ILEVRO 3 mg/mL
nepafenac · SUSPENSION/ DROPS · Novartis Pharmaceuticals Corporation
ILEVRO is a suspension/ drops containing nepafenac at 3 mg/mL, taken ophthalmic. Manufactured by Novartis Pharmaceuticals Corporation.
Key Facts
- Brand Name
- ILEVRO
- Generic Name
- nepafenac
- NDC Code (Product)
0078-0743- Manufacturer
- Novartis Pharmaceuticals Corporation
- Strength
- 3 mg/mL
- Dosage Form
- SUSPENSION/ DROPS
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- NDA203491
- Drug Class
- Nonsteroidal Anti-inflammatory Drug [EPC]
- Marketing Start
- 12/20/2012
Recall History
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 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 ).
Dosage & Administration
2 DOSAGE AND ADMINISTRATION 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. ( 2 ) 2.1 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. 2.2 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.
Contraindications
4 CONTRAINDICATIONS 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). ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS 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 . 6.1 Serious and Otherwise Important Adverse Reactions The following adverse reactions are discussed in greater detail in other sections of labeling. Increased Bleeding Time [see Warnings and Precautions (5.1) ] Delayed Healing [see Warnings and Precautions (5.2) ] Corneal Effects [see Warnings and Precautions (5.3) ] 6.2 Ocular Adverse Reactions The most frequently reported ocular adverse reactions following cataract surgery were capsular opacity, decreased visual acuity, foreign body sensation, increased intraocular pressure (IOP), and sticky sensation. These reactions occurred in approximately …
Frequently Asked Questions
What is ILEVRO used for?
ILEVRO contains nepafenac. It is a suspension/ drops taken ophthalmic. Consult your doctor for specific uses.
Is ILEVRO a controlled substance?
ILEVRO is not classified as a controlled substance by the DEA.
What is the generic name for ILEVRO?
The generic name for ILEVRO is nepafenac. There are 1 other brand versions of nepafenac.
What is the NDC code for ILEVRO 3 mg/mL?
The NDC (National Drug Code) for ILEVRO 3 mg/mL is 0078-0743, listed by Novartis Pharmaceuticals Corporation.