Special Warning : אזהרת שימוש

4.4      Special warnings and precautions for use
Systemic effects
Azopt 1% is a sulphonamide inhibitor of carbonic anhydrase and, although administered topically, is absorbed systemically. The same types of adverse drug reactions that are attributable to sulphonamides may occur with topical administration, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). At the time of prescription, patients should be advised of the signs and symptoms and monitored closely for skin reactions. If signs of serious reactions or hypersensitivity occur, Azopt 1% should be withdrawn immediately.
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 (see section 4.2).


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. 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 Azopt 1% . The concomitant administration of Azopt 1% and oral carbonic anhydrase inhibitors has not been studied and is not recommended (see also section 4.5).

AZOPT was primarily evaluated in concomitant administration with timolol during adjunctive glaucoma therapy. Additionally the IOP-reducing effect of Azopt 1% as adjunctive therapy to the prostaglandin analogue travoprost has been studied. No long term data are available on the use of Azopt 1% as adjunctive therapy to travoprost (see also section 5.1).

There is limited experience with 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. 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 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.

Azopt 1% has not been studied in patients wearing contact lenses. 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 Azopt 1% and wait at least 15 minutes after instillation of the dose before reinsertion.

Potential rebound effects following cessation of treatment with Azopt 1% have not been studied; the IOP-lowering effect is expected to last for 5-7 days.

Paediatric population

The safety and efficacy of Azopt 1% in infants, children and adolescents aged 0 to 17 years have not been established and its use is not recommended in infants, children or adolescents 

 

Effects on Driving

4.7         Effects on ability to drive and use machines
Azopt 1% has a minor influence on the ability to drive and use machines.

Temporary blurred vision or other visual disturbances, may affect the ability to drive or use machines (see also section 4.8). If blurred vision occurs at instillation, the patient must wait until the vision clears before driving or using machines.

Oral carbonic anhydrase inhibitors may impair the ability to perform tasks requiring mental alertness and/or physical coordination (see also section 4.4 and section 4.8).