Generic Name: Nepafenac
Class: Nonsteroidal Anti-inflammatory Agents
VA Class: CN104
Chemical Name: 2-amino-3-benzoylbenzeneacetamide
Molecular Formula: C15H14N2O2
Introduction
Prodrug of amfenac, a prototypical NSAIA.1 2 3 4 5 6 7 8
Uses for Nevanac
Postoperative Ocular Inflammation and Pain
Management of ocular inflammation and pain associated with cataract surgery.1 4 5
Nevanac Dosage and Administration
Administration
Ophthalmic Administration
Apply topically to the eye as an ophthalmic suspension.1
Avoid contamination of the suspension container.9
Shake suspension container well prior to administration.1
Do not administer to an eye that has a contact lens.1 (See Advice to Patients.)
May be used in conjunction with other topical ophthalmic medications such as β-adrenergic blocking agents, carbonic anhydrase inhibitors, α-agonists, cycloplegics, and mydriatics.1 9 If >1 topical ophthalmic drug is used, administer the drugs 10 minutes apart from nepafenac administration.9
Dosage
Pediatric Patients
Postoperative Ocular Inflammation and Pain
Ophthalmic
Patients ≥10 years of age: 1 drop of a 0.1% suspension in the affected eye(s) 3 times daily, beginning 1 day prior to cataract surgery and continuing on the day of the surgery and for 2 weeks after surgery.1
Adults
Postoperative Ocular Inflammation and Pain
Ophthalmic
1 drop of a 0.1% suspension in the affected eye(s) 3 times daily, beginning 1 day prior to cataract surgery and continuing on the day of the surgery and for 2 weeks after surgery.1
Cautions for Nevanac
Contraindications
Known hypersensitivity to nepafenac or any ingredient in the formulation or to other NSAIAs.1
Warnings/Precautions
Warnings
Bleeding
May inhibit platelet aggregation and prolong bleeding time.1
May cause increased bleeding of ocular tissues (including hyphemas) when used in conjunction with ocular surgery.1
Use with caution in patients with underlying bleeding tendencies or in those receiving drugs known to prolong bleeding time.1
Sensitivity Reactions
Hypersensitivity Reactions
Possible cross-sensitivity with aspirin, phenylacetic acid derivatives, and other NSAIAs.1 Use with caution in patients with history of hypersensitivity to these drugs.1
General Precautions
Wound-healing Complications
May slow or delay wound healing.1 (See Specific Drugs under Interactions.)
Ocular Effects
Use may result in keratitis.1 In some susceptible patients, continued use may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration, or corneal perforation; these events may be sight-threatening.1 If manifestations of corneal epithelial breakdown occur, discontinue therapy immediately and monitor for corneal health.1
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 developing adverse corneal effects that may become sight-threatening.1 Use with caution in these patients.1
Use >1 day prior to surgery or use beyond 14 days postoperatively may precipitate or exacerbate adverse corneal effects.1
No substantial effect on intraocular pressure reported; however, changes in intraocular pressure may occur following cataract surgery.1
Specific Populations
Pregnancy
Category C.1
Avoid use in late pregnancy because of known effects on fetal cardiovascular system (possible closure of the ductus arteriosus).1
Lactation
Distributed into milk in rats following oral administration of a single 3 mg/kg-dose;1 9 not known whether distributed into human milk following ophthalmic administration.1 Use with caution.1
Pediatric Use
Safety and efficacy not established in children <10 years of age.1
Geriatric Use
No substantial differences in safety and efficacy relative to younger adults.1
Common Adverse Effects
Capsular opacity, decreased visual acuity, ocular foreign body sensation, increased intraocular pressure, ocular sticky sensation, conjunctival edema, corneal edema, dry eye, lid margin crusting, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, photophobia, tearing, vitreous detachment, headache, hypertension, nausea, vomiting, sinusitis.1
Interactions for Nevanac
Does not inhibit CYP isoenzymes 1A2, 2C9, 2C19, 2D6, 2E1, or 3A4 in vitro.1
Drugs Metabolized by Hepatic Microsomal Enzymes
Pharmacokinetic interactions with drugs metabolized by CYP isoenzymes 1A2, 2C9, 2C19, 2D6, 2E1, or 3A4 unlikely.1
Protein-bound Drugs
Pharmacokinetic interaction unlikely.1
Specific Drugs
Drug | Interaction |
|---|---|
Corticosteroids, topical | Increased potential for wound-healing complications1 |
Nevanac Pharmacokinetics
Absorption
Bioavailability
Prodrug; penetrates the cornea following topical application to the eye and converted by ocular tissue hydrolases to amfenac.1
Following 3 times daily bilateral topical ophthalmic application, low, but quantifiable, plasma concentrations of nepafenac and amfenac observed 2 and 3 hours postdose, respectively.1
Distribution
Extent
Distributed into milk in rats following oral administration of a single 3 mg/kg-dose;1 9 not known whether distributed into human milk following ophthalmic administration.1
Elimination
Metabolism
Converted by ocular tissue hydrolases to amfenac.1 (See Bioavailability under Pharmacokinetics.)
