AZARGA EYE DROPS 5ML

Indications

Approved Uses

Reduction of elevated intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension for whom monotherapy provides insufficient IOP reduction

Dosage & Administration

Dosing by Condition

Open-angle glaucoma or ocular hypertension (adults): instill 1 drop in the affected eye(s) twice daily (approximately 12 hours apart).

Initial Dose

One drop in the affected eye(s) twice daily.

Maintenance Dose

One drop in the affected eye(s) twice daily.

Maximum Dose

One drop in the affected eye(s) twice daily.

Children's Dosage

Not approved for children under 18 years

How to Take

For ocular use (eye drops, suspension): shake well before each use; instill 1 drop into the conjunctival sac of the affected eye(s) as prescribed; avoid touching the dropper tip; after instillation close the eyelid and/or perform nasolacrimal occlusion for ~2 minutes to reduce systemic absorption; if using other ophthalmic products separate by at least 5 minutes; remove contact lenses before use and reinsert after ~15 minutes.

How to Prepare

Shake well before use (ophthalmic suspension); no reconstitution required.

Side Effects

Common Side Effects

Common: blurred vision (transient), eye irritation/discomfort, eye pain, foreign body sensation, and dysgeusia (bitter/abnormal taste); other commonly reported ocular effects include dry eye and conjunctival hyperemia.

Side Effect Frequency

Very common (≥10%): blurred vision, dysgeusia. Common (1-10%): ocular discomfort/irritation/eye pain, foreign body sensation, ocular hyperemia, dry eye, eye discharge; headache can occur; systemic beta-blocker effects (e.g., bradycardia) are uncommon/rare rather than common. Serious reactions (e.g., bronchospasm, AV block, heart failure, anaphylaxis, SJS) are rare/very rare.

Safety & Warnings

Contraindications

Hypersensitivity to brinzolamide/timolol/sulfonamides/beta-blockers or excipients; reactive airway disease (bronchial asthma or history of asthma) or severe COPD; sinus bradycardia; sick sinus syndrome; sinoatrial block; 2nd/3rd degree AV block (unless paced); overt cardiac failure; cardiogenic shock; severe renal impairment (CrCl <30 mL/min); hyperchloremic acidosis.

Warnings & Precautions

Systemic absorption can cause beta-blocker cardiovascular/pulmonary effects; caution in diabetes (may mask hypoglycemia) and thyroid disease (may mask hyperthyroidism); sulfonamide-related hypersensitivity including severe skin reactions; caution in corneal disease/low endothelial cell count; contact lens precautions and benzalkonium chloride effects (remove lenses, reinsert after ~15 min); caution post-filtration surgery (choroidal detachment risk).

Age Restriction

Not recommended for use in patients <18 years (safety/efficacy not established).

Driving Warning

Safe

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Consult Doctor

Children

Not approved for children under 18 years

Storage & Patient Advice

Preparation Instructions

Shake well before use (ophthalmic suspension); no reconstitution required.

Missed Dose

Use the next dose at the usual time; if remembered well before the next scheduled dose, instill it when remembered-do not double the dose.

Overdose

Topical overdose: irrigate/flush the eye(s) with water/lukewarm water; ingestion/systemic overdose may cause beta-blocker effects (bradycardia, hypotension, bronchospasm, acute cardiac failure) and CAI-related electrolyte imbalance/metabolic acidosis-treat symptomatically/supportively and seek urgent medical care.

Patient Counseling

Shake well; wash hands; instill as directed without touching the tip; remove contact lenses and reinsert after ~15 minutes; close eye and/or press the inner corner for ~2 minutes; separate from other eye drops by ≥5 minutes; expect possible transient blurred vision and bitter taste; seek care for wheeze/shortness of breath, fainting, very slow pulse, or severe rash; store below 30°C (per SFDA) and discard the bottle about 4 weeks (28 days) after opening.

Monitoring Requirements

Monitor intraocular pressure and optic nerve/visual fields as clinically indicated; in at-risk patients monitor for systemic beta-blocker effects (heart rate, blood pressure, bronchospasm/respiratory symptoms). Routine serum electrolytes/acid-base monitoring is not required, but consider if overdose is suspected or in significant renal impairment.

Pharmacology

Mechanism of Action

Brinzolamide inhibits carbonic anhydrase II in the ciliary processes, reducing bicarbonate formation and aqueous humor secretion; timolol is a non-selective beta-blocker that reduces aqueous humor production; together they lower intraocular pressure via complementary suppression of aqueous formation.

Duration of Effect

Approximately 12 hours per dose (supports twice-daily administration).

Half-Life

Timolol: ~4-5 hours (systemic/plasma). Brinzolamide: very long terminal half-life due to carbonic anhydrase binding in red blood cells (on the order of weeks to months; commonly cited ~100+ days in RBCs).

Bioavailability

Both brinzolamide and timolol are systemically absorbed after ocular administration (notably via the nasolacrimal pathway); punctal occlusion reduces systemic exposure.

Excretion

Brinzolamide (and metabolites) are eliminated primarily by the kidneys; timolol and its metabolites are also primarily renally excreted (with some hepatic metabolism).

Protein Binding

Timolol: ~60% protein bound. Brinzolamide: ~60% protein bound (and additionally binds extensively to red blood cell carbonic anhydrase).

Product Information

Available Dosage Forms

Eye drops, suspension

Composition per Dose

Each 1 ml of suspension contains: 10 mg Brinzolamide and 5 mg Timolol (as 6.8 mg timolol maleate).

OTC Alternatives

No OTC alternative

Target Organ

Eye

Preservative Free

No

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