Properties
What is it?
Azarga Eye Drops Composition: 1ml suspension contains 10mg brinzolamide and 5mg timolol (as timolol maleate). Indication: To reduce intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension when IOP-lowering monotherapy is insufficient. Dosage and method of administration: Adults, including the elderly: Instill one drop of Azarga into the conjunctival sac of the affected eye twice daily. Following instillation, gentle digital pressure on the lacrimal sac or careful eyelid closure is recommended. This may reduce the systemic absorption of the medicinal product from the eye and decrease the likelihood of systemic side effects. If using more than one topical ophthalmic product, allow at least 5 minutes between applications. If a dose is missed, treatment should be continued with the next dose as planned. The dose should not exceed one drop in the affected eye, daily. If replacing another anti-glaucoma agent with Azarga, discontinue the other agent and start Azarga the following day. Pediatric patients: Due to a lack of efficacy data, Azarga eye drops, suspension is not recommended for use in patients under 18 years of age. Use in patients with hepatic and renal impairment: No studies have been conducted with Azarga eye drops, suspension or timolol 5mg/ml eye drops in patients with renal and hepatic impairment. No dose adjustment is required in patients with hepatic impairment or mild to moderate renal impairment. Azarga eye drops, suspension has not been studied in patients with severe renal impairment (creatinine clearance <30ml/min) or in patients with hypochloraemic acidosis. Since brinzolamide and its metabolites are primarily excreted by the kidneys, Azarga eye drops, suspension is contraindicated in patients with severe renal impairment. Method of administration: For ocular use. The patient should shake the bottle before use. To avoid contamination of the dropper tip or solution, the eyelids and surrounding area should not be touched with the dropper tip. The patient should keep the bottle tightly closed. Contraindications: Hypersensitivity to the active substances or to any of the excipients. Bronchial asthma, a history of bronchial asthma, or severe chronic 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. Hyperchloraemic acidosis Severe renal failure. Hypersensitivity to sulfonamides Pregnancy and lactation: Pregnancy: There are no adequate data on the use of brinzolamide in pregnant women. Animal studies have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown. Well-controlled epidemiological studies of systemic beta-blocker use have not shown malformative effects, but some pharmacological effects such as bradycardia were observed in the fetus and neonates. Limited data on pregnancies have not shown adverse effects of timolol eye drops in pregnant women or on fetal/neonatal health beyond bradycardia and arrhythmia described in the fetus of a woman taking timolol eye drops. No other relevant epidemiological data exist. Azarga eye drops, suspension should not be used during pregnancy unless clearly necessary. Lactation: It is unknown whether brinzolamide is excreted in human milk; animal studies have shown excretion of brinzolamide in milk. Timolol is not detected in human milk. However, adverse effects from therapeutic doses of Azarga eye drops, suspension are not expected in breastfed newborns/infants. Azarga eye drops, suspension may be used during breastfeeding. Effects on ability to drive and use machines: As with any eye drops, temporary blurring of vision or other visual disturbances may affect the ability to drive or operate machinery. If blurring of vision occurs after instillation, the patient should wait until vision clears before driving or operating machinery. Oral carbonic anhydrase inhibitors may impair the ability of elderly patients to perform actions that require mental alertness or/or physical coordination. Storage: Do not store above 30°C.