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Use in adults, including the elderly: The recommended dose is one drop of SIMBRINZA in the affected eye(s) two times daily.
Hepatic and/or renal impairment: SIMBRINZA has not been studied in patients with hepatic impairment and caution is therefore recommended in this population.
SIMBRINZA has not been studied in patients with severe renal impairment (CrCl <30 mL/min) or in patients with hyperchloraemic acidosis. Since the brinzolamide component of SIMBRINZA and its metabolite are excreted predominantly by the kidney, SIMBRINZA is contraindicated in such patients.
Paediatric population: The safety and efficacy of SIMBRINZA in children and adolescents aged 2 to 17 years have not been established. No data are available. SIMBRINZA is not recommended in children or adolescents.
SIMBRINZA must not be used in neonates and infants aged less than 2 years
because of safety concerns.
Method of administration: For ocular use. Patients should be instructed to shake the bottle well before use.
When using nasolacrimal occlusion and closing the eyelids for 2 minutes, the systemic absorption is reduced. This may result in a decrease in systemic side
effects and an increase in local activity.
To prevent contamination of the dropper tip and solution, care must be taken not to touch the eyelids, surrounding areas or other surfaces with the dropper tip of the bottle. Patients should be instructed to keep the bottle tightly closed when not in use.
SIMBRINZA may be used concomitantly with other topical ophthalmic medicinal products to lower intraocular pressure. If more than one topical ophthalmic medicinal product is being used, the medicinal products must be administered at least 5 minutes apart.
If a dose is missed, treatment should be continued with the next dose as planned.
The dose should not exceed 1 drop in the affected eye(s) 2 times daily.
Decrease of elevated intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension for whom monotherapy provides insufficient IOP reduction.
Hypersensitivity to the active substance(s) or to any of the excipients or to sulphonamides.
Patients receiving monoamine oxidase (MAO) inhibitor therapy.
Patients on antidepressants which affect noradrenergic transmission (e.g. tricyclic antidepressants and mianserin).
Patients with severe renal impairment.
Patients with hyperchloraemic acidosis.
Neonates and infants under the age of 2 years.
The medicinal product should not be injected. Patients should be instructed not to swallow SIMBRINZA.
Ocular effects: SIMBRINZA has not been studied in patients with narrow-angle glaucoma and its use is not recommended in these patients.
Systemic effects: SIMBRINZA contains brinzolamide, a sulphonamide inhibitor of carbonic anhydrase and, although administered topically, is absorbed systemically. The same types of adverse reactions that are attributable to sulphonamides may occur with topical administration. If signs of serious reactions or hypersensitivity occur, the use of this medicinal product should be discontinued.
Cardiac disorders: Following administration of SIMBRINZA, small decreases in blood pressure were observed in some patients. Caution is advised when using medicinal products such as antihypertensives and/or cardiac glycosides concomitantly with SIMBRINZA or in patients with severe or unstable and uncontrolled cardiovascular disease.
SIMBRINZA should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud’s phenomenon, orthostatic hypotension or
Mental alertness: Oral carbonic anhydrase inhibitors may impair the ability to perform tasks requiring mental alertness and/or physical coordination in elderly patients. SIMBRINZA is absorbed systemically and therefore this may occur with topical administration.
Benzalkonium chloride: SIMBRINZA contains benzalkonium chloride which may cause eye irritation and is known to discolour soft contact lenses. Contact with soft contact lenses should be avoided. Patients must be instructed to remove contact lens prior to application of SIMBRINZA and wait at least 15 minutes before reinsertion.
See prescribing information for full details.
In clinical trials involving SIMBRINZA dosed twice-daily the most common adverse reactions were ocular hyperaemia and ocular allergic type reactions occurring in approximately 6-7% of patients, and dysgeusia (bitter or unusual taste in the mouth following instillation) occurring in approximately 3% of patients.
See prescribing information for full details.
No specific drug interaction studies have been performed with SIMBRINZA.
SIMBRINZA is contraindicated in patients receiving monoamine oxidase inhibitors and patients on antidepressants which affect noradrenergic transmission (e.g. tricyclic antidepressants and mianserin). Tricyclic antidepressants may blunt the ocular hypotensive response of SIMBRINZA.
Caution is advised due to the possibility of an additive or potentiating effect with CNS depressants (e.g. alcohol, barbiturates, opiates, sedatives, or anaesthetics).
No data on the level of circulating catecholamines after SIMBRINZA administration are available. Caution, however, is advised in patients taking medicinal products which can affect the metabolism and uptake of circulating amines (e.g. chlorpromazine, methylphenidate, reserpine, serotonin-norepinephrine reuptake inhibitors).
Alpha adrenergic agonists (e.g., brimonidine tartrate), as a class, may reduce pulse and blood pressure. Following administration of SIMBRINZA, small decreases in blood pressure were observed in some patients. Caution is advised when using medicinal products such as antihypertensives and/or cardiac glycosides concomitantly with SIMBRINZA.
Caution is advised when initiating (or changing the dose of) concomitant systemic medicinal products (irrespective of pharmaceutical form) which may interact with αadrenergic agonists or interfere with their activity i.e. agonists or antagonists of the adrenergic receptor (e.g. isoprenaline, prazosin).
Brinzolamide 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 SIMBRINZA.
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 topical brinzolamide. The concomitant administration of SIMBRINZA and oral carbonic anhydrase inhibitors is not recommended.
The cytochrome P-450 isozymes responsible for metabolism of brinzolamide include CYP3A4 (main), CYP2A6, CYP2B6, 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.
Pregnancy and Lactation
Pregnancy: There are no or limited amount of data from the use of SIMBRINZA in pregnant women. SIMBRINZA is not recommended during pregnancy and in women of child bearing potential not using contraception.
Lactation: It is unknown whether topical SIMBRINZA is excreted in human milk. Available pharmacodynamic/toxicological data in animals have shown that following oral administration, minimal levels of brinzolamide are excreted in breast milk.
Brimonidine administered orally is excreted in breast milk. SIMBRINZA should not be used by women nursing infants.
See prescribing information for full details.
If overdose with SIMBRINZA occurs treatment should be symptomatic and
supportive. The patient’s airway should be maintained.
Due to the brinzolamide component of SIMBRINZA, electrolyte imbalance,
development of an acidotic state, and possible nervous system effects may occur.
Serum electrolyte levels (particularly potassium) and blood pH levels must be
There is very limited information regarding accidental ingestion with the brimonidine component of SIMBRINZA in adults. The only adverse event reported to date was hypotension. It was reported that the hypotensive episode was followed by rebound hypertension.
Oral overdoses of other alpha-2-agonists have been reported to cause symptoms such as hypotension, asthenia, vomiting, lethargy, sedation, bradycardia, arrhythmias, miosis, apnoea, hypotonia, hypothermia, respiratory depression and seizure.
Paediatric population: Serious adverse effects following inadvertent ingestion with the brimonidine component of SIMBRINZA by paediatric subjects have been reported. The subjects experienced symptoms of CNS depression, typically temporary coma or low level of consciousness, lethargy, somnolence, hypotonia, bradycardia, hypothermia, pallor, respiratory depression and apnoea, and required admission to intensive care with intubation if indicated. All subjects were reported to have made a full recovery, usually within 6-24 hours.