FLURBIPROFEN SODIUM solution/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FLURBIPROFEN SODIUM (UNII: Z5B97MU9K4) (FLURBIPROFEN - UNII:5GRO578KLP)

Available from:

AMICI PHARMACEUTICALS LLC

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Flurbiprofen sodium ophthalmic solution is indicated for the inhibition of intraoperative miosis. Flurbiprofen sodium ophthalmic solution is contraindicated in individuals who are hypersensitive to any components of the medication.

Product summary:

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 -  NDC 69292-722-25 DO NOT USE IF IMPRINTED “Protective Seal” WITH YELLOW  IS NOT INTACT.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLURBIPROFEN SODIUM- FLURBIPROFEN SODIUM SOLUTION/ DROPS
AMICI PHARMACEUTICALS LLC
----------
FLURBIPROFEN SODIUM OPHTHALMIC SOLUTION, USP 0.03%
(STERILE)
RX ONLY
FOR OPHTHALMIC USE ONLY
DESCRIPTION
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:
C
H
FNaO •2H O 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%.
CLINICAL PHARMACOLOGY
15
12
2
2
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, 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.
INDICATIONS AND USAGE
Flurbiprofen sodium ophthalmic solution is indicated for the
inhibition of intraoperative
miosis.
CONTRAINDICATIONS
Flurbiprofen sodium ophthal