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Other Miotics-Antiglaucoma Preparations, Plain
Topical ophthalmic agent; prodrug used for increased IOP in patients with open-angle glaucoma or ocular hypertension; analog of prostaglandin F2-alpha; as effective as timolol in lowering IOP; associated with iridal pigmentation (brown).
Latanoprost/Xalatan Ophthalmic Sol: 0.005%
1 drop (1.5 mcg) applied to each affected eye once daily in the evening. More frequent administration may decrease the intraocular pressure-lowering effect.
1 drop/day per affected eye.
Safety and efficacy have not been established.
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed. Latanoprost should be used with caution in patients with hepatic impairment; data are lacking in these patients.
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed. Latanoprost should be used with caution in patients with renal impairment; data are lacking in these patients. Intermittent hemodialysisNo dosage adjustment is needed.
Xalatan (latanoprost ophthalmic solution) is for ophthalmic use only.Instruct patient on proper instillation of the eye solution (see Patient Information).Wash hands before and after use.Tilt the head back slightly and pull the lower eyelid down with the index finger to form a pouch. Squeeze the prescribed number of drops into the pouch and gently close eyes for 1—2 minutes. Do not blink.Care should be taken to avoid contamination. Do not touch the tip of the dropper to the eye, fingertips, or other surface.The solution 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 5 minutes apart.A delivery aid (i.e., Xal-Ease) is available for administering Xalatan.
Xalatan:- During shipment, the product may be maintained at temperatures up to 104 degrees F for a period not exceeding 8 days- Opened container can be stored for up to 6 weeks at 77 degrees F- Protect from light- Store unopened containers in refrigerator (36 to 46 degrees F)
Latanoprost should not be used in patients with closed-angle glaucoma, or inflammatory or neovascular glaucoma. There is limited experience with latanoprost in these patients.
Latanoprost should be used with caution in patients with aphakia, pseudophakic patients with a torn posterior lens capsule, and patients with known risk factors for macular edema. Macular edema, including cystoid macular edema, has been reported during treatment with this drug.
Latanoprost may gradually change eye color, increasing the amount of brown pigment in the iris. This change may be permanent. Patients should be informed of the possibility of iridal discoloration. Some patients may also develop photophobia and may be more sensitive to sunlight (UV) exposure.
Latanoprost should be used with caution in patients with active intraocular inflammation (e.g., iritis, uveitis).
Latanoprost eye solution is formulated with the preservative benzalkonium chloride, which may be absorbed by soft contact lenses. Users of soft contact lenses should not administer latanoprost while wearing the lenses.
The use of multiple dose containers of ophthalmic products has been associated with bacterial keratitis. Inadvertent contamination of the latanoprost containers may increase the risk of infection in ocular surgery patients, or in patients who develop an ocular infection or ocular trauma, including corneal abrasion. If there is any damage to the ocular epithelial surface, latanoprost should be used with caution. Reactivation of herpes simplex keratitis has been reported during latanoprost therapy. Use caution in patients with a history of herpetic keratitis; avoid use in patients with active herpes simplex keratitis due to the potential for exacerbation of inflammation.
Latanoprost is classified as FDA pregnancy risk category C. Although there are no adequate and well-controlled studies in pregnant women, limited experience in human pregnancy has not resulted in clinically significant risk to the fetus. A minimal amount of drug reaches systemic circulation after ophthalmic administration, suggesting exposure of the drug to the fetus is low. According to the manufacturer, latanoprost should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
According to the manufacturer, it is not known whether latanoprost or its metabolites are excreted in breast milk. Because systemic plasma concentrations of latanoprost are low and the half-life is short after ophthalmic administration, clinically significant amounts of the drug would not be expected to be excreted in breast-milk. To further minimize the amount of drug that reaches the systemic circulation and breast milk, apply pressure over the tear duct by the corner of the eye for 1 minute after ophthalmic administration. According to the manufacturer, caution should be exercised when latanoprost is administered during breast-feeding. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.
The safety and efficacy of latanoprost has not been established in children.
Latanoprost should be used cautiously in patients with renal disease (e.g., renal failure, renal impairment) or hepatic disease. There have been no studies on safe use in these patients.
keratitis / Delayed / 10.0-10.0corneal erosion / Delayed / Incidence not knownmacular edema / Delayed / Incidence not knownuveitis / Delayed / Incidence not knownbronchospasm / Rapid / Incidence not knowntoxic epidermal necrolysis / Delayed / Incidence not known
keratopathy / Delayed / 10.0-10.0blurred vision / Early / 8.0-8.0conjunctival hyperemia / Early / 8.0-8.0blepharitis / Early / 3.0-3.0photophobia / Early / 2.0-2.0conjunctivitis / Delayed / Incidence not knowncorneal edema / Early / Incidence not knownocular inflammation / Early / Incidence not knowniritis / Delayed / Incidence not knowndyspnea / Early / Incidence not knownchest pain (unspecified) / Early / Incidence not knownangina / Early / Incidence not knownpalpitations / Early / Incidence not known
ocular irritation / Rapid / 5.0-15.0foreign body sensation / Rapid / 13.0-13.0ocular pruritus / Rapid / 8.0-8.0iridal discoloration / Delayed / 7.0-7.0lacrimation / Early / 4.0-4.0xerophthalmia / Early / 3.0-3.0ocular pain / Early / 3.0-3.0infection / Delayed / 3.0-3.0blepharedema / Early / 1.0-1.0back pain / Delayed / 1.0-1.0myalgia / Early / 1.0-1.0musculoskeletal pain / Early / 1.0-1.0arthralgia / Delayed / 1.0-1.0rash (unspecified) / Early / 1.0-1.0hypertrichosis / Delayed / Incidence not knownskin hyperpigmentation / Delayed / Incidence not knowninfluenza / Delayed / Incidence not knownpharyngitis / Delayed / Incidence not knownpruritus / Rapid / Incidence not knowndizziness / Early / Incidence not knownheadache / Early / Incidence not known
There are no drug interactions associated with Latanoprost products.
Mechanism of Action: Latanoprost is a selective agonist at a subtype of prostaglandin receptors known as the FP receptor. By acting on the FP receptor, latanoprost increases the outflow of aqueous humor thereby reducing intraocular pressure. According to the manufacturer, studies in both animals and man suggest that increased uveoscleral outflow is the primary mechanism of action.
Latanoprost is administered topically to the eye. The active acid of latanoprost is primarily metabolized by the liver to the 1,2-dinor and 1,2,3,4- tetranor metabolites via fatty acid beta-oxidation with an elimination half-life of 17 minutes. The metabolites are mainly eliminated by the kidneys with 88% of an administered dose being recovered in the urine.
Ophthalmic RouteFollowing ocular administration, latanoprost is absorbed through the cornea where the isopropyl ester prodrug is hydrolyzed to the acid form to become biologically active. Peak aqueous humor concentrations are reached about 2 hours after topical administration. Reduction of intraocular pressure starts approximately 3—4 hours after administration and peaks after 8—12 hours. Plasma levels of the acid of latanoprost can only be measured during the first hour after local administration.