Chemical formula: C₁₅H₁₄N₂O₂ Molecular mass: 254.284 g/mol PubChem compound: 151075
Nepafenac interacts in the following cases:
Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems. Concomitant use of nepafenac with medications that prolong bleeding time may increase the risk of haemorrhage.
There are very limited data on the concomitant use of prostaglandin analogues and nepafenac. Considering their mechanism of action, the concomitant use of these medicinal products is not recommended.
There are no adequate data regarding the use of nepafenac in pregnant women. Studies in animals have shown reproductive toxicity. The potential risk for humans is unknown. Since the systemic exposure in non-pregnant women is negligible after treatment with nepafenac, the risk during pregnancy could be considered low. Nevertheless, as inhibition of prostaglandin synthesis may negatively affect pregnancy and/or embryonal/foetal development and/or parturition and/or postnatal development. Nepafenac is not recommended during pregnancy.
It is unknown whether nepafenac is excreted in human milk. Animal studies have shown excretion of nepafenac in the milk of rats. However, no effects on the suckling child are anticipated since the systemic exposure of the breast-feeding woman to nepafenac is negligible. Nepafenac can be used during breast-feeding.
Nepafenac should not be used by women of child bearing potential not using contraception.
There are no data on the effect of nepafenac on human fertility.
Nepafenac has no or negligible influence on the ability to drive and use machines.
Temporary blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs at instillation, the patient must wait until the vision clears before driving or using machines.
In clinical studies involving 2314 patients receiving nepafenac 1 mg/ml the most common adverse reactions were punctate keratitis, foreign body sensation and eyelid margin crusting which occurred in between 0.4% and 0.2% of patients.
The following adverse reactions are classified according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), or not known (cannot be estimated from available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. The adverse reactions were obtained from clinical trials and post-marketing reports.
Rare: hypersensitivity
Rare: dizziness, headache
Uncommon: keratitis, punctate keratitis, corneal epithelium defect, foreign body sensation in eyes, eyelid margin crusting
Rare: iritis, choroidal effusion, corneal deposits, eye pain, ocular discomfort, dry eye, blepharitis, eye irritation, eye pruritus, eye discharge, allergic conjunctivitis, increased lacrimation, conjunctival hyperaemia
Not known: corneal perforation, impaired healing (cornea), corneal opacity, corneal scar, reduced visual acuity, eye swelling, ulcerative keratitis, corneal thinning, blurred vision
Uncommon: hypertension
Not known: blood pressure increased
Rare: nausea
Not known: vomiting
Rare: cutis laxa (dermatochalasis), allergic dermatitis
Patients with evidence of corneal epithelial breakdown including corneal perforation should immediately discontinue use of nepafenac and should be monitored closely for corneal health.
From post-marketing experience with nepafenac 1 mg/ml eye drops, suspension, cases reporting corneal epithelium defect/disorder have been identified. Severity of these cases vary from non serious effects on the epithelial integrity of the corneal epithelium to more serious events where surgical interventions and/or medical therapy are required to regain clear vision.
Post-marketing experience with topical NSAIDs suggests that patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (eg, dry eye syndrome), rheumatoid arthritis or repeat ocular surgeries within a short period of time may be at increased risk for corneal adverse reactions which may become sight threatening.
The safety and efficacy of nepafenac in children and adolescents have not been established.
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