Rescula (Unoprostone isopropyl) Drug Information: Clinical Pharmacology

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May 27, 2012

Rescula

Glaucoma »

What is glaucoma?

Glaucoma is a disease of the major nerve of vision, called the optic nerve. The optic nerve receives light-generated nerve impulses from the retina and transmits these to the brain, where we recognize those electrical signals as vision. Glaucoma is characterized by a particular pattern of progressive damage to the optic nerve that generally begins with a subtle loss of side vision (peripheral vision). If glaucoma is not diagnosed and treated, it can progress to loss of central vision and blindness.

Glaucoma is usually, but not always, associated with elevated pressure in the eye (intraocular pressure). Generally, it is this elevated eye pressure that leads to damage of the eye (optic) nerve. In some cases, glaucoma may occur in the presence of normal eye pressure. This form of glaucoma is believed to be caused by poor regulation of blood flow to the optic nerve.

How common is glaucoma?

Worldwide, glaucoma...

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Rescula

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Please Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

CLINICAL PHARMACOLOGY

Mechanism of Action

When instilled in the eye, RESCULA (unoprostone isopropyl) ^â is believed to reduce elevated intraocular pressure (IOP), by increasing the outflow of aqueous humor, but the exact mechanism is unknown at this time.

Pharmacokinetics / Pharmacodynamics:

Absorption: After application to the eye, unoprostone isopropyl is absorbed through the cornea and conjunctival epithelium where it is hydrolyzed by esterases to unoprostone free acid.

A study conducted with 18 healthy volunteers dosed bilaterally with unoprostone isopropyl ophthalmic solution twice daily for 14 days demonstrated little systemic absorption of unoprostone isopropyl. The systemic exposure of its metabolite unoprostone free acid was minimal following the ocular administration. Mean peak unoprostone free acid concentration was less than 1.5 ng/mL. Little or no accumulation of unoprostone free acid was observed.

Elimination: Elimination of unoprostone free acid from human plasma is rapid, with a half-life of 14 minutes. Plasma levels of unoprostone free acid dropped below the lower limit of quantitation (< 0.25 ng/mL) 1 hour following ocular instillation. The metabolites are excreted predominately in urine.

Clinical Studies

Clinical studies showed that in patients with mean baseline IOP of 23 mm Hg, RESCULA (unoprostone isopropyl) ^â lowers intraocular pressure by approximately 3-4 mm Hg throughout the day. RESCULA (unoprostone isopropyl) ^â appears to lower intraocular pressure without affecting cardiovascular or pulmonary function.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.