Nepafenac (Ophthalmic route)
Uses of This Medicine:
Nepafenac ophthalmic (eye) drops is used to treat pain and swelling of the eye following cataract surgery. This medicine is a topical nonsteroidal anti-inflammatory drug (NSAID).
This medicine is available only with your doctor's prescription.
Before Using This Medicine:
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of nepafenac eye drops in children younger than 10 years of age. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of nepafenac eye drops in the elderly.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Beta Glucan
- Dabigatran Etexilate
- Pentosan Polysulfate Sodium
- Protein C
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Azilsartan Medoxomil
- Candesartan Cilexetil
- Enalapril Maleate
- Ethacrynic Acid
- Olmesartan Medoxomil
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other medical problems—
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Allergy to NSAIDs (e.g., aspirin, celecoxib, diclofenac, etodolac, ibuprofen, indomethacin, nabumetone, naproxen, piroxicam, rofecoxib, valdecoxib, Advil®, Aleve®, Celebrex®, Ecotrin®, Motrin®, or Voltaren®), history of—Should not be used in patients with this condition.
- Bleeding problems—Use with caution. May make this condition worse.
- Corneal (front part of the eye) denervation or
- Corneal (front part of the eye) epithelial defects or
- Diabetes or
- Ocular (eye) surface diseases (e.g., dry eye syndrome) or
- Ocular (eye) surgeries, complicated or
- Ocular (eye) surgeries, multiple within a short period of time or
- Rheumatoid arthritis—Use with caution. May increase the risk of having serious eye problems.
Proper Use of This Medicine:
Your eye doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to. This medicine is not for long-term use.
Keep using this medicine for at least 2 weeks unless your doctor tells you otherwise.
This medicine can be used with other ophthalmic (eye) medicines. Wait at least 5 minutes before using another eye medicine.
If you or your child are wearing contact lenses, remove them while you are using this medicine. Talk to your eye doctor about this if you have questions.
To use the eye drops:
- Shake the bottle well before each use.
- First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed and apply pressure to the inner corner of the eye with your finger for 1 or 2 minutes to allow the medicine to be absorbed by the eye.
- Immediately after using the eye drops, wash your hands to remove any medicine that may be on them.
- To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, always keep the container tightly closed. Serious damage to the eye and possible loss of vision may result from using contaminated eye drops.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For ophthalmic dosage form (eye drops):
- For eye pain or swelling following cataract surgery:
- Adults, teenagers, and children 10 years of age and older—Use one drop in the affected eye three times a day beginning 1 day before cataract surgery, continued on the day of surgery, and for 2 weeks after the surgery.
- Children younger than 10 years of age—Use and dose must be determined by your doctor.
- For eye pain or swelling following cataract surgery:
If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions While Using This Medicine:
Your eye doctor will check your or your child's eyes at regular visits to make sure it is working properly and is not causing unwanted effects.
If your or your child's symptoms do not improve within a few days or if they become worse, check with your doctor.
Slow or delayed healing may occur while you or your child are using this medicine. Ask your doctor before using this medicine together with a topical corticosteroid (e.g., betamethasone, hydrocortisone).
Using this medicine may increase risk of having corneal (front part of the eye) problems, including keratitis. Stop using this medicine and check with your eye doctor right away if you or your child have blurred vision, changes in vision, or eye redness, irritation, or pain while using this medicine.
Make sure your doctor knows if you are pregnant. Do not use this medicine during the later part of a pregnancy, unless your doctor tells you to.
If you hurt your eye or develop an eye infection, talk with your doctor right away. You may need to change your medicine or stop using it.
Do not use other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects of This Medicine:
- More common
- Blurred vision
- change in vision
- decrease in vision
- loss of vision
- Less common
- Eye pain
- itching of the eye
- swelling and/or redness of the eye and lining of the eyelid
- More common
- Feeling of having something in the eye
- sticky sensation of the eyelids
- Less common
- Change in color vision
- crusting in the corner of the eye
- difficulty seeing at night
- dry eyes
- increased sensitivity of the eyes to sunlight
- nausea or vomiting
- pounding in the ears
- seeing flashes or sparks of light
- seeing floating spots before the eyes, or a veil or curtain appearing across part of vision
- shortness of breath or troubled breathing
- slow or fast heartbeat
- stuffy or runny nose
- tenderness around the eyes and cheekbones
- tightness of the chest or wheezing
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Last Updated: 11/4/2014