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`Home (/ecp/) ... Rx Pharmaceuticals (http://www.bausch.com/ecp/ourproducts/rxpharmaceuticals/) Rx
`Pharmaceuticals (http://www.bausch.com/ecp/ourproducts/rxpharmaceuticals/rxpharmaceuticals) PROLENSA
`(Bromfenac Ophthalmic Solution) (Http://Www.Bausch.Com/Ecp/OurProducts/RxPharmaceuticals/Rx
`Pharmaceuticals/ProlensaBromfenacOphthalmicSolution)
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`PROLENSA (bromfenac ophthalmic solution) 0.07%
`
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`PROLENSA (bromfenac ophthalmic solution) 0.07% is a nonsteroidal
`antiinflammatory drug (NSAID) indicated for the treatment of postoperative
`inflammation and reduction of ocular pain in patients who have undergone
`cataract surgery.
`
`(/ourproducts/rxpharmaceutical/prolensabromfenacophthalmicsolution007copy2/aboutprolensa)
`
`INDICATION FOR PROLENSA
`(bromfenac ophthalmic solution) 0.07%
`
`PROLENSA (bromfenac ophthalmic solution) 0.07% is a nonsteroidal anti
`inflammatory drug (NSAID) indicated for the treatment of postoperative
`inflammation and reduction of ocular pain in patients who have undergone
`cataract surgery.
`IMPORTANT SAFETY INFORMATION ABOUT PROLENSA
`
`PROLENSA contains sodium sulfite, a sulfite that may cause allergic type
`reactions including anaphylactic symptoms and lifethreatening or less
`severe asthmatic episodes in certain susceptible people. The overall
`prevalence of sulfite sensitivity in the general population is unknown and
`probably low. Sulfite sensitivity is seen more frequently in asthmatic than in
`nonasthmatic people.
`
`All topical nonsteroidal antiinflammatory drugs (NSAIDs), including
`bromfenac, may slow or delay healing. Concomitant use of topical NSAIDs
`and topical steroids may increase the potential for healing problems.
`
`There is the potential for crosssensitivity to acetylsalicylic acid, phenylacetic
`acid derivatives, and other NSAIDs, including bromfenac. Use with caution
`in patients who have previously exhibited sensitivities to these drugs.
`
`There have been reports that ocularly applied NSAIDs may cause increased
`bleeding of ocular tissues (including hyphemas) in conjunction with ocular
`surgery. Use with caution in patients with known bleeding tendencies or
`who are receiving other medications which may prolong bleeding time.
`
`Use of topical NSAIDs may result in keratitis. Patients with evidence of
`corneal epithelial breakdown should immediately discontinue use of topical
`NSAIDs, including bromfenac, and should be closely monitored for corneal
`health. Patients with complicated ocular surgeries, corneal denervation,
`
`INDICATION FOR LOTEMAX GEL (loteprednol etabonate
`ophthalmic gel) 0.5%
`
`LOTEMAX GEL (loteprednol etabonate ophthalmic gel) 0.5% is indicated for the
`treatment of postoperative inflammation and pain following ocular surgery.
`IMPORTANT SAFETY INFORMATION ABOUT LOTEMAX GEL
`
`LOTEMAX GEL is contraindicated in most viral diseases of the cornea and
`conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis),
`vaccinia, and varicella, and also in mycobacterial infection of the eye and
`fungal diseases of ocular structures.
`
`Prolonged use of corticosteroids may result in glaucoma with damage to the
`optic nerve, defects in visual acuity and fields of vision. If this product is used
`for 10 days or longer, IOP should be monitored.
`
`Use of corticosteroids may result in posterior subcapsular cataract formation.
`
`Use of steroids after cataract surgery may delay healing and increase the
`incidence of bleb formation and occurrence of perforations in those with
`diseases causing corneal and scleral thinning. The initial prescription and
`renewal of the medication order should be made by a physician only after
`examination of the patient with the aid of magnification, and where
`appropriate, fluorescein staining.
`
`Prolonged use of corticosteroids may suppress the host response and thus
`increase the hazard of secondary ocular infection. In acute purulent
`conditions, steroids may mask infection or enhance existing infections.
`
`Use of corticosteroid medication in the treatment of patients with a history of
`herpes simplex requires great caution. Use of ocular steroids may prolong the
`course and exacerbate the severity of many viral infections of the eye
`(including herpes simplex).
`
`
`
`Fungal infections of the cornea are particularly prone to develop coincidentally
`with longterm local steroid application. Fungus invasion must be considered
`in any persistent corneal ulceration where a steroid has been used or is in
`use.
`
`Patients should not wear contact lenses when using LOTEMAX GEL.
`
`The most common ocular adverse drug reactions were anterior chamber
`inflammation (5%), eye pain (2%) and foreign body sensation (2%).
`
`Please click here
`(/Portals/109//m/BL/United%20States/Files/Package%20Inserts/Pharma/lotemaxgel
`packageinsert.pdf) for Prescribing Information about LOTEMAX GEL.
`
`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 corneal adverse events
`which may become sight threatening. Topical NSAIDs should be used with
`caution in these patients. Postmarketing experience with topical NSAIDs
`suggests that use more than 24 hours prior to surgery or use beyond 14
`days postsurgery may increase patient risk for the occurrence and severity
`of corneal adverse events.
`
`PROLENSA should not be instilled while wearing contact lenses. The
`preservative in PROLENSA, benzalkonium chloride, may be absorbed by
`soft contact lenses. Lenses may be reinserted after 10 minutes following
`administration of PROLENSA.
`
`The most commonly reported adverse reactions in 3%8% of patients were
`anterior chamber inflammation, foreign body sensation, eye pain,
`photophobia, and blurred vision.
`
`Please click here
`(/Portals/109//m/BL/United%20States/Files/Package%20Inserts/Pharma/prolensa
`insert.pdf) for Prescribing Information about PROLENSA.
`
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