Adult Dosing

Intraocular pressure in patients with open-angle glaucoma or ocular hypertension

• Instill one drop in the affected eye(s) bid

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Intraocular pressure in patients with open-angle glaucoma or ocular hypertension

• Hypersensitivity to any of the ingredients of the product

• N/A

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic adjustment: Dose adjustments not defined

• Therapy may lead to gradual increase in the pigmentation of the iris. Color changes seen with administration of unoprostone isopropyl ophthalmic solution may not be noticeable for several months to years. Before initiating therapy patients should be informed of the possibility of increased pigmentation
• Unoprostone isopropyl has been reported to cause pigment changes (darkening) to periorbital pigmented tissues and eyelashes which can be reversed upon discontinuation of therapy in most of the patients
• Use cautiously in patients with active intraocular inflammation (e.g., uveitis) because the inflammation may be exacerbated
• Therapy has been associated with macular edema, including cystoid macular edema. Use cautiously in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema
• To minimize contamination of the dropper tip and solution, care should be taken not to touch the eyelids or surrounding areas with the dropper tip of the bottle
• Use of multiple-dose containers of topical ophthalmic products have been associated with reports of bacterial keratitis. Keep bottle tightly closed when not in use
• The product contains benzalkonium chloride, which may be absorbed by soft contact lenses. Contact lenses should be removed prior to application of solution and may be reinserted 15 minutes following its administration

Pregnancy Category:C

Breastfeeding: It is not known whether the drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when administered to a nursing woman.

• EENT: Burning/stinging, dry eyes, itching, increased length of eyelashes, abnormal vision, eyelid disorder, foreign body sensation, lacrimation disorder, blepharitis, cataract, conjunctivitis, corneal lesion, discharge from the eye, eye hemorrhage, eye pain, keratitis, irritation, photophobia, vitreous disorder

• Synthetic docosanoid; reduces elevated intraocular pressure (IOP) by increasing the outflow of aqueous humor through the trabecular meshwork
• Metabolism: Hydrolyzed by esterases in the cornea to its biological active metabolite, unoprostone free acid
• Excretion: Excreted predominately in urine
• Half-life: 14 minutes

US Trade Name(s)

• Rescula

US Availability

Rescula

• OPH SOLN: 0.15%

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Ophthalmic

Antiglaucoma

Prostaglandin Analogues