Ursobil

Ursobil

ursodeoxycholic acid

Manufacturer:

ABC Farmaceutici

Distributor:

Hind Wing
Concise Prescribing Info
Contents
Ursodeoxycholic acid
Indications/Uses
Used to dissolve cholesterol gallstones not visible on a plain x-ray & ≤15 mm in diameter. Treatment of bile reflux gastritis & primary biliary cholangitis (PBC). Used for liver disease associated w/ cystic fibrosis in childn 6-18 yr.
Dosage/Direction for Use
Dissolution of cholesterol gallstones 10 mg/kg daily in the evening at bedtime for 6-24 mth. Patient weighing >100 kg 5 cap, 81-100 kg 4 cap, 61-80 kg 3 cap, up to 60 kg 2 cap. Treatment of bile reflux gastritis 1 cap daily in the evening before bedtime for 10-14 days. Treatment of PBC Should be taken in the morning, at midday & in the evening during the 1st 3 mth. Can be taken once daily in the evening as liver function values improve. Patient weighing >110 kg 2 cap in the morning, 2 cap at midday, 3 cap in the evening. Subsequently after 3 mth: 7 cap once daily in the evening, 94-109 kg 2 cap in the morning, 2 cap at midday, 2 cap in the evening. Subsequently after 3 mth: 6 cap once daily in the evening, 79-93 kg 1 cap in the morning, 2 cap at midday, 2 cap in the evening. Subsequently after 3 mth: 5 cap once daily in the evening, 63-78 kg 1 cap in the morning, 1 cap at midday, 2 cap in the evening. Subsequently after 3 mth: 4 cap once daily in the evening, 47-62 kg 1 cap in the morning, 1 cap at midday, 1 cap in the evening. Subsequently after 3 mth: 3 cap once daily in the evening. Treatment of liver disease associated w/ cystic fibrosis Childn 6-18 yr 20 mg/kg/day in 2-3 divided doses. May further increase the dose to 30 mg/kg daily if necessary.
Administration
Should be taken with food: Swallow whole, do not chew.
Contraindications
Hypersensitivity to bile acids. Acute cholecystitis & cholangitis; biliary tract obstruction; biliary colic; calcified gallstones; functional gallbladder disorder. Childn w/ biliary atresia & cholestasis even after surgery.
Special Precautions
Regularly test the liver function every 4 wk for the 1st 3 mth of treatment, then monitor at 3 mth interval. Discontinue treatment or reduce dose in case of diarrhoea. Women of childbearing potential should be treated only if they use reliable contraception. Must exclude possibility of pregnancy before treatment initiation. Not to be used during pregnancy unless clearly necessary. When used to dissolve gallstones: Scan gallbladder after 6-10 mth of treatment. Be advised when patient is taking any medicines that contain oestrogenic hormones. When used in the treatment of PBC: Rarely, symptoms may worsen at treatment initiation.
Adverse Reactions
Drug Interactions
Reduced effects w/ cholestyramine, colestipol, Al hydroxide- or smectite-containing antacids. May reduce effects of ciprofloxacin, dapsone, nitrendipine & other medicines that are metabolized in a similar way. May change effects of ciclosporin, or rosuvastatin.
MIMS Class
Cholagogues, Cholelitholytics & Hepatic Protectors
ATC Classification
A05AA02 - ursodeoxycholic acid ; Belongs to the class of bile acids. Used in bile therapy.
Presentation/Packing
Form
Ursobil cap 250 mg
Packing/Price
100's
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