GP-ACETAZOLAMIDE TABLET 250MG

Země: Singapur

Jazyk: angličtina

Zdroj: HSA (Health Sciences Authority)

Aktivní složka:

ACETAZOLAMIDE

Dostupné s:

GOLDPLUS UNIVERSAL PTE LTD

ATC kód:

S01EC01

Léková forma:

TABLET

Složení:

ACETAZOLAMIDE 250 mg

Podání:

ORAL

Druh předpisu:

Prescription Only

Výrobce:

Celogen Generics Private Ltd

Stav Autorizace:

ACTIVE

Datum autorizace:

2023-09-13

Charakteristika produktu

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