Stability
Storage
Ophthalmic
Suspension
2–25°C.1
ActionsActions
Prodrug of amfenac, a prototypical NSAIA.1 2 3 4 5 6 7 8
Amfenac inhibits the synthesis of prostaglandins by inhibiting cyclooxygenase (COX), including both COX-1 and COX-2 isoenzymes.1 2 3 6 8
Ocular effects appear to be associated principally with the inhibition of ocular prostaglandin synthesis.1 2 7
Advice to Patients
Risk of ocular bleeding.1 Risk of anaphylactoid and other sensitivity reactions.1
Importance of learning and adhering to proper administration techniques to avoid contamination of the ophthalmic suspension with common bacteria that can cause ocular infections.9
Importance of removing contact lenses before administration.1 Importance of shaking suspension before administration.1
Importance of administering different topical ophthalmic preparations 10 minutes apart from nepafenac administration.9
Importance of not using topical NSAIAs >1 day prior to surgery or beyond 14 days after surgery.1
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 Risk of use during late pregnancy.1
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.1
Importance of informing patients of other important precautionary information.1 (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Ophthalmic | Suspension | 0.1% | Nevanac (with benzalkonium chloride) | Alcon |
Comparative Pricing
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Nevanac 0.1% Suspension (ALCON VISION): 3/$129.99 or 9/$375.99
Disclaimer
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions June 2006. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
References
1. Alcon Laboratories, Inc. Nevanac (nepafenac ophthalmic suspension) 0.1% prescribing information. Fort Worth, TX; 2005.
2. O’Brien TP. Emerging guidelines for use of NSAID therapy to optimize cataract surgery patient care. Curr Med Res Opin. 2005; 21:1131-37.
3. Takahashi K, Saishin Y, Saishin Y et al. Topical nepafenac inhibits ocular neovascularization. Invest Ophthalmol Vis Sci. 2003; 44:409-15. [PubMed 12506103]
4. Lane SS, Modi SS, Holland EJ et al. Pre- and post-operative nepafenac ophthalmic suspension, 0.1% for anterior segment inflammation after cataract surgery. Paper presented at the annual ASCRS/ASOA symposium and congress. Washington, DC: 2005 Apr 18.
5. Stewart WC, Stewart R, Maxwell WA et al. Pre- and post-operative clinical posology evaluation of nepafenac ophthalmic suspension, 0.1% for anterior segment inflammation after cataract surgery. Paper presented at the annual ASCRS/ASOA symposium and congress. Washington, DC: 2005 Apr 18.
6. Gamache DA, Graff G, Brady MT et al. Nepafenac, a unique nonsteroidal prodrug with potential utility in the treatment of trauma-induced ocular inflammation: I. Assessment of anti-inflammatory efficacy. Inflammation. 2000; 24:357-70. [PubMed 10850857]
7. Ke TL, Graff G, Spellman JM et al. Nepafenac, a unique nonsteroidal prodrug with potential utility in the treatment of trauma-induced ocular inflammation: II. In vitro bioactivation and permeation of external ocular barriers. Inflammation. 2000; 24:371-84. [PubMed 10850858]
8. Kapin MA, Yanni JM, Brady MT et al. Inflammation-mediated retinal edema in the rabbit is inhibited by topical nepafenac. Inflammation. 2003; 27:281-91. [PubMed 14635785]
9. Alcon Laboratories, Inc., Fort Worth, TX: Personal Communication.
More Nevanac resources
- Nevanac Side Effects (in more detail)
- Nevanac Dosage
- Nevanac Use in Pregnancy & Breastfeeding
- Nevanac Drug Interactions
- Nevanac Support Group
- 1 Review for Nevanac - Add your own review/rating
- Nevanac Prescribing Information (FDA)
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