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Azopres

Brinzolamide USP

NAME STRENGTH PACK SIZE DOSAGE FORM
Azopres 2% w/v + 0.5% w/v 5 ml Eye suspension

Composition

Each ml contains Brinzolamide USP 10 mg.

Brinzolamide is an inhibitor of carbonic anhydrase II (CA-II). Inhibition of carbonic anhydrase in the ciliary processes of the eye decreases aqueous humor secretion, presumably by slowing the formation of bicarbonate ions with subsequent reduction in sodium and fluid transport. The result is a reduction in intraocular pressure (IOP).

Indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.

Instill 1 drop 3 times daily in the affected eye(s). If more than one topical ophthalmic drug is being used, the drugs should be administered at least ten (10) minutes apart.

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.

Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias. Sensitization may recur when a sulfonamide is re-administered irrespective of the route of administration. If signs of serious reactions or hypersensitivity occur, discontinue the use of this preparation.

There are no adequate and well-controlled studies in pregnant women. Brinzolamide ophthalmic suspension 1% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether this drug is excreted in human milk. Because many drugs are excretedin human milk and because of the potential for serious adverse reactions in nursing infants from Brinzolamide ophthalmic suspension 1%, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Brinzolamide ophthalmic suspension 1% is contraindicated in patients who are hypersensitive to any component of this product.

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 ophthalmic suspension 1%. The concomitant administration of Brinzolamide ophthalmic suspension 1% and oral carbonic anhydrase inhibitors is not recommended.

Each plastic dropper bottle contains 5 ml sterile Eye Suspension.