Prolensa

NSAIDs

BROMFENAC is a non-steroidal anti-inflammatory drug (NSAID). The eye drops are used to treat pain and swelling after eye surgery.


Commonly Used Brand Name(s): Bromday, Prolensa, Xibrom

Therapeutic Classification: Anti-Inflammatory

Pharmacologic Classification: NSAID

Chemical Classification: Acetic Acid (class)

Bromfenac ophthalmic (eye) solution is used to treat pain or 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.

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 are wearing contact lenses, remove them while you are using this medicine. Talk to your eye doctor about this if you have questions.

Use a single bottle of Prolensa™ eye drops for each eye.

To use the eye drops:

  • The bottle is only partially full to provide proper drop control.
  • 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, 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 once a day starting 1 day before cataract surgery, continued on the day of surgery, and for 2 weeks after the surgery.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take 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. Do not double doses.

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.

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 bromfenac 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 bromfenac eye drops in the elderly.

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. 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.

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.

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.

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:

  • Asthma or
  • Sulfite allergy—Use with caution. This medicine contains sodium sulfite which may cause an allergic reaction in patients with these conditions.
  • Corneal (front part of the eye) denervation or
  • Corneal (front part of the eye) epithelial defects or
  • Diabetes or
  • Ocular (eye) surface diseases (eg, 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 experiencing corneal problems.

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 doctor.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, hives, hoarseness, shortness of breath, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using this medicine.

Slow or delayed healing may occur while you are using this medicine. Ask your doctor before using this medicine together with a topical corticosteroid (eg, betamethasone, clobetasol, hydrocortisone, Lotrisone®).

Using this medicine may increase risk of having keratitis and corneal problems. 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.

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 doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

They need to know if you have any of these conditions:

  • asthma
  • bleeding problems
  • diabetes
  • dry eye syndrome, other eye problems, or recent eye surgery
  • wear soft contact lenses
  • an unusual or allergic reaction to bromfenac, aspirin, other NSAIDS, sulfites, other medicines, foods, dyes or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

This medicine is only for use in the eye. Do not take by mouth. Follow the directions on the prescription label. Remove contact lenses before use. Wash hands before and after use. Tilt your head back slightly and pull your lower eyelid down with your index finger to form a pouch. Try not to touch the tip of the dropper to your eye, fingertips, or any other surface. Squeeze the prescribed number of drops into the pouch. Close the eye gently to spread the drops. Your vision may blur for a few minutes. Use your doses at regular intervals. Do not use your medicine more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

If you miss a dose, use it as soon as you can. If it is almost time for your next dose, use only that dose. Do not use double or extra doses.

Keep out of the reach of children.

Store at room temperature between 15 and 25 degrees C (59 and 77 degrees F). Throw away any unused medicine after the expiration date on the label.

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