FDA records indicate that there are no current recalls for this drug.
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Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Rescula (unoprostone isopropyl ophthalmic solution) 0.15% is indicated for the lowering of intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
History
There is currently no drug history available for this drug.
Other Information
Rescula (unoprostone isopropyl ophthalmic solution) 0.15% is a synthetic docosanoid. Unoprostone isopropyl has the chemical name isopropyl (+)-(Z)-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.
Sources
Rescula Manufacturers
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Sucampo Pharma Americas, Llc
Rescula | Sucampo Pharma Americas, Llc
The recommended dosage is one drop in the affected eye(s) twice daily.
Rescula may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure. If two drugs are used, they should be administered at least five (5) minutes apart[see Patient Counseling Information (17.5)].
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