1. Name Of The Medicinal Product
Diloxanide Tablets 500mg
2. Qualitative And Quantitative Composition
|
|
|
|
3. Pharmaceutical Form
A flat, white tablet, scored and with a characteristic engraving E/F on one face.
4. Clinical Particulars
4.1 Therapeutic Indications
For the treatment of acute and chronic intestinal amoebiasis.
4.2 Posology And Method Of Administration
Adults: One tablet three times daily for ten days.
Children: 20 mg/kg bodyweight daily in divided doses for ten days. Furamide is not suitable for use in children weighing less than 25 kg.
Elderly: There is no need for dosage reduction in the elderly.
If required, a second course of treatment may be prescribed.
4.3 Contraindications
Hypersensitivity to diloxanide furoate.
4.4 Special Warnings And Precautions For Use
Keep all medicines out of the reach of children.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
No clinically-significant drug interactions known.
4.6 Pregnancy And Lactation
The safety of Furamide during pregnancy and lactation has not been established and use during these periods should therefore be avoided.
4.7 Effects On Ability To Drive And Use Machines
No adverse effects known.
4.8 Undesirable Effects
No serious side effects have been reported and the bacterial flora of the gut is not upset. Flatulence sometimes occurs but may usually be disregarded. Occasionally, vomiting, pruritus and urticaria may occur.
4.9 Overdose
Furamide tablets are unlikely to constitute a hazard in overdosage. In severe overdosage, early gastric lavage is recommended. There is no specific antidote. Treatment should be symptomatic and supportive.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Diloxanide furoate is a luminal amoebicide acting principally in the bowel lumen, although its mode of action is not known.
5.2 Pharmacokinetic Properties
In the gut, diloxanide furoate is largely, if not wholly, hydrolysed into diloxanide and furoic acid under the combined action of bacterial and gut esterases. After absorption, diloxanide is very rapidly conjugated to form a glucuronide. In circulating blood, it is present to about 99% as a glucuronide and 1% as free diloxanide. Diloxanide is predominantly excreted in the urine. It is believed that the unabsorbed diloxanide is the active anti-amoebic substance, up to 10% remaining in the gut which is subsequently excreted as diloxanide in the faeces.
5.3 Preclinical Safety Data
Not applicable.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Maize starch, pregelatinized maize starch, dried maize starch, magnesium stearate, purified water.
6.2 Incompatibilities
None known.
6.3 Shelf Life
36 months.
6.4 Special Precautions For Storage
None.
6.5 Nature And Contents Of Container
A white aluminium tube with a polythene foam disc and a white aluminium screw cap with flowed-in PVC. Pack size: 15 tablets.
A white polythene cylindrical bottle and white polypropylene screw cap fitted with a waxed aluminium-faced pulpboard liner. Pack size: 30 tablets.
A rectangular amber-glass bottle with a white tin-plate screw cap fitted with a waxed aluminium-faced pulpboard liner. Pack size: 250 tablets.
A white polythene cylindrical bottle and white polypropylene screw cap fitted with a waxed aluminium-faced pulpboard liner. Pack size: 250 tablets.
6.6 Special Precautions For Disposal And Other Handling
Not applicable.
Administrative Data
7. Marketing Authorisation Holder
Waymade PLC
Sovereign House
Miles Gray Road
Basildon, Essex, SS14 3FR
United Kingdom
8. Marketing Authorisation Number(S)
PL 06464/0900
9. Date Of First Authorisation/Renewal Of The Authorisation
17 November 1999
10. Date Of Revision Of The Text
29 February 2000
Legal Category
POM
No comments:
Post a Comment