SANDOZ FLUOROMETHOLONE SUSPENSION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

FLUOROMETHOLONE

Available from:

SANDOZ CANADA INCORPORATED

ATC code:

S01BA07

INN (International Name):

FLUOROMETHOLONE

Dosage:

0.1%

Pharmaceutical form:

SUSPENSION

Composition:

FLUOROMETHOLONE 0.1%

Administration route:

OPHTHALMIC

Units in package:

5ML

Prescription type:

Prescription

Therapeutic area:

CORTICOSTEROIDS

Product summary:

Active ingredient group (AIG) number: 0106315001; AHFS:

Authorization status:

APPROVED

Authorization date:

2012-06-21

Summary of Product characteristics

_Sandoz Fluorometholone _
_Page 1 of 7 _
PRODUCT MONOGRAPH
Pr
Sandoz Fluorometholone
(Fluorometholone 0.1% Ophthalmic Suspension), USP
Corticosteroid
Sandoz Canada Inc.,
Date of Preparation: June 21, 2012
145 Jules-Léger
Boucherville, QC, Canada
J4B 7K8
Submission Control No: 155809
_Sandoz Fluorometholone _
_Page 2 of 7 _
Pr
Sandoz Fluorometholone
(fluorometholone 0.1% ophthalmic suspension), USP
THERAPEUTIC CLASSIFICATION
Corticosteroid
ACTION AND CLINICAL PHARMACOLOGY
Fluorometholone inhibits the inflammatory response to chemical,
immunological or mechanical
irritants.
INDICATIONS AND CLINICAL USE
For steroid responsive inflammation of palpebral and bulbar
conjunctiva, cornea and anterior
segment of globe.
CONTRAINDICATIONS
Tuberculosis of the eye, fungal diseases of the eye, acute superficial
herpes simplex keratitis; and
most viral diseases of the cornea and conjunctiva. Acute untreated
purulent ocular infections.
Hypersensitivity to the constituents of this medication.
WARNINGS
Use of topical corticosteroid may cause increased intraocular pressure
in certain individuals. It is
necessary that the intraocular pressure be checked frequently and
particularly in patients with a
history of glaucoma or with a family history of glaucoma. If
sensitivity or other untoward
reactions occur, discontinue the medication. Prolonged use may result
in glaucoma, damage to
the optic nerve, defects in visual acuity and visual field, posterior
subcapsular cataract formation,
or may aid in the establishment of secondary ocular infection from
pathogens liberated from
ocular tissue. In those diseases causing thinning of the cornea, or
sclera, perforation has been
known to occur with the use of topical steroids.
Use in Pregnancy:
Safety of the use of topical steroids during pregnancy has not been
established.
PRECAUTIONS
_Sandoz Fluorometholone _
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Fungal invasion is a possibility in any persistent corneal ulceration,
occurring when long term
steroid therapy has been or is presently underway. Intraocular
pressure shoul