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:

Rebel Distributors Corp

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 - Prod. No. 31404 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
REBEL DISTRIBUTORS CORP
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FLURBIPROFEN SODIUM OPHTHALMIC SOLUTION USP, 0.03%
DESCRIPTION
Flurbiprofen Sodium Ophthalmic Solution USP, 0.03% is a sterile
topical nonsteroidal anti-
inflammatory product for ophthalmic use. Flurbiprofen sodium is
represented by the following
structural formula:
C
H
FNaO •2H O
Mol. Wt. 302.27
Chemical Name: Sodium (±)-2-(2-fluoro-4-biphenyl)-propionate
dihydrate.
EACH ML CONTAINS: ACTIVE: Flurbiprofen sodium 0.03%;
INACTIVES: Sodium Citrate, Polyvinyl Alcohol 1.4%, Edetate Disodium,
Potassium Chloride, Sodium
Chloride, Citric Acid, Purified Water. Hydrochloric Acid and/or Sodium
Hydroxide may be added to
adjust pH (6.0 – 7.0).
PRESERVATIVE ADDED: Thimerosal 0.005%.
CLINICAL PHARMACOLOGY
Flurbiprofen sodium is one of a series of phenylalkanoic acids that
have shown analgesic antipyretic,
and antiinflammatory 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.
15
12
2
2
CONTRAINDICATIONS
Flurbiprofen sod