FDA records indicate that there are no current recalls for this drug.
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Questions & Answers
Side Effects & Adverse Reactions
With some nonsteroidal anti-inflammatory drugs, there exists the potential for increased bleeding time due to interference with thrombocyte aggregation. There have been reports that OCUFEN® ophthalmic solution may cause increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery.
There is the potential for cross-sensitivity to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
OCUFEN® ophthalmic solution is indicated for the inhibition of intraoperative miosis.
History
There is currently no drug history available for this drug.
Other Information
OCUFEN® (flurbiprofen sodium ophthalmic solution, USP) 0.03% is a sterile topical nonsteroidal anti-inflammatory product for ophthalmic use.
Chemical Name:
Sodium (±)-2-(2-fluoro-4-biphenylyl) propionate dihydrate.
Structural Formula:
C15H12FNaO2•2H2O Mol. Wt. 302.27
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 pH. The pH of OCUFEN® ophthalmic solution is 6.0 to 7.0. It has an osmolality of 260 - 330 mOsm/kg.
Sources
Ocufen Manufacturers
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Allergan, Inc.
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