Dorzolamide Hydrochloride

1 INDICATIONS AND USAGE Dorzolamide Hydrochloride Ophthalmic Solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Dorzolamide Hydrochloride Ophthalmic Solution is a carbonic anhydrase inhibitor indicated for the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. ( 1 )

6 ADVERSE REACTIONS The most frequently reported adverse reactions associated with Dorzolamide Hydrochloride Ophthalmic Solution were ocular burning, stinging, or discomfort immediately following ocular administration (approximately one-third of patients). Approximately one-quarter of patients noted a bitter taste following administration. Superficial punctate keratitis occurred in 10 to 15% of patients and signs and symptoms of ocular allergic reaction in approximately 10%. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Sagent Pharmaceuticals at 1-866-625-1618 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies in pregnant women with Dorzolamide Hydrochloride Ophthalmic Solution. Dorzolamide caused fetal vertebral malformations when administered orally to rabbits at 2.5 mg/kg/day (37 times the clinical exposure). Dorzolamide administered during the period of organogenesis was not teratogenic in rabbits dosed up to 1 mg/kg/day (15 times the clinical exposure).

5 WARNINGS AND PRECAUTIONS Sulfonamide Hypersensitivity ( 5.1 ) Bacterial Keratitis ( 5.2 ) Corneal Endothelium ( 5.3 ) Allergic Reactions ( 5.4 ) Acute Angle-Closure Glaucoma ( 5.5 ) 5.1 Sulfonamide Hypersensitivity Dorzolamide Hydrochloride Ophthalmic Solution contains dorzolamide, a sulfonamide; and although administered topically, it is absorbed systemically. Therefore, the same types of adverse reactions that are attributable to sulfonamides may occur with topical administration of Dorzolamide Hydrochloride Ophthalmic Solution. Fatalities have occurred, although rarely, due to severe reactions to sulfonamides including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias. 4 CONTRAINDICATIONS Dorzolamide Hydrochloride Ophthalmic Solution is contraindicated in patients who are hypersensitive to any component of this product [see Warnings and Precautions ( 5.1 )]. Dorzolamide Hydrochloride Ophthalmic Solution is contraindicated in patients who are hypersensitive to any component of this product. ( 4 , 5.1 )