Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
TABLET
**4.7 Dosage** Chronic simple (open angle) glaucoma: 250mg 1 to 4 times daily. A complementary effect has been noted when acetazolamide was used with miotics or mydriatics as the case demanded. Secondary glaucoma and preoperative treatment of some cases of acute congestive (closed angle) glaucoma: 250mg every 4 hours. Epilepsy 8 to 30 mg/kg (375 to 1000 mg) daily in divided doses. To alkalinize the urine 250mg every 4 to 6 hours.
ORAL
Medical Information
**4.1 Indications** To decrease ocular aqueous humor secretion in glaucoma (chronic, simple and secondary types). Also used as an adjunct in the treatment of selected cases of epilepsy. To alkalinise the urine in selected cases of salicylate overdosage.
**4.2 Contraindications** Depressed sodium and/or potassium blood levels, in renal failure, adrenal gland failure, metabolic acidosis, and some cases of hepatic cirrhosis, severe glaucoma due to peripheral anterior synechias or in hemorrhagic glaucoma. Long term use in chronic noncongestive angle closure glaucoma is contraindicated. Studies on acetazolamide in mice and rats have consistently demonstrated embryocidal and teratogenic effects at doses in excess of 10 times the human dose. There is no evidence of these effects in humans; however, acetazolamide should not be used in pregnancy, unless the anticipated benefits outweigh these potential hazards and are not attainable in other ways.
S01EC01
acetazolamide
Manufacturer Information
GOLDPLUS UNIVERSAL PTE LTD
Celogen Generics Private Ltd
Active Ingredients
Documents
Package Inserts
GP-Acetazolamide tablet 250mg PI.pdf
Approved: September 13, 2023