Product Description.:
Drops , clear , clear
Colorless to light yellowish
OCUFEN? (flurbiprofen sodium ophthalmic solution, USP) 0.03% is a sterile topical nonsteroidal anti-inflammatory product for ophthalmic use.
Contains: Active: flurbiprofen sodium 0.03% (0.3 mg/mL). Preservative: thimerosal 0.005%. Inactives: citric acid edetate disodium polyvinyl alcohol 1.4% potassium chloride purified water sodium chloride and sodium citrate. May also contain hydrochloric acid and/or sodium hydroxide to adjust the pH. The pH of OCUFEN? ophthalmic solution is 6.0 to 7.0. It has an osmolality of 260-330 mOsm/kg.
INDICATIONS
OCUFEN? ophthalmic solution is indicated for the inhibition of intraoperative miosis.
DOSAGE AND ADMINISTRATION
A total of four (4) drops of OCUFEN? ophthalmic solution should be administered by instilling one (1) drop approximately every 1/2 hour beginning 2 hours before surgery.
SIDE EFFECTS
Transient burning and stinging upon instillation and other minor symptoms of ocular irritation have been reported with the use of OCUFEN? ophthalmic solution. Other adverse reactions reported with the use of OCUFEN? ophthalmic solution include: fibrosis, miosis, and mydriasis.
Increased bleeding tendency of ocular tissues in conjunction with ocular surgery has also been reported.
DRUG INTERACTIONS
Interaction of OCUFEN? ophthalmic solution with other topical ophthalmic medications has not been fully investigated.
Although clinical studies with acetylcholine chloride and animal studies with acetylcholine chloride or carbachol revealed no interference, and there is no known pharmacological basis for an interaction, there have been reports that acetylcholine chloride and carbachol have been ineffective when used in patients treated with OCUFEN? ophthalmic solution.
