PROSTIN VR PEDIATRIC Sterile Solution for intravascular infusion contains 500 micrograms alprostadil, more commonly known as prostaglandin E₁, in 1.0 ml dehydrated alcohol.

The chemical name for alprostadil is (11α, 13E, 15S)-11, 15 dihydroxy -9- oxoprost-13-en-1-oic acid, and the molecular weight is 354.49.

Alprostadil is a white to off-white crystalline powder with a melting point between 110° and 116° C. Its solubility at 35°C is 8000 micrograms per 100 ml double distilled water.

Caverject: For Intracavernosal Use

Caverject Sterile Powder contains alprostadil as the naturally occurring form of prostaglandin E₁ (PGE₁) and designated chemically as (11alpha, 13E, 15S)-11,15-dihydroxy-9-oxoprost-13-en-1-oic acid. The molecular weight is 354.49.

Alprostadil is a white to off-white crystalline powder with a melting point between 115° and 116°C. Its solubility at 35°C is 8000 micrograms per 100 milliliter double distilled water. Alprostadil is available as a sterile freeze-dried powder for intracavernosal use in two sizes: 10-microgram vial--When reconstituted as directed with 1 milliliter of bacteriostatic water for injection or sterile water, both preserved with benzyl alcohol 0.945% w/v, gives 1.13 milliliters of reconstituted solution. Each milliliter contains 10.5 micrograms alprostadil, 172 milligrams lactose, 47 micrograms sodium citrate, and 8.4 milligrams benzyl alcohol. The deliverable amount of alprostadil in each milliliter is 10 micrograms because approximately 0.5 microgram is lost due to adsorption to the vial and syringe; 20-microgram vial--When reconstituted as directed with 1 milliliter of bacteriostatic water for injection or sterile water, both preserved with benzyl alcohol 0.945% w/v, gives 1.13 milliliter of reconstituted solution. Each milliliter contains 20.5 micrograms alprostadil, 172 milligrams lactose, 47 micrograms sodium citrate, and 8.4 milligrams benzyl alcohol. The deliverable amount of alprostadil in each milliliter is 20 micrograms because approximately 0.5 microgram is lost due to adsorption to the vial and syringe. When necessary, the pH of alprostadil for injection was adjusted with hydrochloric acid and/or sodium hydroxide before lyophilization.

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