Acetazolamide

Acetazolamide

Goedgekeurde toepassingen

• 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.
• 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.

Vormen en sterktes

• Acetazolamide Tablets USP, 125 mg are available for oral administration as white to off white, round tablet, debossed HP 287 on one side and scored on other side.

Hoe het wordt ingenomen

• 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.

Mag niet worden gebruikt bij

• 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.
• Acetazolamide therapy is contraindicated in situations in which sodium and/or potassium blood serum levels are depressed, in cases of marked kidney and liver disease or dysfunction, in suprarenal gland failure, and in hyperchloremic acidosis.
• It is contraindicated in patients with cirrhosis because of the risk of development of hepatic encephalopathy.

Waarschuwingen en voorzorgen

• 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.

Vaak voorkomende bijwerkingen

• 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,...

Zwangerschap

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.

Handelsvergunninghouder:

Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

Versie van de productinformatie:

12 mei 2026

De secties hierboven zijn geciteerd uit de Engelstalige productinformatie, want dat is het document dat de goedkeuring draagt. Waar een Europese instantie dezelfde informatie in het Nederlands publiceert, staat de link bij de bronnen. Wij vertalen regelgevende teksten niet zelf: een vertaalfout in een contra-indicatie is gevaarlijker dan een regel in een vreemde taal.

Deze sectie geeft de goedgekeurde productinformatie weer. De formulering is ingedikt uit de samenvatting van de toezichthouder zelf, en het volledige document staat bij de bronnen.