acetazolamide

FDA Drug Profile — acetazolamide

Drug Details

Generic Name
acetazolamide
Brand Names
acetazolamide
Application Number
ANDA205530
Sponsor
AvKARE
NDC Codes
12
Dosage Forms
TABLET, CAPSULE, EXTENDED RELEASE, CAPSULE
Routes
ORAL
Active Ingredients
ACETAZOLAMIDE

Indications and Usage

INDICATIONS AND USAGE: For adjunctive treatment of: chronic simple (open-angle) glaucoma, secondary glaucoma, and preoperatively in acute angleclosure glaucoma where delay of surgery is desired in order to lower intraocular pressure. Acetazolamide extended-release capsules are also indicated for the prevention or amelioration of symptoms associated with acute mountain sickness despite gradual ascent.

Warnings

WARNINGS: Fatalities have occurred, although rarely, due to severe reactions to sulfonamides including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, anaphylaxis, agranulocytosis, aplastic anemia, and other blood dyscrasias. Sensitizations may recur when a sulfonamide is readministered irrespective of the route of administration. If signs of hypersensitivity or other serious reactions occur, discontinue use of this drug. Caution is advised for patients receiving concomitant high-dose aspirin and acetazolamide, as anorexia, tachypnea, lethargy, metabolic acidosis, coma, and death have been reported.