Država: Velika Britanija
Jezik: angleščina
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Betaxolol hydrochloride
Dowelhurst Ltd
S01ED02
Betaxolol hydrochloride
5mg/1ml
Eye drops
Ocular
No Controlled Drug Status
Valid as a prescribable product
BNF: 11060000
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Betaxolol 0.5% Eye Drops 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active Ingredient Betaxolol 5.0 mg/ml (as Betaxolol hydrochloride 5.6 mg/ml) Excipient(s) with known effect Benzalkonium chloride 0.01%w/v For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Eye drops, solution. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Reduction of elevated intraocular pressure in conditions such as ocular hypertension and chronic open-angle glaucoma. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults (including the elderly): recommended therapy is one drop of_ _Betaxolol 0.5% Eye Drops to be instilled into the affected eye(s) twice a day. Children: No clinical studies have been performed to establish safety and efficacy in children. Therefore, this product is currently not recommended for use in children. When using nasolacrimal occlusion or closing the eyelids for 2 minutes, the systemic absorption is reduced. This may result in a decrease in systemic side effects and an increase in local activity. Intraocular pressure should be reassessed approximately four weeks after starting treatment because response to Betaxolol 0.5% Eye Drops may take a few weeks to stabilise. If necessary, concomitant treatment with miotics, adrenaline and/or carbonic anhydrase inhibitors can be instituted. In order to prevent the active substance(s) from being washed out when additional ophthalmic medication is used, an interval of at least 10 minutes between each application is recommended. The use of two topical beta-adrenergic agents is not recommended. Transfer from a single antiglaucoma agent: Continue the agent and add one drop of Betaxolol 0.5% Eye Drops_ _in each affected eye twice daily. On the following day, discontinue the previous agent completely, and continue with Betaxolol 0.5% Eye Drops_._ When several antiglaucoma agents are being used, the patient should be assessed on an individual basis. Adjustment should involve one agent at a time at int Preberite celoten dokument