MAXIDEX STERILE OPHTHALMIC SUSPENSION 0.1% [SIN04840P]

Product Info

MAXIDEX STERILE OPHTHALMIC SUSPENSION 0.1%

[SIN04840P]

4.1 Therapeutic Indications

MAXIDEX contains dexamethasone, a synthetic corticosteroid.

MAXIDEX is indicated in the management of conditions generally responsive to corticosteroids such as:

• Certain inflammatory eye conditions of the anterior segment: acute and chronic anterior uveitis, iridocyclitis, iritis and cyclitis, herpes zoster ophthalmicus.

• Certain external diseases such as phlyctenular kerato-conjunctivitis, nonpurulent conjunctivitis, including vernal, allergic, catarrhal. It is very effective where allergy is a main factor.

• Recurrent marginal ulceration of toxic or allergic etiology.

• Thermal and chemical burns.

• Post-operatively to reduce inflammatory reactions.

4.2 Posology and method of administration

MAXIDEX ophthalmic suspension
Posology

• Topical application (1 or 2 drops in the conjunctival sac).

• FOR SEVERE OR ACUTE INFLAMMATION: drops may be used every 30 to 60 minutes as initial therapy, being tapered to discontinuation as inflammation subsides.

• If favorable response is not obtained in 3 to 4 days, additional systemic or conjunctival therapy may be indicated.

• FOR CHRONIC INFLAMMATION: drops may be used every 3 to 6 hours, or as frequently as necessary. Being tapered to discontinuation as inflammation subsides.

• ALLERGIES OR MINOR INFLAMMATION: drops may be used every 3 to 4 hours until the desired response is obtained, being tapered to discontinuation as inflammation subsides. Prolonged treatment over several days should only be carried out under medical supervision.

Use in pediatric patients (below 18 years)
The safety and efficacy of MAXIDEX ophthalmic suspension in children have not been established.

Use in patients with hepatic or renal impairment
No studies have been performed in patients with renal or hepatic impairment.

Use in geriatric patients (65 years of age or above)
No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Method of administration
For ocular use only.
Shake the bottle well before use.

After cap is removed, if tamper evident snap collar is loose, it should be removed before using the product. To prevent contamination of the dropper tip and suspension, care must be taken not to touch the eyelids, surrounding areas or other surfaces with the dropper tip. Keep the bottle tightly closed when not in use.

Nasolacrimal occlusion or gently closing the eyelid(s) after administration is recommended. This may reduce the systemic absorption of medicinal products administered via ocular route and result in a decrease in systemic adverse reactions.

If more than one topical ophthalmic product is being used, the products must be administered at least 5 minutes apart. Eye ointments should be administered last.

4.3 Contraindications

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

• Acute untreated bacterial infections which like other diseases caused by micro-organisms, may be masked or enhanced by the presence of the steroid.

• Herpes simplex keratitis

• Vaccinia, varicella, and other viral infections of cornea or conjunctiva.

• Fungal disease of ocular structures or untreated parasitic eye infections.

• Mycobacterial ocular infections