profenal- suprofen solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

suprofen (UNII: 988GU2F9PE) (suprofen - UNII:988GU2F9PE)

Available from:

Alcon Laboratories, Inc.

INN (International Name):

suprofen

Pharmaceutical form:

SOLUTION

Composition:

10 mg in 1 mL

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

PROFENAL Ophthalmic Solution is indicated for inhibition of intraoperative miosis. PROFENAL is contraindicated in epithelial herpes simplex keratitis (dendritic keratitis) and in individuals hypersensitive to any component of the medication.

Product summary:

Sterile ophthalmic solution, 2.5 mL in plastic DROP-TAINER® dispensers. 2.5 mL NDC 0065-0348-25 STORAGE: Store at room temperature. Rx Only U.S. Patents Nos. 4,035,376; 4,559,343 Alcon Laboratories, Inc. Fort Worth, Texas  76134  USA Printed in USA 343005-0798      Revised: July 1998

Summary of Product characteristics

PROFENAL- SUPROFEN SOLUTION
ALCON LABORATORIES, INC.
----------
PROFENAL® 1%
(SUPROFEN)
STERILE OPHTHALMIC SOLUTION
DESCRIPTION
PROFENAL® (suprofen) 1% ophthalmic solution is a topical nonsteroidal
anti-inflammatory product
for ophthalmic use. Suprofen chemically is α
-methyl-4-(2-thienylcarbonyl)benzeneacetic acid, with an
empirical formula of C
H O S, and a molecular weight of 260.3. The chemical structure of
suprofen
is:
PROFENAL Sterile Ophthalmic Solution contains suprofen 1.0% (10
mg/mL), thimerosal 0.005% (0.05
mg/mL), caffeine 2% (20 mg/mL), edetate disodium, dibasic sodium
phosphate, monobasic sodium
phosphate, sodium chloride, sodium hydroxide and/or hydrochloric acid
(to adjust pH to 7.4) and
purified water.
DM-00
CLINICAL PHARMACOLOGY
Suprofen 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 cyclooxygenase 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 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,
PROFENAL has been shown to inhibit the miosis induced during the
course of cataract surgery.
PROFENAL could possibly interfere with the miotic effect of
intraoperatively administered
acetylcholine chloride.
Results from clinical studies indicate that PROFENAL Ophthalmic
Solution has no significant effect on
intraocular pressure.
There are no data available on the systemic absorption of ocularly
applied suprofen. The oral dose of
suprofen is 200 mg ever