoProfen is potentially irritating to tissues, it should be administered carefully to
• avoid extravasation.
• NeoProfen 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.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Quoted from the official label, section “Overdosage”.

Use in children

Safety and effectiveness have only been established in premature infants.

Quoted from the official label, section “Pediatric Use”.

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 Recordati Rare Diseases Inc. at 1-888-575-8344, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
• 6.1 Clinical Trials Experience The most frequently reported adverse events with NeoProfen were as shown in Table 1.
• Table 1.
• Adverse Events within 30 Days of Therapy in the Multicenter Study* Adverse Event % Incidence NeoProfen Placebo * Within 30 days of therapy, with an event rate greater on NeoProfen than on placebo, and greater than 2 events on NeoProfen. ** 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.
• 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 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 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
• 6.2 Renal 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.
• 6.3 Additional 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.
• 6.4 Postmarketing 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.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• Infection NeoProfen may alter signs of infection.
• Patients' caregivers should be informed to monitor the infant for any signs of infection.
• Platelet Aggregation Patients' caregivers should be informed that like other NSAIDS, NeoProfen can inhibit clot formation therefore their infant should be monitored for any signs of bleeding.
• Administration Patients' caregivers should be informed that the infants' skin and tissues should be monitored as leakage from administration may be irritating to tissue.

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

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 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• How Supplied NeoProfen (ibuprofen lysine) Injection is dispensed in treated NeoProfen (ibuprofen lysine) Injection is dispensed in a glass vial having a silicon dioxide coating or polymer coating that inhibits the formation of particulates that result from the interaction of the ibuprofen lysine with untreated glass. clear glass single-use vials, each containing 2 mL of sterile solution (NDC 55292-122-52).
• 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.
• NeoProfen is supplied in a carton containing 3 single-use vials.
• Storage and Handling
• Store at 20 – 25°C (68 – 77°F); excursions permitted 15 – 30°C (59 – 86°F) [see USP Controlled Room Temperature].
• Protect from light.
• Store vials in carton until contents have been used.

Quoted from the official label, section “How Supplied”.

How to store it

Store at 20 – 25°C (68 – 77°F); excursions permitted 15 – 30°C (59 – 86°F) [see USP Controlled Room Temperature]. Protect from light. Store vials in carton until contents have been used.

Quoted from the official label, section “Storage and Handling”.

What is in it

• 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.
• The structural formula is:
• NeoProfen 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

Quoted from the official label, section “Description”.

Ingredients people check for

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Same active substance, strength and form in other countries

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Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Same active substance

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See every product with Ibuprofen Lysine