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MAXIDEX STERILE OPHTHALMIC OINTMENT 0.1% [SIN04153P]
Active ingredients: MAXIDEX STERILE OPHTHALMIC OINTMENT 0.1%
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Product Info
MAXIDEX STERILE OPHTHALMIC OINTMENT 0.1%
[SIN04153P]
Product information
Active Ingredient and Strength | DEXAMETHASONE - 0.1% |
Dosage Form | OINTMENT |
Manufacturer and Country | ALCON-COUVREUR NV - BELGIUM |
Registration Number | SIN04153P |
Licence Holder | NOVARTIS (SINGAPORE) PTE LTD |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | S01BA01 |
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 Ointment:
Posology
Apply ribbon of ointment into the conjunctival sac(s) up to 4 times daily. When a favorable response is observed, dosage may be reduced gradually to once a day application for several days.
Use in pediatric patients (below 18 years)
The safety and efficacy of MAXIDEX ophthalmic ointment 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.
To prevent contamination of the tube tip and ointment, care must be taken not to touch the eyelids, surrounding areas or other surfaces with the tube tip. Keep the tube tightly closed when not in use.
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
