MedPath

Acetazolamide

Generic Name
Acetazolamide
Drug Type
Small Molecule
Chemical Formula
C4H6N4O3S2
CAS Number
59-66-5
Unique Ingredient Identifier
O3FX965V0I

Overview

One of the carbonic anhydrase inhibitors that is sometimes effective against absence seizures. It is sometimes useful also as an adjunct in the treatment of tonic-clonic, myoclonic, and atonic seizures, particularly in women whose seizures occur or are exacerbated at specific times in the menstrual cycle. However, its usefulness is transient often because of rapid development of tolerance. Its antiepileptic effect may be due to its inhibitory effect on brain carbonic anhydrase, which leads to an increased transneuronal chloride gradient, increased chloride current, and increased inhibition. (From Smith and Reynard, Textbook of Pharmacology, 1991, p337)

Indication

For adjunctive treatment of: edema due to congestive heart failure; drug-induced edema; centrencephalic epilepsies; chronic simple (open-angle) glaucoma

Associated Conditions

  • Acute angle-closure glaucoma
  • Edema
  • Familial periodic paralysis
  • Generalized Tonic-Clonic Seizures
  • Metabolic Alkalosis
  • Open Angle Glaucoma (OAG)
  • Other and unspecified effects of high altitude
  • Cystine renal calculi
  • Drug-induced edema
  • Nonuveitic secondary glaucoma
  • Salicylate intoxication

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/05/20
Phase 2
Recruiting
2025/04/25
Not Applicable
Not yet recruiting
2025/01/15
Phase 2
Recruiting
Shionogi Apnimed Sleep Science
2024/08/02
Phase 3
Recruiting
2024/07/26
Phase 2
Recruiting
Sanjay R Patel
2024/07/12
Phase 4
Recruiting
2024/07/12
Phase 4
Recruiting
2024/07/12
Phase 4
Recruiting
2024/06/26
Phase 4
Recruiting
2024/05/16
Phase 4
Recruiting

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
A-S Medication Solutions
50090-3132
ORAL
500 mg in 1 1
6/23/2020
A-S Medication Solutions
50090-3003
ORAL
250 mg in 1 1
1/22/2020
Zydus Lifesciences Limited
65841-762
ORAL
500 mg in 1 1
2/22/2024
Zydus Pharmaceuticals (USA) Inc.
70710-1238
ORAL
125 mg in 1 1
3/26/2024
ANI Pharmaceuticals, Inc.
70954-033
ORAL
125 mg in 1 1
3/22/2023
Ajanta Pharma USA Inc.
27241-133
ORAL
250 mg in 1 1
8/11/2023
Bryant Ranch Prepack
63629-1194
ORAL
125 mg in 1 1
5/19/2023
Taro Pharmaceuticals U.S.A., Inc.
51672-4023
ORAL
250 mg in 1 1
9/6/2016
Taro Pharmaceuticals U.S.A., Inc.
51672-4022
ORAL
125 mg in 1 1
9/6/2016
Alembic Pharmaceuticals Inc.
62332-349
ORAL
500 mg in 1 1
6/13/2022

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
GP-ACETAZOLAMIDE TABLET 250MG
SIN16860P
TABLET
250 mg
9/13/2023
AA PHARMA ACETAZOLAMIDE TABLET 250 mg
SIN01140P
TABLET
250 mg
5/13/1988

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
Diamox Tablet
15204
Medicine
A
9/9/1991
GLAUMOX acetazolamide (as sodium) 500 mg powder for injection vial
142075
Medicine
A
6/1/2009

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
ACETAZOLAMIDE
aa pharma inc
00545015
Tablet - Oral
250 MG
12/31/1982
ACETAZOLAM
valeant canada lp / valeant canada s.e.c.
00295019
Tablet - Oral
250 MG
12/31/1974
DIAMOX TABLETS 250MG
wyeth-ayerst canada inc.
02238072
Tablet - Oral
250 MG
10/27/1999
DIAMOX TAB 250MG
storz, division of wyeth-ayerst canada inc.
02039222
Tablet - Oral
250 MG
12/31/1994
DIAMOX SEQUELS
wyeth canada
02238073
Capsule (Sustained-Release) - Oral
500 MG
12/23/1998
NOVO-ZOLAMIDE TAB 250MG
novopharm limited
00488275
Tablet - Oral
250 MG
12/31/1981
DIAMOX SRC 500MG
storz, division of wyeth-ayerst canada inc.
02039230
Capsule (Sustained-Release) - Oral
500 MG / SRC
12/31/1994

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

Help Us Improve

Your feedback helps us provide better drug information and insights.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.