Description
Diclofenac ophthalmic (eye) solution is used to treat pain or swelling of the eye following cataract surgery. It is also used to relieve temporary pain and photophobia (oversensitivity of the eyes to light) in patients undergoing corneal refractive surgery (surgical procedure to reduce or cure certain eye or vision problems). This medicine is a topical nonsteroidal anti-inflammatory drug (NSAID).
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Solution
Before Using
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:
Allergies
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.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of diclofenac eye drops in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of diclofenac eye drops in the elderly.
Breastfeeding
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.
Drug Interactions
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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Other Interactions
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 aspirin, phenylacetic acid, and other NSAIDs (e.g., ibuprofen, naproxen, Advil®, Aleve®, Celebrex®, Ecotrin®, or Motrin®), history of or
- Bleeding problems—Use with caution. May make these conditions 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 corneal problems.
Proper Use
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 eye doctor tells you otherwise.
If you 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:
- The bottle is only partially full to provide proper drop control.
- First, wash your hands. Tilt your head back and press 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 your eyes. Do not blink. Keep your 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, keep the container tightly closed. Serious damage to the eye and possible loss of vision may result from using contaminated eye drops.
Dosing
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—Use one drop in the affected eye four times a day, starting 24 hours after cataract surgery and continued for 2 weeks after surgery.
- Children—Use and dose must be determined by your doctor.
- For corneal refractive surgery:
- Adults—Use one or two drops in the affected eye within an hour before corneal surgery. Then, use one or two drops in the affected eye within 15 minutes after corneal surgery and continued four times a day for up to 3 days.
- Children—Use and dose must be determined by your doctor.
- For eye pain or swelling following cataract surgery:
Missed Dose
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.
Storage
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
Your eye doctor will check your eyes at regular visits to make sure it is working properly and is not causing unwanted effects.
If your symptoms do not improve within a few days or if they become worse, check with your eye doctor.
Slow or delayed healing may occur while you are using this medicine. Ask your eye doctor before using this medicine together with a topical corticosteroid (e.g., betamethasone, hydrocortisone).
Using this medicine may increase risk of having eye or vision problems (e.g., keratitis or other corneal problems). Stop using this medicine and check with your eye doctor right away if you have blurred vision, changes in vision, or eye redness, irritation, or pain while using this medicine.
Make sure your eye doctor knows if you are pregnant. Do not use this medicine during the later part of a pregnancy unless your doctor tells you to.
While applying the medicine, your eyes will probably sting or burn for a short time. This is to be expected.
Do not use other medicines unless they have been discussed with your eye doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
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 or nurse immediately if any of the following side effects occur:
More common
- Eye redness, irritation, or pain
- tearing of the eyes
Less common
- Blindness
- blurred vision
- burning, dry, or itching eyes
- clear or yellow fluid from the eye
- decreased vision or any change in vision
- redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
- sensitivity to light
- sticky or matted eyelashes
- throbbing pain
Incidence not known
- Feeling of something in the eye
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:
More common
- Burning and stinging of the eye
Less common
- Abdominal or stomach pain
- chills
- cold flu-like symptoms
- cough or hoarseness
- dizziness
- fever
- headache
- lack or loss of strength
- nausea
- pain
- runny nose
- sleeplessness
- sneezing
- stuffy nose
- swelling or puffiness of the face
- trouble with sleeping
- unable to sleep
- vomiting
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.
CON-XXXXXXXX
