AZOPT OPHTHALMIC SUSPENSION 1% [SIN11029P]

Product Info

AZOPT OPHTHALMIC SUSPENSION 1%

[SIN11029P]

4.1 Therapeutic indications
AZOPT^® eye drops contain brinzolamide, a carbonic anhydrase inhibitor.
AZOPT eye drops is indicated to decrease elevated intraocular pressure (IOP) in adult patients with ocular hypertension or 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.

4.2 Posology and method of administration

Posology
When used as monotherapy or adjunctive therapy, the dose is 1 drop of AZOPT eye drops in the conjunctival sac of the affected eye(s) twice daily. Some patients may have a better response with 1 drop 3 times a day.

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

If more than one topical ophthalmic medication is being used, the medicines must be administered at least 5 minutes apart. Eye ointments should be administered last.

Use in elderly
No dosage alteration in elderly patients is necessary.

Use in children
The safety and efficacy of AZOPT eye drops in patients below the age of 18 have not been established and its use is not recommended in these patients.

Use in patients with hepatic impairment
AZOPT eye drops has not been studied in patients with hepatic impairment, and is therefore not recommended in such patients.

Use in patients with renal impairment

AZOPT eye drops has not been studied in patients with severe renal impairment (creatinine clearance < 30 ml/min/1.73 m²) or in patients with hyperchloraemic acidosis. Since brinzolamide and its main metabolite are excreted predominantly by the kidney, AZOPT eye drops is therefore contraindicated in such patients (see also 4.3). However, in patients with moderate renal impairment (creatinine clearance 30–60 mL/min/1.73 m²) there is no need for dose adjustments with topical administration of brinzolamide 1%.

Method of administration
For ocular use.
Shake well before use.

After cap is removed, if tamper evident snap collar is loose, this should be removed before using the product.

To avoid contamination, the dropped tip should not touch any surface. The dropper tip should also not come into contact with the eye as this may cause injury to the eye. Patients should be instructed to keep the bottle tightly closed when not in use.

Nasolacrimal occlusion and closing the eyelid for 2 minutes after instillation is recommended. This may result in a decrease in systemic side effects and an increase in local activity.

Patients must be instructed to remove soft contact lenses prior to application of Azopt, and to wait 15 minutes after instillation of the dose before reinsertion.

4.3 Contraindications

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

• Known hypersensitivity to sulphonamides (see also 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Severe renal impairment.

• Hyperchloraemic acidosis (see section 4.2).