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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)

Background

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

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Title
Posted
Study ID
Phase
Status
Sponsor
2017/06/06
Phase 4
Completed
2017/06/06
Phase 4
Completed
2017/06/01
Phase 4
Completed
2017/05/25
Phase 4
Completed
2017/05/24
Phase 4
Completed
2017/05/17
Phase 4
Completed
2017/05/16
Phase 1
Completed
Grant S Lipman
2017/04/11
Not Applicable
Completed
2017/01/05
Phase 1
Completed
2016/12/29
Not Applicable
Completed
Post Graduate Institute of Medical Education and Research, Chandigarh

FDA Drug Approvals

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Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Nostrum Laboratories, Inc.
29033-030
ORAL
500 mg in 1 1
12/18/2018
AvKARE
42291-090
ORAL
250 mg in 1 1
1/9/2024
PD-Rx Pharmaceuticals, Inc.
72789-237
ORAL
250 mg in 1 1
2/16/2024
Micro Labs Limited
42571-243
ORAL
500 mg in 1 1
5/23/2022
Heritage Pharmaceuticals Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.
23155-313
INTRAVENOUS
500 mg in 5 mL
8/1/2022
AvPAK
50268-042
ORAL
500 mg in 1 1
1/9/2024
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
23155-288
ORAL
250 mg in 1 1
8/1/2022
A-S Medication Solutions
50090-4511
ORAL
125 mg in 1 1
10/10/2022
TRUPHARMA, LLC
52817-201
ORAL
250 mg in 1 1
6/21/2022
Bryant Ranch Prepack
63629-1195
ORAL
250 mg in 1 1
10/18/2023

EMA Drug Approvals

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Status
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No EMA approvals found for this drug.

HSA Drug Approvals

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No HSA approvals found for this drug.

NMPA Drug Approvals

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Drug Type
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Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

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TGA Drug Approvals

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