Ocufen Description

OCUFEN® (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:

Contains: Active: flurbiprofen sodium 0.03% (0.3 mg/mL). Preservative: thimerosal 0.005%. Inactives: citric acid; edetate disodium; polyvinyl alcohol 1.4%; potassium chloride; purified water; sodium chloride; and sodium citrate. May also contain hydrochloric acid and/or sodium hydroxide to adjust the pH. The pH of OCUFEN® ophthalmic solution is 6.0 to 7.0. It has an osmolality of 260 - 330 mOsm/kg.

Ocufen Indications And Usage

OCUFEN® ophthalmic solution is indicated for the inhibition of intraoperative miosis.

Ocufen Contraindications

OCUFEN® ophthalmic solution is contraindicated in individuals who are hypersensitive to any components of the medication.

Ocufen Side Effects

With nonsteroidal anti-inflammatory drugs, there exists the potential for increased bleeding due to interference with thrombocyte aggregation. There have been reports that OCUFEN® ophthalmic solution may cause increased bleeding of ocular tissues including hyphemas in conjunction with ocular surgery.

There exists the potential for cross-sensitivity to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.

Ocufen Precautions

General

Wound healing may be delayed with the use of OCUFEN® (flurbiprofen sodium ophthalmic solution, USP) 0.03%.

It is recommended that OCUFEN® ophthalmic solution be used with caution in surgical patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time.

Drug Interactions

Interaction of OCUFEN® 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 OCUFEN® 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

Pregnancy category C . 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. OCUFEN® 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 efffectiveness have been observed between elderly and younger patients.

Ocufen Overdosage

Overdosage will not ordinarily cause acute problems. If accidentally ingested, drink fluids to dilute.