FLURBIPROFEN SODIUM solution/ drops

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Proficient Rx LP

Οδός χορήγησης:

OPHTHALMIC

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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.

Περίληψη προϊόντος:

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 63187-937-25 DO NOT USE IF IMPRINTED “Protective Seal” WITH YELLOW IS NOT INTACT.

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

FLURBIPROFEN SODIUM- FLURBIPROFEN SODIUM SOLUTION/ DROPS
PROFICIENT RX LP
----------
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
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,
15
12
2
2
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 Ophthalmic Solut