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SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Lotemax 0.5% Eye Drops, Suspension
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
The suspension contains 0.5%w/v loteprednol etabonate (5 mg/ml).
Each drop contains 0.19 mg loteprednol etabonate.
Excipient: Benzalkonium Chloride (0.01%)
For excipients, see 6.1For a full list of excipients, see section 6.1.
4.2 Posology and method of administration
Adults and elderly
One to two drops four times daily beginning 24 hours after surgery and continuing throughout the post-operative period.
The duration of treatment should NOTnot exceed 2 weeks.
Children and adolescents
Lotemax should not be used in the paediatric age group until further data become available.
Shake the bottle vigorously before using the eye drops.
This product is sterile when packaged. Patients should be advised not to allow the dropper tip to touch any surface, as this may contaminate the suspension. The bottle should be closed immediately after use.
5. PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: Corticosteroid
ATC code: [under application]S01BA14
5.1 Pharmacodynamic properties
Corticosteroids suppress the inflammatory response to inciting agents of mechanical, chemical or immunological nature. No generally accepted explanation of this steroid property has been advanced. Loteprednol etabonate is a new class of corticosteroid with potent antiinflammatory activity designed to be active at the site of action. Its antiinflammatory activity is similar to the most powerful steroid used in ophthalmology but with less intraocular pressure. Animal studies have shown that loteprednol etabonate has a binding affinity to steroid receptors that is 4.3 times greater than dexamethasone. This new class of steroids consists of bioactive molecules whose in-vivo transformation to non-toxic substances can be predicted from their chemistry and knowledge of enzymatic pathways in the body. Cortienic acid is an inactive metabolite of hydrocortisone and analogs of cortienic acid are also devoid of corticosteroid activity. Loteprednol etabonate is an ester derivative of one of these analogs, D1 cortienic acid etabonate (PJ-91).
Placebo controlled studies demonstrated that Lotemax is significantly more effective than placebo for the treatment of external ocular inflammation.
Corticosteroids are capable of producing a rise in intraocular pressure in susceptible individuals. In a small study, Lotemax demonstrated a significantly longer time to produce a rise in pressure than did prednisolone acetate. The overall incidence of patients who had an intraocular pressure elevation of ³10 mm Hg was lower in the Lotemax treated patients. In many patients treated with Lotemax the ultimate rise in intraocular pressure never achieved the levels seen in patients treated with prednisolone acetate. In clinical trials only 2% of all patients had an intraocular pressure elevation of ³10 mm Hg. In the small percentage of patients who did show a significant rise in intraocular pressure, pressure rapidly returned to normal on discontinuation of the medicinal products.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Disodium Edetate
GlycerinGlycerol
Povidone
Purified Water
Tyloxapol
Hydrochloric Acid (pH adjuster)
Sodium Hydroxide (pH adjuster)
Benzalkonium Chloride
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
31 March 2008
10. DATE OF REVISION OF THE TEXT
28 April 200431 March 2008
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