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Optanep

Optanep

nepafenac

Manufacturer:

World Medicine

Distributor:

Vista Pharma
Concise Prescribing Info
Contents
Nepafenac
Indications/Uses
Prevention & treatment of post-op pain & inflammation associated w/ cataract surgery in adults.
Dosage/Direction for Use
Adult including elderly Prevention & treatment of pain & inflammation Instill 1 drop on conjunctival sac of affected eye(s) once daily beginning 1 day prior to cataract surgery, continued on the day of surgery, & for 1st 2 wk of post-op period. Extend treatment to 1st 3 wk of post-op period. Administer additional drop 30-120 min prior to surgery. Risk reduction of post-op macular edema associated w/ cataract surgery in diabetic patient Instill 1 drop in conjunctival sac of affected eye(s) once daily beginning 1 day prior to cataract surgery, continued on the day of surgery & up to 60 days of post-op period. Administer additional drop 30-120 min prior to surgery.
Contraindications
Hypersensitivity to nepafenac, or other NSAIDs. Patients w/ urticaria, acute rhinitis, or asthma attacks precipitated by ASA or other NSAIDs.
Special Precautions
Potential for cross-sensitivity to ASA, phenylacetic acid derivatives, & other NSAIDs. Administer at least 5 min apart if >1 topical ophth medicinal product is being used. Careful not to touch eyelids, surrounding areas, or other surfaces w/ dropper tip of bottle to prevent contamination of dropper tip & soln. Do not inj. Avoid sunlight during treatment. Not to be used for reducing post-op macular edema risk associated w/ cataract surgery. Ocular effects eg, keratitis; epithelial breakdown, corneal thinning, erosion, ulceration or perforation. Discontinue use immediately & monitor closely for corneal health in patients w/ evidence of corneal epithelial breakdown. Concomitant use w/ corticosteroids, especially in patients w/ high risk for side effects. Patients w/ complicated ocular surgeries, corneal denervation & epithelial defects, DM, ocular surface diseases (eg, dry eye syndrome), RA or repeat ocular surgeries w/in short period of time; w/ known bleeding tendencies or who are receiving other medicinal products that prolong bleeding time. Prolonged use may increase risk for occurrence & severity of corneal adverse reactions in patients. May mask acute ocular infection. Concomitant use w/ anti-infectives in case of ocular infection. Do not wear contact lenses during treatment. Contains benzalkonium Cl, require close monitoring w/ frequent or prolonged use since may cause punctate keratopathy &/or toxic ulcerative keratopathy; eye irritation; discoloration of soft contact lenses. Avoid contact w/ soft contact lenses. Remove contact lenses before administration & wait at least 15 min to wear them. Contains propylene glycol which may cause eye irritation. Temporary blurred vision or other visual disturbances may affect ability to drive or use machines. Renal or hepatic impairment. Use medically appropriate contraceptive method during treatment in women of childbearing potential. Not recommended during pregnancy. Lactation. Not recommended in childn & adolescents.
Adverse Reactions
Eye pain, punctate keratitis, hypersensitivity. Foreign body sensation, & eyelid margin crusting.
Drug Interactions
Very low potential for interaction w/ other medicinal products & protein-binding interactions. Concomitant use w/ prostaglandin analogues are not recommended. May retard healing w/ topical steroids. May increase risk of hemorrhage w/ medications that prolong bleeding time.
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.
Presentation/Packing
Form
Optanep ophth susp 3 mg/mL (0.3% w/v)
Packing/Price
1.7 mL x 1's
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