Flurbiprofen Sodium
FDA Drug Information • Also known as: Flurbiprofen Sodium
- Brand Names
- Flurbiprofen Sodium
- Route
- OPHTHALMIC
- Dosage Form
- SOLUTION/ DROPS
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
DESCRIPTION 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
What Is Flurbiprofen Sodium Used For?
INDICATIONS AND USAGE Flurbiprofen Sodium Ophthalmic Solution is indicated for the inhibition of intraoperative miosis.
Dosage and 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.
Side Effects (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, 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.
Warnings and 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.
Drug Interactions
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.
Contraindications
CONTRAINDICATIONS Flurbiprofen Sodium Ophthalmic Solution is contraindicated in individuals who are hypersensitive to any components of the medication.
Pregnancy and Breastfeeding
Pregnancy: Flurbiprofen has been shown to be embryocidal, delay parturition, prolong gestation, reduce weight, and/or slightly retard growth of fetuses when given to rats in daily oral doses of 0.4 mg/kg (approximately 300 times the human daily topical dose) and above. There are no adequate and well-controlled studies in pregnant women. Flurbiprofen Sodium Ophthalmic Solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from flurbiprofen sodium, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Overdosage
OVERDOSAGE Overdosage will not ordinarily cause acute problems. If accidentally ingested, drink fluids to dilute.
How Supplied
HOW SUPPLIED Product: 50090-3946 NDC: 50090-3946-0 2.5 mL in a BOTTLE, DROPPER / 1 in a CARTON
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.