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Urlyx/Urlyx 500

Urlyx/Urlyx 500

ursodeoxycholic acid

Manufacturer:

Globela Pharma
/
Lloyd

Distributor:

InnoGen Pharmaceuticals
Concise Prescribing Info
Contents
Ursodeoxycholic acid
Indications/Uses
Urlyx Dissolution of cholesterol-rich gallstones in patients w/ functioning gallbladders. Urlyx 500 Management of cholestatic liver diseases eg, primary biliary cirrhosis (PBC).
Dosage/Direction for Use
Urlyx Initially 1 cap every 8 hr. Urlyx 500 Adult PBC 13-15 mg/kg daily in 2-4 divided doses.
Administration
Should be taken with food. Urlyx 500: Tab can be broken in halves to provide recommended dose.
Contraindications
Urlyx Complete atresia of bile duct, radiopaque calcified gallstones, non-functional gallbladder, acute cholecystitis. Urlyx 500 Hypersensitivity. Patients w/ complete biliary obstruction of extrahepatic origin; widespread intrahepatic obstruction.
Special Precautions
Use only if clearly necessary during pregnancy. Caution when administered to lactating mother. Urlyx Not to be given to patients w/ intestinal & hepatic disorder that interferes w/ enterohepatic circulation of bile salts. Ineffective for the dissolution of calcified & pigmented gallstones & is of no value in patients w/o patent & functioning gallbladder. Not to be used w/ drugs that increase bile cholesterol eg, estrogenic hormones & cholesterol-lowering drug (eg, clofibrate). Avoid concomitant use w/ bile acid binding drugs including antacids, charcoal & cholestyramine. Urlyx 500 Not indicated for decompensated cirrhosis. Exercise caution to maintain bile flow of patients; when administered in a setting of partial biliary obstruction of extra-hepatic origin. Monitor serum LFTs (γ-GT, alkaline phosphatase, AST, ALT) & bilirubin level every mth for 3 mth after start of therapy & every 6 mth thereafter. Consider discontinuation when serum LFTs increase to level considered clinically significant. Not to be administered concomitantly w/ colestyramine, colestipol or antacids containing Al hydroxide &/or smectite (Al oxide). Women of childbearing potential should use reliable contraception (eg, non-hormonal or low-oestrogen oral contraceptives). Safety & effectiveness in childn have not been established.
Adverse Reactions
Pasty stools or diarrhea. Urlyx Nausea, vomiting, & other GI disturbances; pruritus; more calcification of cholesterol stones.
Drug Interactions
Urlyx Effectiveness of therapy may be reduced w/ bile-acid binding drugs including antacids, charcoal & cholestyramine. Urlyx 500 Inhibited absorption & efficacy w/ colestyramine, colestipol or antacids containing Al hydroxide &/or smectite (Al oxide). Can affect absorption of ciclosporin from the intestine. May possibly affect absorption of other lipophilic substances. Rare cases of reduced absorption of ciprofloxacin. Reduced plasma peak conc (Cmax) of nitrendipine. Reduced therapeutic effect of dapsone. Increased hepatic cholesterol secretion & may encourage biliary lithiasis w/ oestrogenic hormones & blood cholesterol lowering agents (eg, clofibrate).
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
Urlyx cap 250 mg
Packing/Price
100's
Form
Urlyx 500 FC tab 500 mg
Packing/Price
100's
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