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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

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.

Disclaimer
Products protected by valid patents are not offered for commercial sale in countries where the sale of such products constitutes patent infringement but are offered solely for uses reasonably related to the development and submission of information under a law regulating the manufacture, use or sale of drugs. It is within the buyer’s responsibility and liability to check the patent situation of the product in the imported market(s).
Polpharma’s strategic investment in HPAPI facility
We have launched an investment in a specialized facility
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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