Azarga

Azarga

brinzolamide + timolol

Manufacturer:

Novartis

Distributor:

Zuellig
/
Firma Chun Cheong
Concise Prescribing Info
Contents
Per mL Brinzolamide 10 mg, timolol (as maleate) 5 mg
Indications/Uses
IOP reduction in adult patients w/ open-angle glaucoma or ocular HTN for whom monotherapy is insufficient.
Dosage/Direction for Use
Adult & elderly 1 drop in the conjunctival sac of the affected eye(s) bd.
Contraindications
Hypersensitivity to brinzolamide & timolol maleate, other β-blockers, or sulphonamides. Reactive airway disease including bronchial asthma or history thereof, or severe COPD. Sinus bradycardia, sick sinus syndrome, SA block, 2nd or 3rd degree AV block not controlled w/ pacemaker, overt cardiac failure, cardiogenic shock. Severe allergic rhinitis. Hyperchloraemic acidosis. Severe renal impairment.
Special Precautions
Risk of same types of CV, pulmonary & other adverse reactions seen w/ systemic β-adrenergic blockers; same types of adverse reactions attributable to sulphonamides; hypersensitivity reactions, including SJS & TEN w/ sulphonamide derivates. Reports of acid-base disturbances w/ oral carbonic anhydrase inhibitors. Reports of choroidal detachment w/ administration of aq suppressant therapy after filtration procedures. Critically assess therapy w/ β-blockers in patients w/ CV diseases (eg, CHD, Prinzmetal's angina & cardiac failure) & hypotension. β-blockers may mask signs of hyperthyroidism, &/or signs & symptoms of acute hypoglycaemia; may potentiate muscle weakness consistent w/ certain myasthenic symptoms; may block systemic β-agonist effects eg, of adrenaline; may induce dryness of eyes. Carbonic anhydrase inhibitors may affect corneal hydration. Careful monitoring of patients w/ compromised corneas (eg, patients w/ DM or corneal dystrophies) is recommended. Use of 2 topical β-adrenergic blockers or 2 local carbonic anhydrase inhibitors is not recommended. Concomitant administration w/ oral carbonic anhydrase inhibitors is not recommended. Not recommended in patients w/ narrow-angle glaucoma. Caution in patients w/ 1st degree heart block; severe peripheral circulatory disturbance/disorders (ie, severe forms of Raynaud's disease or syndrome); mild/moderate COPD; labile diabetes or those subject to spontaneous hypoglycaemia; history of atopy or severe anaphylactic reaction to a variety of allergens; pseudoexfoliative glaucoma or pigmentary glaucoma; corneal diseases; risk of renal impairment; severe hepatic impairment. Contains benzalkonium Cl. Remove contact lenses prior to instillation & reinsert after 15 min. Administer at least 5 min apart if using >1 topical ophth medicinal product (eye oint should be administered last). Minor influence on the ability to drive & use machines. Do not use during pregnancy unless clearly necessary. Discontinue breastfeeding or discontinue/abstain from Azarga therapy. Safety & efficacy in childn & adolescents 0-18 yr have not yet been established.
Adverse Reactions
Dysgeusia; punctate keratitis, blurred vision, eye pain, eye irritation; decreased heart rate.
Drug Interactions
Potential additive effects on known systemic effects of carbonic anhydrase inhibition w/ concomitant use of oral carbonic anhydrase inhibitor & brinzolamide eye drops. Inhibited brinzolamide metabolism w/ CYP3A4 inhibitors (eg, ketoconazole, itraconazole, clotrimazole, ritonavir, troleandomycin). Potential additive effects w/ concomitant use of ophth β-blockers & oral Ca channel blockers, β-adrenergic blockers, antiarrhythmics (including amiodarone), digitalis glycosides, parasympathomimetics, guanethidine. Decreased response to adrenaline w/ β-blockers. Potentiated hypertensive reaction to sudden w/drawal of clonidine when taking β-blockers. Potentiated systemic β-blockade w/ CYP2D6 inhibitors (eg, quinidine, fluoxetine, paroxetine) & timolol. Increased hypoglycaemic effect of antidiabetic agents w/ β-blockers. Risk of mydriasis w/ concomitant use of ophth β-blockers & adrenaline.
MIMS Class
Antiglaucoma Preparations
ATC Classification
S01ED51 - timolol, combinations ; Belongs to the class of beta blocking agents. Used in the treatment of glaucoma.
Presentation/Packing
Form
Azarga eye drops susp
Packing/Price
5 mL x 1's
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