nepafenac ophthalmic (Rx)

Brand and Other Names:Nevanac, Ilevro
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

ophthalmic suspension

  • 0.1% (Nevanac)
  • 0.3% (Ilevro)

Ocular Pain & Inflammation

Indicated for pain and inflammation associated with cataract surgery

0.1%: 1 gtt three times daily to affected eye(s) beginning 1 day before cataract surgery, on the day of surgery and through 2 weeks postoperatively

0.3%: 1 gtt once daily beginning 1 day before cataract surgery, on day of surgery, and continue through the first 2 weeks postoperatively; an additional drop should be adminsitered 30-120 minutes before surgery

Administration

Do not wear contact lenses while treating

Shake well before treating

Dosage Forms & Strengths

ophthalmic suspension

  • 0.1% (Nevanac)
  • 0.3% (Ilevro)

Ocular Pain & Inflammation

<10 years

  • Safety and efficacy not established

>10 years

  • Indicated for pain and inflammation associated with cataract surgery
  • 0.1%: 1 gtt three times daily to affected eye(s) beginning 1 day before cataract surgery, on the day of surgery and through 2 weeks postoperatively
  • 0.3%: 1 gtt once daily beginning 1 day before cataract surgery, on day of surgery, and continue through the first 2 weeks postoperatively; an additional drop should be adminsitered 30-120 minutes before surgery

Administration

Do not wear contact lenses while treating

Shake well before treating

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Adverse Effects

1-10%

Capsular opacity (5-10%)

Decreased visual acuity (5-10%)

Foreign body sensation (5-10%)

Increased IOP (5-10%)

Sticky sensation (5-10%)

Conjunctival edema (1-5%)

Corneal edema (1-5%)

Dry eye (1-5%)

Headache (1-4%)

HTN (1-4%)

Lid margin crusting (1-5%)

N/V (1-4%)

Ocular discomfort (1-5%)

Ocular hyperemia (1-5%)

Ocular pain (1-5%)

Ocular pruritus (1-5%)

Photophobia (1-5%)

Tearing (1-5%)

Vitreous detachment (1-5%)

Postmarketing Reports

Increased bleeding time

Delayed effects

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Warnings

Contraindications

Hypersensitivity to NSAIDs or any ingredients

Cautions

Sensitivity to aspirin or phenylacetic acid deivatives

May cause increased bleeding in ocular tissues

May cause keratitis & corneal damage (risk increased if applied earlier than 1 day presurgery or longer than 2 wk postsurgery)

Use caution in patients with bleeding predisposition, ocular disease states, diabetes ( corneal adverse effects may result in loss of vision), rheumatoid arthritis

Do not wear contact lenses while on the medication

Risk of corneal adverse effects increases with use 1 day before surgery or >14 days following surgery

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Pregnancy & Lactation

Pregnancy Category: C

Lactation: Unknown if excreted in breast milk; use caution

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

Non-steroidal anti-inflammatory prodrug, converted to amfenac which putatively inhibits prostaglandin biosynthesis

Absorption

Absoption: Low systemic absorption

Peak Plasma: nepafenac 0.31 ng/mL; amfenac: 0.42 ng/mL

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Images

BRAND FORM. UNIT PRICE PILL IMAGE
Nevanac ophthalmic (eye)
-
0.1 % drops
Ilevro ophthalmic (eye)
-
0.3 % drops
Ilevro ophthalmic (eye)
-
0.3 % drops

Copyright © 2010 First DataBank, Inc.

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Patient Handout

Patient Education
nepafenac ophthalmic (eye)

NEPAFENAC SUSPENSION - OPHTHALMIC

(ne-PA-fen-ak)

COMMON BRAND NAME(S): Ilevro, Nevanac

USES: This medication is used to relieve eye pain, irritation, and redness following cataract eye surgery. Nepafenac belongs to a class of drugs known as nonsteroidal anti-inflammatory drugs (NSAIDs). It works by blocking certain natural substances (prostaglandins) in your body that cause pain and swelling.

HOW TO USE: Apply this medication to the operated eye(s) as directed by your doctor. The instructions for use depend on the strength of the eye drops prescribed. Follow your doctor's instructions.If you are using nepafenac 0.1% eye drops, apply it usually 3 times daily starting 1 day before surgery, and continue use on the day of surgery and for 2 weeks after surgery, or as directed by your doctor.If you are using nepafenac 0.3% eye drops, apply it usually once daily starting 1 day before surgery, and continue use on the day of surgery and for 2 weeks after surgery, or as directed by your doctor. Your doctor may also instruct you to apply an additional drop one-half hour to 2 hours before surgery.To apply eye drops, wash your hands first. Shake the bottle well before each dose. To avoid contamination, do not touch the dropper tip or let it touch your eye or any other surface.This medication should not be used while wearing contact lenses. Consult your doctor or pharmacist for details.Tilt your head back, look upward, and gently pull down the lower eyelid to make a pouch. Hold the dropper directly over your eye and place one drop into the pouch. Look downward and gently close your eyes for 1 to 2 minutes. Try not to blink and do not rub your eye. Repeat these steps for your other eye if so directed.Do not rinse the dropper. Replace the dropper cap after each use.If you are using another kind of eye medication (e.g., drops or ointments), wait at least 5 minutes before applying other medications. Use eye drops before eye ointments to allow the eye drops to enter the eye.This medication is usually used for up to 14 days after eye surgery or as directed by your doctor. Do not start using this medication early, use it more often than prescribed, or continue using it for longer than directed by your doctor. Prolonged use of nepafenac eye drops (more than 2 weeks) may increase the risk of very serious side effects of the eye.Inform your doctor if your condition persists or worsens.

SIDE EFFECTS: This medication may temporarily sting or burn your eyes for 1-2 minutes when applied. Eye redness and headache may also occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: eye swelling/pain, eye discharge/extreme watering, vision changes.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using nepafenac, tell your doctor or pharmacist if you are allergic to it; or to aspirin, or to other NSAIDs (e.g., ibuprofen, celecoxib); or if you have any other allergies. This product may contain inactive ingredients (such as preservatives like benzalkonium chloride), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma (including a history of worsening breathing after taking aspirin or other NSAIDs), bleeding problems, previous eye surgery, other eye problems (e.g., dry eye syndrome, corneal problems), diabetes, rheumatoid arthritis, nasal polyps.Your vision may be temporarily unstable after applying this drug. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug are: anti-platelet medications (e.g., clopidogrel), "blood thinners" (e.g., warfarin), corticosteroid drugs (e.g., prednisone), other eye medications (e.g., corticosteroid eye drops).Check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (NSAIDs such as aspirin, ibuprofen, or naproxen) which, if used together with nepafenac, may increase your risk for bleeding. Low-dose aspirin, as prescribed by your doctor for specific medical reasons such as heart attack or stroke prevention (usually 81-162 milligrams a day), should be continued. Consult your doctor or pharmacist for more details.

OVERDOSE: This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others.This medication has been prescribed for your current condition only. Do not use it later for another eye condition unless told to do so by your doctor. A different medication may be necessary in that case.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

STORAGE: Store in the refrigerator or at room temperature away from light and moisture. Do not freeze. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.