Pedia Injection (Ibuprofen)

Adult administration

This medicine is administered only via intravenous infusion. It is preferable to administer it without dilution over 15 minutes, and if necessary, the infusion volume can be adjusted using 9mg/mL (0.9%) normal saline or 50mg/mL (5%) dextrose solution. Total infusion volume should consider the total fluid administered for the day.

Child administration

Administered under the supervision of an experienced neonatologist in a neonatal intensive care unit. The treatment is given as three intravenous infusions at 24-hour intervals, with the first infusion starting after 6 hours of life. Ibuprofen dosage is based on body weight.

This medication must be administered only after conducting an echocardiogram to confirm the absence of pulmonary hypertension and duct-dependent congenital heart disease in newborns with cardiac function issues. It should not be used prophylactically in premature infants less than 28 weeks gestational age within the first three days of life, as there is a risk of developing pulmonary hypertension and hypoxemia. It should not be used in newborns with high bilirubin levels, as it may increase bilirubin concentrations in the blood and raise the risk of encephalopathy. Care must be taken when assessing for infections, as this drug may mask symptoms of infection. Injection should be done carefully to prevent tissue irritation or extravasation of the drug. As this drug suppresses platelet function, careful observation for signs of bleeding is necessary. Use with aminoglycoside antibiotics may alter blood drug concentrations, so close monitoring via blood tests is required. It may affect renal and gastrointestinal function, necessitating frequent assessment of these organs. Severe skin reactions such as exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis may occur; discontinue administration immediately if a skin rash or abnormal symptoms appear. This medication should not be given to newborns with the following conditions: life-threatening infections, active bleeding, thrombocytopenia, severe renal dysfunction, certain congenital heart diseases, necrotizing enterocolitis, and hypersensitivity to this medication or its additives. Various adverse reactions may occur in multiple organ systems, including the blood and lymphatic systems, nervous system, respiratory system, gastrointestinal tract, kidneys, and skin during treatment with this drug, thus requiring careful monitoring of the patient's condition. This medication may interact with diuretics, anticoagulants, corticosteroids, nitric oxide, other NSAIDs, and aminoglycoside antibiotics, so caution is advised when used concurrently with these drugs. In cases of overdose, central nervous system depression, seizures, gastrointestinal disturbances, hypotension, renal dysfunction, and other complications may occur; appropriate supporting treatment is necessary. Check the condition of the ampoule before use, use it only once, and discard any remaining medication. When disinfecting the ampoule, do not use chlorhexidine; instead, use 60% ethanol or 70% isopropyl alcohol, and allow to dry completely after disinfection. During administration, infuse intravenously over 15 minutes without dilution, and use normal saline or dextrose solution to adjust the infusion rate. Care must be taken to avoid contact with acidic solutions, and it is recommended to flush the infusion line before and after administration. Discard any remaining medication after opening the ampoule and use it immediately to prevent microbial contamination.

Serious side effects

Severe skin reactions (exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis), acute generalized exanthematous pustulosis (AGEP), drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome, severe hypoxemia, bleeding symptoms, severe allergic reactions, pulmonary hypertension, acute kidney injury, tubular acidosis, seizures, altered consciousness, coma, severe neurological symptoms, severe edema, or urination abnormalities, elevated blood pressure

Mild side effects

• Thrombocytopenia
• neutropenia
• intraventricular hemorrhage
• periventricular leukomalacia
• bronchopulmonary dysplasia
• pulmonary hemorrhage
• hypoxemia
• necrotizing enterocolitis
• intestinal perforation
• gastrointestinal bleeding

Store this medication in a sealed container to prevent air entry, at a temperature between 1°C and 30°C at room temperature. This storage will help maintain the effectiveness of the medication.

Appearance

An injection in a colorless to pale yellow liquid contained in a colorless transparent glass ampoule

Package unit

10mg/2mL ampoule x 4