Azarga Eye Drops
Composition:

1 ml suspension contains 10 mg brinzolamide and 5 mg timolol (as timolol maleate).

Indications:

Reduction of intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension when monotherapy to lower IOP is insufficient.

Dosage and Administration:

Adults, including elderly:

• Instill one drop of Azarga into the conjunctival sac of the affected eye(s) twice daily.

• After instillation, nasolacrimal occlusion or gentle eyelid closure is recommended to reduce systemic absorption and systemic side effects.

• When multiple ophthalmic products are used, at least a 5-minute interval between applications is necessary.

• If a dose is missed, continue treatment with the next scheduled dose; do not exceed one drop per affected eye daily.

• When switching from another anti-glaucoma agent to Azarga, stop the other agent and start Azarga the next day.

Pediatric patients:

• Due to lack of efficacy data, Azarga eye drops are not recommended for patients under 18 years old.

Use in liver and kidney impairment:

• Studies with Azarga or timolol 5 mg/ml eye drops have not been conducted in patients with liver or kidney impairment.

• Dose adjustment is not required in patients with mild or moderate liver or kidney impairment.

• Azarga has not been studied in patients with severe kidney impairment (creatinine clearance <30 ml/min) or hypochloremic acidosis. Because brinzolamide and its metabolites are mainly excreted by the kidneys, Azarga is contraindicated in patients with severe kidney impairment.

Method of Administration:

For ocular use only.
Shake the bottle well before use.
To avoid contamination, do not touch eyelids or surrounding areas with the tip of the bottle. Keep the bottle tightly closed.

Contraindications:

• Hypersensitivity to active substances or excipients

• Bronchial asthma, history of bronchial asthma, or severe obstructive pulmonary disease

• Sinus bradycardia, second or third-degree atrioventricular block, severe heart failure, cardiogenic shock

• Acute allergic rhinitis and bronchial hyperreactivity; hypersensitivity to other beta-blockers

• Hypochloremic acidosis

• Severe renal failure

• Hypersensitivity to sulfonamides

Pregnancy and Lactation:

• Pregnancy:Adequate data on brinzolamide use in pregnant women is lacking. Animal studies show reproductive toxicity. The potential risk to humans is unknown.
  Well-controlled epidemiological studies with systemic beta-blockers did not show teratogenic effects, but some pharmacological effects such as fetal and neonatal bradycardia have been observed. Limited pregnancy data with timolol eye drops did not show adverse effects on fetus/newborn, except for bradycardia and arrhythmias in neonates born to mothers treated with timolol eye drops. No other valuable epidemiological data is available.
  Azarga eye drops should not be used during pregnancy unless absolutely necessary.

• Lactation: It is unknown if brinzolamide is excreted in breast milk; animal studies show brinzolamide excretion into milk. Timolol is not detected in human milk.
  Side effects on breastfed infants are unlikely at therapeutic doses. Use during breastfeeding is possible.

Effects on Ability to Drive and Use Machines:

• Temporary blurred vision or other visual disturbances may affect the ability to drive or operate machinery after instillation. Patients should wait until vision clears before driving or operating machinery.

• Oral carbonic anhydrase inhibitors may impair elderly patients’ ability to perform tasks requiring mental alertness or physical coordination.

Storage:

• Do not store above 30ºC.