Xalaprost Ophthalmic Solution

Xalaprost Sterile Ophthalmic Solution is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

Latanoprost is an analogue of prostaglandin F_2α. Latanoprost is a prostanoid selective FP receptor agonist that is believed to reduce the intraocular pressure (IOP) by increasing the outflow of aqueous humor. Studies in animals and man suggest that the main mechanism of action is increased uveoscleral outflow. Elevated IOP represents a major risk factor for glaucomatous field loss. The higher the level of IOP, the greater the likelihood of optic nerve damage and visual field loss.

The recommended dosage is 1 drop (1.5 mcg) in the affected eye(s) once daily in the evening. This is for topical ophthalmic use only. Not for injection or oral use.

In vitro studies have shown that precipitation occurs when eye drops containing thimerosal are mixed with Xalaprost. If such drugs are used they should be administered with an interval of at least 5 minutes between applications.

Known hypersensitivity to latanoprost, benzalkonium chloride or any other ingredients in this product.

Eyelash changes (increased length, thickness, pigmentation, and number of lashes); eyelid skin darkening; intraocular inflammation (iritis/uveitis); iris pigmentation changes; and macular edema, including cystoid macular edema. The ocular adverse events and ocular signs and symptoms reported in 5- 15% of the patients on Xalaprost in the 6 month, multicenter, double-masked, active-controlled trials were blurred vision, burning and stinging, conjunctival hyperemia, foreign body sensation, itching, increased pigmentation of the iris, and punctate epithelial keratopathy. Local conjunctiva hyperemia was observed; however, less than 1% of the Xalaprost treated patients required discontinuation of therapy because of intolerance to conjunctival hyperemia.

Pregnancy Category C. There are no adequate and well controlled studies in pregnant women. The drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Ophthalmic Solution may gradually increase the pigmentation of the iris. The eye color change is due to increased melanin content in the stromal melanocytes of the iris rather than to an increase in the number of melanocytes. During clinical trials, the increase in brown iris pigment has not been shown to progress further upon discontinuation of treatment, but the resultant color change may be permanent. Eyelid skin darkening, which may be reversible. There may be increased length, thickness, pigmentation, the number of lashes or hairs, and misdirected growth of eyelashes. Eyelash changes are usually reversible upon discontinuation of treatment. It should be used with caution in patients with a history of intraocular inflammation (iritis/uveitis) and should generally not be used in patients with active intraocular inflammation. Xalaprost should be used with caution in patients who do not have an intact posterior capsule or who have known risk factors for macular edema.

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Drugs for miotics and glaucoma

Before opening the cap, keep the bottle in its box in a refrigerator (2°-8° C) protected from light. After opening, keep the bottle in its box in a cool place below 25° C. The contents should be used within one month after the dropper is opened. Keep out of reach of children