Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
AZOPT is indicated to decrease elevated intraocular pressure in:
as monotherapy in adult patients unresponsive to beta-blockers or in adult patients in whom beta-blockers are contraindicated, or as adjunctive therapy to beta-blockers or prostaglandin analogues (see also section 5.1).
When used as monotherapy or adjunctive therapy, the dose is one drop of AZOPT in the conjunctival sac of the affected eye(s) twice daily. Some patients may have a better response with one drop three times a day.
No dose adjustment in elderly patients is necessary.
AZOPT has not been studied in patients with hepatic impairment and is therefore not recommended in such patients.
AZOPT has not been studied in patients with severe renal impairment (creatinine clearance <30 ml/min) or in patients with hyperchloraemic acidosis. Since brinzolamide and its main metabolite are excreted predominantly by the kidney, AZOPT is therefore contra-indicated in such patients (see also section 4.3).
The safety and efficacy of AZOPT in infants, children and adolescents aged 0 to 17 years have not been established. Currently available data are described in sections 4.8 and 5.1. AZOPT is not recommended for use in infants, children and adolescents.
For ocular use.
Nasolacrimal occlusion or gently closing the eyelid after instillation is recommended. This may reduce the systemic absorption of medicinal products administered via the ocular route and result in a decrease in systemic side effects.
Instruct the patient to shake the bottle well before use. After the cap is removed, if tamper evident snap collar is loose, remove 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 of the bottle. Instruct patients to keep the bottle tightly closed when not in use.
When substituting another ophthalmic antiglaucoma agent with AZOPT, discontinue the other agent and start the following day with AZOPT.
If more than one topical ophthalmic medicinal product is being used, the medicines must be administered at least 5 minutes apart. Eye ointments should be administered last.
If a dose is missed, treatment should be continued with the next dose as planned. The dose should not exceed one drop in the affected eye(s) three times daily.
No case of overdose has been reported.
Treatment should be symptomatic and supportive. Electrolyte imbalance, development of an acidotic state, and possible nervous system effects may occur. Serum electrolyte levels (particularly potassium) and blood pH levels must be monitored.
2 years.
4 weeks after first opening.
This medicinal product does not require any special storage conditions.
5 and 10 ml opaque low density polyethylene bottles with polypropylene screw caps (droptainer).
The following pack sizes are available: outer cartons containing 1 × 5 ml, 3 × 5 ml and 1 × 10 ml bottles. Not all pack sizes may be marketed.
No special requirements.
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