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Urdafalk Forte

Urdafalk Forte

ursodeoxycholic acid

Manufacturer:

Dr Falk

Marketer:

Darya-Varia
Full Prescribing Info
Contents
Ursodeoxycholic acid.
Description
Each film-coated tablet contains: Ursodeoxycholic acid 500 mg.
Indications/Uses
For the dissolution of cholesterol gallstones in the gall bladder. The gallstones must not show as shadows on X-ray images and should not exceed 10 mm in diameter. Gall bladder function must not be significantly impaired, despite the gallstones.
For the treatment of primary biliary cirrhosis (PBC) in patients without decompensated hepatic cirrhosis.
Dosage/Direction for Use
For dissolution of cholesterol gallstones: Approx. 10 mg of UDCA per kg of body weight.
For the treatment of PBC: The daily dose depends on body weight and ranges from 1½ to 3½ filmcoated tablets (14 ± 2 mg of UDCA per kg of body weight).
Contraindications
Acute inflammation of the gall bladder or biliary tract.
Occlusion of the biliary tract (occlusion of the common bile duct or a cystic duct).
Frequent episodes of biliary colic.
Radio-opaque calcified gallstones.
Impaired contractility of the gall bladder.
Hypersensitivity to bile acids or any of the excipients.
Calcified cholesterol stones, radiopaque stones or radiolucent bile pigment stones.
Unremitting acute cholecystitis, cholangitis, biliary obstruction, pancreatitis or biliary gastrointestinal fistula.
Pregnancy.
Inflammatory disease and other conditions of the small intestine.
Colon and liver which interfere with entero hepatic circulation of bile salt.
Special Precautions
URDAFALK FORTE film-coated tablets should be taken under medical supervision.
The safety and efficacy of URDAFALK FORTE in pediatric aged less than 18 years have not been established.
Adverse Reactions
The most commonly reported adverse reactions and post-marketing experience are gout flares, liver function abnormalities, diarrhoea, nausea, headache, arthralgia, rash and oedema.
Drug Interactions
URDAFALK FORTE film-coated tablets should not be administered concomitantly with colestyramine, colestipol or antacids containing aluminium hydroxide and/or smectite (aluminium oxide).
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
Urdafalk Forte FC tab 500 mg
Packing/Price
5 × 10's (Rp880,000/boks)
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