FLURBIPROFEN SODIUM solution/ drops

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

flurbiprofen sodium (UNII: Z5B97MU9K4) (flurbiprofen - UNII:5GRO578KLP)

Dostopno od:

Rebel Distributors Corp

Pot uporabe:

OPHTHALMIC

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

Flurbiprofen sodium ophthalmic solution 0.03% is indicated for the inhibition of intraoperative miosis. Flurbiprofen sodium ophthalmic solution 0.03% is contraindicated in individuals who are hypersensitive to any components of the medication.

Povzetek izdelek:

Flurbiprofen sodium ophthalmic solution, USP is available for topical ophthalmic administration as a 0.03% sterile solution, and is supplied in a white opaque low density polyethylene bottle with a controlled dropper tip and a gray high impact polystyrene cap in the following size: 2.5 mL in 5 mL bottle - NDC 42254-023-25 Note: Store at 15°-25°C (59°-77°F). Rx Only Revised January 2004 © 2004 PACIFIC PHARMA Irvine, CA 92612, U.S.A. 71587PY11P Relabeled by: Rebel Distributors Corp Thousand Oaks, CA 91320

Status dovoljenje:

New Drug Application Authorized Generic

Lastnosti izdelka

FLURBIPROFEN SODIUM- FLURBIPROFEN SODIUM SOLUTION/ DROPS
REBEL DISTRIBUTORS CORP
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FLURBIPROFEN SODIUM
OPHTHALMIC SOLUTION, USP 0.03%
Sterile
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:
CONTAINS: ACTIVE: flurbiprofen sodium 0.03% (0.3mg/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 flurbiprofen
sodium ophthalmic solution
0.03% is 6.0 to 7.0. It has an osmolality of 260 - 330 mOsm/kg.
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, flurbiprofen
sodium ophthalmic solution 0.03% 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 0.03% is indicated for the
inhibition of intraoperative miosi