brinzolamide

HOS-084094 · has-adverse-reaction-information · PDF-Seite 5

Summary of the safety profile In clinical studies involving 2 732 patients treated with AZOPT as monotherapy or adjunctive therapy to timolol maleate 5 mg/ml, the most frequently reported treatment-related adverse reactions were: dysgeusia (6.0%) (bitter or unusual taste, see description below) and temporary blurred vision (5.4%) upon instillation, lasting from a few seconds to a few minutes (see also section 4.7). 5 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. System Organ Classification MedDRA Preferred Term (v.15.1) Infections and infestations Uncommon: nasopharyngitis, pharyngitis, sinusitis Not Known: rhinitis Blood and lymphatic system Uncommon: red blood cell count decreased, blood chloride disorders increased Immune system disorders Not Known: hypersensitivity Metabolism and nutrition disorders Not known: decreased appetite Psychiatric disorders Uncommon: apathy, depression, depressed mood, libido decreased, nightmare, nervousness Rare: insomnia Nervous system disorders Uncommon: motor dysfunction, amnesia, dizziness, paraesthesia, headache Rare: memory impairment, somnolence Not Known: tremor, hypoaesthesia, ageusia Eye disorders Common: blurred vision, eye irritation, eye pain, foreign body sensation in eyes, ocular hyperaemia Uncommon: corneal erosion, keratitis, punctate keratitis, keratopathy, deposit eye, corneal staining, corneal epithelium

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HOS-084090 · has-contraindication-information · PDF-Seite 3

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. • Known hypersensitivity to sulphonamides (see also section 4.4). • Severe renal impairment. • Hyperchloraemic acidosis.

HOS-084089 · has-indication-information · PDF-Seite 2

AZOPT is indicated to decrease elevated intraocular pressure in: • ocular hypertension • open-angle glaucoma as monotherapy in adult patients unresponsive to beta-blockers or in adult patients in whom beta- blockers are contraindicated, or as adjunctive therapy to beta-blockers or prostaglandin analogues (see also section 5.1).

HOS-084092 · has-interaction-information · PDF-Seite 4

Specific interaction studies with other medicinal products have not been performed with AZOPT. In clinical studies, AZOPT was used concomitantly with prostaglandin analogues and timolol ophthalmic preparations without evidence of adverse interactions. Association between AZOPT and miotics or adrenergic agonists has not been evaluated during adjunctive glaucoma therapy. AZOPT 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 AZOPT. 4 The cytochrome P-450 isozymes responsible for metabolism of brinzolamide include CYP3A4 (main), CYP2A6, CYP2C8 and CYP2C9. 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.

HOS-084093 · has-pregnancy-information · PDF-Seite 5

Pregnancy There are no or limited amount of data from the use of ophthalmic brinzolamide in pregnant women. Studies in animals have shown reproductive toxicity following systemic administration (see also section 5.3). AZOPT is not recommended during pregnancy and in women of childbearing potential not using contraception. Breast-feeding It is unknown whether brinzolamide/metabolites are excreted in human milk following topical ocular administration. Animal studies have shown the excretion of minimal levels of brinzolamide in breast milk following oral 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 AZOPT therapy taking in to account the benefit of breast-feeding for the child and the benefit of therapy for the woman. Fertility Animal studies with brinzolamide demonstrated no effect on fertility. Studies have not been performed to evaluate the effect of topical ocular administration of brinzolamide on human fertility.

HOS-084091 · has-warning-information · PDF-Seite 3

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. 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. 3 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. The concomitant administration of AZOPT 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 as adjunctive therapy to the prostaglandin analogue travoprost has been studied. No long term data are available on the use of AZOPT as adjunctive therapy to travoprost(see also section 5.1). 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. AZOPT 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

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