DIAMOX Sodium Powder for solution for injection Ref.[6055] Active ingredients: Acetazolamide

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Mercury Pharmaceuticals Ltd., Capital House, 85 King William Street, London EC4N 7BL, UK

Therapeutic indications

Acetazolamide is an enzyme inhibitor which acts specifically on carbonic anhydrase. It is indicated in the treatment of:

  • Glaucoma: DIAMOX injection is useful in glaucoma (chronic simple (open angle) glaucoma, secondary glaucoma and perioperatively in acute angle closure glaucoma where delay of surgery is desired in order to lower intraocular pressure) because it acts on inflow, decreasing the amount of aqueous secretion.
  • Abnormal retention of fluids: DIAMOX injection is a diuretic whose effect is due to the effect on the reversible hydration of carbon dioxide and dehydration of carbonic acid reaction in the kidney. The result is a renal loss of HCO3-ion which carries out sodium, water and potassium. DIAMOX injection can be used in conjunction with other diuretics when effects on several segments of the nephron are desirable in the treatment of fluid retaining states.
  • Epilepsy: In conjunction with other anticonvulsants best results with DIAMOX injection have been seen in petit mal in children. Good results, however, have been seen in patients, both children and adults, with other types of seizures such as grand mal, mixed seizure patterns, myoclonic jerk patterns, etc

Posology and method of administration

Routes of Administration

Intravenous or intramuscular injection. The direct intravenous route is preferred as intramuscular use is limited by the alkaline pH of the solution.

Glaucoma (simple acute congestive and secondary)

Adults: 250-1000mg per 24 hours, usually in divided doses for amounts over 250mg daily.

Abnormal retention of fluid: Congestive heart-failure, drug-induced oedema.

Adults: For diuresis, the starting dose is usually 250-375mg once daily in the morning. If, after an initial response, the patient fails to continue to lose oedema fluid, do not increase the dose but allow for kidney recovery by omitting a day.

Best results are often obtained on a regime of 250-375mg daily for two days, rest a day, and repeat or merely giving DIAMOX injection every other day. The use of DIAMOX injection does not eliminate the need for other therapy, e.g. digitalis, bed rest and salt restriction in congestive heart failure and proper supplementation with elements such as potassium in drug-induced oedema.

For cases of fluid retention associated with pre-menstrual tension, a daily dose (single) of 125-375mg is suggested.

Epilepsy

Adults: 250-1000mg daily in divided doses.

Children: 8-30mg/kg in daily divided doses and not to exceed 750mg/day.

The change from other medication to DIAMOX injection should be gradual.

Elderly: DIAMOX injection should only be used with particular caution in elderly patients or those with potential obstruction in the urinary tract or with disorders rendering their electrolyte balance precarious or with liver dysfunction.

For reconstitution please refer to section to section 6.6 below.

Overdose

No specific antidote. Supportive measures with correction of electrolyte and fluid balance. Force fluids.

Shelf life

24 months.

Special precautions for storage

Do not store above 25°C.

Nature and contents of container

Glass vial with butyl rubber plug and aluminium ring seal.

Pack size 500mg vial.

Special precautions for disposal and other handling

Reconstitute each vial of DIAMOX Injection with at least 5ml of water for injection prior to use. The reconstituted solution is clear and colourless and does not contain an antimicrobial preservative. Any unused solution can be stored in a refrigerator for up to 24 hours but any solution not used within this period must be discarded.

The direct intravenous route of administration is preferred. Intramuscular injection may be employed but is painful due to the alkaline pH of the solution.

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