Generic name: poractant alfa
Dosage form: intratracheal suspension
This dosage information does not include all the information needed to use Curosurf safely and effectively. See full prescribing information for Curosurf.
The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.
FOR INTRATRACHEAL ADMINISTRATION ONLY.
CUROSURF is administered intratracheally by instillation through a 5 French end-hole catheter, and briefly disconnecting the endotracheal tube from the ventilator. Alternatively, CUROSURF may be administered through the secondary lumen of a dual lumen endotracheal tube without interrupting mechanical ventilation.
Before administering CUROSURF, assure proper placement and patency of the endotracheal tube. At the discretion of the clinician, the endotracheal tube may be suctioned before administering Curosurf. The infant should be allowed to stabilize before proceeding with dosing.
The initial recommended dose of CUROSURF is 2.5 mL/kg birth weight. This dose may be determined from the CUROSURF dosing chart below.
For endotracheal tube instillation using a 5 French end-hole catheter
Slowly withdraw the entire contents of the vial of CUROSURF into a 3 or 5 mL plastic syringe through a large-gauge needle (e.g., at least 20 gauge). Attach the pre-cut 8-cm 5 end-hole French catheter to the syringe. Fill the catheter with CUROSURF. Discard excess CUROSURF through the catheter so that only the total dose to be given remains in the syringe.
Immediately before CUROSURF administration, the infant's ventilator settings should be changed to a rate of 40-60 breaths/minute, inspiratory time 0.5 second, and supplemental oxygen sufficient to maintain SaO2>92%. Keep the infant in a neutral position (head and body in alignment without inclination). Briefly disconnect the endotracheal tube from the ventilator. Insert the pre-cut 5 French catheter into the endotracheal tube and instill the first aliquot (1.25 mL/kg birth weight) of CUROSURF. The infant should be positioned such that either the right or left side is dependent for this aliquot. After the first aliquot is instilled, remove the catheter from the endotracheal tube and manually ventilate the infant with 100% oxygen at a rate of 40-60 breaths/minute for one minute. When the infant is stable, reposition the infant such that the other side is dependant and administer the remaining aliquot using the same procedures. Do not suction airways for 1 hour after surfactant instillation unless signs of significant airway obstruction occur. After completion of the dosing procedure, resume usual ventilator management and clinical care. In the clinical trials, ventilator management was modified to maintain a PaO2 of about 55 mmHg, PaCO2 of 35-45, and pH >7.3.
For endotracheal instillation using the secondary lumen of a dual lumen endotracheal tube
Slowly withdraw the entire contents of the vial of CUROSURF into a 3 or 5 mL plastic syringe through a large-gauge needle (e.g., at least 20 gauge). Do not attach 5 French end-hole catheter. Keep the infant in a neutral position (head and body in alignment without inclination). Administer CUROSURF through the proximal end of the secondary lumen of the endotracheal tube as a single dose, given over 1 minute, and without interrupting mechanical ventilation. After completion of this dosing procedure, ventilatory management may require transient increases in FiO2, ventilatory rate, or PIP.
Up to two repeat doses of 1.25 mL/kg birth weight each may be administered, using the same techniques described for the initial dose. Repeat doses should be administered, at approximately 12-hour intervals, in infants who remain intubated and in whom RDS is considered responsible for their persisting or deteriorating respiratory status. The maximum recommended total dose (sum of the initial and up to two repeat doses) is 5 mL/kg.
|CUROSURF DOSING CHART|
|WEIGHT (grams)||INITIAL DOSE 2.5mL/kg||REPEAT DOSE 1.25mL/kg||WEIGHT (grams)||INITIAL DOSE 2.5mL/kg||REPEAT DOSE 1.25mL/kg|
|EACH DOSE (mL)||EACH DOSE (mL)|
Directions for Use
CUROSURF should be inspected visually for discoloration prior to administration. The color of CUROSURF is white to creamy white. CUROSURF should be stored in a refrigerator at +2 to +8°C (36-46°F). Before use, the vial should be slowly warmed to room temperature and gently turned upside-down, in order to obtain a uniform suspension. DO NOT SHAKE.
Instructions for use
Unopened, unused vials of CUROSURF that have warmed to room temperature can be returned to refrigerated storage within 24 hours for future use.
Do not warm to room temperature and return to refrigerated storage more than once. Protect from light. Each single-use vial should be entered only once and the vial with any unused material should be discarded after the initial entry.
Transient episodes of bradycardia, decreased oxygen saturation, reflux of the surfactant into the endotracheal tube, and airway obstruction have occurred during the dosing procedure of CUROSURF.
These events require interrupting the administration of CUROSURF and taking the appropriate measures to alleviate the condition. After stabilization, dosing may resume with appropriate monitoring.