Brinzolamide 10mg/ml Eye Drops 5ml

Each ml of suspension contains 10 mg brinzolamide.

Each ml of suspension contains 0.15 mg benzalkonium chloride.

Therapeutic indications
Brinzolamide 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

Posology

When used as monotherapy or adjunctive therapy, the recommended dose is one drop of Brinzolamide 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.

Special populations

Elderly population

No dose adjustment in elderly patients is necessary.

Patients with hepatic and renal impairment

Brinzolamide has not been studied in patients with hepatic impairment and is therefore not recommended in such patients.

Brinzolamide 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, Brinzolamide is therefore contra- indicated in such patients (see also section 4.3).

Paediatric population

The efficacy and safety of brinzolamide in infants, children and adolescents aged 0 to 17 years has not been established. Currently available data are described in sections 4.8 and 5.1. Brinzolamide 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. 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. Remove contact lenses prior to application and wait at least 15 minutes before reinsertion. Instruct patients to keep the bottle tightly closed when not in use.

When substituting another ophthalmic antiglaucoma agent with Brinzolamide, discontinue the other agent and start the following day with Brinzolamide.

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.