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The Pharmaceutical Journal Vol 264 No 7092 p604
April 15, 2000 Products

Prescription products

Azopt eye-drops

Azopt packaging Composition: Brinzolamide 10mg/ml.
Presentation: Eye-drops.
Action: Carbonic anhydrase inhibitor.
Indications: To decrease elevated intraocular pressure in ocular hypertension and 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.
Contraindications: Hypersensitivity to brinzolamide or any of the excipients; known hypersensitivity to sulphonamides; severe renal impairment; hyperchloraemic acidosis.
Dosage and administration: Adults and elderly, monotherapy or adjunctive therapy, one drop into the conjunctival sac of the affected eye(s) twice daily. Some patients may have a better response with one drop three times a day. Nasolacrimal occlusion or gently closing the eyelid after instillation is recommended. When substituting another ophthalmic antiglaucoma agent with brinzolamide, discontinue other agent and start brinzolamide the following day. If more than one topical ophthalmic medication is being used, administer at least five minutes apart.
Children under 18 years, not recommended. Safety and efficacy has not been established.
Pregnancy, should not be used unless clearly necessary.
Hepatic impairment, not recommended.
Overdosage: No case reported. Treatment should be symptomatic and supportive. See SPC.
Precautions: Concomitant administration with oral carbonic anhydrase inhibitors has not been studied and is not recommended. Careful monitoring is recommended in patients with compromised corneas, including those wearing contact lenses and other cases such as patients with diabetes mellitus. Azopt contains benzalkonium chloride and close monitoring is required with frequent or prolonged use in dry-eye patients. Do not administer while wearing contact lenses (patients must wait 15 minutes before inserting lenses).
If blurred vision occurs at instillation, the patient must wait until the vision clears before driving or operating machinery.
Drug interactions: Specific interaction studies have not been performed. Although administered topically, brinzolamide is absorbed systemically and acid-base disturbances have been reported with oral carbonic anhydrase inhibitors. Caution is advised if CYP3A4 inhibitors are given concomitantly.
Side effects: Common undesirable effects (less than 10 per cent) definitely, probably or possibly related to treatment included: blurred vision; ocular discomfort; foreign body sensation; ocular hyperaemia; taste perversion; headache. Uncommon (less than 1 per cent) effects were: dry eye; ocular pain, discharge and pruritus; keratitis; blepharitis; conjunctivitis; lid margin crusting; sticky sensation; tearing; eye fatigue; keratopathy; conjunctival follicles; abnormal vision; chest pain; alopecia; dry mouth; nausea; dyspepsia; dermatitis; paresthesia; depression; dizziness; rhinitis; dyspnoea; pharyngitis; bronchitis; epistaxis; haemoptysis.
The most frequently reported events with brinzolamide as monotherapy or adjunctive therapy with timolol maleate 0.5 per cent were taste perversion and temporary blurred vision upon instillation. Corneal erosion was seen in brinzolamide adjunctive studies with timolol.
Net price: 5ml £7.17.
Supplier: Alcon Laboratories (UK) Ltd, Pentagon Park, Boundary Way, Hemel Hempstead, Herts HP2 7UD. Tel 01442 341234, fax 01442 341200.
Legal class: POM.