Country: Singapore
Language: English
Source: HSA (Health Sciences Authority)
Dexamethasone
NOVARTIS (SINGAPORE) PTE LTD
S01BA01
0.10%
SOLUTION
Dexamethasone 0.1%
OPHTHALMIC
Prescription Only
ALCON-COUVREUR NV
ACTIVE
1990-06-22
Maxidex Jul 2023.SIN Page 1 of 9 1. NAME OF THE MEDICINAL PRODUCT MAXIDEX * 0.1% STERILE OPHTHALMIC SUSPENSION MAXIDEX * 0.1 % STERILE OPHTHALMIC OINTMENT (DEXAMETHASONE) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION MAXIDEX * OPHTHALMIC SUSPENSION 1 ml of suspension contains 1 mg dexamethasone. Preservative: 1 ml of suspension contains 0.1 mg benzalkonium chloride. For the full list of excipients, see section 6.1. MAXIDEX * OPHTHALMIC OINTMENT 1 g of ointment contains 1 mg dexamethasone. Preservative: 1 g of ointment contains 0.5 mg methylparaben and 0.1 mg propylparaben. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM MAXIDEX OPHTHALMIC SUSPENSION Sterile ophthalmic suspension. Opaque, white to pale yellow suspension, no agglomerates. MAXIDEX OPHTHALMIC OINTMENT Sterile ophthalmic ointment. A greasy, translucent, white to off-white, homogeneous ointment. 4. CLINICAL PARTICULARS 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 Maxidex Jul 2023.SIN Page 2 of 9 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 t Read the complete document