ACETAZOLAMIDE
Acetazolamide is a carbonic anhydrase inhibitor indicated as adjunctive therapy for edema associated with congestive heart failure or drug-induced causes. It is used in the management of centrencephalic epilepsies (including petit mal and unlocalized seizures) and to reduce intraocular pressure in chronic simple (open-angle) glaucoma and secondary glaucoma. It is also indicated preoperatively in acute angle-closure glaucoma when a delay in surgery is desired. Additionally, acetazolamide is indicated for the prevention or amelioration of symptoms associated with acute mountain sickness in climbers.
How ACETAZOLAMIDE Works
Acetazolamide is a potent inhibitor of the enzyme carbonic anhydrase. By inhibiting this enzyme in the proximal renal tubule, it prevents the hydration of carbon dioxide and the dehydration of bicarbonate, leading to increased renal excretion of sodium, potassium, bicarbonate, and water. In the eye, this inhibition reduces the rate of aqueous humor secretion, thereby lowering intraocular pressure. Its anticonvulsant activity may result from a direct inhibition of carbonic anhydrase in the CNS or from the resulting systemic metabolic acidosis. In the context of altitude sickness, the induced metabolic acidosis acts as a respiratory stimulant, increasing arterial oxygenation and accelerating acclimatization.
Details
- Status
- Prescription
- First Approved
- 1974-07-18
- Routes
- ORAL
- Dosage Forms
- TABLET, CAPSULE, EXTENDED RELEASE
Companies
ACETAZOLAMIDE Approval History
What ACETAZOLAMIDE Treats
5 indicationsACETAZOLAMIDE is approved for 5 conditions since its original approval in 1974. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Edema
- Congestive Heart Failure
- Epilepsy
- Glaucoma
- Acute Mountain Sickness
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Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ACETAZOLAMIDE FDA Label Details
ProIndications & 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, secondary glaucoma, and preoperatively in acute angle-closure glaucoma where delay of surgery is desired in order to lower intraocular pressure. Acetazolamide Tablets are also indicated for the prevention or amelioration of symptoms associated with acute mountain sickness in climbers attempting rapid ascent and in those who are very susceptible to acute mountain sickness despite gradual ascent.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.