Flurbiprofen 100 mg/1
Flurbiprofen · TABLET, FILM COATED · Bryant Ranch Prepack
Flurbiprofen is a nonsteroidal anti-inflammatory drug (NSAID) used to reduce pain, fever, and inflammation from conditions like arthritis and other painful disorders. It comes as a 100 mg oral tablet and requires a prescription.
Key Facts
- Brand Name
- Flurbiprofen
- Generic Name
- Flurbiprofen
- NDC Code (Product)
63629-8808- Manufacturer
- Bryant Ranch Prepack
- Strength
- 100 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA074431
- Drug Class
- Nonsteroidal Anti-inflammatory Drug [EPC]
- Marketing Start
- 06/02/1995
Recall History
Pharmacy Innovations
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
American Pharmaceutical Ingredients LLC
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Flurbiprofen sodium ophthalmic solution is indicated for the inhibition of intraoperative miosis.
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.
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.
Contraindications
CONTRAINDICATIONS Flurbiprofen sodium ophthalmic solution is contraindicated in individuals who are hypersensitive to any components of the medication.
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.
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.
Frequently Asked Questions
What is Flurbiprofen used for?
Flurbiprofen is a nonsteroidal anti-inflammatory drug (NSAID) used to reduce pain, fever, and inflammation from conditions like arthritis and other painful disorders. It comes as a 100 mg oral tablet and requires a prescription.
Is Flurbiprofen a controlled substance?
Flurbiprofen is not classified as a controlled substance by the DEA.
What is the generic name for Flurbiprofen?
The generic name for Flurbiprofen is Flurbiprofen. There are 5 other brand versions of Flurbiprofen.
What is the NDC code for Flurbiprofen 100 mg/1?
The NDC (National Drug Code) for Flurbiprofen 100 mg/1 is 63629-8808, listed by Bryant Ranch Prepack.