Azopt

Posology When used as monotherapy or adjunctive therapy, the dose is one drop of AZOPT 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 AZOPT has not been studied in patients with hepatic impairment and is therefore not recommended in such patients. AZOPT has not been studied in patients with severe renal impairment (creatinine clearance < 30 ml/min) or in patients with hyperchloraemic acidosis.

3). 3 Paediatric population The safety and efficacy of AZOPT in infants, children and adolescents aged 0 to 17 years have not been established. 1. AZOPT 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 AZOPT, discontinue the other agent and start the following day with AZOPT. 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.

7). 6 Tabulated summary of adverse reactions The following adverse reactions have been reported with brinzolamide 10mg/ml eye drops, suspension and are classified according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1 000 to <1/100), rare (≥1/10 000 to <1/1 000), very rare (<1/10 000), or not known (cannot be estimated from the available data).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. The adverse reactions were obtained from clinical trials and post-marketing spontaneous reports. 4), dermatitis, erythema Musculoskeletal and connective tissue disorders Uncommon: back pain, muscle spasms, myalgia Not Known: arthralgia, pain in extremity Renal and urinary disorders Uncommon: renal pain Not Known: pollakiuria Reproductive system and breast disorders Uncommon: erectile dysfunction General disorders and administration site conditions Uncommon: pain, chest discomfort, fatigue, feeling abnormal Rare: chest pain, feeling jittery, asthenia, irritability Not Known: peripheral oedema, malaise Injury, poisoning and procedural complications Uncommon: foreign body in eye Description of selected adverse events Dysgeusia (bitter or unusual taste in the mouth following instillation) was the most frequently reported systemic adverse reaction associated with the use of AZOPT during clinical studies.

It is likely caused by passage of the eye drops in the nasopharynx via the nasolacrimal canal. 2). AZOPT is a sulphonamide inhibitor of carbonic anhydrase with systemic absorption. Gastrointestinal, nervous system, haematological, renal and metabolic effects are generally associated with systemic carbonic anhydrase inhibitors.

The same type of adverse reactions that are attributable to oral carbonic anhydrase inhibitors may occur with topical administration. No unexpected adverse reactions have been observed with AZOPT when used as adjunctive therapy to travoprost.

Systemic effects AZOPT 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 should be withdrawn immediately. Acid-base disturbances have been reported with oral carbonic anhydrase inhibitors.

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.

4 Oral carbonic anhydrase inhibitors may impair the ability to perform tasks requiring mental alertness and/or physical coordination. AZOPT 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.

5). AZOPT was primarily evaluated in concomitant administration with timolol during adjunctive glaucoma therapy. Additionally the IOP-reducing effect of AZOPT as adjunctive therapy to the prostaglandin analogue travoprost has been studied.

1). There is limited experience with AZOPT 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.

1. 4). • Severe renal impairment. • Hyperchloraemic acidosis.