Monograph: |
FLURBIPROFEN SODIUM
DESCRIPTION:
CHEMICAL NAME: Sodium ()2-(2-fluoro- 4-biphenyl)-propionate dihydrate.
ACTIONS/CLINICAL PHARMACOLOGY:
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, vasodilatation, 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, CADIFLUR 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.
INDICATIONS AND USAGE:
CADIFLUR is indicated for the inhibition of intraoperative miosis.
CONTRAINDICATIONS:
CADIFLUR is contraindicated in individuals who are hypersensitive to any
components of the medication.
WARNINGS:
With nonsteroidal anti-inflammatory drugs, there exists the potential for
increased bleeding due to interference with thrombocyte aggregation. There have
been reports that CADIFLUR 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.
PRECAUTIONS:
GENERAL: Wound healing may be delayed with the use of CADIFLUR. It is
recommended that CADIFLUR (flurbiprofen sodium ophthalmic solution) 0.03% 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 CADIFLUR 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 CADIFLUR.
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:
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 67
times the human daily topical dose) and above. There are no adequate and well-
controlled studies in pregnant women. CADIFLUR 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.
DRUG INTERACTIONS:
Interaction of CADIFLUR 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 CADIFLUR.
(SEE ALSO PRECAUTIONS)
ADVERSE REACTIONS:
Transient burning and stinging upon instillation and other minor symptoms of
ocular irritation have been reported with the use of CADIFLUR. Other adverse
reactions reported with the use of CADIFLUR include: fibrosis, miosis,and
mydriasis.
Increased bleeding tendency of ocular tissues in conjunction with ocular surgery
has also been reported.
OVERDOSAGE:
Overdosage will not ordinarily cause acute problems. If accidentally ingested,
drink fluids to dilute.
DOSAGE AND ADMINISTRATION:
A total of four (4) drops of CADIFLUR should be administered by instilling 1
drop approximately every 1/2 hour beginning 2 hours before surgery.
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