Acetazolamide
CAS No.
59-66-5
Reference product
DIAMOX/Mercury
Polymorphic form
Form II
Therapeutic Area
Cardiovascular system
Status
commercial
EU DMF readiness
✓
US DMF readiness
✓
CEP
✓
Other documentation
Korean DMF
💉 Available also
in injectable form
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Drug description:
Acetazolamide belongs to the class of carbonic anhydrase inhibitors.
Acetazolamide tablets and injection indicated for the treatment of glaucoma (open angle glaucoma, secondary glaucoma, and acute angle closure glaucoma where delay of surgery is desired in order to lower intra-ocular pressure), epilepsy and also indicated for the treatment of abnormal retention of fluids in congestive heart failure and drug induced oedema.
It is formulated as powder, solution for injection for intravenous or intramuscular route of administration and tablets for oral route of administration.
Mechanism of action:
Acetazolamide is an inhibitor of carbonic anhydrase. By inhibiting the reaction catalyzed by this enzyme in the renal tubules, acetazolamide increases the excretion of bicarbonate and of cations, chiefly sodium and potassium, and so promotes alkaline diuresis. Continuous administration of acetazolamide is associated with metabolic acidosis and resultant loss of diuretic activity. Therefore, the effectiveness of Acetazolamide tablets in diuresis diminishes with continuous use. By inhibiting carbonic anhydrase in the eye, acetazolamide decreases intra-ocular pressure and is therefore useful in the treatment of glaucoma.
for the R&D and Production of highly active substances
with an OEL value of 10 ng/m3 (OEB 6).
The HP API investment includes separate process
laboratories (PDL), analytical laboratories (ADL)
with the possibility of performing Quality Control
analyses, and a GMP kilo-lab production line with
volume up to 1.5 kg with potential volume increase.
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