Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Flurbiprofen Sodium Ophthalmic Solution, USP 0.03% is supplied in a plastic bottle with a controlled drop tip in the following size: 2.5 mL - NDC 63187-937-25 DO NOT USE IF IMPRINTED “Protective Seal” WITH YELLOW IS NOT INTACT. symbol; Principal Display Panel NDC 63187-937-25 Flurbiprofen Sodium Ophthalmic Solution, USP 0.03% (Sterile) FOR OPHTHALMIC USE ONLY Rx only 2.5 mL 63187-937-25
- HOW SUPPLIED Flurbiprofen Sodium Ophthalmic Solution, USP 0.03% is supplied in a plastic bottle with a controlled drop tip in the following size: 2.5 mL - NDC 63187-937-25 DO NOT USE IF IMPRINTED “Protective Seal” WITH YELLOW IS NOT INTACT. symbol
- Principal Display Panel NDC 63187-937-25 Flurbiprofen Sodium Ophthalmic Solution, USP 0.03% (Sterile) FOR OPHTHALMIC USE ONLY Rx only 2.5 mL 63187-937-25
Overview
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: C 15 H 12 FNaO 2 •2H 2 O Mol. Wt. 302.27 Each mL Contains: ACTIVE: Flurbiprofen sodium 0.03%. INACTIVES: Citric Acid, Edetate Disodium, Polyvinyl Alcohol 1.4%, Potassium Chloride, Purified Water, Sodium Chloride, Sodium Citrate. Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust pH (6.0 – 7.0). PRESERVATIVE: Thimerosal 0.005%. ChemStructure.jpg
Indications & Usage
Flurbiprofen Sodium Ophthalmic Solution is indicated for the inhibition of intraoperative miosis.
Dosage & Administration
A total of four (4) drops of Flurbiprofen Sodium Ophthalmic Solution should be administered by instilling one (1) drop approximately every 1/2 hour beginning 2 hours before surgery.
Warnings & Precautions
WARNINGS 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 Flurbiprofen Sodium 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 nonsteroidal anti-inflammatory drugs. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.
Contraindications
Flurbiprofen Sodium Ophthalmic Solution is contraindicated in individuals who are hypersensitive to any components of the medication.
Adverse Reactions
Transient burning and stinging upon instillation and other minor symptoms of ocular irritation have been reported with the use of Flurbiprofen Sodium Ophthalmic Solution. Other adverse reactions reported with the use of Flurbiprofen Sodium Ophthalmic Solution include: fibrosis, hyphema, miosis, mydriasis, and ocular hyperemia. Increased bleeding tendency of ocular tissues in conjunction with ocular surgery has also been reported (see Warnings ). To report SUSPECTED ADVERSE REACTIONS, contact Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC, at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Drug Interactions
Interaction of Flurbiprofen Sodium 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 Flurbiprofen Sodium Ophthalmic Solution.
Storage & Handling
Storage: Store at 15°–25°C (59°–77°F). Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA ©Bausch & Lomb Incorporated Revised: July 2016 9100604 (Folded) 9100704 (Flat) Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320
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