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  • CLASSES

    Other Miotics-Antiglaucoma Preparations, Plain

    DEA CLASS

    Rx

    DESCRIPTION

    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).

    COMMON BRAND NAMES

    Xalatan

    HOW SUPPLIED

    Latanoprost/Xalatan Ophthalmic Sol: 0.005%

    DOSAGE & INDICATIONS

    For use as a first-line agent for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
    Ophthalmic dosage (Xalatan 0.005%)
    Adults

    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.

    MAXIMUM DOSAGE

    Adults

    1 drop/day per affected eye.

    Elderly

    1 drop/day per affected eye.

    Adolescents

    Safety and efficacy have not been established.

    Children

    Safety and efficacy have not been established.

    DOSING CONSIDERATIONS

    Hepatic Impairment

    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.

    Renal Impairment

    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 hemodialysis
    No dosage adjustment is needed.

    ADMINISTRATION

    Ophthalmic Administration

    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.

    STORAGE

    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 in original package until time of use
    - Store unopened containers in refrigerator (36 to 46 degrees F)

    CONTRAINDICATIONS / PRECAUTIONS

    Closed-angle glaucoma

    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.

    Aphakia

    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.

    Sunlight (UV) exposure

    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.

    Iritis, uveitis

    Latanoprost should be used with caution in patients with active intraocular inflammation (e.g., iritis, uveitis).

    Contact lenses

    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.

    Corneal abrasion, keratitis, ocular infection, ocular surgery, ocular trauma

    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.

    Pregnancy

    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.

    Breast-feeding

    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.

    Children

    The safety and efficacy of latanoprost has not been established in children.

    Hepatic disease, renal disease, renal failure, renal impairment

    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.

    ADVERSE REACTIONS

    Severe

    keratitis / Delayed / 10.0-10.0
    corneal erosion / Delayed / Incidence not known
    macular edema / Delayed / Incidence not known
    uveitis / Delayed / Incidence not known
    bronchospasm / Rapid / Incidence not known
    toxic epidermal necrolysis / Delayed / Incidence not known

    Moderate

    keratopathy / Delayed / 10.0-10.0
    blurred vision / Early / 8.0-8.0
    conjunctival hyperemia / Early / 8.0-8.0
    blepharitis / Early / 3.0-3.0
    photophobia / Early / 2.0-2.0
    conjunctivitis / Delayed / Incidence not known
    corneal edema / Early / Incidence not known
    ocular inflammation / Early / Incidence not known
    iritis / Delayed / Incidence not known
    dyspnea / Early / Incidence not known
    chest pain (unspecified) / Early / Incidence not known
    angina / Early / Incidence not known
    palpitations / Early / Incidence not known

    Mild

    ocular irritation / Rapid / 5.0-15.0
    foreign body sensation / Rapid / 13.0-13.0
    ocular pruritus / Rapid / 8.0-8.0
    iridal discoloration / Delayed / 7.0-7.0
    lacrimation / Early / 4.0-4.0
    xerophthalmia / Early / 3.0-3.0
    ocular pain / Early / 3.0-3.0
    infection / Delayed / 3.0-3.0
    blepharedema / Early / 1.0-1.0
    back pain / Delayed / 1.0-1.0
    myalgia / Early / 1.0-1.0
    musculoskeletal pain / Early / 1.0-1.0
    arthralgia / Delayed / 1.0-1.0
    rash (unspecified) / Early / 1.0-1.0
    hypertrichosis / Delayed / Incidence not known
    skin hyperpigmentation / Delayed / Incidence not known
    influenza / Delayed / Incidence not known
    pharyngitis / Delayed / Incidence not known
    pruritus / Rapid / Incidence not known
    dizziness / Early / Incidence not known
    headache / Early / Incidence not known

    DRUG INTERACTIONS

    There are no drug interactions associated with Latanoprost products.

    PREGNANCY AND LACTATION

    Pregnancy

    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.

    MECHANISM OF ACTION

    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.

    PHARMACOKINETICS

    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.

    Other Route(s)

    Ophthalmic Route
    Following 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.