DIAMOX Tablet (2015)
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Περιεχόμενα
Name of the medicinal product
DIAMOX 250mg Tablets. Acetazolamide Mercury Pharma 250mg Tablets.
Qualitative and quantitative composition
Each tablet contains 250mg acetazolamide BP. For excipients see 6.1.
Pharmaceutical form
Tablet. Round, convex, white tablets engraved with FW 147 on one side and cored in quarters on the other.
Therapeutic indications
DIAMOX Tablets are for oral administration. Acteazolamide is an enzyme inhibitor which acts specifically on carbonic anhydrase. It is indicated in the treatment of: Glaucoma: DIAMOX Tablets is useful in ...
Posology and method of administration
Glaucoma (simple acute congestive and secondary) Adults: 250-1,000mg (1-4 tablets) per 24 hours, usually in divided doses for amounts over 250mg daily. Abnormal retention of fluid: Congestive heart failure, ...
Contraindications
Acetazolamide is contra-indicated in situations in which sodium and/or potassium blood levels are depressed, in cases of marked kidney and liver disease or dysfunction, suprarenal gland failure, and hyperchloremic ...
Special warnings and precautions for use
Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents in several indications. A meta-analysis of randomised placebo controlled trials of anti-epileptic drugs ...
Interaction with other medicinal products and other forms of interaction
Acetazolamide is a sulphonamide derivative. Sulphonamides may potentiate the effects of folic acid antagonists. Possible potentiation of the effects of folic acid antagonists, hypoglycaemics and oral anti-coagulants ...
Pregnancy and lactation
Use in pregnancy Acetazolamide has been reported to be teratogenic and embryotoxic in rats, mice, hamsters and rabbits at oral or parenteral doses in excess of ten times those recommended in human beings. ...
Effects on ability to drive and use machines
Increasing the dose does not increase the diuresis and may increase the incidence of drowsiness and/or paraesthesia. Less commonly, fatigue, dizziness and ataxia have been reported. Disorientation has ...
Undesirable effects
Adverse reactions during short-term therapy are usually non-serious. Those effects which have been noted include: paraesthesia, particularly a tingling feeling in the extremities; some loss of appetite; ...
Overdose
No specific antidote. Supportive measures with correction of electrolyte and fluid balance. Force fluids.
Pharmacodynamic properties
Pharmacotherapeutic group: Carbonic anhydrase inhibitors ATC Code: S01EC01 Acetazolamide is an inhibitor of carbonic anhydrase. By inhibiting the reaction catalysed by this enzyme in the renal tubules, ...
Pharmacokinetic properties
Acetazolamide is fairly rapidly absorbed from the gastro-intestinal tract with peak plasma concentrations occurring about 2 hours after administration by mouth. It has been estimated to have a plasma half-life ...
Preclinical safety data
Not applicable.
List of excipients
Dicalcium phosphate Corn starch Magnesium stearate Sodium starch glycolate Povidone
Incompatibilities
None.
Shelf life
48 months.
Special precautions for storage
Do not store above 25°C. Store in the original pack in order to protect from light and moisture.
Nature and contents of container
Amber glass bottles with metal screw-on caps. Polypropylene bottles with plastic screw-on caps. The product is supplied in bottles of 112 tablets.
Special precautions for disposal and other handling
None.
Marketing authorization holder
Mercury Pharmaceuticals Ltd, Capital House, 85 King William Street, London EC4N 7BL, UK
Marketing authorization number(s)
PL 12762/0147
Date of first authorization / renewal of the authorization
12/12/2003
Date of revision of the text
15/01/2015
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