Rx Item-Alprostadil 500 mcg/ml Vial 5X1ml By Teva Pharma Refrigerated

ALPROSTADIL- alprostadil injection
Bedford Laboratories

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


DESCRIPTION
Alprostadil Injection, USP for intravascular infusion contains 500 micrograms alprostadil, more commonly known as prostaglandin E1 in mL dehydrated alcohol.
The chemical name for alprostadil is (1R ,2R ,3R)-3-Hydroxy-2-[(E)-(3S)-3-hydroxy-1-octenyl]-5-oxocyclopentane heptanoic acid, and the molecular weight is 354.49.
Alprostadil is white to off-white crystalline powder with melting point between 110? and 116? C. Its solubility at 35? is 8000 micrograms per 100 mL double distilled water.
CLINICAL PHARMACOLOGY
Alprostadil (prostaglandin E1 is one of 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. Intravenous doses of to 10 micrograms of alprostadil per kilogram of body weight lower the blood pressure in mammals by decreasing peripheral resistance. Reflex increases in cardiac output and rate accompany the reduction in blood pressure.
INDICATIONS AND USAGE
Alprostadil injection 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 O2 values; that is, patients with low O2 values respond best, and patients with O2 values of 40 torr or more usually have little response.
Alprostadil injection should be administered only by trained personnel in facilities that provide pediatric intensive care.
DOSAGE AND ADMINISTRATION
The preferred route of administration for alprostadil injection is continuous intravenous infusion into large vein. Alternatively, alprostadil injection may be administered through an umbilical artery catheter placed at the ductal opening. Increases in blood O2 (torr) have been the same in neonates who received the drug by either route of administration
HOW SUPPLIED
Alprostadil Injection, USP is available as follows:
NDC 55390-503-10 1 mL vials, individually-boxed.
Each mL contains 500 micrograms alprostadil in dehydrated alcohol.
Store in refrigerator at 2? to 8? (36? to 46? F).

Rx Item-Alprostadil 500 mcg/ml Vial 5X1m
NDC No.00703-1501-02 UPC/GTIN No.3-07031-50102-6 MPN No. 150102 Only Lic.-Physician, Pharmacy, Dentist, Drug Mfg, Dist., Gov, Hospital, Lic.Lab, Naturalist, Naturopath, NP, Optometrist, Pharmacist, PA

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Teva Pharmaceuticals USA

ALPROSTADIL INJECTION VIA
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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