Flurbiprofen Ophthalmic Solution

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:

C15H12 FNaO2 •2H2O         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%.

Flurbiprofen Sodium Ophthalmic Solution is indicated for the inhibition of intraoperative miosis.

General:

Topical nonsteroidal anti-inflammatory drugs (NSAIDs) may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems.

It is recommended that Flurbiprofen Sodium Ophthalmic Solution be used with caution in surgical patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time.

Information for Patients:

Patients should be instructed to avoid allowing the tip of the bottle to contact the eye or surrounding structures because this could cause the tip to become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.

To avoid the potential for cross-contamination, the patient should be advised to use one bottle for each eye with bilateral ocular surgery. The use of the same bottle of eye drops for both eyes is not recommended with ocular surgery.

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.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Long-term studies in mice and/or rats have shown no evidence of carcinogenicity with flurbiprofen.

Long-term mutagenicity studies in animals have not been performed.

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.

Pediatric Use:

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use:

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

FLURBIPROFEN (flure BI proe fen) is a non-steroidal anti-inflammatory drug (NSAID). The eye drops are used to treat pain and swelling after eye surgery.

This drug also comes in other forms, including Oral tablet

This drug can cause serious side effects. See which side effects you should report to your doctor right away.

Know how to use your medication, and learn what might happen if you miss a dose.

Talk to your healthcare provider if you have any of these conditions.

Know what to watch for and get tips for reducing your risks while taking this drug.