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Drug Details
Ursofalk Suspension
- Drug Class Description
Bile acids. - Generic Name
Ursodeoxycholic acid - Presentation
Suspension for oral administration - Description
5ml (=1 measuring spoon) of Ursofalk Suspension contains the following active ingredient: ursodeoxycholic acid 250mg. - Indications
Ursofalk Suspension is indicated in the treatment of primary biliary cirrhosis (PBC) and for the dissolution of radiolucent gallstones in patients with a functioning gall bladder. - Adult Dosage
Method of administration: Oral.
Primary Biliary Cirrhosis
Adults and the elderly: 10-15mg ursodeoxycholic acid (UDCA) per kg per day in two to four
divided doses. The following dosage regimen is recommended:
Body Weight (kg) Spoonfuls (5ml) (in 2 divided doses) mg (UDCA) / kg/day 50-62 2-4 10.0-16.1 63-85 3-5 11.9 -14.7 86-120 4-7 11.6-14.6 Children: Dosage should be related to bodyweight.
Dissolution of Gallstones
Adults: 8 - 12mg ursodeoxycholic acid (UDCA) per kg per day in two divided doses. The
following dosage regimen is recommended:
Body Weight (kg) Spoonfuls (5ml) (in 2 divided doses) mg (UDCA) / kg/day 50-62 2 8.1-10.0 63-85 3 8.8-11.9 86-120 4 8.3-11.6 If doses are unequal the larger dose should be taken in late evening to counteract the rise in biliary cholesterol saturation which occurs in the early morning. The late evening dose may usefully be taken with food to help maintain bile flow overnight.
The time required for dissolution of gallstones is likely to range from 6 to 24 months depending on stone size and composition.
Follow-up cholecystograms or ultrasound investigation may be useful at 6 month intervals until the gallstones have disappeared.
Treatment should be continued until 2 successive cholecystograms and/or ultrasound investigations
4 - 12 weeks apart have failed to demonstrate gallstones. This is because these techniques do not permit reliable visualisation of stones less than 2mm in diameter.
The likelihood of recurrence of gallstones after dissolution by bile acid treatment has been estimated as up to 50% at 5 years.
The efficiency of Ursofalk Suspension in treating radio-opaque or partially radio-opaque gallstones has not been tested but these are generally thought to be less soluble than radiolucent stones.
Non-cholesterol stones account for 10-15% of radiolucent stones and may not be dissolved by bile acids.
Elderly: There is no evidence to suggest that any alteration in the adult dose is needed but the relevant precautions should be taken into account.
Children: Cholesterol rich gallstones are rare in children but when they occur, dosage should be related to bodyweight.
- Child Dosage
Biliary cirrhosis, 10 - 15 mg/kg daily in two to four divided doses. Gallstones, 8 - 12 mg/kg daily in two divided doses after meals; one dose always after evening meal. Continue treatment until 2 successive cholecystograms or ultrasounds fail to detect gallstones. - Contra Indications
Ursofalk Suspension is not suitable for the dissolution of radio-opaque gallstones and should not be used in patients with a non-functioning gall bladder.
- Special Precautions
A product of this class has been found to be carcinogenic in animals.
The relevance of these findings to the clinical use of Ursofalk Suspension has not been established
- Interactions
Some drugs, such as cholestyramine, charcoal, colestipol and certain antacids (e.g. aluminium hydroxide) bind bile acids in vitro. They could therefore have a similar effect in vivo and may interfere with the absorption of Ursofalk Suspension.
Drugs which increase cholesterol elimination in bile, such as oestrogenic hormones, oestrogcn-rich contraceptive agents and certain blood cholesterol lowering agents, such as clofibrate, should not he taken with Ursofalk Suspension.
UDCA may increase the absorption of cyclosporin in transplantation patients
- Adverse Drug Reactions
Diarrhoea may occur rarely