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).
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.
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: Mechanism of Action: 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
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.