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  • Alcon Azopt 1%
    / Novartis


    Active Ingredient

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Eye Drops

    5 ml

    partial basket chart 22441 1611

    Related information


    Dosage

    When used as monotherapy or adjunctive therapy, the dose is one drop of Alcon Azopt 1% 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.
    Hepatic and renal impairment: Alcon Azopt 1% has not been studied in patients with hepatic impairment and is therefore not recommended in such patients. Alcon Azopt 1% 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, Alcon Azopt 1% is therefore contra-indicated in such patients.
    Paediatric population: The safety and efficacy of Alcon Azopt 1% in infants, children and adolescents aged 0 to 17 years has not been established. Alcon Azopt 1% 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 Alcon Azopt 1% , discontinue the other agent and start the following day with Alcon Azopt 1% . 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.


    Indications

    Indicated to decrease elevated intraocular pressure in: ocular hypertension and in open-angle glaucoma as monotherapy in patients unresponsive to beta-blockers or in patients in whom beta-blockers are contraindicated, or as adjunctive therapy to beta-blockers.


    Contra-Indications

    Hypersensitivity to the active substance or any of the excipients. Known hypersensitivity to sulphonamides. Severe renal impairment. Hyperchloraemic acidosis.


    Special Precautions

    Systemic effects: Alcon Azopt 1% is a sulphonamide inhibitor of carbonic anhydrase and, although administered topically, is absorbed systemically. The same types of adverse reactions that are attributable to sulphonamides may occur with topical administration. If signs of serious reactions or hypersensitivity occur, discontinue the use of this preparation. Acid-base disturbances have been reported with oral carbonic anhydrase inhibitors. Use with caution in patients with risk of renal impairment because the possible risk of metabolic acidosis. Brinzolamide has not been studied in pre-term infants (less than 36 weeks gestational age) or those less than 1 week of age. Patients with significant renal tubular immaturity or abnormalities should only receive brinzolamide after careful consideration of the risk benefit balance because of the possible risk of metabolic acidosis. Oral carbonic anhydrase inhibitors may impair the ability to perform tasks requiring mental alertness and/or physical coordination. Alcon Azopt 1% is absorbed systemically and therefore this may occur with topical administration.
    Concomitant therapy: There is a potential for an additive effect on the known systemic effects of carbonic anhydrase inhibition in patients receiving an oral carbonic anhydrase inhibitor and Alcon Azopt 1% . The concomitant administration of Alcon Azopt 1% and oral carbonic anhydrase inhibitors has not been studied and is not recommended. AZOPT was primarily evaluated in concomitant administration with timolol during adjunctive glaucoma therapy. Additionally the IOP-reducing effect of Alcon Azopt 1% as adjunctive therapy to the prostaglandin analogue travoprost has been studied. No long term data are available on the use of Alcon Azopt 1% as adjunctive therapy to travoprost. There is limited experience with Alcon Azopt 1% in the treatment of patients with pseudoexfoliative glaucoma or pigmentary glaucoma. Caution should be used in treating these patients and close monitoring of intraocular pressure (IOP) is recommended. Alcon Azopt 1% has not been studied in patients with narrow-angle glaucoma and its use is not recommended in these patients. The possible role of brinzolamide on corneal endothelial function has not been investigated in patients with compromised corneas (particularly in patients with low endothelial cell count). Specifically, patients wearing contact lenses have not been studied and careful monitoring of these patients when using brinzolamide is recommended, since carbonic anhydrase inhibitors may affect corneal hydration and wearing contact lenses might increase the risk for the cornea. Careful monitoring of patients with compromised corneas such as patients with diabetes mellitus or corneal dystrophies is recommended. Benzalkonium chloride, which is commonly used as a preservative in ophthalmic products, has been reported to cause punctate keratopathy and/or toxic ulcerative keratopathy. Since Alcon Azopt 1% contains benzalkonium chloride, close monitoring is required with frequent or prolonged use in dry eye patients, or in conditions where the cornea is compromised. Alcon Azopt 1% has not been studied in patients wearing contact lenses. Alcon Azopt 1% contains benzalkonium chloride which may cause eye irritation and is known to discolour soft contact lenses. Contact with soft contact lenses is to be avoided. Patients must be instructed to remove contact lenses prior to the application of Alcon Azopt 1% and wait at least 15 minutes after instillation of the dose before reinsertion.
    Potential rebound effects following cessation of treatment with Alcon Azopt 1% have not been studied; the IOP-lowering effect is expected to last for 5-7 days.


    Side Effects

    The most frequently reported treatment-related adverse reactions were: dysgeusia (6.0%) (bitter or unusual taste) and temporary blurred vision (5.4%) upon instillation, lasting from a few seconds to a few minutes. Additional common adverse reactions were: eye irritation, eye pain, foreign body sensation in eyes and ocular hyperaemia.
    For full details see prescribing information.


    Drug interactions

    Alcon Azopt 1% is a carbonic anhydrase inhibitor and, although administered topically, is absorbed systemically. Acid-base disturbances have been reported with oral carbonic anhydrase inhibitors. The potential for interactions must be considered in patients receiving Alcon Azopt 1%. It is expected that inhibitors of CYP3A4 such as ketoconazole, itraconazole, clotrimazole, ritonavir and troleandomycin will inhibit the metabolism of brinzolamide by CYP3A4. Caution is advised if CYP3A4 inhibitors are given concomitantly. However, accumulation of brinzolamide is unlikely as renal elimination is the major route. Brinzolamide is not an inhibitor of cytochrome P-450 isozymes.
    For full details see prescribing information.


    Pregnancy and Lactation

    Pregnancy: Alcon Azopt 1% is not recommended during pregnancy and in women of childbearing potential not using contraception.
    Lactation: It is unknown whether brinzolamide/metabolites are excreted in human milk following topical ocular administration. A risk to the newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Alcon Azopt 1% therapy taking in to account the benefit of breast- feeding for the child and the benefit of therapy for the woman.
    For full details see prescribing information.


    Overdose

    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.


    Important notes

    Shelf-life: 2 years. 1 month after first opening.
    Storage: Store at 4-30°C.


    Manufacturer
    Alcon
    Licence holder
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