Unoprostone Isopropyl CAS NO 120373-24-2 Inquire about Unoprostone Isopropyl


Tecoland supplies Unoprostone Isopropyl bulk active pharmaceutical ingredient (API) to the pharmaceutical industry. Our Unoprostone Isopropyl is manufactured by cGMP compliant facility. Welcome to contact us for further details including current DMF status for the product and up to date regulatory status of the manufacturing facility. We look forward to assisting you with your research and development projects.

What is Unoprostone Isopropyl?

Rescula (unoprostone isopropyl) Ophthalmic Solution 0.15% is a synthetic docosanoid. Unoprostone isopropyl has the chemical name isopropyl (+)-(Z)-7-[(1R,2R,3R,5S)-3,5­dihydroxy-2-(3-oxodecyl)cyclopentyl]-5-heptenoate. Its molecular formula is C25H44O5 . 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.

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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.

Indications:

Rescula (unoprostone isopropyl) Ophthalmic Solution 0.15% is indicated for the lowering of intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

Mechanism of Action:

Although the mechanism of action is unknown, unoprostone isopropyl may reduce elevated intraocular pressure by increasing the outflow of aqueous humor upon ocular administration. Isopropyl unoprostone is the isopropyl ester of unoprostone. It has a role as an antiglaucoma drug, an antihypertensive agent and a prodrug.

Dosage and Administration:

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.

Storage and Handling:

Rescula (unoprostone isopropyl) Ophthalmic Solution 0.15% is supplied sterile in a low-density polyethylene bottle with a low-density polyethylene dropper tip, a turquoise polypropylene closure, and a clear tamper-evident shrinkband.
5 mL in a 7.5 mL bottle NDC 17350-015-05
Store between 2° – 25°C (36° – 77°F).

Unoprostone Isopropyl Side effects:

The following adverse reactions have been identified during post-approval use of Rescula. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Voluntary reports of adverse reactions occurring with the use of Rescula include corneal erosion. There have been rare spontaneous reports with a different formulation of unoprostone isopropyl (0.12%) of chemosis, dry mouth, nausea, vomiting and palpitations.

Disclaimer:

Information on this page is provided for general information purposes. You should not make a clinical treatment decision based on information contained in this page without consulting other references including the package insert of the drug, textbooks and where relevant, expert opinion. We cannot be held responsible for any errors you make in administering drugs mentioned on this page, nor for use of any erroneous information contained on this page.