Not scheduled

Intratracheal instillation

• Poractant alfa: Suspension for intratracheal use (120 mg/1.5 mL, 240 mg/3 mL)

• Beractant: Suspension for intratracheal use (100 mg/4 mL)

• Bovine surfactant extract: Suspension (strengths vary by manufacturer)

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Neonatal Respiratory Distress Syndrome (RDS) — Prevention (Prophylaxis)

Eligibility: Preterm neonates <29 weeks gestation or extremely low birth weight; administer within 15 minutes of birth

Product Starting Dose Titration Usual Maintenance Dose Maximum Dose

Poractant alfa 200 mg/kg intratracheal May repeat 100 mg/kg at ≥12-hour intervals if persistent oxygen requirement Not applicable (acute therapy) 400 mg/kg total (3 doses)

Beractant 100 mg/kg (4 mL/kg) intratracheal May repeat every 6 hours based on FiO₂ requirement Not applicable (acute therapy) 400 mg/kg total (4 doses)

Clinical Notes:

• Prewarm vial to room temperature before use

• Administer via endotracheal tube under strict NICU protocol

• Adjust ventilator settings immediately post-administration

1. Neonatal Respiratory Distress Syndrome (RDS) — Rescue Treatment

Eligibility: Established RDS with FiO₂ >0.30–0.40 on mechanical ventilation

Product Starting Dose Titration Usual Maintenance Dose Maximum Dose

Poractant alfa 200 mg/kg intratracheal Additional 100 mg/kg doses at ≥12-hour intervals if needed Not applicable (acute therapy) 400 mg/kg total (3 doses)

Beractant 100 mg/kg (4 mL/kg) intratracheal Repeat every 6 hours based on clinical response Not applicable (acute therapy) 400 mg/kg total (4 doses)

Clinical Notes:

• Early administration (within first 2 hours of life) improves outcomes

• Ensure optimal ventilator synchronization before instillation

• Monitor for rapid improvement in lung compliance requiring ventilator adjustment

Secondary Indications — Adults (Off-label, if any)

Not applicable — Surfactant therapy is not established for adult use in India

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

1. Neonatal Respiratory Distress Syndrome (RDS)

Product Starting Dose Titration Maximum Dose Route Key Notes

Poractant alfa 200 mg/kg 100 mg/kg × up to 2 additional doses at ≥12-hour intervals 400 mg/kg total Intratracheal via ETT Prewarm to room temperature; rapid bolus technique

Beractant 100 mg/kg (4 mL/kg) Repeat every 6 hours × up to 3 additional doses 400 mg/kg total Intratracheal via ETT Tilt infant during dosing for even pulmonary distribution

Safety Monitoring:

• Continuous SpO₂ and heart rate monitoring during administration

• Blood gas analysis pre- and post-dose

• Ventilator parameter reassessment within 15–30 minutes

Secondary Indications — Paediatric Doses (Off-label, if any)

1. Meconium Aspiration Syndrome (MAS)

Parameter Details

Indication Severe MAS requiring mechanical ventilation

Dose 100–200 mg/kg poractant alfa intratracheal

Repeat dosing Once if oxygenation remains poor after 12–24 hours

Duration Single or repeated dosing over 12–24 hours

Evidence basis Case series and Indian specialist NICU practice

Status OFF-LABEL; Specialist only

1. Neonatal Pulmonary Hemorrhage (Salvage Therapy)

Parameter Details

Indication Severe pulmonary hemorrhage unresponsive to conventional management

Dose 100–200 mg/kg poractant alfa intratracheal

Repeat dosing At specialist discretion based on gas exchange

Evidence basis Limited case-series data; institutional protocols

Status OFF-LABEL; Specialist only

Age/Weight Restriction:

Not recommended below 24 weeks gestation or <500 g birth weight except under NICU specialist supervision with full informed parental consent

No adjustment required — Surfactant acts locally in the lungs and is not systemically absorbed

Rationale: Pulmonary surfactant is not absorbed systemically and does not undergo hepatic metabolism

