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Simbrinza

Simbrinza

Manufacturer:

Novartis Indonesia
Concise Prescribing Info
Contents
Per mL Brinzolamide 10 mg, brimonidine 1.3 mg
Indications/Uses
Decrease of elevated IOP in adults w/ open-angle glaucoma or ocular HTN for whom monotherapy is insufficient or who were already in multiple medications.
Dosage/Direction for Use
Adult including elderly 1 drop in the affected eye(s) twice daily.
Contraindications
Hypersensitivity to brinzolamide, brimonidine or to sulphonamides. Patients receiving MAOIs & antidepressants affecting noradrenergic transmission (eg, TCAs & mianserin). Severe renal impairment, hyperchloraemic acidosis. Neonates & infants <2 yr.
Special Precautions
Ocular allergic reactions, delayed ocular hypersensitivity. Not to be injected. Instruct patients not to swallow the product. Not recommended in patients w/ narrow-angle glaucoma. Careful monitoring of patients w/ compromised corneas eg, patients w/ DM or corneal dystrophies; wearing contact lenses. Discontinue use if signs of serious reactions or hypersensitivity occurs. Patients w/ severe or unstable & uncontrolled CV disease; depression, cerebrovascular or coronary insufficiency, Raynaud's disease, orthostatic hypotension or thromboangiitis obliterans. Concomitant use w/ antihypertensives &/or cardiac glycosides. Acid-base disturbances. Benzalkonium Cl content may cause eye irritation & discolour soft contact lenses; punctuate keratopathy &/or toxic ulcerative keratopathy. Closely monitor frequent or prolonged use in dry eye patients. Avoid contact w/ soft contact lenses. Remove contact lens prior to instillation & reinsert after at least 15 min. May impair ability to perform tasks requiring mental alertness &/or physical coordination. Possible risk of metabolic acidosis in patients w/ risk of renal impairment. Hepatic impairment. Not recommended during pregnancy & in women of child bearing potential not using contraception. Not to be used by women nursing infants. Not recommended in childn or adolescents 2-17 yr.
Adverse Reactions
Somnolence, dizziness, dysgeusia; eye allergy, keratitis, eye pain, ocular discomfort, blurred vision, abnormal vision, ocular hyperaemia, conjunctival blanching; dry mouth.
Drug Interactions
MAOIs. TCAs may blunt the ocular hypotensive response. Additive or potentiating effect w/ CNS depressants eg, alcohol, barbiturates, opiates, sedatives or anaesth. Drugs affecting metabolism & uptake of circulating amines eg, chlorpromazine, methylphenidate, reserpine, serotonin-norepinephrine reuptake inhibitors. Reduced pulse & BP w/ α-adrenergic agonists. Concomitant use w/ antihypertensives &/or cardiac glycosides; agonists or antagonists of the adrenergic receptor eg, isoprenaline, prazosin. Additive systemic effects w/ oral carbonic anhydrase inhibitors. Inhibited metabolism w/ CYP3A4 inhibitors eg, ketoconazole, itraconazole, clotrimazole, ritonavir & troleandomycin.
ATC Classification
S01EC54 - brinzolamide, combinations ; Belongs to the class of carbonic anhydrase inhibitors. Used in the treatment of glaucoma.
Presentation/Packing
Form
Simbrinza eye susp
Packing/Price
5 mL x 1's
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