Lung Surfactant (Respiratory Distress Syndrome — Neonatal) Pregnancy: §4.6 states 'Not relevant' — Curosurf is given to preterm neonates

Poractant Alfa (Porcine Surfactant)

Brand names: Curosurf

Poractant alfa is a natural porcine-derived pulmonary surfactant administered endotracheally to treat (and in selected infants prevent) neonatal respiratory distress syndrome due to surfactant deficiency in preterm infants.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: Not applicable — no adult dose is given in the SPC. Curosurf posology is stated only for preterm infants with respiratory distress syndrome (RDS)

Route: Endotracheopulmonary — instilled as a bolus into the lower trachea via an endotracheal tube, or via a thin catheter (LISA technique)

Frequency: See paedDose — a single starting dose, with further doses as described

Neonatal regimen (see paedDose for the structured value). RESCUE TREATMENT: the recommended starting dose is 100-200 mg/kg (1.25-2.5 mL/kg) as a single dose as soon as possible after diagnosing RDS; additional doses of 100 mg/kg (1.25 mL/kg), each at about 12-hourly intervals, may also be given if RDS is considered the cause of persisting or deteriorating respiratory status (maximum total dose 300-400 mg/kg). PROPHYLAXIS: a single dose of 100 to 200 mg/kg as soon as possible after birth, preferably within 15 minutes; further doses of 100 mg/kg can be given 6 to 12 hours after the first dose and then 12 hours later in babies with persistent signs of RDS who remain ventilator-dependent (maximum total dose 300 to 400 mg/kg). Curosurf should only be administered by those trained and experienced in the care, resuscitation and stabilisation of preterm infants, with continuous monitoring of heart rate and arterial oxygen concentration or oxygen saturation. Warm the vial to room temperature and turn it gently upside down a few times without shaking. After administration, pulmonary compliance can improve rapidly, requiring prompt adjustment of ventilator settings, and the inspired oxygen concentration should be adjusted rapidly to avoid hyperoxia.

Paediatric dose

Route: Endotracheopulmonary (bolus instillation into the lower trachea via the endotracheal tube, with or without disconnecting the baby from the ventilator, at delivery-room intubation-surfactant-extubation, or via a thin catheter using the LISA technique)

Frequency: Rescue: a single starting dose as soon as possible after diagnosing RDS, with additional 100 mg/kg doses at about 12-hourly intervals if required. Prophylaxis: a single dose as soon as possible after birth (preferably within 15 minutes), with further 100 mg/kg doses 6 to 12 hours later and then 12 hours after that if required

Max: Maximum total dose of 300-400 mg/kg

The starting dose is a range, so no single per-kg number is given and dosePerKg is left null. Rescue treatment: starting dose 100-200 mg/kg, equivalent to 1.25-2.5 mL/kg, as a single dose; additional doses 100 mg/kg (1.25 mL/kg). Prophylaxis: single dose 100 to 200 mg/kg after birth; further doses 100 mg/kg. Maximum total dose 300-400 mg/kg in both regimens. With the LISA technique the doses are the same as for the other administration modalities, instilled as a single bolus over 0.5-3 minutes through a thin catheter placed into the trachea of an infant on CPAP under direct laryngoscopy, with CPAP continued throughout.

Dose adjustments

Renal

The safety and efficacy of Curosurf in patients with renal or hepatic impairment have not been evaluated (§4.2)

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Hypersensitivity to the active substance(s) or to any of the excipients; the SPC adds that no specific contraindications are yet known (§4.3)

Side effects

Sepsis, intracranial haemorrhage and pneumothorax (uncommon)
Bradycardia and hypotension (rare)
Decreased oxygen saturation (rare)
Pulmonary haemorrhage and bronchopulmonary dysplasia (rare)
Hyperoxia, neonatal cyanosis, apnoea and endotracheal intubation complications (frequency not known)
A slight tendency towards an increased incidence of patent ductus arteriosus has been reported in treated infants, attributed to haemodynamic changes from rapid lung expansion

Clinical monograph

How it works

It replaces deficient endogenous surfactant, the phospholipid-protein complex that lowers alveolar surface tension, thereby preventing alveolar collapse at end-expiration and improving lung compliance and oxygenation.

Prescribing in practice

It must be administered via the endotracheal route by clinicians skilled in neonatal intubation and ventilation, with monitoring for transient airway obstruction, desaturation and bradycardia during instillation.
Rapid improvement in lung compliance after dosing necessitates prompt adjustment of ventilator settings and oxygen to avoid hyperoxia and air leak.
Administer according to the SPC and local neonatal protocols; repeat doses may be given if respiratory distress persists or recurs.

Monitoring

Monitor oxygen saturation, heart rate and ventilation continuously during and after administration, adjusting respiratory support to the rapidly changing lung mechanics.

Counselling the patient

Explain to parents that this medicine replaces a natural substance the premature baby's lungs have not yet made enough of, helping the lungs stay open.
It is given directly into the breathing tube by the neonatal team.
The baby's ventilator settings will be adjusted quickly as breathing improves.

Evidence & guidelines

Surfactant replacement is a cornerstone of neonatal RDS care, with trials and meta-analyses showing reduced mortality and air leak, and animal-derived surfactants such as poractant alfa generally favoured over synthetic alternatives.

Reference: BAPM RDS Clinical Practice Guidelines; Polin et al. Pediatrics 2014; Cochrane Review: Seger and Soll 2009 (surfactant types comparison); Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways