Properties
What is it?
AZOPT eye drops 10mg/1ml 5ml bottle Composition: Active substance: Brinzolamide; 1 ml of solution contains 10 mg of brinzolamide; Excipients: Benzalkonium chloride, Mannitol (E421), Carbomer (974P), Tyloxapol, Disodium edetate, Sodium chloride, Hydrochloric acid and/or Sodium hydroxide (for pH adjustment), Purified water. Indications: AZOPT, eye drops 10 mg/ml is a carbonic anhydrase inhibitor responsible for lowering elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma, as monotherapy in adult patients unresponsive to beta-blockers or in adult patients for whom beta-blockers are contraindicated, or as add-on therapy to beta-blockers or prostaglandin analogues. Contraindications: Hypersensitivity to the active substance or any of the other components of the preparation. Hypersensitivity to sulfonamide derivatives. Severe renal impairment. Hyperchloremic acidosis. Dosage and administration: Dosage regimen: The dosage of AZOPT, eye drops 10 mg/ml for the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma is as follows: One drop in the affected eye(s) twice daily. Some patients may experience better efficacy with 1 drop three times daily. If a dose is missed, treatment should be continued with the next dose as planned. The dose should not exceed 1 drop in the affected eye(s) three times daily. Children: The safety and efficacy of brinzolamide eye drops, 10 mg/ml have not been studied in patients aged 0-17 years and therefore the use of the preparation in such patients is not recommended. Elderly patients: No overall differences in safety and efficacy were observed between elderly and younger patients. Dose adjustment is not required for elderly patients. Use in patients with hepatic and renal impairment: The use of brinzolamide, 10 mg/ml in patients with hepatic impairment has not been studied and is therefore not recommended for such patients. Brinzolamide has not been studied in patients with severe renal impairment (creatinine clearance <30 ml/min/1.73 m2). Since brinzolamide and its main metabolite are excreted from the body primarily by the kidneys, the preparation is contraindicated in such patients. However, in patients with moderate renal impairment (creatinine clearance 30-60 ml/min/1.73 m2), no dose adjustment is necessary with topical administration of 1% brinzolamide. Method of administration: For instillation into the eyes. To avoid contamination of the dropper tip and the contents of the bottle, care must be taken not to touch the eyelids, surrounding areas, or any other surfaces with the dropper tip. Occlusion of the nasolacrimal duct or closure of the eyelids reduces systemic absorption. This may reduce systemic side effects and increase local activity. Shake well before use. After removing the cap, if the tamper-evident seal is loose, remove it before use. If more than one topical ophthalmic preparation is used, each subsequent preparation should be administered at least 5 minutes later. Ophthalmic ointments should be administered last. Use during pregnancy or lactation: Pregnancy: Data on the ophthalmic use of brinzolamide in pregnant women are lacking or limited. Animal studies with brinzolamide have shown reproductive toxicity following systemic administration. Animal studies with brinzolamide have not shown teratogenicity at doses up to 18 mg/kg/day and 6 mg/kg/day in rats and rabbits, respectively. A reduction in fetal body weight and an increase in developmental abnormalities during gestation were observed in rats at an oral dose of 18 mg/kg/day (which was 514 times the recommended human dose). Brinzolamide eye drops are not recommended for treatment during pregnancy. Lactation: It is unknown whether brinzolamide/metabolites are excreted in human milk following topical use. However, a risk to the infant cannot be excluded. In animal studies, minimal levels of brinzolamide were detected in maternal milk following oral administration. A decision should be made whether to discontinue breastfeeding or to discontinue/withhold therapy with propacaine, taking into account the benefit of breastfeeding to the infant and the benefit of therapy to the woman. Fertility: Studies to assess the effect of topical brinzolamide on the eyes have not been conducted. No effect on fertility was observed in rats following oral administration of brinzolamide. Storage conditions: Store at a temperature of 4 - 30 0C. Keep out of reach of children.