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Brinzolamide (Azopt)

Trade Name : Azopt

Alcon Laboratories, Inc.

SUSPENSION/ DROPS

Strength 10 mg/mL

BRINZOLAMIDE Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Brinzolamide (Azopt) which is also known as Azopt and Manufactured by Alcon Laboratories, Inc.. It is available in strength of 10 mg/mL per ml. Read more

Brinzolamide (Azopt) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • 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.
  • AZOPT is a carbonic anhydrase inhibitor indicated for in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma ().
  • The recommended dose isu00a0one drop of AZOPT (brinzolamide ophthalmic suspension) 1% in the affected eye(s) three times daily. AZOPT (brinzolamide ophthalmic suspension) 1% may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure. If more than one topical ophthalmic drug is being used, the drugs should be administered at least ten (10) minutes apart.
  • Instill one drop 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 ().
  • Solution containing 10u00a0mg/mL brinzolamide.
  • Solution containing 10 mg/mL brinzolamide ().
  • AZOPT (brinzolamide ophthalmic suspension) 1% is contraindicated in patients who are hypersensitive to any component of this product.
  • Hypersensitivity to any component of this product ()
  • No data
  • Sulfonamide hypersensitivity reactions ().
  • Corneal edema may occur in patients with low endothelial cell counts ().
  • 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.u00a0n In clinical studies of AZOPT (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.u00a0n 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.
  • Most common adverse reactions are blurred vision and bitter, sour or unusual taste ().
  • u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0
  • No data
  • There is a potential additive effect of the known systemic effects of carbonic anhydrase inhibition in patients receiving both oral and topical carbonic anhydrase inhibitors ().
  • Rare instances of acid-base alterations have occurred with high-dose salicylate therapy ().
  • No data
  • 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 (brinzolamide ophthalmic suspension) 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-dihydro-2H-thieno [3,2-e]-1,2-thiazine-6-sulfonamide-1,1- dioxide. Its empirical formula is CHNOS, and its structural formula is:
  • Brinzolamide has a molecular weight of 383.5 and a melting point of about 131u00b0C. It is a white powder, which is insoluble in water, very soluble in methanol and soluble in ethanol.n AZOPT (brinzolamide ophthalmic suspension) 1% 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.n Each mL of AZOPT (brinzolamide ophthalmic suspension) 1% contains: brinzolamide 10 mg. Benzalkonium chloride 0.1 mg. mannitol, carbomer 974P, tyloxapol, edetate disodium, sodium chloride, purified water, with hydrochloric acid and/or sodium hydroxide to adjust pH.
  • No data
  • Brinzolamide caused urinary bladder tumors in female mice at oral doses of 10 mg/kg/day and in male rats at oral doses of 8 mg/kg/day in 2 year studies. Brinzolamide was not carcinogenic in male mice or female rats dosed orally for up to 2 years. The carcinogenicity appears secondary to kidney and urinary bladder toxicity. These levels of exposure cannot be achieved with topical ophthalmic dosing in humans. The following tests for mutagenic potential were negative: (1) mouse micronucleus assay; (2) sister chromatid exchange assay; and (3) Ames test. The 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/day (375 times the recommended human ophthalmic dose).
  • In two, three-month clinical studies, AZOPT (brinzolamide ophthalmic suspension) 1% dosed three times per dayu00a0in patients with elevated intraocular pressure (IOP), produced significant reductions in IOPs (4 to 5 mmHg). These IOP reductions are equivalent to the reductions observed with TRUSOPT* (dorzolamide hydrochloride ophthalmic solution) 2% dosed three times per day in the same studies.n In two clinical studies in patients with elevated intraocular pressure, AZOPT (brinzolamide ophthalmic suspension) 1% was associated with less stinging and burning upon instillation than TRUSOPT* 2%.
  • AZOPT (brinzolamide ophthalmic suspension) 1% is supplied in plastic DROP-TAINER dispensers with a controlled dispensing-tip as follows:n 10 mL NDC 0065-0275-1015 mL NDC 0065-0275-15n n Store AZOPT (brinzolamide ophthalmic suspension) 1% at 4 to 30u00b0C (39 to 86u00b0F). Shake well before use.
  • No data
  • No data

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