pharmacopeia
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/api/v1/drug/acetazolamide

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Carbonic Anhydrase Inhibitors.

Carbonic Anhydrase

Indications

Sourced from openFDA
  • 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.ICD-10: G40.909, H40.9, I50.9, R60.9

Contraindications

Sourced from openFDA
  • Hypersensitivity to acetazolamide or any excipients in the formulation. Since acetazolamide is a sulfonamide derivative, cross sensitivity between acetazolamide, sulfonamides and other sulfonamide derivatives is possible.contraindicated

Dosage & administration

Sourced from openFDA

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 per 24 hours, usually in divided doses for amounts over 250 mg. It has usually been found that a dosage in excess of 1 g per 24 hours does not produce an increased effect. In all cases, the dosage should be adjusted with careful individual attention both to symptomatology and ocular tension. Continuous supervision by a physician is advisable. In treatment of secondary glaucoma and in the preoperative treatment of some cases of acute congestive (closed-angle) glaucoma , the preferred dosage is 250 mg every four hours, although some cases have responded to 250 mg twice daily on short-term therapy. In some acute cases, it may be more satisfactory to administer an initial dose of 500 mg followed by 125 or 250 mg every four hours depending on the individual case. A complementary effect has been noted when acetazolamide has been used in conjunction with miotics or mydriatics as the case demanded. Epilepsy: It is not clearly known whether the beneficial effects observed in epilepsy are due to direct inhibition of carbonic anhydrase in the central nervous system or whether they are due to the slight degree of acidosis produced by the divided dosage. The best results to date have been seen in petit mal in pediatric patients.

Warnings & precautions

Sourced from openFDA

Fatalities have occurred, although rarely, due to severe reactions to sulfonamides including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias, and anaphylaxis. 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.

Adverse reactions

Sourced from openFDA

Body as a whole: Headache, malaise, fatigue, fever, flushing, growth retardation in children, flaccid paralysis, anaphylaxis Digestive: Gastrointestinal disturbances such as nausea, vomiting, diarrhea Hematological/Lymphatic: Blood dyscrasias such as aplastic anemia, agranulocytosis, leukopenia, thrombocytopenia, thrombocytopenic purpura, melena Hepato-biliary disorders: Abnormal liver function, cholestatic jaundice, hepatic insufficiency, fulminant hepatic necrosis Metabolic/Nutritional: Metabolic acidosis, electrolyte imbalance, including hypokalemia, hyponatremia, osteomalacia with long-term phenytoin therapy, loss of appetite, taste alteration, hyper/hypoglycemia Nervous: Drowsiness, paraesthesia (including numbness and tingling of extremities and face), depression, excitement, ataxia, confusion, convulsions, dizziness Skin: Allergic skin reactions including urticaria, photosensitivity, Stevens-Johnson syndrome, toxic epidermal necrolysis Otologic : Hearing disturbances, tinnitus Eye Disorders: choroidal effusion, choroidal detachment, transient myopia. Transient myopia is the result of forward movement of the ciliary body leading to a narrowing of the angle. Urogenital: Crystalluria, increased risk of nephrolithiasis with long-term therapy, hematuria, glycosuria, renal failure, polyuria Postmarketing Experience: The following adverse reactions have been identified during post approval use of acetazolamide.

Use in specific populations

Sourced from openFDA

Pregnancy: Teratogenic effects Acetazolamide, administered orally or parenterally, has been shown to be teratogenic (defects of the limbs) in mice, rats, hamsters, and rabbits. There are no adequate and well-controlled studies in pregnant women. Acetazolamide should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.

Overdosage

Sourced from openFDA

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. Serum electrolyte levels (particularly potassium) and blood pH levels should be monitored. Supportive measures are required to restore electrolyte and pH balance. The acidotic state can usually be corrected by the administration of bicarbonate. Despite its high intraerythrocytic distribution and plasma protein binding properties, acetazolamide is dialyzable. This may be particularly important in the management of acetazolamide overdosage when complicated by the presence of renal failure.

Approval history

Sourced from openFDA
  • Feb 28, 1995ANDAANDA040089Hikma
  • Dec 10, 2008ANDAANDA040784Xgen Pharms
  • Dec 10, 2008ANDAANDA040904Heritage Pharma
  • Jul 14, 2011ANDAANDA090779Indicus Pharma
  • May 9, 2012ANDAANDA200880Mylan Asi
  • Dec 19, 2014ANDAANDA202693Avet Lifesciences
  • Sep 30, 2016ANDAANDA203434Novast Labs
  • Oct 27, 2016ANDAANDA205530Heritage Pharma

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
5,862 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Off Label Use70412%
  2. 2Drug Ineffective67712%
  3. 3Condition Aggravated2884.9%
  4. 4Headache2834.8%
  5. 5Fatigue2524.3%
  6. 6Dyspnoea2454.2%
  7. 7Nausea2404.1%
  8. 8Metabolic Acidosis2023.4%
  9. 9Product Use In Unapproved Indication1923.3%
  10. 10Diarrhoea1743.0%
  11. 11Vomiting1692.9%
  12. 12Dizziness1572.7%
  13. 13Pain1562.7%
  14. 14Intraocular Pressure Increased1502.6%
  15. 15Acute Kidney Injury1462.5%

Literature

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Recent PubMed references pinned to Acetazolamide as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 185 ClinicalTrials.gov registrations naming Acetazolamide as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Acetazolamide work?
Mechanism-of-action class: Carbonic Anhydrase Inhibitors.
What is Acetazolamide used for?
According to FDA labeling, Acetazolamide carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Acetazolamide?
Acetazolamide is classified as Carbonic anhydrase inhibitors, Carbonic Anhydrase Inhibitor, Carbonic Anhydrase Inhibitors, Decreased Adrenocorticotropic Hormone Secretion, Decreased Central Nervous System Disorganized Electrical Activity, Decreased Central Nervous System Organized Electrical Activity, Decreased Intraocular Fluid Pressure, Increased Collecting Duct Water Permeability, Increased Renal HCO3- Excretion, Increased Renal K+ Excretion, Increased Renal Na+ Excretion.
What are the contraindications for Acetazolamide?
Acetazolamide labeling lists contraindications including: Hypersensitivity to acetazolamide or any excipients in the formulation. Since acetazolamide is a sulfonamide derivative, cross sensitivity between acetazolamide, sulfonamides and other sulfonamide derivatives is possible.. Always consult the full prescribing information and a clinician.
Note. Data for acetazolamide is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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