• Unresuscitated neonates with congenital anomalies incompatible with life

• Known hypersensitivity to surfactant components (porcine protein for poractant alfa; bovine protein for beractant)

• Untreated pneumothorax or tension pneumothorax (must be drained before surfactant administration)

• Pulmonary hypoplasia — reduced efficacy expected

• Active air leak syndromes — pneumothorax must be drained prior to administration

• Rapid improvement in lung compliance post-dose — requires immediate ventilator adjustment to prevent volutrauma

• Monitor closely for pulmonary hemorrhage during and after administration

• Endotracheal tube may become blocked due to surfactant viscosity — ensure adequate suction equipment available

• Bradycardia and desaturation during instillation — may require temporary interruption of dosing

Not applicable — This drug is exclusively for neonatal use

Not applicable — This drug is exclusively for neonatal use

Not applicable — This drug is exclusively for neonatal use

None documented — Pulmonary surfactant acts locally within the alveoli and is not systemically absorbed; no systemic drug interactions expected

None reported in clinical practice — No systemic absorption occurs

• Transient bradycardia during instillation (common; usually resolves spontaneously)

• Oxygen desaturation during administration

• Endotracheal tube reflux or blockage due to viscosity

• Transient decrease in pulmonary compliance immediately post-instillation

• Mild hypotension (uncommon)

Adverse Effect Clinical Action

Severe pulmonary hemorrhage Immediate supportive management; consider repeat surfactant cautiously

Apnea or airway obstruction Reposition ETT; suction if needed; manual ventilation support

Severe hypoxia requiring resuscitation Stop instillation; provide full resuscitation

Anaphylactic/immunologic reaction (rare) Immediate resuscitation protocol; avoid re-exposure

→ All serious effects require immediate NICU intervention

During administration Continuous SpO₂, heart rate; observe for bradycardia, desaturation, ETT reflux

Post-dose (15–30 min) PaO₂/SpO₂, FiO₂ requirement, chest movement, ventilator parameter reassessment

Long-term None required after acute phase resolution

• Curosurf® (poractant alfa) — most commonly used

• Survanta® (beractant)

• Neosurf™ (bovine surfactant extract)

• Surfaid® (institutional procurement)

Product Approximate Price

Poractant alfa (120 mg/1.5 mL) ₹6,000–8,000 per vial

Poractant alfa (240 mg/3 mL) ₹8,500–9,500 per vial

Beractant (100 mg/4 mL) ₹5,000–7,000 per vial

Note: May be available at subsidized rates under Government NICU programmes (SNCU/Level III facilities)

• Poractant alfa permits higher initial dosing (200 mg/kg) compared to beractant (100 mg/kg); RCT data suggest faster improvement in oxygenation with poractant alfa

• Always prewarm surfactant to room temperature; cold surfactant has reduced spreading properties

• Confirm RDS diagnosis clinically and radiologically before administration — do not use empirically for all respiratory distress

• After instillation, immediately reassess ventilator settings — rapid compliance improvement can cause overdistension and pneumothorax if not adjusted

• Avoid unnecessary delays in administration — early surfactant (within 2 hours) produces better outcomes than late rescue

• Ensure correct ETT position and patency before dosing; surfactant retention in ETT reduces effective dose

surfactant; poractant alfa; beractant; respiratory distress syndrome; RDS; neonatology; NICU; meconium aspiration; preterm neonate; India

RxIndia v1.0 — 06 May 2025

• CDSCO approved product inserts (Curosurf®, Survanta®)

• National Neonatology Forum (NNF) India — Guidelines for Neonatal Care

• Indian Academy of Pediatrics (IAP) — Neonatal Resuscitation and Care Guidelines

• AIIMS NICU Protocols (New Delhi)

• ICMR Guidelines on Care of Preterm and Low Birth Weight Neonates

• Journal of Neonatology India — Practice Recommendations

• Select RCTs/meta-analyses (cited for off-label indications only)