Drug Description

Presentation

Indications

Adult Dosage

CUROSURF should only be administered by those trained and experienced in the care and resuscitation of preterm infants. It is administered via the intratracheal route in intubated infants undergoing mechanical ventilation for respiratory distress syndrome and whose heart rate and arterial oxygen concentration or oxygen saturation are being continuously monitored. Intubation should not be undertaken merely to administer surfactant.

CUROSURF is available in ready to use vials that should be stored in a refrigerator at +2 °C to +8 °C. The vial should be warmed to ambient temperature before use, for example by holding it in the hand for a few minutes and gently turned upside down, without shaking, in order to obtain a uniform suspension.

The suspension should be withdrawn from the vial using a sterile needle and syringe.

Posology

Prophylaxis

A single dose of 100 to 200 mg / Kg should be administered as soon as possible after birth (preferably within 15 minutes). Further doses of 100 mg/Kg can be given 6 to 12 hours after the first dose and then 12 hours later in babies who have persistent signs of RDS and remain ventilator-dependent (maximum total dose of 300 to 400 mg/Kg).

Rescue treatment

It is advisable to commence the treatment as soon as possible after diagnosing RDS. Therapy with CUROSURF starting more than 48 hours after diagnosing RDS has not been investigated. Initially, a single dose of 100 to 200 mg / Kg (1.25 to 2.5 ml/Kg) is advised.

Up to two further doses of 100 mg/Kg, administered at about 12 hourly intervals, may also be indicated in infants who remain intubated and in whom RDS is considered responsible for their persisting or deteriorating respiratory status (maximum total dose of 300 to 400 mg/Kg).

Method of administration

Curosurf can be administered either by :

Disconnecting the baby from the ventilator

Disconnect the baby momentarily from the ventilator and administer 1.25 to 2.5 ml/Kg of the suspension, as a single bolus, directly into the lower trachea via the endotracheal tube. Perform approximately one minute of hand-bagging and then reconnect the baby to the ventilator at the same settings as before administration. Further doses (1.25 ml/Kg) that may be required can be administered in the same manner.

OR

Without disconnecting the baby from the ventilator

Administer 1.25 to 2.5 ml/Kg of the suspension, as a single bolus, directly into the lower trachea by passing a catheter through the suction port and into the endotracheal tube. Further doses (1.25 ml/Kg) that may be required can be administered in the same manner.

After administration of CUROSURF, pulmonary compliance (chest expansion), can improve rapidly, thus requiring prompt adjustment of the ventilator settings.

The improvement of alveolar gas exchange can result in a rapid increase of arterial oxygen concentration, therefore, a rapid adjustment of the inspired oxygen concentration should be made to avoid hyperoxia. In order to maintain proper blood oxygenation values, in addition to periodic haemo-gas analysis, continuous monitoring of transcutaneous PaO₂ or oxygen saturation is also advisable.

Child Dosage

Elderly Dosage

Contra Indications

No specific contraindications are yet known.

Special Precautions

The baby's general condition should be stabilised. Correction of acidosis, hypotension, anaemia, hypoglycaemia and hypothermia is also recommended.

Babies born following very prolonged rupture of the membranes (greater than 3 weeks), may not show optimal response.

Surfactant administration can be expected to reduce the severity of RDS but cannot be expected to eliminate entirely the mortality and morbidity associated with preterm birth, as preterm babies may be exposed to other complications of their immaturity. After administration of CUROSURF a transient depression of cerebro-electrical activity has been recorded lasting 2 to 10 minutes. The impact of this is not clear

Interactions

Not known

Adverse Reactions

The baby's general condition should be stabilised. Correction of acidosis, hypotension, anaemia, hypoglycaemia and hypothermia is also recommended.

Babies born following very prolonged rupture of the membranes (greater than 3 weeks), may not show optimal response.

Surfactant administration can be expected to reduce the severity of RDS but cannot be expected to eliminate entirely the mortality and morbidity associated with preterm birth, as preterm babies may be exposed to other complications of their immaturity. After administration of CUROSURF a transient depression of cerebro-electrical activity has been recorded lasting 2 to 10 minutes. The impact of this is not clear.

Manufacturer

Drug Availability

Updated