Source: FDA, National Drug Code (US)
Unoprostone Isopropyl is a docosanoid, a structural analogue of an inactive biosynthetic cyclic derivative of arachidonic acid, 13, 14-dihydro-15-keto-prostaglandin F2α. Its chemical name is isopropyl (+)-7[(1R, 2R, 3R, 5S)-3,5-dihydroxy-2-(3-oxodecyl) cyclopentyl]-5-heptenoate. Its molecular formula is C25H44O5 and its chemical structure is:
Unoprostone isopropyl is a clear, colorless viscous liquid that is very soluble in acetonitrile, ethanol, ethyl acetate, isopropanol, dioxane, ether, and hexane. It is practically insoluble in water. RESCULA (unoprostone isopropyl ophthalmic solution) 0.15% is supplied as a sterile, isotonic, buffered aqueous solution of unoprostone isopropyl with a pH of 5.0–6.5 and an osmolality of 235-300 mOsmol/kg.
Each mL of Rescula contains 1.5 mg of unoprostone isopropyl. Benzalkonium chloride 0.015% is added as a preservative. Inactive ingredients are: mannitol, polysorbate 80, edetate disodium, sodium hydroxide or hydrochloric acid (to adjust pH), and water for injection.
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RESCULA (unoprostone isopropyl ophthalmic solution) 0.15% is a clear, isotonic, buffered, preserved colorless solution of unoprostone isopropyl 0.15% (1.5 mg/mL). RESCULA 0.15% is supplied as 5 mL solution in a 7.5 mL natural polypropylene bottle with a natural polypropylene dropper tip, a turquoise polypropylene closure and a clear tamper-evident shrinkband. Made in Canada by CIBA Vision Sterile Manufacturing for: CIBA Vision, A Novartis Company, Duluth, GA 30097 |
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