Clinical particulars

Therapeutic indication

Brinzolamide/brimonidine tartrate ophthalmic suspension 1%/0.2% is a fixed combination of a carbonic anhydrase inhibitor and an alpha 2 adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

Contamination of Topical Ophthalmic Products After Use

There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products. These containers have been inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface.

Brinzolamide 1%

In clinical studies of brinzolamide ophthalmic suspension 1%, the most frequently reported adverse reactions reported in 5 to 10% of patients were blurred vision and bitter, sour or unusual taste. Adverse reactions occurring in 1 to 5% of patients were blepharitis, dermatitis, dry eye, foreign body sensation, headache, hyperemia, ocular discharge, ocular discomfort, ocular keratitis, ocular pain, ocular pruritus and rhinitis.

The following adverse reactions were reported at an incidence below 1%: allergic reactions, alopecia, chest pain, conjunctivitis, diarrhea, diplopia, dizziness, dry mouth, dyspnea, dyspepsia, eye fatigue, hypertonia, keratoconjunctivitis, keratopathy, kidney pain, lid margin crusting or sticky sensation, nausea, pharyngitis, tearing and urticaria.

Brimonidine Tartrate 0.2%

In clinical studies of brimonidine tartrate 0.2%, adverse reactions occurring in approximately 10 to 30% of the subjects, in descending order of incidence, included oral dryness, ocular hyperemia, burning and stinging, headache, blurring, foreign body sensation, fatigue/drowsiness, conjunctival follicles, ocular allergic reactions, and ocular pruritus.

USE IN SPECIFIC POPULATIONS

Pregnancy

There are no adequate and well-controlled studies in pregnant women. Brinzolamide/brimonidine tartrate ophthalmic suspension 1%10. 2% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Pediatric Use

The individual component, brinzolamide, has been studied in pediatric glaucoma patients 4 weeks to 5 years or age. The individual component, brimonidine tartrate, has been studied in pediatric patients 2 to 7 years old.

OVERDOSAGE

Although no human data are available, electrolyte imbalance, development of an acidotic state, and possible nervous system effects may occur following an oral overdose of brinzolamide. Serum electrolyte levels (particularly potassium) and blood pH levels should be monitored. Very limited information exists on accidental ingestion of brimonidine in adults; the only adverse event reported to date has been hypotension. Symptoms of brimonidine overdose have been reported in neonates, infants, and children receiving brimonidine as part of medical treatment of congenital glaucoma or by accidental oral ingestion. Treatment of an oral overdose includes supportive and symptomatic therapy; a patent airway should be maintained.

Storage: Store at a temperature not exceeding 30°C. Protect from light & Moisture. Do not freeze.

Keep out of the sight and reach of children.

FOR EXTERNAL USE ONLY

FOR OPHTHALMIC USE ONLY

Packing: 5 ML opaque plastic bottle with nozzle packed in Mono-carton with Pack insert.