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PROSTIN VR STERILE is a brand name for Alprostadil. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Prostin VR is indicated to temporarily maintain the patency of the ductus arteriosus until corrective or palliative surgery can be performed in infants who have congenital defects and who depend upon the patent ductus for survival. Such congenital heart defects include pulmonary atresia, pulmonary stenosis, tricuspid…
Verbatim from this product's MHRA label. Tap a section to expand.
1 micrograms/kg/min. 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.
4). 005 microgram/kg/min) alprostadil have been used successfully in neonates, specifically when transport of the infant is necessary. 1 micrograms/kg/min is currently unclear. 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), Prostin VR 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. 6. The diluted solution should contain no more than 20 micrograms/ml alprostadil.
PARTICULAR CARE SHOULD BE TAKEN IN CALCULATING AND PREPARING DILUTIONS OF PROSTIN VR.
The most frequent adverse reactions observed with Prostin VR infusion in neonates with ductal- dependent congenital heart defects are related to the drug's known pharmacological effects. The following undesirable effects have been observed and reported during treatment with alprostadil (436 neonates treated) with the following frequencies: Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000).
System Organ Class Frequency Undesirable effects Nervous system disorders Common Seizures Cardiac disorders Common Bradycardia, hypotension, tachycardia Vascular disorders Uncommon Vascular fragility Respiratory, thoracic and mediastinal disorders Very common Apnoea Metabolism and nutrition disorders Common Hypokalaemia Common DiarrhoeaGastrointestinal disorders Uncommon Gastric obstruction, gastric mucosal hypertrophy Musculoskeletal and connective tissue disorders Uncommon Exostosis Very common Transient pyrexiaGeneral disorders and administration site conditions Common Cutaneous vasodilatation (flushing)* *This is the only adverse event directly related to the route of administration, being more frequent with intra-arterial administration.
The relationship of the following adverse events to the drug, in decreasing frequency, is unknown: sepsis, cardiac arrest, disseminated intravascular coagulation, and oedema. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Prostin VR 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 Prostin VR should be used where ventilatory assistance is immediately available.
Prostin VR 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 Prostin VR 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 Prostin VR 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.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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.
, 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. Excipient information Each 1 ml vial of Prostin VR contains 790 mg anhydrous ethanol (see section 2), which is equivalent to less than 20 ml beer or 8 ml wine.
9 mg/100 ml. For comparison, for an adult drinking a glass of wine or 500 ml of beer, the BAC is likely to be about 50 mg/100 ml. The ethanol content in this preparation is likely to affect children. These effects may include somnolence and changes in behaviour.
2). g. propylene glycol or ethanol may lead to accumulation of ethanol and induce adverse effects, particularly in young children with low or immature metabolic capacity. The ethanol content in this medicinal product should be carefully considered in the following patient groups who may be at higher risk of ethanol-related adverse effects: - Patients with liver disease - Patients with epilepsy The amount of ethanol in this medicinal product may alter the effects of other medicines.