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AZOPT: PRESCRIBING INFORMATION
Brinzolamide (Azopt) 1% contains a carbonic anhydrase inhibitor formulated for multidose topical ophthalmic use. Brinzolamide is described chemically as: (R)-(+)-4-Ethylamino-2-(3-methoxypropyl)-3,4-dihydro2H-thieno [3,2-e]-1,2-thiazine-6-sulfonamide-1,1-dioxide. Its empirical formula is C12H21N3O5S3.
Brinzolamide has a molecular weight of 383.5 and a melting point of about 131°C. It is a white powder, which is insoluble in water, very soluble in methanol and soluble in ethanol.
Brinzolamide eye drops (Azopt) is supplied as a sterile, aqueous suspension of brinzolamide which has been formulated to be readily suspended and slow settling, following shaking. It has a pH of approximately 7.5 and an osmolality of 300 mOsm / kg.
Each mL of Brinzolamide ophthalmic suspension (Azopt) contains:
Active ingredient: brinzolamide 10 mg. Preservative: Benzalkonium chloride 0.01 mg.
Inactive ingredients: mannitol, carbomer 974P, tyloxapol, edetate disodium, sodium chloride, purified water, with hydrochloric acid and/or sodium hydroxide to adjust pH.
INDICATIONS AND USAGE
Azopt (Brinzolamide ophthalmic suspension) 1% is a carbonic anhydrase inhibitor indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.
DOSAGE AND ADMINISTRATION
The recommended dose is one drop of Azopt (Brinzolamide eye drops) 1% in the affected eye(s) three times daily. If more than one topical ophthalmic drug is being used, the drugs should be administered at least ten (10) minutes apart.
DOSAGE FORMS AND STRENGTHS
Solution containing 10 mg / mL brinzolamide.
Azopt (Brinzolamide) 1% is contraindicated in patients who are hypersensitive to any component of this product.
WARNINGS AND PRECAUTIONS
Azopt warnings and precautions
Clinical Studies Experience
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to the rates in the clinical studies of another drug and may not reflect the rates observed in practice.
In clinical studies of Brinzolamide (Azopt) 1%, the most frequently reported adverse events reported in 5-10% of patients were blurred vision and bitter, sour or unusual taste. Adverse events occurring in 1-5% of patients were blepharitis, dry eye, dermatitis, foreign body sensation, hyperemia, headache, ocular discharge, ocular keratitis, ocular discomfort, ocular pain, ocular pruritus and rhinitis.
The following adverse reactions were reported at an incidence below 1%: allergic reactions, chest pain, alopecia, conjunctivitis, diplopia, diarrhea, dizziness, dyspnea, dry mouth, dyspepsia, hypertonia, eye fatigue, keratoconjunctivitis, kidney pain, keratopathy, lid margin crusting or sticky sensation, pharyngitis, nausea, tearing and urticaria.
Oral Carbonic Anhydrase Inhibitors
There is a potential for an additive effect on the known systemic effects of carbonic anhydrase inhibition in patients receiving an oral carbonic anhydrase inhibitor and Brinzolamide eye drops (Azopt). The concomitant administration of this medicine and oral carbonic anhydrase inhibitors is not recommended.
High-Dose Salicylate Therapy
Carbonic anhydrase inhibitors may produce acid-base and electrolyte alterations. These alterations were not reported in the clinical trials with brinzolamide. However, in patients treated with oral carbonic anhydrase inhibitors, rare instances of acid-base alterations have occurred with high-dose salicylate therapy. Therefore, the potential for such drug
interactions should be considered in patients receiving Brinzolamide ophthalmic suspension (Azopt) 1%.
USE IN SPECIFIC POPULATIONS
Azopt use in specific populations
Although no human data are available, electrolyte imbalance, development of an acidotic state, and possible nervous system effects may occur following oral administration of an overdose. Serum electrolyte levels (particularly potassium) and blood pH levels should be monitored.
Azopt clinical pharmacology
Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity data on brinzolamide are not available. The following tests for mutagenic potential were negative: (1) in vivo mouse micronucleus assay; (2) in vivo sister chromatid exchange assay; and (3) Ames E. coli test. The in vitro mouse lymphoma forward mutation assay was negative in the absence of activation, but positive in the presence of microsomal activation. In reproduction studies of brinzolamide in rats, there were no adverse effects on the fertility or reproductive capacity of males or females at doses up to 18 mg / kg per day (375 times the recommended human ophthalmic dose).
If more than one topical ophthalmic drug is being used, the drugs should be administered at least ten minutes apart.
In two, three-month clinical studies, Azopt (Brinzolamide) 1% dosed three times per day (TID) in patients with elevated intraocular pressure (IOP), produced significant reductions in IOPs (4 -5 mmHg). These IOP reductions are equivalent to the reductions observed with Trusopt (dorzolamide hydrochloride ophthalmic solution) 2% dosed TID in the same studies.
In two clinical studies in patients with elevated intraocular pressure, Brinzolamide (Azopt) was associated with less stinging and burning upon instillation than Trusopt 2%.
HOW SUPPLIED / STORAGE AND HANDLING
Brinzolamide eye drops (Azopt) 1% is supplied in plastic Drop-Tainer dispensers with a controlled dispensing-tip as follows:
5 ml, 10 ml, 15 ml
Storage and Handling
Store Brinzolamide ophthalmic suspension (Azopt) 1% at 4-30°C (39-86°F). Shake well before use.
Manufactured and distributed by Alcon pharmaceutical company and its divisions.
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