Drugplain

Flurbiprofen Sodium .3 mg/mL

Flurbiprofen Sodium · SOLUTION/ DROPS · A-S Medication Solutions

No Recall History
Plain English

Flurbiprofen Sodium is a solution/ drops containing flurbiprofen sodium at .3 mg/mL, taken ophthalmic. Manufactured by A-S Medication Solutions.

Key Facts

Brand Name
Flurbiprofen Sodium
Generic Name
Flurbiprofen Sodium
NDC Code (Product)
50090-3946
Manufacturer
A-S Medication Solutions
Strength
.3 mg/mL
Dosage Form
SOLUTION/ DROPS
Route
OPHTHALMIC
Marketing Status
Application #
ANDA074447
Marketing Start
03/31/2018

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

toxic anterior segment syndrome15 reports
iridocyclitis12 reports
drug ineffective6 reports
abdominal discomfort5 reports
arthralgia5 reports
palpitations5 reports
squamous cell carcinoma5 reports
eye irritation3 reports
off label use3 reports
eye pain2 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

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 Sodium used for?

Flurbiprofen Sodium contains Flurbiprofen Sodium. It is a solution/ drops taken ophthalmic. Consult your doctor for specific uses.

Is Flurbiprofen Sodium a controlled substance?

Flurbiprofen Sodium is not classified as a controlled substance by the DEA.

What is the generic name for Flurbiprofen Sodium?

The generic name for Flurbiprofen Sodium is Flurbiprofen Sodium. There are no other listed brand versions of Flurbiprofen Sodium.

What is the NDC code for Flurbiprofen Sodium .3 mg/mL?

The NDC (National Drug Code) for Flurbiprofen Sodium .3 mg/mL is 50090-3946, listed by A-S Medication Solutions.

Product NDC

50090-3946

Package NDC

50090-3946-0

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)