Ocufen

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Flurbiprofen sodium dihydrate 0.03%

Available from:

Allergan New Zealand Ltd

INN (International Name):

Flurbiprofen sodium dihydrate 0.03%

Dosage:

0.03% w/v

Pharmaceutical form:

Eye drops, solution

Composition:

Active: Flurbiprofen sodium dihydrate 0.03% Excipient: Citric acid monohydrate Hydrochloric acid Polyvinyl alcohol Potassium chloride Sodium chloride Sodium citrate dihydrate Sodium hydroxide Water

Units in package:

Ampoule, plastic, Purell PE 1840H resin ampoule 0.4 mL, 5 dose units

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Aesica Pharmaceuticals Limited

Product summary:

Package - Contents - Shelf Life: Ampoule, plastic, Purell PE 1840H resin ampoule 0.4 mL - 5 dose units - 24 months from date of manufacture stored at or below 25°C - Ampoule, plastic, 0.4 mL - 5 dose units - 24 months from date of manufacture stored at or below 25°C - Ampoule, plastic, (4 x 5) x 0.4 mL - 20 dose units - 24 months from date of manufacture stored at or below 25°C - Ampoule, plastic, (8 x 5) x 0.4 mL - 40 dose units - 24 months from date of manufacture stored at or below 25°C - Ampoule, plastic, (10 x 5) x 0.4 mL - 50 dose units - 24 months from date of manufacture stored at or below 25°C

Authorization date:

1996-05-01

Summary of Product characteristics

OCUFEN
® 
flurbiprofen sodium Datasheet Version 3.0 
Page 1 of 4 

NEW ZEALAND DATA SHEET 

NAME OF MEDICINE: 
OCUFEN
®
 flurbiprofen sodium 0.03% 

PRESENTATION: 
OCUFEN
®
 eye drops: each mL contains flurbiprofen sodium 0.3mg with
Liquifilm
®

(polyvinyl alcohol) 14mg, potassium chloride, sodium chloride,
sodium citrate, citric 
acid,  purified water and sodium hydroxide or hydrochloric acid if
needed for pH 
adjustment. 

USES: ACTIONS 
CLINICAL PHARMACOLOGY 
Flurbiprofen sodium is one of a series of phenylalkanoic acids that
have shown 
analgesic, antipyretic and anti-inflammatory activity in
anti-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, vasodilation, 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, OCUFEN
®
 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. 

PHARMACOKINETICS 
An orally administered dose of flurbiprofen is rapidly absorbed,
metabolised in the 
liver and quickly and evenly distributed to most tissues other than
those of the central 
nervous system.  The mean half-life of elimination was seen with
three times daily 
dosing of 50 mg for 10 days.  Urinary excretion of unchanged drug
(23.2%) and 
metabolites in humans accounts for 100% of the dose administer