Adult Dosing

• Not applicable for use in adults

Pediatric Dosing

Prophylaxis of Respiratory Distress Syndrome (RDS)

• Premature infants/Infants <29 wks of gestational age: 3 mL/kg intratracheally; q12 hrs for a total up to 3 doses
• Max: 9 mL/kg

Note:

• Start within 30 min. of birth

Treatment of Respiratory Distress Syndrome (RDS)

• Infants <72 hrs of age: 3mL/kg Infasurf intratracheally; q12 hrs for a total up to 3 doses
• Max: 9 mL/kg

Note:

• Give within 8 hrs of symptom appearance or ASAP after ventilation

[Outline]

• Adult Dosing
• Pediatric Dosing

• Prophylaxis and treatment of respiratory distress syndrome (RDS) in the newborn

• Hypersensitivity to any of the ingredients of the product

• N/A

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

• Intended for intratracheal use only
• Endotracheal intubation, ventilator management, and general care of premature infants at risk for RDS should be carried out in organized care unit by well equipped and experienced staff
• Monitor the patients for changes in respiratory condition and accordingly modify oxygen therapy and ventilatory support
• Discontinue the treatment and take appropriate measures on development of transient episodes of reflux into the endotracheal tube, cyanosis, bradycardia, or airway obstruction
• Avoid repeated dosing
• Intraventricular hemorrhage (IVH) and periventricular leukomalacia (PVL) may occur
• Safety and efficacy is not established for use of drug in conjunction with experimental therapies of RDS
• Efficacy data is limited to 100 mg phospholipid/kg body weight and up to a total of 4 doses

Pregnancy category: Not applicable

Breastfeeding: Not applicable.

• RESP: Airway obstruction, reflux of surfactant into the endotracheal tube, requirement for manual ventilation reintubation, apnea, pulmonary air leaks, pulmonary interstitial emphysema, pulmonary hemorrhage, hypoxia, hypoventilation, ETT displacement, ETT obstruction
• DERM: Cyanosis
• CV: Bradycardia, patent ductus arteriosus, intraventricular hemorrhage, periventricular leukomalacia
• CNS: Severe intracranial hemorrhage
• RESP: Pulmonary air leaks, pulmonary interstitial emphysema, pulmonary hemorrhage
• GI: Necrotizing enterocolitis
• MISC: Sepsis

• Lung surfactant; stabilizes alveoli by modifying alveolar surface tension and restores surface activity
• Metabolism: Unknown
• Excretion: Unknown
• Half life: Unknown

US Trade Name(s)

• Infasurf

US Availability

Infasurf

• SUSP: 35 mg/mL (6 mL vials)

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Pulmonary

Lung Surfactants