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Flurbiprofen Sodium (Ophthalmic)
Flurbiprofen Sodium Ophthalmic Solution USP, 0.03% is a topical nonsteroidal anti-inflammatory product for ophthalmic use. It has the following molecular formula C15H12FNaO2 • 2H2O with a molecular weight of 302.28. Chemical Name: Sodium(+)-2-fluoro-a-methyl-4-biphenyl-acetate dihydrate. Each ml Contains:
Flurbiprofen sodium is one of a series of phenylalkanoic acids that have shown analgesic, antipyretic, and anti-inflammatory activity in animal inflammatory diseases. Its mechanism of action is believed to be through inhibition of the cyclo-oxygenase enzyme that is essential in the biosynthesis of prostaglandins. Prostaglandins have been shown in many animal models to be mediators of certain kinds of intraocular inflammation. In studies performed on animal eyes, prostaglandins have been shown to produce disruption of the blood-aqueous humor barrier, vasodilation, increased vascular permeability, leukocytosis, and increased intraocular pressure. Prostaglandins also appear to play a role in the miotic response produced during ocular surgery by constricting the iris sphincter independently of cholinergic mechanisms. In clinical studies, flurbiprofen sodium ophthalmic solution has been shown to inhibit the miosis induced during the course of cataract surgery. Results from clinical studies indicate that flurbiprofen sodium has no
significant effect upon intraocular pressure.
Flurbiprofen sodium ophthalmic solution is indicated for the inhibition of intraoperative miosis.
Atotal of four (4) drops of flurbiprofen sodium ophthalmic solution should be administered by instilling 1 drop approximately every ½ hour beginning 2 hours before surgery. HOW SUPPLIED Flurbiprofen Sodium Ophthalmic Solution USP, 0.03% is supplied in a plastic bottle with a controlled drop tip in the following size: 2.5 mL - Prod. No. 31404 DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT. Storage: Store between 15°- 30° C (59°- 86° F). Caution: Federal law prohibits dispensing without prescription.
The most frequent adverse reactions reported with the use of flurbiprofen sodium ophthalmic solution are transient burning and stinging upon instillation and other minor symptoms of ocular irritation. Increased bleeding tendency of ocular tissues in conjunction with ocular surgery has also been reported.
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.
With nonsteroidal anti-inflammatory drugs, there exists the potential for increased bleeding 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 exists 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.
General Wound healing may be delayed with the use of flurbiprofen sodium ophthalmic solution. 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. Drug Interactions See DRUG INTERACTIONS section. Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in mice and/or rats have shown no evidence of carcinogenicity or impairment of fertility with flurbiprofen. Long-term mutagenicity studies in animals have not been performed. 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 185 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.
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