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Ashford Laboratories Pvt. Ltd.,
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S. V. Road, Santacruz (West),
Mumbai (Bombay) - 400 054. India.
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Email:info@ashfordlab.com

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Ashford Laboratories,
4-11-24-1402 Fukae Kitamachi,
Higashi Nada Ku, Kobe 658-0013,
Japan.
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PROSTADIL™ Injection Alprostadil (Prostaglandin E1) 500mcg/ ml DESCRIPTION ADVERSE REACTIONS
Prostadil Pediatric Sterile Solution for intravascular infusion contains 500 micrograms alprostadil, more commonly known as prostaglandin E1 in 1.0 ml dehydrated alcohol.

CLINICAL PHARMACOLOGY
Alprostadil (prostaglandin E1) is one of the family of naturally occurring acidic lipids with various pharmacologic effects. Vasodilation, inhibition of platelet aggregation and stimulation of intestinal and uterine smooth muscle are among the most notable of these effects. In infants with restricted systemic blood flow alprostadil often increased pH in those having acidosis, increased systemic blood pressure, and decreased the ratio of pulmonary artery pressure to aortic pressure.

Alprostadil must be infused continuously because it is very rapidly metabolized. The metabolites are excreted primarily by the kidney, and The preferred route of administration for PROSTADIL Pediatric Sterile Solution is excretion is essentially complete within 24 hours after administration. No unchanged alprostadil has been found in the urine, and there is no evidence of tissue retention of alprostadil or its metabolites.

INDICATIONS AND USAGE
PROSTADIL Pediatric Sterile Solution is indicated for palliative, not definitive, therapy to temporarily maintain the patency of the ductus arteriosus until corrective or palliative surgery can be performed in neonates who have congenital heart defects and who depend upon the patent ductus for survival. Such congenital heart defects include pulmonary atresia, pulmonary stenosis, tricuspid atresia, tetralogy of Fallot, interruption of the aortic arch, coarctation of the aorta, or transposition of the great vessels with or without other defects. In infants with restricted pulmonary blood flow, the increase in blood oxygenation is inversely proportional to pretreatment pO2 values; that is, patients with low pO2 values respond best, and patients with pO2 values of 40 or more usually have little response. PROSTADIL Pediatric should be administered only by trained personnel in facilities that provide pediatric intensive care.

WARNINGS
NOTE: PROSTADIL Pediatric Sterile Solution must be diluted before it is administered. Neonates receiving PROSTADIL Pediatric are recommended doses for more than 120 hours should be closely monitored for evidence of antral hyperplasia and gastric outlet obstruction. PROSTADIL Pediatric should be infused for the shortest time and at the lowest dose that will produce the desired effects.

PRECAUTIONS
Because alprostadil inhibits platelet aggregation, use PROSTADIL Pediatric cautiously in neonates with bleeding tendencies. PROSTADIL Pediatric should not be used in neonates with respiratory distress syndrome. Necessary Monitoring: In all neonates, arterial pressure should be monitored intermittently by umbilical artery catheter, auscultation, or with a Doppler transducer. Should arterial pressure fall significantly, decrease the rate of infusion immediately.

Apnea is experienced by about 10 to 12% of neonates with congenital heart defects treated with PROSTADIL Pediatric Sterile Solution. Apnea is most often seen in neonates weighing less than 2 kg at birth and usually appears during the first hour of drug infusion. Therefore, respiratory status should be monitored throughout treatment, and PROSTADIL Pediatric should be used where ventilatory assistance is immediately available

Carcinogenesis, Mutagenesis, and Impairment of Fertility
Long-term carcinogenicity studies and fertility studies have not been done. The Ames and Alkaline Elution assays reveal no potential for mutagenesis.

DRUG INTERACTIONS
No drug interactions have been reported between PROSTADIL and the standard therapy in neonates with restricted pulmonary or systemic blood flow.

ADVERSE REACTIONS
Apnea has been reported in the neonates treated. Other common adverse reactions reported have been fever and seizures. The following reactions have been reported: cerebral bleeding, hyperextension of the neck, hyperirritability.

OVERDOSAGE
Apnea, bradycardia, pyrexia, hypotension, and flushing may be signs of drug overdosage. If apnea or bradycardia occurs, discontinue the infusion, and provide appropriate medical treatment. Caution should be used in restarting the infusion. If pyrexia or hypotension occurs, reduce the infusion rate until these symptoms subside. Flushing is usually a result of incorrect intraarterial catheter placement, and the catheter should be repositioned.

DOSAGE AND ADMINISTRATION
The preferred route of administration for PROSTADIL Pediatric Sterile Solution is continuous intravenous infusion into a large vein. Alternatively, PROSTADIL Pediatric may be administered through an umbilical artery catheter placed at the ductal opening. Increases in blood pO2 have been the same in neonates who received the drug by either route of administration.

A starting dose of 0.1 micrograms per kilogram of body weight per minute is the recommended starting dose based on clinical studies; however, adequate clinical response has been reported using a starting dose of 0.05 micrograms per kilogram of body weight per minute. After a therapeutic response is achieved (increased pO in infants with restricted pulmonary blood flow or increased 2systemic 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. This may be accomplished by reducing the dosage from 0.1 to 0.05 to 0.025 to 0.01 micrograms per kilogram of body weight per minute. If response to 0.05 micrograms per kilogram of body weight per minute is inadequate, dosage can be increased up to 0.4 micrograms per kilogram of body weight per minute although, in general, higher infusion rates do not produce greater effects.

Dilution Instructions
To prepare infusion solutions, dilute 1 ml of PROSTADIL Pediatric Sterile Solution with Sodium Chloride Injection USP or Dextrose Injection USP. Undiluted PROSTADIL Pediatric Sterile Solution may interact with the plastic sidewalls of volumetric infusion chambers causing a change in the appearance of the chamber and creating a hazy solution. Should this occur, the solution and the volumetric infusion chamber should be replaced. Dilute to volumes appropriate for the pump delivery system available. Prepare fresh infusion solutions every 24 hours. Discard any solution more than 24 hours old (TABLE1)

      Sample Dilutions and Infusion Rates to Provide a Dosage of 0.1 Micrograms per Kilogram of Body Weight per Minute

Add 1 ampoule (500 micrograms) alprostadil to Approximate Concentration of resulting solution (micrograms/ml) Infusion rate (ml/min per kg of body weight)
 250ml 2 0.02
 100ml 5 0.02
 50ml 10 0.01
 25ml 20 0.005

Example
To provide 0.1 micrograms/kilogram of body weight per minute to an infant weighing 2.8 kilograms using a solution of 1 ampoule PROSTADIL Pediatric in 100 ml of saline or dextrose: INFUSION RATE = 0.02 ml/min per kg X 2.8 kg = 0.056 ml/min or 3.36 ml/hr.

STORAGE
Store between 2°C to 8°C in air tight containers.

PRESENTATION
Each Box contains 1 ampoule of 1 ml.

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