Ibuprofen Lysine Injection 20 mg Per 2 mL (10 mg/mL) Single-Dose (3 Vials) (RX)

Ibuprofen Lysine Injection 20 mg per 2 mL (10 mg/mL) by XGen Pharmaceuticals is a sterile, preservative-free, single-dose injectable solution specifically engineered for professional hospital use. This product is designed to deliver fast-acting, reliable relief for clinical conditions that require intravenous administration of ibuprofen, providing both anti-inflammatory and antipyretic benefits. Each package contains 3 single-dose vials, supporting precise dosing and safety.

What It Is Used For

• Treatment of clinically significant patent ductus arteriosus (PDA) in premature infants (most common use)
• Management of pain and inflammation when oral or enteral delivery is not feasible
• Reduction of fever in hospitalized patients when IV therapy is required

Ibuprofen Lysine Injection is most commonly utilized in the neonatal intensive care setting for targeted closure of patent ductus arteriosus in preterm infants.

Details & Features

• Strength: 20 mg per 2 mL vial (10 mg/mL concentration)
• Form: Ready-to-use sterile injectable solution
• Package: 3 single-dose vials per box for accurate and secure dosing
• Preservative-Free: Reduced risk of additive-related reactions
• Fast-Acting: Rapid onset for critical care and NICU protocols
• Reliable Manufacturer: Produced by XGen Pharmaceuticals, a leader in quality and innovation
• For Hospital and Licensed Clinical Use Only

Directions for Use

• For intravenous (IV) use only.
• Preparation: Inspect vial for particulate matter or discoloration. Use aseptic technique for both preparation and administration.
• Administration: Infuse as a slow IV injection over the time specified by your healthcare institution or dosing protocol—commonly up to 15 minutes in neonatal use.
• Single Dose Only: Discard any unused portion of the vial after opening.

To be administered exclusively by trained healthcare professionals in a hospital setting.

Dosage

For the Treatment of PDA in Preterm Infants:

• Initial Dose: 10 mg/kg as an IV infusion
• Second & Third Doses: 5 mg/kg each, at 24 and 48 hours after the initial dose (if clinically indicated)

For Other Indications (as determined by physician):

• Dosage and frequency must be determined by a healthcare provider based on patient-specific factors, indication, age, and body weight.

Consult medical protocols and/or product insert for detailed dosing guidelines.

Allergies

Contraindicated In:

• Patients with known hypersensitivity to ibuprofen, other NSAIDs, or any component of the injection
• Patients with a history of asthma, urticaria, or allergic-type reactions after NSAID use.

Drug Interactions

• Other NSAIDs or Aspirin: Increased risk for adverse effects
• Anticoagulants (e.g., Warfarin): Heightened risk of bleeding
• Corticosteroids: Elevated risk of GI ulceration or bleeding
• ACE Inhibitors, ARBs, Diuretics: May augment kidney impairment
• Aminoglycoside Antibiotics: Possible elevated nephrotoxicity in neonates

Comprehensive medication review is needed before administration.

Side Effects or Warnings

Common Side Effects:

• Mild changes in lab values (creatinine, platelet count)
• Local irritation at injection site

Serious Side Effects:

• Kidney dysfunction (especially in premature infants)
• Bleeding tendencies, GI hemorrhage
• Hypotension or hypertension
• Infection risk due to altered immune response
• Electrolyte imbalances (hyponatremia, hyperkalemia)

Warnings:

• Only for use under close hospital supervision and monitoring
• Not for use in patients with active bleeding, significant renal impairment, or necrotizing enterocolitis
• Risk of bronchopulmonary dysplasia in neonates
• Not indicated for routine pain or fever management in adults.

If any severe side effects, signs of allergic reaction, or unusual symptoms occur, contact a physician or initiate emergency protocols immediately.

Choose Ibuprofen Lysine Injection 20 mg per 2 mL (10 mg/mL) by XGen Pharmaceuticals — Trusted, Targeted Hospital Therapy for PDA Closure and IV NSAID Needs.