Azarga

Azarga

brinzolamide + timolol

Manufacturer:

Novartis Healthcare

Distributor:

Zuellig
Concise Prescribing Info
Contents
Per mL Brinzolamide 10 mg, timolol maleate 5 mg
Indications/Uses
Decrease IOP in adult w/ open-angle glaucoma or ocular HTN for whom monotherapy provides insufficient IOP reduction.
Dosage/Direction for Use
Instill 1 drop in the conjunctival sac of the affected eye(s) bid. If >1 ophth agent is being used, administer 5 min apart.
Contraindications
Hypersensitivity to brinzolamide, timolol maleate or to sulphonamides. Reactive airway disease including bronchial asthma or history of bronchial asthma or severe COPD. Sinus bradycardia, sick sinus syndrome, sino-atrial block, 2nd or 3rd degree AV block, overt cardiac failure or cardiogenic shock. Hyperchloremic acidosis. Severe renal impairment.
Special Precautions
Risk of metabolic acidosis in patients w/ renal impairment. Monitor patients w/ compromised corneas (eg, patients w/ DM or corneal dystrophies). History of CV disease (eg, CHD, Prinzmetal's angina & cardiac failure) & hypotension. Severe peripheral circulatory disturbance/disorders (eg, Raynaud's disease or syndrome); bronchospasm in patients w/ asthma; subject to spontaneous hypoglycaemia or w/ labile diabetes; may mask signs of hyperthyroidism; potentiate muscle weakness. Concomitant use w/ other β-blocking agents & oral carbonic anhydrase inhibitor. History of atopy or severe anaphylactic reaction to a variety of allergens. Choroidal detachment. May block systemic β-agonist effects eg, adrenaline. Pseudoexfoliative glaucoma or pigmentary glaucoma. Close monitoring of IOP. Not recommended in patients w/ narrow-angle glaucoma. Benzalkonium Cl content may cause punctuate keratopathy &/or toxic ulcerative keratopathy. May cause irritation & discolor soft contact lenses. Avoid contact w/ soft contact lenses. May impair ability to drive or operate machinery. Pregnancy & lactation. Childn <18 yr.
Adverse Reactions
Dysgeusia; blurred vision, eye pain & irritation.
Drug Interactions
Acid-base disturbances w/ oral carbonic anhydrase inhibitors. May inhibit metabolism w/ CYP3A4 inhibitors eg, ketoconazole, itraconazole, clotrimazole, ritonavir & troleandomycin. Potential additive effect on the known systemic effects w/ carbonic anhydrase inhibitor. Risk of hypotension &/or marked bradycardia w/ oral Ca channel blockers, guanethidine or β-adrenergic blocking agents, antiarrhythmics (including amiodarone), digitalis glycosides or parasympathomimetics. May potentiate hypertensive reaction to sudden w/drawal of clonidine. May potentiate systemic β-blockade effect w/ CYP2D6 inhibitors eg, quinidine, cimetidine, fluoxetine, paroxetine & timolol. May increase hypoglycemic effect of antidiabetic agents. Concomitant use w/ adrenaline may result to mydriasis.
ATC Classification
S01ED51 - timolol, combinations ; Belongs to the class of beta blocking agents. Used in the treatment of glaucoma.
Presentation/Packing
Form
Azarga ophth susp
Packing/Price
5 mL x 1's (P1,221/container)
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