Tevanac Ophthalmic Solution

ILEVRO ® 0.3% is indicated for the treatment of pain and inflammation associated with cataract surgery. ILEVRO ® 0.3% is a nonsteroidal, anti-inflammatory prodrug indicated for the treatment of pain and inflammation associated with cataract surgery ( 1 ).

• One drop of ILEVRO ® 0.3% should be applied to the affected eye one-time-daily beginning 1 day prior to cataract surgery, continued on the day of surgery and through the first 2 weeks of the postoperative period
• An additional drop should be administered 30 to 120 minutes prior to surgery
• Recommended Dosing One drop of ILEVRO ® 0.3% should be applied to the affected eye one time daily beginning 1 day prior to cataract surgery, continued on the day of surgery and through the first 2 weeks of the postoperative period
• An additional drop should be administered 30 to 120 minutes prior to surgery
• Use with Other Topical Ophthalmic Medications ILEVRO ® 0.3% may be administered in conjunction with other topical ophthalmic medications such as beta-blockers, carbonic anhydrase inhibitors, alpha-agonists, cycloplegics, and mydriatics
• If more than one topical ophthalmic medication is being used, the medicines must be administered at least 5 minutes apart

Sterile ophthalmic suspension 0.3%: 1.7 mL in a 4 mL bottle and 3 mL in a 4 mL bottle. Sterile ophthalmic suspension 0.3%: 3 mL in a 4 mL bottle. ( 3 )

The safety and effectiveness of ILEVRO ® 0.3% in pediatric patients below the age of 10 years have not been established.

No overall differences in safety and effectiveness have been observed between elderly and younger patients.

• Slow or Delayed Healing Inform the patient of the possibility that slow or delayed healing may occur while using NSAIDs [see Warnings and Precautions ]
• Avoiding Contamination of the Product Instruct the patient to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures because this could cause the tip to become contaminated by common bacteria known to cause ocular infections
• Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions
• Use of the same bottle for both eyes is not recommended with topical eye drops that are used in association with surgery. …

• ILEVRO ® 0.3% is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formula or to other nonsteroidal anti-inflammatory drugs (NSAIDs)
• Hypersensitivity to any of the ingredients in the formula or to other non-steroidal anti-inflammatory drugs (NSAIDS)

Increased bleeding time due to interference with thrombocyte aggregation ( 5.1 ) Delayed healing ( 5.2 ) Corneal effects including keratitis ( 5.3 ) 5.1 Increased Bleeding Time With some NSAIDs including ILEVRO ® 0.3%, there exists the potential for increased bleeding time due to interference with thrombocyte aggregation. There have been reports that ocularly applied nonsteroidal anti-inflammatory drugs may cause increased bleeding of ocular tissues (including hyphema) in conjunction with ocular surgery. It is recommended that ILEVRO ® 0.3% be used with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time. …

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to the rates in the clinical studies of another drug and may not reflect the rates observed in practice. Most common adverse reactions (5% to 10%) are capsular opacity, decreased visual acuity, foreign body sensation, increased intraocular pressure, and sticky sensation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Harrow Eye, LLC at 1-833-4HARROW or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . …

8.1 Pregnancy Teratogenic Effects. Pregnancy Category C: Reproduction studies performed with nepafenac in rabbits and rats at oral doses up to 10 mg/kg/day have revealed no evidence of teratogenicity due to nepafenac, despite the induction of maternal toxicity. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.