This Sterile Ophthalmic Solution is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
Drugs for miotics and glaucoma
Latanoprost is an analogue of prostaglandin F2α. 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 one drop (1.5 ?g) in the affected eye(s) once daily in the evening. If one dose is missed, treatment should continue with the next dose as normal. The dosage of this Sterile Ophthalmic Solution should not exceed once daily; the combined use of two or more prostaglandins, or prostaglandin analogs including this Sterile Ophthalmic Solution is not recommended. It has been shown that administration of these prostaglandin drug products more than once daily may decrease the intraocular pressure lowering effect or cause paradoxical elevations in IOP. Reduction of the intraocular pressure starts approximately 3 to 4 hours after administration and the maximum effect is reached after 8 to 12 hours. it may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes apart.
In vitro studies have shown that precipitation occurs when eye drops containing thimerosal are mixed with latanoprost. 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
Teratogenic Effects: Pregnancy Category C. Reproduction studies have been performed in rats and rabbits. In rabbits, an incidence of 4 of 16 dams had no viable fetuses at a dose that was approximately 80 times the maximum human dose, and the highest nonembryocidal dose in rabbits was approximately 15 times the maximum human dose. There are no adequate and well-controlled studies in pregnant women.It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers: It is not known whether this drug or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution it is administered to a nursing woman.
Apart from ocular irritation and conjunctival or episcleral hyperemia, the ocular effects of
latanoprost administered at high doses are not known. Intravenous administration of large doses
of latanoprost in monkeys has been associated with transient bronchoconstriction; however, in 11
patients with bronchial asthma treated with latanoprost, bronchoconstriction was not induced.
Intravenous infusion of up to 3 μg/kg in healthy volunteers produced mean plasma
concentrations 200 times higher than during clinical treatment and no adverse reactions were
observed. Intravenous dosages of 5.5 to 10 μg/kg caused abdominal pain, dizziness, fatigue, hot
flushes, nausea, and sweating.
If overdosage with XALATAN Sterile Ophthalmic Solution occurs, treatment should be
symptomatic.
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
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