INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo MAXIDEX™ Ophthalmic suspension

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

MAXIDEX™ Ophthalmic suspension

COMPOSITION:
Each mL contains
dexamethasone 1,0 mg.
Preserved with benzalkonium chloride 0,01% (m/v).

PHARMACOLOGICAL CLASSIFICATION:
A 15.3 Combination antibiotics and/or sulphonamides and corticosteroids.

PHARMACOLOGICAL ACTION:
Dexamethasone is a 9-fluoro 16-methyl substituted hydrocortisone analog with an anti-inflammatory potency approximately 25 times that of hydrocortisone. Therapeutic concentrations are attained in the aqueous humor of the eye following application into the conjunctival sac.

INDICATIONS:
Ophthalmic:
Steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe.

Otic: Steroid responsive inflammatory conditions of the external auditory meatus such as allergic otitis externa selected purulent and non-purulent infective otitis externa when in oedema and inflammation.

CONTRA-INDICATIONS:
Contra-indicated in epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and many other viral diseases of the cornea and conjunctiva. Mycobacterial infection of the eye. Fungal diseases of ocular structures. Hypersensitivity to a component of the medication. The use of these combinations is always contraindicated after uncomplicated removal of a corneal foreign body. Topical corticosteroids should not be used in the treatment of mechanical lacerations and abrasions of the eye. They delay healing and promote the development and spread of infection.

WARNINGS:
Prolonged use may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision and posterior subcapsular cataract formation. If this product is used for 10 days or longer, intraocular pressure should be routinely monitored even though it may be difficult in children and uncooperative patients. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. Corneal ulceration may be aggravated when corticosteroids are applied.
It is important that corneal ulcers are correctly diagnosed before treatment with corticosteroids are initiated Employment of steroid medication in the treatment of herpes simplex requires great caution; frequent slit lamp microscopy is mandatory. In acute purulent conditions of the eye, steroids may mask progression of infection until sight is lost or enhance existing infection.
IF THE EYE HAS NOT RESPONDED TO TREATMENT WITHIN 48 HOURS, THE PATIENT SHOULD BE REFERRED TO AN OPHTHALMOLOGIST BECAUSE OF THE POSSIBILITY OF INDUCING CORNEAL ABSCESS, FUNGAL KERATOPATHY OR GLAUCOMA.
As the possibility of adverse effects on the corneal permeability and the danger of disruption of the corneal epithelium with prolonged or repeated usage of benzalkonium chloride preserved preparations cannot be excluded, regular ophthalmological examination is required. Caution should be exercised in the use of benzalkonium chloride preserved topical medication over an extended period in patients with extensive ocular surface disease.

DOSAGE AND DIRECTIONS FOR USE:
SHAKE BOTTLE WELL BEFORE USE:
Ophthalmic: One or two drops topically in the conjunctival sac(s). For severe or acute inflammation every 30 to 60 minutes as initial therapy, reducing the dosage to every two to four hours when a favourable response is observed. Further reduction may be made to one drop three or four times daily if sufficient to control inflammation. If favourable response is not obtained in three to four days, additional systemic or conjunctival therapy may be indicated.
For chronic inflammation, every three to eight hours as necessary.
For allergies or minor inflammation, every three to four hours until the desired response is obtained.
Otic: Three to four drops in the aural canal two to four times daily.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side effects in decreasing order of frequency are: elevation of intraocular pressure (IOP) with possible development of glaucoma and infrequent optic nerve damage; posterior subcapsular cataract formation; and delayed wound healing.
A steroid glaucoma may be produced after a week or more of treatment in patients predisposed to chronic simple glaucoma.
Furthermore, it has been convincingly demonstrated that topical corticosteroid therapy frequently induces intraocular, hypertension in normal eyes and increases pressure in eyes with initially elevated pressure. Glaucoma has not always been reversible on cessation of corticosteroid treatment.
The local administration of corticosteroids to the eyes of patients with bacterial, viral and fungal conjunctivitis, may mask evidence of progression of infection until sight is lost.
Corticosteroids may cause progression of the dendritic keratitis (herpes simplex infection), resulting in irreversible clouding of the cornea.

Secondary infection: Corticosteroids promote the development and spread of infection.
Fungal infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroid.
The possibility of fungal invasion must be considered in any persistent corneal ulceration where steroid treatment has been used. Secondary bacterial ocular infection following suppression of host responses also occurs.
Steroid medication may also give rise to serious exacerbations of herpes infections of the eye.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See Side-effects and special precautions above. Discontinue use immediately.

IDENTIFICATION:
White to pale yellow opaque suspension.

PRESENTATION:
Low density polyethylene bottle containing 5 mL.

STORAGE INSTRUCTIONS:
Store at room temperature below 25°C. KEEP OUT OF REACH OF CHILDREN.
Do not use more than 30 days after opening.

REFERENCE NUMBER:
H.1143 (Act 101/1965)

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Alcon Laboratories (SA)(Pty) Ltd
Surrey Avenue
Randburg, 2194

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
1 October 1993

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