Label: ACETAZOLAMIDE tablet

  • NDC Code(s): 27241-132-04, 27241-133-04
  • Packager: Ajanta Pharma USA Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 6, 2025

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  • DESCRIPTION
    Acetazolamide, USP an inhibitor of the enzyme carbonic anhydrase, is a white to faintly yellowish white crystalline, odorless powder, weakly acidic, very slightly soluble in water and slightly ...
  • CLINICAL PHARMACOLOGY
    Acetazolamide is a potent carbonic anhydrase inhibitor, effective in the control of fluid secretion (eg, some types of glaucoma), in the treatment of certain convulsive disorders (eg, epilepsy) ...
  • INDICATIONS AND USAGE
    For adjunctive treatment of: edema due to congestive heart failure; drug-induced edema; centrencephalic epilepsies (petit mal, unlocalized seizures); chronic simple (open-angle) glaucoma ...
  • CONTRAINDICATIONS
    Hypersensitivity to acetazolamide or any excipients in the formulation. Since acetazolamide is a sulfonamide derivative, cross sensitivity between acetazolamide, sulfonamides and other sulfonamide ...
  • WARNINGS
    Fatalities have occurred, although rarely, due to severe reactions to sulfonamides including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis ...
  • PRECAUTIONS
    General - Increasing the dose does not increase the diuresis and may increase the incidence of drowsiness and/or paresthesia. Increasing the dose often results in a decrease in diuresis. Under ...
  • ADVERSE REACTIONS
    Body as a whole: Headache, malaise, fatigue, fever, pain at injection site, flushing, growth retardation in children, flaccid paralysis, anaphylaxis - Digestive: Gastrointestinal disturbances ...
  • OVERDOSAGE
    No specific antidote is known. Treatment should be symptomatic and supportive. Electrolyte imbalance, development of an acidotic state, and central nervous effects might be expected to occur ...
  • DOSAGE AND ADMINISTRATION
    Glaucoma: Acetazolamide should be used as an adjunct to the usual therapy. The dosage employed in the treatment of chronic simple (open-angle) glaucoma ranges from 250 mg to 1 g of acetazolamide ...
  • HOW SUPPLIED
    Acetazolamide Tablets, USP are supplied as follows: 125 mg - White, round, scored in half, on one side, "A3" debossed on the other side. NDC 27241-132-04 - Bottle of 100 with child-resistant ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    NDC 27241-132-04 - 100 Tablets - AcetaZOLAMIDE Tablets, USP - 125 mg - Rx Only - ajanta - NDC 27241-133-04 - 100 Tablets - AcetaZOLAMIDE Tablets, USP - 250 mg - Rx Only - ajanta
  • INGREDIENTS AND APPEARANCE
    Product Information