(flure BI proe fen)
- Flurbiprofen Sodium
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Solution, Ophthalmic, as sodium:
Ocufen: 0.03% (2.5 mL [DSC]) [contains edetate disodium, thimerosal]
Generic: 0.03% (2.5 mL)
Brand Names: U.S.
- Ocufen [DSC]
- Nonsteroidal Anti-inflammatory Drug (NSAID), Ophthalmic
Reversibly inhibits cyclooxygenase-1 and 2 (COX-1 and 2) enzymes, which results in decreased formation of prostaglandin precursors; has antipyretic, analgesic, and anti-inflammatory properties
Other proposed mechanisms not fully elucidated (and possibly contributing to the anti-inflammatory effect to varying degrees), include inhibiting chemotaxis, altering lymphocyte activity, inhibiting neutrophil aggregation/activation, and decreasing proinflammatory cytokine levels.
Use: Labeled Indications
Intraoperative miosis: Inhibition of intraoperative miosis
Hypersensitivity to flurbiprofen or any component of the formulation
Intraoperative miosis: Ophthalmic: Instill 1 drop every 30 minutes, beginning 2 hours prior to surgery for a total of 4 drops in each affected eye.
Refer to adult dosing.
For ophthalmic use only; avoid contact of bottle tip with skin or eye. Separate bottles should be used for each eye if both eyes require treatment.
Store at 15°C to 25°C (59°F to 79°F).
Corticosteroids (Ophthalmic): Nonsteroidal Anti-Inflammatory Agents (Ophthalmic) may enhance the adverse/toxic effect of Corticosteroids (Ophthalmic). Healing of ophthalmic tissue during concomitant administration of ophthalmic products may be delayed. Monitor therapy
Prostaglandins (Ophthalmic): Nonsteroidal Anti-Inflammatory Agents (Ophthalmic) may diminish the therapeutic effect of Prostaglandins (Ophthalmic). Nonsteroidal Anti-Inflammatory Agents (Ophthalmic) may enhance the therapeutic effect of Prostaglandins (Ophthalmic). Monitor therapy
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
Frequency not defined.
Cardiovascular: Hyperemia (ocular)
Hematologic & oncologic: Hemorrhagic diathesis (ocular tissue; in conjunction with ocular surgery)
Ophthalmic: Anterior chamber eye hemorrhage, burning sensation of eyes (transient), eye irritation, miosis, mydriasis, stinging of eyes (transient)
Miscellaneous: Fibrosis (ocular)
Concerns related to adverse effects:
• Aspirin/NSAID sensitivity: Use with caution in patients with previous sensitivity to aspirin or other NSAIDs, including patients who experience bronchospasm, asthma, rhinitis, or urticaria following NSAID or aspirin.
• Bleeding/hemostasis: May increase bleeding time associated with ocular surgery. Use with caution in patients with known bleeding tendencies or those receiving anticoagulants.
• Delayed healing: Healing time may be slowed or delayed.
• Post-surgical patients: To minimize the risk of infection following surgery of both eyes, two separate bottles of eye drops (one for each eye) should be used; instruct patients not to use the same bottle for both eyes.
Pregnancy Risk Factor
Adverse events were observed following systemic administration of flurbiprofen in animal reproduction studies. If ophthalmic agents are needed during pregnancy, the minimum effective dose should be used in combination with punctal occlusion to decrease potential exposure to the fetus (Samples 1988).
What is this drug used for?
• It is used during eye surgery.
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
• Vision changes
• Eye pain
• Severe eye irritation
• Bleeding in the eye
• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.
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