Prolensa

Prolensa is a prescription medication used to treat eye inflammation and eye pain in patients who have undergone cataract surgery. Prolensa belongs to a group of drugs called non-steroidal anti-inflammatory drugs (NSAIDs). It works by stopping the release of certain natural substances that cause pain and swelling.

This medication comes in the form of an eye drop to be given once a day beginning the day before cataract surgery, on the day of surgery, and for 14 days after surgery.

Common side effects in clinical trials include eye pain, eye discomfort in bright light, blurred vision, and the feeling of "something in the eye" (foreign body sensation).

Prolensa is a prescription medication used to treat eye inflammation and eye pain in patients who have undergone cataract surgery.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Bausch & Lomb Incorporated

Serious side effects have been reported with Prolensa. See “Drug Precautions” section.

Common side effects in clinical trials include eye pain, eye discomfort in bright light, blurred vision, and the feeling of "something in the eye" (foreign body sensation).

This is not a complete list of Prolensa side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Prolensa does not have any listed drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Prolensa including:

• Sulfite Allergic Reactions: Contains a sulfite that may cause allergic type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in people with this allergy.
• Slow or Delayed Healing: All topical nonsteroidal anti-inflammatory drugs (NSAIDs), including Prolensa, may slow or delay healing.
• Potential for Cross-Sensitivity: There is the potential for cross-sensitivity to aspirin and other NSAIDs, including Prolensa. Therefore, caution should be used if you have previously exhibited sensitivities to these drugs.
• Increased Bleeding Time: With some NSAIDs, including Prolensa, increased bleeding time may be possible, especially when it is given after surgery. Prolensa should be used with caution in those with known bleeding tendencies or who are receiving blood thinners.
• Keratitis and Corneal (front layer part of the eye) Reactions: Use of Prolensa may result in keratitis (inflammation of the eye). Long-term use of Prolensa may also result in eye damage, leading to loss of sight. Patients with changes in eyesight should immediately discontinue use of topical Prolensa.
• Loss of sight: Those with complicated ocular surgeries, eye defects or damage, diabetes, eye diseases (such as dry eye syndrome), rheumatoid arthritis, or repeat ocular surgeries within a short period of time may be at increased risk for eye problems which may result in loss of sight. Prolensa should be used with caution in these patients.
• Eye Surgery Precaution: Use of Prolensa more than 24 hours before surgery or beyond 14 days after surgery may increase risk for the occurrence and severity of corneal (front layer of the eye) adverse events.

Prolensa can cause blurred vision. Do not drive or operate heavy machinery until you know how Prolensa affects you.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Prolensa, there are no specific foods that you must exclude from your diet when receiving Prolensa.

Before taking Prolensa, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• have a sulfa allergy
• have had an allergic reaction to this medication before, to any other NSAID, or to aspirin (Ecotrin)
• have eye defects, damage, or dysfunction
• have rheumatoid arthritis
• have or have had other recent ocular surgeries
• have diabetes
• take blood thinners
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Prolensa falls into category C. There are no well-done studies in pregnant women. However, NSAIDs (including Prolensa) are known to cause harm to the baby’s heart (ductus arteriosus). Therefore, the use of Prolensa during late pregnancy should be avoided. Prolensa should be given to a pregnant woman only if clearly needed.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Caution should be used when Prolensa is given to a nursing (breastfeeding) woman.
 

Use Prolensa exactly as prescribed.

This medication is to be given once a day starting on the day before cataract surgery, on the day of surgery, and for 14 days after surgery.

Prolensa may be given along with other ophthalmic (eye) medications. Drops of each medication prescribed should be given at least 5 minutes apart.

Prolensa should not be given while wearing contact lenses. Remove contact lenses before using Prolensa. The preservative in Prolensa may be absorbed by soft contact lenses. Lenses may be reinserted after 10 minutes following administration of Prolensa.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Prolensa at the same time.

Take Prolensa exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

Insert one eye drop into the affected eye once daily. It should be given one day before cataract surgery, on the day of cataract surgery, and for 14 days after cataract surgery.

If you take too much Prolensa, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Store Prolensa at 15º – 25ºC (59º – 77ºF).

Keep this and all medicines out of the reach of children.