Quốc gia: Singapore
Ngôn ngữ: Tiếng Anh
Nguồn: HSA (Health Sciences Authority)
ACETAZOLAMIDE
GOLDPLUS UNIVERSAL PTE LTD
S01EC01
TABLET
ACETAZOLAMIDE 250 mg
ORAL
Prescription Only
Celogen Generics Private Ltd
ACTIVE
2023-09-13
1 NAME OF THE MEDICINAL PRODUCT GP-ACETAZOLAMIDE TABLET 250MG 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Acetazolamide Ph. Eur 250mg Excipients QS For excipients see 5.1. 3 PHARMACEUTICAL FORM White color, round shaped tablet with break line on one side & plain on other side. The break line only serves to facilitate breaking for ease of swallowing and does not divide the tablet into equal half-doses. 4 CLINICAL PARTICULARS 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. 4.3 PRECAUTIONS Increasing the dose does not increase and may often decrease the diuresis and may yet produce drowsiness and/or paresthesia. Choroidal effusion, acute myopia and secondary angle-closure glaucoma: Sulfonamide or sulfonamide derivative drugs can cause an idiosyncratic reaction resulting in choroidal effusion with visual field defect, transient myopia and acute angle-closure glaucoma. Symptoms may include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation. Untreated acute angle-closure glaucoma can lead to permanent vision loss. The primary treatment is to discontinue dru Đọc toàn bộ tài liệu