Nepafenac


Generic Medicine Info
Indications and Dosage
Ophthalmic
Risk reduction of postoperative macular oedema associated with cataract surgery in diabetic patients
Adult: As 0.1% susp: Instil 1 drop into the affected eye(s) tid. As 0.3% susp: Instil 1 drop into the affected eye(s) once daily. Initiate treatment 1 day prior to cataract surgery, continue on the day of surgery and up to 60 days of the postoperative period; instil an additional drop 30-120 minutes before surgery. Treatment recommendations may vary among countries and individual products (refer to detailed product guidelines).

Ophthalmic
Postoperative ocular inflammation, Postoperative ocular pain
Adult: Prevention and treatment of pain and inflammation associated with cataract surgery: As 0.1% susp: Instil 1 drop into the affected eye(s) tid. As 0.3% susp: Instil 1 drop into the affected eye(s) once daily. Initiate treatment 1 day prior to cataract surgery, continue on the day of surgery and for the 1st 2 weeks of the postoperative period; treatment may be extended up to 3 weeks. Instil an additional drop 30-120 minutes before surgery.
Contraindications
Hypersensitivity to nepafenac or other NSAIDs. Patients in whom attacks of asthma, acute rhinitis, or urticaria are precipitated by aspirin or other NSAIDs.
Special Precautions
Patient with diabetes mellitus; predisposition to bleeding (known bleeding tendencies or receiving medications which interfere with coagulation); rheumatoid arthritis; complicated ocular surgery, repeat ocular surgeries (within a short timeframe), ocular surface disease (e.g. dry eye syndrome), corneal denervation, corneal epithelial defects. May mask symptoms of ocular infection. Pregnancy and lactation.
Adverse Reactions
Significant: Corneal effects (e.g. keratitis, corneal epithelial damage, punctate keratitis), increased intraocular bleeding (including hyphaema); may slow or delay healing.
Eye disorders: Foreign body sensation in eyes, crusting of eyelid, sticky sensation, decreased visual acuity, increased intraocular pressure, conjunctival oedema, eye pain, eye discomfort, eye pruritus, ocular hyperaemia, lacrimation, xerophthalmia, photophobia, vitreous detachment, blurred vision, dermatochalasis.
Gastrointestinal disorders: Nausea, vomiting.
Immune system disorders: Rarely, hypersensitivity.
Nervous system disorders: Rarely, headache, dizziness.
Respiratory, thoracic and mediastinal disorders: Sinusitis.
Skin and subcutaneous tissue disorders: Rarely, allergic dermatitis.
Vascular disorders: Hypertension.
Patient Counseling Information
This drug may cause temporary blurring of vision or other visual disturbances, if affected, do not drive or operate machinery. Avoid exposure to sunlight during treatment. Wearing contact lenses is not recommended after cataract surgery; if contact lenses are needed to be used during treatment, remove them prior to administration and wait at least 15 minutes before reinsertion.
Drug Interactions
Concomitant use with ophthalmic corticosteroids may delay the healing of ophthalmic tissue. May increase the risk of haemorrhage with drugs that prolong bleeding time.
Action
Description: Nepafenac is an NSAID and analgesic prodrug that penetrates the cornea after topical ocular administration. It is converted by ocular tissue hydrolases to amfenac, the active form that inhibits prostaglandin synthesis by reducing the activity of the enzyme, cyclooxygenase, resulting in decreased formation of prostaglandin precursors.
Pharmacokinetics:
Absorption: Low plasma concentrations of nepafenac and amfenac are detected following ophthalmic administration.
Metabolism: Undergoes rapid bioactivation to amfenac (active) via hydrolases in the ocular tissue; subsequently, amfenac is extensively metabolised via hydroxylation of the aromatic ring to form more polar metabolites.
Chemical Structure

Chemical Structure Image
Nepafenac

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 151075, Nepafenac. https://pubchem.ncbi.nlm.nih.gov/compound/Nepafenac. Accessed May 27, 2022.

Storage
Store between 2-25°C. Protect from light (0.3% ophthalmic susp). Storage recommendations may vary between individual products. Refer to detailed product guidelines.
MIMS Class
Ophthalmic Decongestants, Anesthetics, Anti-Inflammatories
ATC Classification
S01BC10 - nepafenac ; Belongs to the class of non-steroidal antiinflammatory agents. Used in the treatment of inflammation of the eye.
References
Anon. Nepafenac. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 17/12/2021.

Buckingham R (ed). Nepafenac. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 17/12/2021.

Ilevro Ophthalmic Suspension 0.3% (Novartis Corporation [Malaysia] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 17/12/2021.

Ilevro Suspension/Drops (Novartis Pharmaceuticals Corporation). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 17/12/2021.

Joint Formulary Committee. Nepafenac. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 17/12/2021.

Nevanac 1 mg/mL Eye Drops, Suspension (Novartis Pharmaceuticals UK Limited). MHRA. https://products.mhra.gov.uk. Accessed 17/12/2021.

Nevanac 3 mg/mL Eye Drops, Suspension (Novartis Pharmaceuticals UK Limited). MHRA. https://products.mhra.gov.uk. Accessed 17/12/2021.

Nevanac Ophthalmic Suspension 0.1% (Novartis Corporation [Malaysia] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 17/12/2021.

Nevanac Suspension/Drops (Alcon Laboratories, Inc). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 17/12/2021.

Novartis New Zealand Limited. Ilevro 0.3% Eye Drops Suspension data sheet 15 September 2021. Medsafe. http://www.medsafe.govt.nz. Accessed 12/04/2022.

Disclaimer: This information is independently developed by MIMS based on Nepafenac from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2024 MIMS. All rights reserved. Powered by MIMS.com
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