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    Active Ingredient
    Alprostadil 0.5 mg/ml

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Ampoule

    1 ml X 0.5 mg/ml

    partial basket chart 35608 16676

    Related information


    Dosage

    The infusion is generally initiated at a rate of 0.05 to 0.1 micrograms alprostadil per kilogram of body weight per minute. Starting dosages
    lower than that have been used with apparent good response, but this experience has been largely anecdotal. The most experience has been
    with 0.1 microgram/kg/min. After a therapeutic response is achieved (increased pO2 in infants with restricted pulmonary blood flow or increased systemic blood pressure and blood pH in infants with restricted systemic blood flow), reduce the infusion rate to provide the lowest possible dosage that maintains the response. If response to 0.1 microgram/kg/min is inadequate, dosage can be cautiously increased up to 0.4 microgram/kg/min although, in general, higher infusion rates do not produce greater effects. The preferable route of administration for Sterile solution is by continuous intravenous infusion into a large vein. Alternatively, Sterile solution may be administered through an umbilical artery catheter with its tip positioned at the ductal opening. Increases in blood oxygenation (pO2) are similar by both routes of administration.
    Dilution instructions: To prepare infusion solutions, dilute 0.2 ml, 0.5 ml or 1 ml Concentrate for solution for infusion with sterile sodium chloride solution or sterile dextrose (or glucose) solution. If undiluted PROSTIN VR Concentrate for solution for infusion comes in direct contact with a 5 plastic container, plasticizers are leached from the sidewalls. The solution may turn hazy and the appearance of the container may change. Should this occur, the solution should be discarded and the plastic container should be replaced. This appears to be a concentration-dependent phenomenon. To minimize the possibility of haze formation, PROSTIN VR Concentrate for solution for infusion should be added directly to the intravenous infusion solution avoiding contact with the walls of plastic containers. Dilute to volumes appropriate for the pump delivery system available. Prepare fresh dilution every 24 hours. Discard any dilution more than 24 hours old.
    IMPORTANT No ampoule file is needed to open the ampoules. The neck of the ampoule is prescored at the point of constriction. A colored dot on the ampoule head helps to orientate the ampoule. Take the ampoule and face the colored dot. The ampoule opens easily by placing the thumb on the colored dot and gently pressing downwards as shown.
    For full details see prescribing information.


    Indications

    Palliative therapy to temporily maintain potency ductus arteriosus until corrective/palliative surgery on neonates with ductus dependent congenital heart defect.


    Contra-Indications

    Hypersensitivity to the active substance (alprostadil) or to any of the excipients.


    Special Precautions

    Discard any dilution more than 24 hours old. Sterile solution should be administered only by medically trained personnel in facilities in which pediatric patients can receive or have access to pediatric intensive care. Approximately 10-12% of neonates with congenital heart defects treated with Sterile solution experienced apnea. Apnea is most often seen in neonates, especially those weighing less than 2 kg at birth, and usually appears during the first hour of drug infusion. Therefore, Sterile solution should only be used where ventilatory assistance is immediately available. Pathologic studies of the ductus arteriosus and pulmonary arteries of infants treated with prostaglandin E1 have disclosed histologic changes compatible with a weakening effect upon these structures. The specificity or clinical relevance of these findings is not known. Cortical proliferation of the long bones only occurred during long-term infusions of alprostadil in neonates and dogs (14 days or more). The proliferation in infants regressed after withdrawal of the drug. Use Sterile solution cautiously in neonates with histories of bleeding tendencies. Care should be taken to avoid the use of Sterile solution in neonates with respiratory distress syndrome (hyaline membrane disease), which sometimes can be confused with cyanotic heart disease. In the event that full diagnostic facilities are not immediately available, the diagnostic should be based on the presence of cyanosis (pO2 less than 40 torr) and x-ray evidence of a restricted pulmonary blood flow. 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 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. Sterile solution should be infused for the shortest time and at the lowest dose which will produce the desired effects. The risk of long-term infusion of Sterile solution should be weighed against the possible benefits that these critically ill infants might derive from its administration. In all neonates, intermittently monitor arterial pressure by umbilical artery catheter, auscultation, or with a Doppler transducer. Should arterial pressure fall significantly, decrease the rate of infusion immediately. A weakening of the wall of the ductus arteriosus and pulmonary artery has been reported, particularly during prolonged administration.
    For full details see prescribing information.


    Side Effects

    In neonates whose ductus arteriosus must be kept patent, the most frequent adverse reactions observed with Sterile solution infusion are related to its known pharmacological effects. The incidences of the following most common (more than 1%) adverse reactions are based on U.S. and foreign experience in 436 patients.
    Occurred rather frequently: Apnea, flushing (but less frequent if administered intravenously), and bradycardia.
    Occurred sporadically: Seizures, hypotension, tachycardia, and diarrhea. The relationship of the following adverse events to the drug is unknown.
    In order of decreasing frequency, they were: sepsis, cardiac arrest, disseminated intravascular coagulation, hypokalemia and edema.
    For full details see prescribing information.


    Drug interactions

    No drug interactions have been reported to occur between alprostadil and the standard therapy employed in neonates with congenital heart defects. Standard therapy includes antibiotics, such as penicillin or gentamicin; vasopressors, such as dopamine or isoproterenol; cardiac glycosides; and diuretics, such as furosemide Warfarin, heparin.
    For full details see prescribing information.


    Pregnancy and Lactation

    Not applicable.


    Overdose

    Apnea, bradycardia, pyrexia, hypotension and flushing may be signs of drug overdose. If apnea or bradycardia occur, the infusion should be discontinued and the appropriate medical treatment initiated. Caution should be used if the infusion is restarted. If pyrexia or hypotension occur, the infusion rate should be reduced until these symptoms subside. Flushing is usually attributed to incorrect intra-arterial catheter placement is usually alleviated by repositioning the tip of the catheter.


    Manufacturer
    PFIZER Manufacturing Belgium NV, Belgium
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