Nevanac

DRUG DESCRIPTION

NEVANAC® (nepafenac ophthalmic suspension) 0.1% is a sterile, topical, nonsteroidal anti-inflammatory (NSAID) prodrug for ophthalmic use. Each mL of NEVANAC® suspension contains 1 mg of nepafenac. Nepafenac is designated chemically as 2-amino-3-benzoylbenzeneacetamide with an empirical formula of C15H14N2O2. The structural formula of nepafenac is:

NEVANAC®
  (nepafenac) Structural Formula Illustration

Nepafenac is a yellow crystalline powder. The molecular weight of nepafenac is 254.28. NEVANAC®ophthalmic suspension is supplied as a sterile, aqueous 0.1% suspension with a pH approximately of 7.4.

The osmolality of NEVANAC®ophthalmic suspension is approximately 305 mOsmol/kg.

Each mL of NEVANAC® contains: Active: nepafenac 0.1% Inactives: mannitol, carbomer 974P, sodium chloride, tyloxapol, edetate disodium, benzalkonium chloride 0.005% (preservative), sodium hydroxide and/or hydrochloric acid to adjust pH and purified water, USP.

What are the possible side effects of nepafenac ophthalmic (Nevanac)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have vision problems, crusting or drainage of your eyes, swollen eyelids, or severe eye pain.

Less serious side effects may be more likely to occur (some are effects of cataract surgery and not side effects of the medication):

  • dry or sticky feeling in the eye;
  • feeling like something is in your eye;
  • ...

Read All Potential Side Effects and See Pictures of Nevanac »

What are the precautions when taking nepafenac ophthalmic suspension (Nevanac)?

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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding problems, previous eye...

Read All Potential Precautions of Nevanac »


Nevanac Consumer (continued)

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 your doctor has prescribed this medication because he or she 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 immediately if any of these unlikely but serious side effects occur: eye swelling, eye discharge/extreme watering.

Tell your doctor immediately if any of these rare but very serious side effects occur: vision changes, eye pain.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: 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.

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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding problems, previous eye surgery, other eye problems (e.g., dry eye syndrome, corneal problems), diabetes, rheumatoid arthritis, asthma, 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 during the first 6 months. Avoid use during the last 3 months of pregnancy due to the possible harm to an unborn baby. 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.


Nevanac Patient Information Including Side Effects

Brand Names: Nevanac

Generic Name: nepafenac ophthalmic (Pronunciation: ne PA fan ak off THAL mik)

  • What is nepafenac ophthalmic (Nevanac)?
  • What are the possible side effects of nepafenac ophthalmic (Nevanac)?
  • What is the most important information I should know about nepafenac ophthalmic (Nevanac)?
  • What should I discuss with my healthcare professional before using nepafenac ophthalmic (Nevanac)?
  • How should I use nepafenac ophthalmic (Nevanac)?
  • What happens if I miss a dose (Nevanac)?
  • What happens if I overdose (Nevanac)?
  • What should I avoid while using nepafenac ophthalmic (Nevanac)?
  • What other drugs will affect nepafenac ophthalmic (Nevanac)?
  • Where can I get more information?

What is nepafenac ophthalmic (Nevanac)?

Nepafenac is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). It reduces pain and inflammation in the eyes.

Nepafenac ophthalmic (for the eyes) is used to reduce pain and swelling after cataract surgery.

Nepafenac ophthalmic may also be used for other purposes not listed in this medication guide.

What are the possible side effects of nepafenac ophthalmic (Nevanac)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have vision problems, crusting or drainage of your eyes, swollen eyelids, or severe eye pain.

Less serious side effects may be more likely to occur (some are effects of cataract surgery and not side effects of the medication):

  • dry or sticky feeling in the eye;
  • feeling like something is in your eye;
  • eye redness;
  • itching or watering of the eye;
  • increased sensitivity to light;
  • headache;
  • nausea, vomiting; or
  • stuffy nose.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about nepafenac ophthalmic (Nevanac)?

Before using nepafenac ophthalmic, tell your doctor if you are allergic to any drugs or other eye drops

Also tell your doctor if you have diabetes, dry eye syndrome, rheumatoid arthritis, a bleeding or blood-clotting disorder, such as hemophilia, or arthritis.

Do not use this medication while you are wearing contact lenses. This medication may contain a preservative that can be absorbed by soft contact lenses. Wait at least 15 minutes after using nepafenac before putting your contact lenses in.

Do not allow the dropper tip to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

Do not use nepafenac ophthalmic for longer than 14 days after your surgery unless your doctor tells you to.

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