Nepafenac

Prescription

Handelsnamen: ILEVRO

Darreichungsform

Drops

Applikationsweg

OPHTHALMIC

Hersteller

Harrow Eye, LLC

About This Medication

11 DESCRIPTION ILEVRO ® 0.3% is a sterile, topical, NSAID prodrug for ophthalmic use. Each mL of ILEVRO ® 0.3% contains 3 mg of nepafenac. Nepafenac is designated chemically as 2-amino-3-benzoylbenzeneacetamide with an empirical formula of C 15 H 14 N 2 O 2 . The structural formula of nepafenac is: Nepafenac is a yellow crystalline powder. The molecular weight of nepafenac is 254.28 g/mol. ILEVRO ® 0.3% is supplied as a sterile, aqueous suspension with a pH approximately of 6.8. The osmolality of ILEVRO ® 0.3% is approximately 300 mOsm/kg. Each mL of ILEVRO ® 0.3% contains: Active: nepafenac 0.3%. Inactives: boric acid, propylene glycol, carbomer 974P, sodium chloride, guar gum, carboxymethylcellulose sodium, edetate disodium, benzalkonium chloride 0.005% (preservative), sodium hydroxide and/or hydrochloric acid to adjust pH and purified water, USP. structural formula of nepafenac

Wirkstoffe

Wirkstoff	Stärke
Nepafenac	-

Indikationen und Anwendung

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 ).

So funktioniert es

12.1 Mechanism of Action After topical ocular dosing, nepafenac penetrates the cornea and is converted by ocular tissue hydrolases to amfenac, a NSAID. Nepafenac and amfenac are thought to inhibit the action of prostaglandin H synthase (cyclooxygenase), an enzyme required for prostaglandin production.

Dosierung und Verabreichung

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.

Side Effects Overview

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 5% to 10% of patients. Other ocular adverse reactions occurring at an incidence of approximately 1% to 5% included conjunctival edema, corneal edema, dry eye, lid margin crusting, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, photophobia, tearing, and vitreous detachment. Some of these reactions may be the consequence of the cataract surgical procedure. 6.3 Non-Ocular Adverse Reactions Non-ocular adverse reactions reported at an incidence of 1% to 4% included headache, hypertension, nausea/vomiting, and sinusitis.

Warnhinweise und Vorsichtsmaßnahmen

5 WARNINGS AND PRECAUTIONS 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. 5.2 Delayed Healing Topical NSAIDs including ILEVRO ® 0.3%, may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems. 5.3 Corneal Effects Use of topical NSAIDs may result in keratitis. In some susceptible patients, continued use of topical NSAIDs may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration, or corneal perforation. These events may be sight threatening. Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs including ILEVRO ® 0.3% and should be closely monitored for corneal health. Postmarketing experience with topical NSAIDs suggests that patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (e.g., dry eye syndrome), rheumatoid arthritis, or repeat ocular surgeries within a short period of time may be at increased risk for corneal adverse events, which may become sight threatening. Topical NSAIDs should be used with caution in these patients. Postmarketing experience with topical NSAIDs also suggests that use more than 1 day prior to surgery or use beyond 14 days post-surgery may increase patient risk and severity of corneal adverse events. 5.4 Contact Lens Wear ILEVRO ® 0.3% should not be administered while using contact lenses.

Kontraindikationen

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 )

Pharmakokinetik

12.3 Pharmacokinetics Following bilateral topical ocular once-daily dosing of ILEVRO ® 0.3%, the concentrations of nepafenac and amfenac peaked at a median time of 0.5 hour and 0.75 hour, respectively on both Day 1 and Day 4. The mean steady-state C max for nepafenac and for amfenac were 0.847 ± 0.269 ng/mL and 1.13 ± 0.491 ng/mL, respectively. Nepafenac at concentrations up to 3000 ng/mL and amfenac at concentrations up to 1000 ng/mL did not inhibit the in vitro metabolism of six specific marker substrates of cytochrome P450 (CYP) isozymes (CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP2E1, and CYP3A4). Therefore, drug-drug interactions involving CYP mediated metabolism of concomitantly administered drugs are unlikely.

Frequently Asked Questions

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 ).

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 …

5 WARNINGS AND PRECAUTIONS 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 …

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 )

Nepafenac is a prescription medication. You will need a valid prescription from a licensed healthcare provider.

Similar Drops Products

Sulfacetamide Sodium And Prednisolone …

Azelastine Hydrochloride Ophthalmic Solution …

Tetrahydrozoline Hydrochloride And Polyethylene …

Rose Bengal Sodium

Ofloxacin Ophthalmic Solution Usp, …

Dorzolamide Hydrochloride And Timolol …

Browse all Drops products →

References & Data Sources

• DailyMed — Nepafenac drug label (National Library of Medicine)
• openFDA — Nepafenac label data (U.S. Food & Drug Administration)
• RxNorm — RXCUI 1362132 (NLM Normalized Drug Names)
• NDC Directory — Nepafenac (FDA National Drug Code)

Medizinischer Haftungsausschluss

Die Informationen auf dieser Seite dienen ausschließlich zu Bildungszwecken und sollten nicht als Ersatz für professionellen ärztlichen Rat, Diagnose oder Behandlung verwendet werden.

Wenden Sie sich bei Fragen zu einem medizinischen Zustand oder einem Arzneimittel stets an Ihren Arzt oder einen anderen qualifizierten Angehörigen der Gesundheitsberufe.

Datenquellen: DailyMed (NLM), openFDA, MFDS