BRINMIDE | Brinzolamide Eye Drops
Composition:
Brinzolamide IP…………………………………………………………1% w/v
Benzalkonium Chloride (As Preservative)………………………0.01% w/v
Aqueous Base……………………………………………………………q.s.
Clinical Particulars
Therapeutic Indications: Brinmide is a carbonic anhydrase inhibitor indicated in the treatment of elevated intraocular pressure (IOP) in patients with ocular hypertension or open-angle glaucoma.
Contamination of Topical Ophthalmic Products After Use: There have been reports of bacterial keratitis associated with the use or 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 or 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, diarrhoea, diplopia, dizziness, dry mouth, dyspnea, dyspepsia, eye fatigue, hypertonia, keratoconjunctivitis, keratopathy, kidney pain, lid margin crusting or sticky sensation, nausea, pharyngitis, tearing and urticaria.
Use in Specific Population
Pregnancy Risk Summary: There are no adequate and well-controlled studies in pregnant women to inform drug-associated risk. In reproductive toxicity studies, brinzolamide administered orally to rats induced foetal toxicity at 375 times the recommended human ophthalmic dose (RHOD) based on mg/kg. In rabbits, no foetal toxicity was observed following oral administered. The background risk of major birth defects and miscarriage for the indicated population is unknown.
Paediatric Use: A 3-month controlled clinical study was conducted in which Brinzolamide was dosed only twice a day in paediatric patient 4 weeks to 5 years of age. Patients were not required to discontinue their IOP-lowering medications(s) until initiation of monotherapy with Brinzolamide. IOP-lowering efficacy was not demonstrated in this study in which the mean decrease in elevated IOP was between 0mmHg and 2 mmHg. Five out of 32 patients demonstrated an increase in corneal diameter of one millimetre.
Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients.
Overdosage: Although no human data are available, electrolyte imbalance, development of an acidotic state and possible nervous system effects may occur following oral administered of an overdose. Serum electrolyte levels (particularly potassium) and blood Ph levels should be monitored.
Storage: Store in a dry, well-ventilated place at a temperature not exceeding 25°C. Protect from light. Do not freeze.
Keep out of reach of children.
For external use only.
Not for injection
Packing: 5 ml plastic bottle with nozzle packed in Mono-carton with pack insert.
