For corticosteroid responsive inflammation of the palpebral and bulbar conjunctiva, cornea and
anterior segment of the globe.

Topically as drops into the conjunctival sac.
1 – 2 drops into the conjunctival sac 2 – 4 times daily. During the first 24 to 48 hours of treatment,
the dosage may be safely increased to 2 drops at one hour intervals. The treatment should not be
withdrawn too early.
The safety and efficacy of Optilone has not been proven in children aged 2 years or less.

Eye drops containing corticosteroids should not be used for longer than a week except under an eye
specialist's careful surveillance combined with regular measurement of intraocular pressure.
Prolonged use may result in glaucoma, corneal thinning and perforation, subcapsular cataract
formation, or may facilitate the development of secondary ocular infections especially from fungi and
viruses.
A 'red eye', where the diagnosis is unconfirmed, may be due to herpes simplex virus, and a
corticosteroid may aggravate the condition, leading to corneal ulceration, with possible damage to
vision and even loss of the eye.
Adverse topical effects of steroid treatment, such as skin atrophy, striae and teleangiectasia, may
occur especially in the facial skin.
Optilone contains benzalkonium chloride which is irritant to the eye and could cause discoloration of
soft contact lenses. Avoid contact with soft contact lenses. Remove contact lenses before Optilone is
used and wait for at least 15 minutes before reinsertion.
Concomitant ocular medication should be administered 5 minutes prior to the installation of
Optilone.

None known.

Pregnancy
Fluorometholone should only be used during pregnancy if it is clearly necessary. Fluorometholone is,
as are other corticosteroids, teratogenic in animal studies.
Lactation
Fluorometholone may pass into breast milk so it is recommended that Optilone is not used in nursing
mothers unless clearly necessary.

Instillation of any eye drop could result in transient blurring of vision. If this occurs, the patient
should wait for the blurring to subside before driving or operating machinery.

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
The following undesirable effects have been reported since Optilone was marketed.
Frequency:
Common: affecting >1/100 and <1/10 patients
Not known: the incidence cannot be determined from available information.
Eye disorders
Not known: Eye irritation, conjunctival hyperaemia, eye pain, visual disturbance, foreign body
sensation in eyes, eyelid oedema, blurred vision, eye discharge, eye pruritis, lacrimation increased,
ocular hyperaemia, eye oedema, mydriasis, eye inflammation, corneal disorder, cataract (including
subcapsular).
Immune system disorders
Not known: Hypersensitivity
Investigations
Common: Intraocular pressure increased
Nervous system disorders
Not known: Dysgeusia, headache, dizziness
Skin and subcutaneous tissue disorders
Not known: Rash
Vascular disorders
Not known: Hypertension

To report any side effects please contact National Pharmacovigilance and Drug Safety
Center (NPC) details below:
The National Pharmacovigilance and Drug Safety Centre (NPC)
 Fax: +966-11-205-7662
 Call NPC at +966-11-2038222, Exts: 2317-2356-2353-2354-2334-2340.
 Toll free phone: 8002490000
 E-mail: npc.drug@sfda.gov.sa
Website: www.sfda.gov.sa/npc

No case of overdose has been reported. Overdosage will not ordinarily cause acute problems.
If accidental overdosage occurs in the eye, the eye should be flushed with water or normal saline. If
accidentally ingested, the patient should drink fluids to dilute.

Pharmacotherapeutic group: Corticosteroids, plain
ATC code: S01BA07

Fluorometholone is a synthetic corticosteroid (glucocorticoid), a derivative of desoxyprednisolone. It
is a member of the group of universally known steroids used for the treatment of eye inflammation.
Glucocorticosteroids bind to cytoplasmic receptors and control the synthesis of infection mediators
thus damping inflammatory reactions (swelling, fibrin deposition, capillary dilatation, phagocyte
migration) and also capillary proliferation, collagen deposition and scarring.
Although topical corticosteroid treatment often increases intraocular pressure both in normal eyes and
in the eyes of a patient with increased intraocular pressure, fluorometholone increases intraocular
pressure less than, for example, dexamethasone. A study showed that fluorometholone after six
weeks' treatment increased intraocular pressure statistically significantly less than dexamethasone
(mean change dexamethasone: 9 mmHg, mean change fluorometholone: 3 mmHg).

When tritium-labelled 0.1 % fluorometholone suspension was administered locally, the peak concentration of the radioactive substance in aqueous humour was achieved 30 minutes after
administration. A rapidly forming metabolite occurred at high concentrations both in aqueous
humour and corneal extracts, which shows that fluorometholone is metabolised to a certain extent
while penetrating the cornea and aqueous humour.

Any preclinical safety data relevant to the prescriber has been included in other sections of the
Summary of Product Characteristics.

Polyvinyl Alcohol
Polysorbate 80
Disodium Hydrogen Phosphate Anhydrous
Sodium Dihydrogen Phosphate Anhydrous
Sodium Chloride
Disodium Edetate
Benzalkonium Chloride
Sodium Hydroxide
Water for Injection

None known.

Do not store above 30°C

Primary:
Immediate Container: LDPE (Low-Density Polyethylene) Bottle 24-25 mm dia; white (around
1% TiO2), round shape with rounded shoulder; indented ring for tamper
evident cap locking mechanism.
Cap: HDPE (High-Density Polyethylene) White (around 1% TiO2), round
shape with locking ring.
Nozzle: LDPE (Low-Density Polyethylene) Nozzle White (around 1.6% TiO2).
Secondary:
Outer carton: 280g/m2 grammage paper, dimension 29 mm x 29.5 mm x 73 mm,
printing as per drawing
Label: 20 x 73mm, self adhesive
Insert/Leaflet: 50-60 g/m2 paper, both size printed

This product is sterile when packaged. To prevent contamination, care should be taken to avoid
touching the applicator tip to the eye or to any other surface.
The use of the product by more than one person may spread infection.
Keep the bottle tightly closed when not in use.
There are no special precautions for disposal.