Dorzolamide Hydrochloride Solution/ Drops Recall
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Questions & Answers
Side Effects & Adverse Reactions
Dorzolamide Hydrochloride Ophthalmic Solution is a sulfonamide and, although administered topically, is absorbed systemically. Therefore, the same types of adverse reactions that are attributable to sulfonamides may occur with topical administration with 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. Sensitization may recur when a sulfonamide is readministered irrespective of the route of administration. If signs of serious reactions or hypersensitivity occur, discontinue the use of this preparation.
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FDA Safety Alerts
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There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Dorzolamide Hydrochloride Ophthalmic Solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.
There is currently no drug history available for this drug.
Dorzolamide Hydrochloride Ophthalmic Solution is a carbonic anhydrase inhibitor formulated for topical ophthalmic use.
Dorzolamide hydrochloride is described chemically as: (4S-trans)-4-(ethylamino)-5,6-dihydro-6-methyl-4H-thieno[ 2,3-b]thiopyran-2-sulfonamide 7,7-dioxide monohydrochloride. Dorzolamide hydrochloride is optically active.
The specific rotation is
α 25° (C=1, water) = ~ -17°.
Its empirical formula is C10H16N2O4S3•HCl and its structural formula is:
Dorzolamide hydrochloride has a molecular weight of 360.9 and a melting point of about 264°C. It is a white to offwhite, crystalline powder, which is soluble in water and slightly soluble in methanol and ethanol.
Dorzolamide Hydrochloride Ophthalmic Solution is supplied as a sterile, isotonic, buffered, slightly viscous, aqueous solution of dorzolamide hydrochloride. The pH of the solution is approximately 5.6, and the osmolarity is 260-330 mOsM. Each mL of Dorzolamide Hydrochloride Ophthalmic Solution 2% contains 20 mg dorzolamide (22.3 mg of dorzolamide hydrochloride). Inactive ingredients are hydroxyethyl cellulose, mannitol, purified water, and sodium citrate dihydrate. Sodium hydroxide may be used to adjust pH. Benzalkonium chloride 0.0075% is added as a preservative.