Xalatan

— THERAPEUTIC CATEGORIES —
  • Glaucoma
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Xalatan Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Latanoprost 0.005%; oph soln; contains benzalkonium chloride.

    Pharmacological Class

    Prostaglandin analogue.

    How Supplied

    Soln—2.5mL

    Storage

    Protect from light. 

    Store unopened bottle(s) under refrigeration at 2°C to 8°C (36°F to 46°F).

    During shipment to the patient, the bottle may be maintained at temperatures up to 40°C (104°F) for a period not exceeding 8 days. 

    Once opened for use, store at room temperature up to 25°C (77°F) for 6 weeks.

    Manufacturer

    Pfizer Ophthalmics

    Generic Availability

    YES

    Mechanism of Action

    Latanoprost is a prostaglandin F2α analogue that is believed to reduce the IOP by increasing the outflow of aqueous humor.

    Xalatan Indications

    Indications

    Open-angle glaucoma. Ocular hypertension.

    Xalatan Dosage and Administration

    Adult

    1 drop in the affected eye(s) once daily in the PM.

    Children

    Not recommended.

    Administration

    Dosage should not exceed once daily.

    Reductions in IOP start ~3-4 hours after administration; max effect is reached after 8-12 hours.

    May be used concomitantly with other topical ophthalmic drug products to lower IOP.

    Remove contact lenses prior to instillation; may be reinserted 15 minutes after administration.

    Missed dose: Treatment should continue with the next dose as normal.

    Xalatan Contraindications

    Not Applicable

    Xalatan Boxed Warnings

    Not Applicable

    Xalatan Warnings/Precautions

    Warnings/Precautions

    Do not exceed recommended dose (may reduce efficacy). Ocular inflammation. Aphakia. Pseudophakia with torn posterior lens capsule. Risk for macular edema. History of herpetic keratitis. Contact lenses (remove; may reinsert lenses 15mins after administration). Pregnancy. Nursing mothers.

    Warnings/Precautions

    Pigmentation

    • Increased pigmentation of the iris, periorbital tissue, and eyelashes has been reported and is expected to increase as long as latanoprost is administered.
    • Pigmentation is due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes.
    • Pigmentation of the iris is likely to be permanent; periorbital tissue and eyelash changes may be reversible.
    • The effects of increased pigmentation beyond 5 years are unknown.
    • Iris color may become more brownish (changes may not be noticeable for several months to years); neither nevi nor freckles of the iris appear to be affected by treatment.
    • Treatment can be continued in patients who develop increased iris pigmentation; examine patients regularly.

    Eyelash Changes

    • May gradually change eyelashes and vellus hair in the treated eye.
    • Changes include increased length, thickness, pigmentation, number of lashes or hairs, and misdirected growth of eyelashes.
    • Changes are usually reversible upon discontinuation.

    Intraocular Inflammation

    • Use with caution in patients with a history of iritis/uveitis.
    • Do not use in patients with active intraocular inflammation.
    • Treatment may exacerbate inflammation.

    Macular Edema

    • Macular edema has been reported during treatment.
    • Aphakic patients, pseudophakic patients with a torn posterior lens capsule, patients with known risk factors for macular edema: Use caution.

    Herpetic Keratitis

    • Reactivation of herpes simplex keratitis during treatment has been reported.
    • Use with caution in patients with a history of herpetic keratitis.
    • Avoid in active herpes simplex keratitis; inflammation may be exacerbated.

    Bacterial Keratitis

    • Bacterial keratitis has been reported in patients who used multiple-dose containers of topical ophthalmic products.
    • The containers were inadvertently contaminated by patients.

    Contact Lens Use

    • Contains benzalkonium chloride, which may be absorbed by contact lenses.
    • Remove contact lenses prior to administration; reinsert 15 minutes after.

    Pregnancy Considerations

    No adequate and well-controlled studies in pregnant women. 

    Nursing Mother Considerations

    Use caution; consider the clinical need for the mother vs the potential risk for the breastfed child.

    Pediatric Considerations

    Safety and effectiveness in pediatric patients have not been established. 

    Geriatric Considerations

    No overall differences in safety or effectiveness were observed between elderly and younger patients. 

    Xalatan Pharmacokinetics

    Absorption

    Absorbed through the cornea where the isopropyl ester prodrug is hydrolyzed to the acid form to become biologically active.

    Metabolism

    Hepatic.

    Elimination

    Renal.Half-life: 17 minutes

     

    Xalatan Interactions

    Interactions

    Allow at least 5mins between application of other topical oph agents.

    Interactions

    The combined use of 2 or more prostaglandins or prostaglandin analogs is not recommended; use of these products more than once daily may decrease the IOP lowering effect or cause paradoxical elevations in IOP.

    Precipitation may occur when eye drops containing thimerosal are mixed with Xalatan; if more than 1 topical ophthalmic drug is being used, administer the drugs at least 5 minutes apart.

    Xalatan Adverse Reactions

    Adverse Reactions

    Blurred vision, burning, stinging, conjunctival hyperemia, foreign body sensation, itching, increased ocular pigmentation (eg, iris, eyelid, eyelashes; may be permanent), punctate keratitis, other eyelash/lid changes, photophobia, upper respiratory tract infection, pain, angina, rash; intraocular inflammation, macular edema (including cystoid macular edema).

    Xalatan Clinical Trials

    Clinical Trials

    Among patients with mean baseline intraocular pressure (IOP) of 24-25mmHg, treatment with Xalatan for 6 months resulted in 6-8mmHg reductions in IOP. The IOP reduction with Xalatan 0.005% dosed once daily was found to be equivalent to the effect observed with timolol 0.5% dosed twice daily.

    A 3-year open label, prospective safety study with a 2 -year extension phase was conducted to evaluate the progression of increased iris pigmentation with Xalatan use. The analysis was based on 380 patients who continued in the extension phase. Results showed the onset of noticeable increased iris pigmentation occurred within the first year of treatment for the majority of patients.

    Signs of increasing iris pigmentation continued throughout the 5 years of the study. Reduction in IOP was similar regardless of the development of increased iris pigmentation.

    Xalatan Note

    Not Applicable

    Xalatan Patient Counseling

    Patient Counseling

    Possibility of increased pigmentation (eg, increased brown pigmentation of the iris, eyelid skin darkening). This may be reversible after discontinuation.

    Eyelash changes are possible, which may result in a disparity between eyes in length, thickness, pigmentation, number of eyelashes or vellus hairs, and/or direction of eyelash growth. This is usually reversible upon discontinuation.

    Avoid touching the tip of the dispensing container to the eye. Contamination may occur and potentially cause ocular infections. Serious damage to the eye may be possible if a contaminated solution is used.

    Intercurrent ocular condition (eg, trauma, infection), ocular surgery, ocular reactions (eg, conjunctivitis, eyelid reactions): Seek immediate medical advice concerning continued use of multi-dose container.

    Xalatan contains benzalkonium chloride; remove contact lenses before administering and wait 15 minutes before reinserting.

    Separate use of other ophthalmic drugs by at least 5 minutes.

    Cost Savings Program

    Xalatan Savings Card

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