Alprospire indicated for For palliative therapy to maintain the patency of the ductus arteriosus.

Compostion

• Each 1 ml of Alprospire contains 500 micrograms (0.5 mg) alprostadil.
• PHARMACEUTICAL FORM: Concentrate for Solution for Infusion (Clear, colourless solution).

Dosage and method of administration

For administration by intravenous drip or constant rate infusion pump.

In infants with lesions restricting pulmonary blood flow (blood is flowing through the ductus arteriosus from the aorta to the pulmonary artery), Alprospire may be administered by continuous infusion through an umbilical artery catheter placed at or just above the junction of the descending aorta and the ductus arteriosus, or intravenously.

Adverse effects have occurred with both routes of administration, but the types of reactions are different. A higher incidence of flushing has been associated with intra-arterial than with intravenous administration.

The infusion is generally initiated at a rate of 0.05 to 0.1 micrograms alprostadil per kilogram of body weight per minute. The most experience has been with 0.1 micrograms/kg/min.

After a therapeutic response (an increase in pO2 in neonates with restricted pulmonary blood flow or an increase in systemic blood pressure and blood pH in neonates with restricted systemic blood flow) has been obtained, the infusion rate should be reduced to the lowest possible dosage that will maintain the desired response.

Paediatric population: Alprospire contains a quantity of ethanol that is likely to affect children.

Special warnings and precautions for use

Alprospire should be administered only by well trained healthcare professionals and in facilities with immediate access to paediatric intensive care.

Apnoea may occur in about 10-12% of neonates with congenital heart defects treated with alprostadil. There is some evidence that apnoea is dose related. Apnoea is most often seen in neonates weighing less than 2 kg at birth and usually appears during the first hour of drug infusion. Therefore Alprospire should be used where ventilatory assistance is immediately available.

Alprospire should be infused for the shortest time possible and at the lowest dose that will produce the desired effects. The risk of long-term infusion of Alprospire should be weighed against the possible benefits that critically ill infants may derive from its administration.

Pathologic studies of the ductus arteriosus and pulmonary arteries of infants treated with prostaglandin E1 have disclosed histologic changes related with the weakening effect upon these structures. The specificity or clinical relevance of these results is not known.

Cortical proliferation of the long bones has followed long-term infusions of alprostadil in infants and dogs. The proliferation in infants regressed after withdrawal of the drug.

Since prostaglandin E1 is a potent inhibitor of platelet aggregation, use Alprospire cautiously in neonates with histories of bleeding tendencies.

Alprostadil should not be used in neonates (or infants) with respiratory distress syndrome (hyaline membrane disease). A differential diagnosis should always be made between respiratory distress syndrome and cyanotic heart disease (restricted pulmonary blood flow). In the event that full diagnostic facilities are not immediately available, the diagnosis should be based on the presence of cyanosis (pO2 less than 40 torr) and x-ray
evidence of a restricted pulmonary blood flow.

Arterial pressure should be monitored by umbilical artery catheter, auscultation or with a Doppler transducer. Should arterial pressure fall significantly, the rate of infusion should be immediately decreased.

Weakening of the ductus arteriosus wall and pulmonary artery has been reported, particularly during prolonged administration.

The administration of alprostadil to neonates may result in gastric outlet obstruction secondary to antral hyperplasia. This effect appears to be related to duration of therapy and cumulative dose of the drug. Neonates receiving alprostadil at recommended doses for more than 120 hours should be closely monitored for evidence of antral hyperplasia and gastric outlet obstruction.

In neonates (or infants) with decreased pulmonary blood flow, the oxygenation increase is inversely proportional to the previous pO2 values; ie, better responses are obtained in patients with low pO2 values (less than 40 mmHg), whereas patients with high pO2 values (more than 40 mmHg) have usually a minimal response.

In neonates (or infants) with decreased pulmonary blood flow, alprostadil efficacy is measured by monitoring blood oxygenation increase. In neonates (or infants) with decreased systemic blood flow the efficacy is determined by monitoring the increase in systemic blood pressure and blood pH.

Alprospire – Product Information

	Prostin VR – English Information Leaflet.
	Alprospire – Simplified Arabic Information from Pharmacia1.com.

• License Holder: Inspire Pharma Company / Egypt.
• ATC code: C01EA01 / alprostadil .

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