NEVANAC 1 mg/mL
nepafenac · SUSPENSION/ DROPS · Harrow Eye, LLC
NEVANAC is a suspension/ drops containing nepafenac at 1 mg/mL, taken ophthalmic. Manufactured by Harrow Eye, LLC.
Key Facts
- Brand Name
- NEVANAC
- Generic Name
- nepafenac
- NDC Code (Product)
82667-500- Manufacturer
- Harrow Eye, LLC
- Strength
- 1 mg/mL
- Dosage Form
- SUSPENSION/ DROPS
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- NDA021862
- Drug Class
- Nonsteroidal Anti-inflammatory Drug [EPC]
- Marketing Start
- 01/01/2025
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE NEVANAC ® 0.1% is indicated for the treatment of pain and inflammation associated with cataract surgery. NEVANAC 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 NEVANAC should be applied to the affected eye three times daily beginning 1 day prior to cataract surgery, continued on the day of surgery and through the first 2 weeks of the postoperative period. ( 2.1 ) 2.1 Recommended Dosing One drop of NEVANAC 0.1% should be applied to the affected eye three times daily beginning 1 day prior to cataract surgery, continued on the day of surgery and through the first 2 weeks of the postoperative period. Shake the container well prior to dosing. 2.2 Use With Other Topical Ophthalmic Medications NEVANAC 0.1% 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 NEVANAC 0.1% is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formula or to other non-steroidal 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 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) ] Most common adverse reactions (5% to 10%) are capsular opacity, decreased visual acuity, foreign body sensation, increased intraocular pressure (IOP), and sticky sensation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Harrow Eye, LLC at 833-4HARROW(427769) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice. 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 5% to 10% of patients. Other ocular adverse…
Frequently Asked Questions
What is NEVANAC used for?
NEVANAC contains nepafenac. It is a suspension/ drops taken ophthalmic. Consult your doctor for specific uses.
Is NEVANAC a controlled substance?
NEVANAC is not classified as a controlled substance by the DEA.
What is the generic name for NEVANAC?
The generic name for NEVANAC is nepafenac. There are 2 other brand versions of nepafenac.
What is the NDC code for NEVANAC 1 mg/mL?
The NDC (National Drug Code) for NEVANAC 1 mg/mL is 82667-500, listed by Harrow Eye, LLC.