Overview
11 DESCRIPTION Poractant alfa is an extract of natural porcine lung (pulmonary) surfactant consisting of 99% polar lipids (mainly phospholipids) and 1% hydrophobic low molecular weight surfactant associated proteins (SP). The molecular weight of SP-B is 8.7 KDa and the molecular weight of SP-C is 3.7 KDa.
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Endogenous pulmonary surfactant reduces surface tension at the air-liquid interface of the alveoli during ventilation and stabilizes the alveoli against collapse at resting transpulmonary pressures. A deficiency of pulmonary surfactant in preterm infants results in Respiratory Distress Syndrome (RDS) characterized by poor lung expansion, inadequate gas exchange, and a gradual collapse of the lungs (atelectasis). CUROSURF compensates for the deficiency of surfactant and restores surface activity to the lungs of these infants. 12.2 Pharmacodynamics In vitro - CUROSURF lowers minimum surface tension to ≤ 4mN/m as measured by the Wilhelmy Balance System. 12.
Indications
- 1 INDICATIONS AND USAGE CUROSURF ® (poractant alfa) Intratracheal Suspension is indicated for the rescue treatment of Respiratory Distress Syndrome (RDS) in premature infants. CUROSURF reduces mortality and pneumothoraces associated with RDS. CUROSURF is a surfactant indicated for the rescue treatment, including the reduction of mortality and pneumothoraces, of Respiratory Distress Syndrome (RDS) in premature infants. ( 1 )
Common Doses
- 2.5 mL
- 1.25 mL
- 5 mL
- 0.625 mL
Dosage
2 DOSAGE AND ADMINISTRATION Before administering CUROSURF, assure proper placement and patency of endotracheal tube ( 2.1 ) Administer intratracheally either in ( 2.1 ): Two divided aliquots through a 5 French end-hole catheter; or A single bolus through secondary lumen of a dual lumen endotracheal tube without interrupting mechanical ventilation Initial recommended dose is 2.5 mL/kg birth weight ( 2.2 ) Up to two repeat doses of 1.25 mL/kg birth weight may be administered at approximately 12-hour intervals ( 2.2 ) Maximum total dose (initial plus repeat doses) is 5 mL/kg ( 2.
Contraindications
- 4 CONTRAINDICATIONS None. None.
Side Effects
- 6 ADVERSE REACTIONS Common adverse reactions associated with the administration of CUROSURF include bradycardia, hypotension, endotracheal tube blockage, and oxygen desaturation. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Chiesi USA, Inc. at 1-888-661-9260 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates...
Interactions
- No major interactions listed on the FDA label. Always consult a healthcare professional.