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]
Pharmacology
Mechanism of Action
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.
Pharmacokinetics/Pharmacodynamics
Absorption
Low levels (0.2 to 0.5 ng/mL [Nevanac]; 0.6 to 1.6 ng/mL [Ilevro]) of nepafenac and amfenac are detected in the plasma following ophthalmic administration
Metabolism
Hydrolyzed in ocular tissue to amfenac (active)
Use: Labeled Indications
Ocular pain and inflammation associated with cataract surgery: Treatment of pain and inflammation associated with cataract surgery
Contraindications
Hypersensitivity to nepafenac, other NSAIDs, or any component of the formulation
Canadian labeling: Additional contraindications (not in US labeling): Asthma, urticarial, or acute rhinitis precipitated by acetylsalicylic acid or other NSAIDs.
Dosage and Administration
Dosing: Adult
Ocular pain and inflammation associated with cataract surgery: Ophthalmic:
0.1% suspension: Instill 1 drop into affected eye(s) 3 times daily, beginning 1 day prior to surgery, the day of surgery, and through the first 2 weeks of the postoperative period
0.3% suspension: 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 to 120 minutes prior to surgery.
Dosing: Geriatric
Refer to adult dosing.
Dosing: Pediatric
Ocular pain and inflammation associated with cataract surgery: Ophthalmic: Children ≥10 years and Adolescents: Refer to adult dosing.
Administration
Ophthalmic: 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. To minimize the risk of infection following surgery of both eyes, two separate bottles of eye drops (one for each eye) should be used; do not use the same bottle for both eyes.
Storage
Store at 2°C to 25°C (36°F to 77°F). Discard 28 days after opening. Protect from light (Ilevro).
Drug Interactions
Corticosteroids (Ophthalmic): Nonsteroidal Anti-Inflammatory Agents (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
Prostaglandins (Ophthalmic): Nonsteroidal Anti-Inflammatory Agents (Ophthalmic) may diminish the therapeutic effect of Prostaglandins (Ophthalmic). Nonsteroidal Anti-Inflammatory Agents (Ophthalmic) may enhance the therapeutic effect of Prostaglandins (Ophthalmic). Monitor therapy
Adverse Reactions
1% to 10%:
Cardiovascular: Hypertension (≤4%)
Central nervous system: Foreign body sensation of eye (≤10%), headache (≤4%)
Gastrointestinal: Nausea (≤4%), vomiting (≤4%)
Ophthalmic: Decreased visual acuity (≤10%), increased intraocular pressure (≤10%), sticky sensation of eye (≤10%), conjunctival edema (≤5%), corneal edema (≤5%), crusting of eyelid (≤5%), eye discomfort (≤5%), eye pain (≤5%), eye pruritus (≤5%), lacrimation (≤5%), ocular hyperemia (≤5%), photophobia (≤5%), vitreous detachment (≤5%), xerophthalmia (≤5%)
Respiratory: Sinusitis (≤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
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
What is this drug used for?
- It is used to treat swelling and pain after cataract surgery.
Frequently reported side effects of this drug
- Foreign body sensation of eye
- Eye stickiness
Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:
- Vision changes
- Eye pain
- Severe eye irritation
- Signs of a significant reaction like 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. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
