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Poractant Side Effects

For the Consumer

Applies to poractant: intratracheal suspension

Side effects include:

Transient bradycardia, hypotension, endotracheal tube blockage, decreased oxygen saturation.

For Healthcare Professionals

Applies to poractant: intratracheal suspension

General

Transient adverse effects include bradycardia, hypotension, endotracheal tube blockage and oxygen desaturation.[Ref]

Cardiovascular

Very common (10% or more): Patent ductus arteriosus (up to 60%) in premature infants
Rare (less than 0.1%): Bradycardia, hypotension[Ref]

Patent ductus arteriosus has also been reported with other exogenous surfactants and is attributed to hemodynamic changes induced by the rapid expansion of the lungs with surfactant administration.[Ref]

Other

Very common (10% or more): Acquired pneumonia (up to 17%) and septicemia (14%) in premature infants
Uncommon (0.1% to 1%): Sepsis[Ref]

Nervous system

Very common (10% or more): Intracranial hemorrhage (up to 51%) in premature infants
Uncommon (0.1% to 1%): Intracranial hemorrhage
Frequency not reported: Abnormal electroencephalogram[Ref]

The occurrence of intracranial hemorrhages after instillation of this drug has been related to the reduction in mean arterial blood pressure and early peaks in arterial oxygenation (PaO2). High PaO2 peaks by ventilator adjustment immediately after instillation should be avoided.
Preterm newborns have relatively high incidences of cerebral hemorrhages and cerebral ischemia, reported as periventricular leukomalacia and hemodynamic anomalies such as patent ductus arteriosus and persistence of fetal circulation despite the provision of intensive care.
Seizures may also occur in the perinatal period.[Ref]

Respiratory

Very common (10% or more): In premature infants: Pulmonary interstitial emphysema (up to 23%), pneumothorax (up to 21%), bronchopulmonary dysplasia (up to 18%)
Uncommon (0.1% to 1%): Pneumothorax
Rare (less than 0.1%): Bronchopulmonary dysplasia, decreased oxygen saturation
Frequency not reported: Hyperoxia, cyanosis neonatal, apnea, endotracheal intubation complication
Postmarketing reports: Pulmonary hemorrhage (known complication of premature birth and very low birth)[Ref]

Apnea and sepsis may occur as consequences of the immaturity of the infants.
Preterm babies commonly develop hematological and electrolyte disorders which may be worsened by severe illness and mechanical ventilation. Other complications of prematurity, including the following disorders directly related to illness severity and use of mechanical ventilation necessary for reoxygenation, may also occur: Pneumothorax, interstitial pulmonary emphysema and pulmonary hemorrhage. The prolonged use of high concentrations of oxygen and mechanical ventilation are associated with the development of bronchopulmonary dysplasia and retinopathy of prematurity.[Ref]

References

1. "Product Information. Curosurf (poractant)" Dey Laboratories, Napa, CA.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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