Cholemax

Cap: Dissolution of radiolucent cholesterol gallstones <20 mm in diameter. Prevention of gallstone formation in obese patients undergoing rapid wt loss. Oral susp: Primary biliary cholangitis (PBC). Dissolution of radiolucent gallstones in patients w/ functioning gallbladder. Hepatobiliary disorders associated w/ cystic fibrosis in childn 1 mth to 18 yr.

Cap Gallstone dissolution 8-10 mg/kg daily in 2 or 3 divided doses. Prevention of gallstone 300 mg bid. Oral susp PBC Administer in 3 divided doses for the 1st 3 mth. Subsequently, administer once daily in the evening when liver function parameters improve. Patient weighing 81-115 kg, 40-47 kg, 24-27 kg & 16-19 kg 13-16 mg/kg daily, 48-80 kg, 32-39 kg & 8-15 kg 12-16 mg/kg daily, 28-31 kg 14-16 mg/kg daily, 20-23 kg 13-15 mg/kg daily. Dissolution of cholesterol gallstones Approx 10 mg/kg daily in the evening. Patient weighing >100 kg 25 mL, 81-100 kg 20 mL, 66-80 kg 15 mL, 51-65 kg 12.50 mL. Continue treatment until 2 successive cholecystograms &/or ultrasound investigation 4-12 wk apart have failed to demonstrate gallstones. Hepatobiliary disorders associated w/ cystic fibrosis Childn 1 mth to 18 yr 20 mg/kg daily in 2-3 divided doses, further increase to 30 mg/kg daily if necessary. Childn weighing >10 kg 20-25 mg/kg daily, ≤10 kg 20 mg/kg daily.

Cap: Should be taken with food.; Oral susp: May be taken with or without food.

Hypersensitivity to ursodeoxycholic acid or bile acid. Cap: Calcified cholesterol stones, radiopaque stones or radiolucent bile pigment stones. Patients w/ compelling reasons for cholecystectomy including unremitting acute cholecystitis, cholangitis, biliary obstruction, gallstone pancreatitis or biliary-GI fistula. Oral susp: Acute inflammation of gallbladder or biliary tract. Occlusion of common bile or cystic duct. Frequent episodes of biliary colic. Radio-opaque calcified gallstones. Impaired contractility of gallbladder. Unsuccessful portoenterostomy or w/o recovery of good bile flow w/ biliary atresia when used in hepatobiliary disorders associated w/ cystic fibrosis in childn 1 mth to 18 yr.

Cap: Measure AST & ALT at initiation of & during therapy. Perform ultrasound of gallbladder at 6-mth interval for 1st yr of therapy. Pregnancy & lactation. Oral susp: Discontinue therapy in case of persistent diarrhoea. Not to be used if gallbladder cannot be visualised on X-ray images, or in cases of calcified gallstones, impaired contractility of gallbladder or frequent episodes of biliary colic. Decompensation of hepatic cirrhosis when used for treatment of advanced stage of PBC. Monitor AST (SGOT), ALT (SGPT) & γ-glutamyl transferase every 4 wk during 1st 3 mth of treatment, & every 3 mth thereafter; early detection of potential hepatic deterioration, particularly in patients w/ advance stage PBC. Visualize gall bladder through oral cholecystography 6-10 mth after beginning of treatment to assess therapeutic progress & timely detection of any calcification of gallstones. Women of childbearing potential & female patients should use reliable contraception (non-hormonal or low-oestrogen OC measures). Not to be used during pregnancy. Elderly.

Diarrhea or pasty stools. Cap: Abdominal & back pain, viral infection, headache, dyspepsia, URTI, nausea, sinusitis, constipation, vomiting, pharyngitis, arthralgia, flatulence, cough, bronchitis, UTI, arthritis, myalgia, allergy, cholecystitis, rhinitis, fatigue. Dizziness, flu-like symptoms, musculoskeletal pain, dysmenorrhea, alopecia, sinusitis.

Decreased absorption w/ Al-containing antacids, bile acid sequestrants. Reduced efficacy due to increased hepatic cholesterol secretion w/ clofibrate, estrogen, hormonal contraceptives. Oral susp: Not to be administered w/ colestyramine, colestipol or antacids containing Al hydroxide &/or smectite (Al oxide). Affected absorption of ciclosporin. Reduced absorption of ciprofloxacin. Reduced C_max & AUC of nitrendipine. Slightly elevated plasma levels of rosuvastatin. Reduced therapeutic effect of dapsone.

Cholagogues, Cholelitholytics & Hepatic Protectors

A05AA02 - ursodeoxycholic acid ; Belongs to the class of bile acids. Used in bile therapy.

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