Description

Curosurf is a natural pulmonary surfactant suspension used for intratracheal treatment or prevention of respiratory distress syndrome in premature newborns. It helps reduce alveolar surface tension and improve lung compliance and oxygenation.

• Manufacturer Name: Chiesi
• Drug Class: Natural pulmonary surfactant
• Dosage Form: Intratracheal Suspension
• Storage: Store refrigerated at 2–8°C. Protect from light and do not freeze. Gently warm to room temperature before use and shake gently; unused opened suspension should be discarded according to institutional policy.
• Pack Size: Pack of 1

Ingredients

• Poractant alfa, a natural porcine-derived pulmonary surfactant: 80 mg/mL
• Phospholipid-based surfactant preparation containing natural pulmonary surfactant components

Benefits

• Prevention of respiratory distress syndrome in premature newborns at high risk due to surfactant deficiency
• Treatment of established neonatal respiratory distress syndrome
• Supports alveolar stability, lung compliance, and oxygen exchange in surfactant-deficient newborns

Usage & Safety

For Adult

• Not indicated for routine adult use.
• Must be administered intratracheally by healthcare professionals experienced in neonatal respiratory care and mechanical ventilation.

For Children

• For premature newborns with or at risk of respiratory distress syndrome.
• Usual initial dose: 200 mg/kg intratracheally, equivalent to 2.5 mL/kg.
• If respiratory distress persists or worsens, additional doses of 100 mg/kg, equivalent to 1.25 mL/kg, may be given at approximately 12-hour intervals according to the neonatologist’s assessment.
• Administration requires airway support, monitoring of oxygenation and ventilation, and readiness to manage rapid changes in lung compliance.
• No routine dose is established for older children or adults.

Side Effects

• Common or administration-related effects: bradycardia, oxygen desaturation, transient changes in blood pressure, airway obstruction, and reflux of product into the endotracheal tube.
• Respiratory effects may include worsening ventilation difficulty, pulmonary hemorrhage, pneumothorax, or need for adjustment of ventilator settings.
• Serious reactions may include severe hypoxia, persistent bradycardia, pulmonary hemorrhage, or hypersensitivity-type reactions.
• Careful monitoring is required during and after each dose.

Contraindications

• Known hypersensitivity to poractant alfa or any component of the product.
• Do not administer by intravenous, intramuscular, subcutaneous, oral, or other non-intratracheal routes.
• Use only under specialist neonatal supervision in a properly equipped clinical setting.
• Transient airway obstruction, bradycardia, oxygen desaturation, or reflux of the suspension may occur during administration; ventilation and airway management should be immediately available.

Precautions & Warnings

• No clinically important systemic drug interactions are generally expected because the product is administered directly into the lungs.
• Do not mix with other medicines or diluents in the same vial, syringe, or airway circuit unless compatibility has been specifically established.
• Other respiratory treatments and ventilator settings may need adjustment because lung compliance and oxygenation can improve rapidly after dosing.
• Concurrent airway medications should be administered only according to neonatal intensive-care protocols.

Pregnancy

• This product is intended for administration to newborns and is not used as a maternal treatment during pregnancy.
• Maternal pregnancy exposure information is not applicable to routine use.
• Breastfeeding considerations are not applicable when the product is administered intratracheally to a newborn.