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  • Ilevro
    (Nepafenac) - Alcon

    THERAPEUTIC CLASS

    NSAID

    DEA CLASS

    RX

    INDICATIONS

    Treatment of pain and inflammation associated with cataract surgery.

    ADULT DOSAGE

    Adults: 1 drop to the affected eye qd, beginning 1 day prior to cataract surgery, continued on the day of surgery, and through the first 2 weeks of postoperative period. Administer additional drop 30-120 min prior to surgery. With Other Topical Ophthalmic Medications: Administer at least 5 min apart.

    PEDIATRIC DOSAGE

    Pediatrics: ≥10 yrs: 1 drop to the affected eye qd, beginning 1 day prior to cataract surgery, continued on the day of surgery, and through the first 2 weeks of postoperative period. Administer additional drop 30-120 min prior to surgery. With Other Topical Ophthalmic Medications: Administer at least 5 min apart.

    HOW SUPPLIED

    Sus: 0.3% [1.7mL]

    WARNINGS/PRECAUTIONS

    Potential for increased bleeding time due to interference with thrombocyte aggregation. Increased bleeding of ocular tissues (eg, hyphemas) reported in conjunction with ocular surgery; caution with known bleeding tendencies. May slow or delay healing, or result in keratitis. Continued use may result in sight threatening epithelial breakdown, corneal thinning/erosion/ulceration/perforation; d/c if evidence of corneal epithelial breakdown occurs and monitor for corneal health. Caution with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus (DM), ocular surface diseases (eg, dry eye syndrome), rheumatoid arthritis (RA), or repeat ocular surgeries within a short period of time. Use >1 day prior to surgery or beyond 14 days post-surgery may increase risk and severity of corneal adverse events. Avoid use with contact lenses and during late pregnancy.

    ADVERSE REACTIONS

    Capsular opacity, decreased visual acuity, foreign body sensation, increased intraocular pressure, sticky sensation, conjunctival edema, corneal edema, dry eye, lid margin crusting, ocular discomfort, ocular hyperemia/pain/pruritus, photophobia, tearing, vitreous detachment.

    DRUG INTERACTIONS

    May increase potential for healing problems with topical steroids. Caution with agents that may prolong bleeding time.

    PREGNANCY

    Category C, caution in nursing.

    MECHANISM OF ACTION

    NSAID; thought to inhibit the action of prostaglandin H synthase (cyclooxygenase), an enzyme required for prostaglandin production.

    PHARMACOKINETICS

    Absorption: Cmax=0.847ng/mL (nepafenac), 1.13ng/mL (amfenac); Tmax=0.5 hr (nepafenac), 0.75 hr (amfenac). Metabolism: Hydrolysis via ocular tissue hydrolases to amfenac (metabolite).

    ASSESSMENT

    Assess for previous hypersensitivity to the drug, bleeding tendencies, complicated or repeated ocular surgeries, corneal denervation, corneal epithelial defects, DM, ocular surface diseases, RA, contact lens use, pregnancy/nursing status, and possible drug interactions.

    MONITORING

    Monitor for hypersensitivity reactions, wound healing problems, keratitis, increased bleeding time, bleeding of ocular tissues in conjunction with ocular surgery, epithelial breakdown, corneal thinning/erosion/ulceration/perforation, and other adverse reactions.

    PATIENT COUNSELING

    Inform of possibility that slow or delayed healing may occur. Instruct to avoid allowing the tip of the container to contact the eye or surrounding structures. Advise that use of the same bottle for both eyes is not recommended. Instruct not to use while wearing contact lens. Advise to notify physician if an intercurrent ocular condition (eg, trauma or infection) develops or if undergoing ocular surgery to assess continuation of therapy.

    ADMINISTRATION/STORAGE

    Administration: Ocular route. Shake well before use. Storage: 2-25°C (36-77°F). Protect from light.