FLURBIPROFEN OPHTHALMIC SOLUTION 0.0003 2.5 ML
Generic: Flurbiprofen Sodium
FLURBIPROFEN OPHTHALMIC SOLUTION 0.0003 2.5 ML
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Identification
Flurbiprofen Sodium
Flurbiprofen Sodium
Amici Pharma, Inc.
HUMAN PRESCRIPTION DRUG
Administration
SOLUTION/ DROPS
OPHTHALMIC
ANDA074447
Active Ingredients
| Ingredient | Strength |
|---|---|
| FLURBIPROFEN SODIUM | .3 mg/mL |
Pharmacological Class
Data sourced from openFDA / DailyMed. For full prescribing information, consult the drug label.
Wholesale compliance resources
Drug Resources
Clinical Drug Information
Indications & Usage
INDICATIONS AND USAGE Flurbiprofen sodium ophthalmic solution is indicated for the inhibition of intraoperative miosis.
Warnings
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.
Dosage & Administration
DOSAGE AND 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.
Adverse Reactions
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 Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Clinical data sourced from openFDA drug labeling. For complete prescribing information, consult the full drug label.