Infasurf Adverse Reactions

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Warnings Special Precautions Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Full Prescribing Info

Adverse Reactions

The most common adverse reactions associated with Infasurf dosing procedures in the controlled trials were cyanosis (65%), airway obstruction (39%), bradycardia (34%), reflux of surfactant into the endotracheal tube (21%), requirement for manual ventilation (16%), and reintubation (3%). These events were generally transient and not associated with serious complications or death.
The incidence of common complications of prematurity and RDS in the four controlled Infasurf trials are presented in Table 3. Prophylaxis and treatment study results for each surfactant are combined. (See Table 3.)

Click on icon to see table/diagram/image

Follow-up Evaluations: Two-year follow-up data of neurodevelopmental outcomes in 415 infants enrolled in 5 centers that participated in the Infasurf vs. Exosurf Neonatal controlled trials demonstrated significant developmental delays in equal percentages of Infasurf and Exosurf Neonatal patients.

View ADR Monitoring Form

Infasurf Adverse Reactions

Manufacturer:

ONY

Distributor:

Pharm-D