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Nepafenac

Pronunciation

(ne pa FEN ak)

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Suspension, Ophthalmic:

Ilevro: 0.3% (1.7 mL, 3 mL) [contains benzalkonium chloride, edetate disodium, propylene glycol]

Nevanac: 0.1% (3 mL) [contains edentate disodium benzalkonium chloride]

Brand Names: U.S.

  • Ilevro
  • Nevanac

Pharmacologic Category

  • Nonsteroidal Anti-inflammatory Drug (NSAID), Ophthalmic

Pharmacology

Nepafenac is a prodrug which once converted to amfenac inhibits prostaglandin synthesis by decreasing the activity of the enzyme, cyclooxygenase, which results in decreased formation of prostaglandin precursors.

Absorption

Low levels (0.2-0.5 ng/mL) of nepafenac and amfenac are detected in the plasma following ophthalmic administration

Metabolism

Hydrolyzed in ocular tissue to amfenac (active)

Use: Labeled Indications

Treatment of pain and inflammation associated with cataract surgery

Contraindications

Hypersensitivity to nepafenac, other NSAIDs, or any component of the formulation

Dosing: Adult

Pain, inflammation associated with cataract surgery: Ophthalmic:

Ilevro™: Instill 1 drop into affected eye(s) once daily, beginning 1 day prior to surgery, the day of surgery, and through the first 2 weeks of the postoperative period. Instill 1 additional drop 30-120 minutes prior to surgery.

Nevanac®: Instill 1 drop into affected eye(s) 3 times/day, beginning 1 day prior to surgery, the day of surgery, and through the first 2 weeks of the postoperative period

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Pain, inflammation associated with cataract surgery: Ophthalmic: Children ≥10 years and Adolescents: Refer to adult dosing.

Dosing: Renal Impairment

No dosage adjustment provided in manufacturer's labeling.

Dosing: Hepatic Impairment

No dosage adjustment provided in manufacturer's labeling.

Administration

For topical ophthalmic use only; shake well prior to use. Remove contact lenses prior to using solutions containing benzalkonium chloride. To avoid contamination, do not touch tip of container to any surface. May be administered with other eye drops; wait at least 5 minutes before administering other eye drops.

Storage

Ilevro™: Store at 2°C to 25°C (36°F to 77°F). Protect from light.

Nevanac®: Store at 2°C to 25°C (36°F to 77°F).

Drug Interactions

Corticosteroids (Ophthalmic): NSAID (Ophthalmic) may enhance the adverse/toxic effect of Corticosteroids (Ophthalmic). Healing of ophthalmic tissue during concomitant administration of ophthalmic products may be delayed. Exceptions: Loteprednol. Monitor therapy

Adverse Reactions

1% to 10%:

Cardiovascular: Hypertension (1% to 4%)

Central nervous system: Headache (1% to 4%)

Gastrointestinal: Nausea (1% to 4%), vomiting (1% to 4%)

Ocular: Capsular opacity (5% to 10%), foreign body sensation (5% to 10%), intraocular pressure increased (5% to 10%), sticky sensation (5% to 10%), visual acuity decreased (5% to 10%), conjunctival edema (1% to 5%), corneal edema (1% to 5%), dry eye (1% to 5%), lid margin crusting (1% to 5%), ocular discomfort (1% to 5%), ocular hyperemia (1% to 5%), ocular pain (1% to 5%), ocular pruritus (1% to 5%), photophobia (1% to 5%), tearing (1% to 5%), vitreous detachment (1% to 5%)

Respiratory: Sinusitis (1% to 4%)

Warnings/Precautions

Concerns related to adverse effects:

• Aspirin/NSAID sensitivity: Use with caution in patients with previous sensitivity to acetylsalicylic acid and phenylacetic acid derivatives, including patients who experience bronchospasm, asthma, rhinitis, or urticaria following NSAID or aspirin.

• Keratitis: May cause keratitis; continued use in a patient with keratitis may cause severe corneal adverse reactions, potentially resulting in loss of vision. Immediately discontinue use in patients with evidence of corneal epithelial damage.

Disease-related concerns:

• Bleeding disorders: Use with caution in patients with a predisposition to bleeding (bleeding tendencies or medications which interfere with coagulation).

• Diabetes: Use with caution in patients with diabetes mellitus; may be at risk of corneal adverse events, potentially resulting in loss of vision.

• Ocular disease: Use with caution in patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, ocular surface disease, or repeat ocular surgeries (within a short timeframe); may be at risk of corneal adverse events, potentially resulting in loss of vision.

• Rheumatoid arthritis: Use with caution in patients with rheumatoid arthritis; may be at risk of corneal adverse events, potentially resulting in loss of vision.

Special populations:

• Surgery patients: May slow/delay healing or prolong bleeding time following surgery. Increased intraocular bleeding (including hyphema) has been reported. To minimize the risk of infection following surgery of both eyes, two separate bottles of eye drops (one for each eye) should be used; instruct patients not to use the same bottle for both eyes.

Other warnings/precautions:

• Contact lenses: May contain benzalkonium chloride which may be absorbed by soft contact lenses; contact lenses should not be worn during treatment.

• Duration of therapy: Use for more than 1 day prior to surgery or for 14 days beyond surgery may increase risk and severity of corneal adverse events.

Pregnancy Risk Factor

C

Pregnancy Considerations

Teratogenic events were not observed in animal reproduction studies. Exposure to nonsteroidal anti-inflammatory drugs late in pregnancy may lead to premature closure of the ductus arteriosus.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience foreign body sensation of eye or eye stickiness. Have patient report immediately to prescriber vision changes, ophthalmalgia, or severe eye irritation (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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