Pedea 5 mg, 10 mg Solution for injection
PDF Leaflet Revision Date: 04 April 2025
Clinical Summary
Quick overview from the medicine insert
Indication
Treatment of haemodynamically significant patent ductus arteriosus in preterm newborns <34 weeks gestational age.
Dosage (summary)
IV: 10 mg/kg (1st dose), 5 mg/kg (2nd & 3rd doses) at 24-hour intervals.
Special Populations
- Preterm infants
- Neonates
Key Drug Interactions
- Diuretics
- Anticoagulants
- Corticosteroids
- Nitric oxide
- Other NSAIDs
- Zidovudine
- Ritonavir
- Aminoglycosides
Contraindications
- Hypersensitivity to ibuprofen
- Life-threatening infection
- Active bleeding
- Thrombocytopenia
- Significant renal impairment
- Congenital heart disease requiring ductus arteriosus patency
- Necrotising enterocolitis
Common side effects
- Thrombocytopenia
- Intraventricular haemorrhage
- Bronchopulmonary dysplasia
- Necrotising enterocolitis
- Oliguria
Counselling Points
- Administer in neonatal intensive care unit
- Monitor for signs of bleeding
- Avoid prophylactic use in preterm infants
- Discard unused solution after opening
Serious warnings
- Increased risk of pulmonary and renal adverse events in preterm infants <28 weeks
- Risk of bilirubin encephalopathy
- Serious skin reactions
- Monitor for bleeding
Important Disclaimer
The Pedea 5 mg, 10 mg Solution for injection professional information leaflet below is the property of Equity Pharmaceuticals and is provided on Medinsert exactly as issued, with no.. alterations or editorial changes. We make every effort to keep content current by updating documents as soon as new versions become available. Medinsert serves as a trusted access point for healthcare professionals, but does not replace official sources or clinical judgement. For more details, please read our full disclaimer. read more>>
Healthcare Professionals Only
This content is for registered healthcare professionals
Sign in or create a free account to read the full package insert.
Free for HPCSA-registered professionals. Powered by Medinsert.
