Item Number: AZOPT
Each ml of suspension contains 10 mg brinzolamide.
AZOPT is indicated to decrease elevated intraocular pressure in:
• ocular hypertension
• open-angle glaucoma
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).
Posology and method of administration
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.
Hepatic and renal impairment
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.
Method of administration
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.
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
• Known hypersensitivity to sulphonamides (see also section 4.4).
• Severe renal impairment.
• Hyperchloraemic acidosis.