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Ursotwin ® Capsules

MINAPHARM is continuing its success in Hepatology Field by introducing Ursotwin® (Ursodeoxycholic acid 500 mg) which ensures Compliance & Flexibility in Advanced Liver Disease.

Ingredient: Ursodeoxycholic acid 500mg
Multinational Partner: MINAPHARM
Launch Date: January 1, 2009
Pack: Ursotwin® is available in a box of two strips, each strip contains ten capsules.

Product General

Disease Area

Ursotwin is of great benefit regarding the Dose Flexibility and high Patient Comlpiance specifically in Advanced Liver Diseases mainly:

(1) Primary sclerosing cholangitis: Inflammation and fibrosis of intra &/or extra-hepatic bile duct system, with doses up to 30mg/kg/day.

(2) Primary Biliary Cirrhosis: Cholestatic disorder due to destruction of small and intermediate sized intrahepatic bile ducts.

(3) Intrahepatic Cholestasis in Pregnancy: Cholestasis of pregnancy associated with high fetal risk.It was difficult or nearly impossible to treat it in the past. It results in bile acids crossing the placenta.

(4) Non Alcoholic Steato-Hepatitis (NASH): To denote chronic liver disease associated with steatosis and inflammatory response with an increase in liver enzymatic activity, in absence of considerable alcohol consumption, viral or autoimmune hepatitis.

 

 

Insert leaflet

COMBINATION:

Each hard gelatin capsule contains:

  • Ursodeoxycholic acid 500mg.
  • Excipients: corn starch, aerosil (silicon dioxide), magnesiumstearate.
  • Capsule shell: gelatin, titanium dioxide, erythrosine ‐ FD & C red3, indigo carmine ‐ FD & C blue 2.

INDICATIONS:

  • For the dissolution of radiolucent cholesterol gallstones notlarger than 15 mm in diameter in patients with a sill functioning gall bladder despite the gall stone(s).
  • For the treatment of bile reflux gastritis.
  • For the symptomatic treatment of cholestatic liver diseases e.g.Primary Biliary Cirrhosis (PBC), Non‐Alcoholic SteatoHepatitis(NASH) & Chronic Hepatitis.The use of Ursotwin® capsules in primary biliary cirrhosis may becontinued indefinitely.In patients with primary biliary cirrhosis, in rare cases the clinicalsymptoms may worsen at the beginning of treatment, e.g.pruritis may increase. Should this occur, therapy should becontinued with a dose of one Ursotwin® capsule daily, and thedosage then gradually increased (by 1 capsule daily each week)until the dose indicated in the respective dosage regimen isreached.
  • For the symptomatic treatment of toxic metabolic liver diseases.

 

DOSAGE AND ADMINISTRATION:

The following daily dose is recommended for various indications:

  • For dissolution of cholesterol gall stones:
    • Approx. 10 mg/kg body weight daily, equivalent to:
Up to 50 kg 1 capsule
Up to 100 kg 2 capsules
Over 100 kg 3 capsules
    • The capsules should be swallowed as whole with some liquid in theevening at bedtime.
    • The capsules must be taken regularly.
    • The time required for dissolution of gallstones is generally 6‐24months. If there is no reduction in the size of the gall stones a􀅌er 12months, the therapy should not be continued.
    • The success of treatment should be checked by ultrasoundinvestigation or cholecystograms every 6 months. At the follow‐upexaminations, a check should be made to see whether calcification ofthe stones has occurred in the meantime. Should this be the case, sotreatment must be ended.
  • For the treatment of bile reflux gastritis:
    • One capsule daily swallowed whole with some liquid in the evening atbedtime.
    • Ursotwin® capsules should generally be taken for 10‐14 days. Theduration of use depends on the course of the condition. The duration ofuse is decided on an individual basis by the doctor responsible fortreatment.
  • For the symptomatic treatment of cholestatic liver diseases e.g.Primary Biliary Cirrhosis (PBC), Non‐Alcoholic SteatoHepatitis (NASH)& Chronic Hepatitis:
    • The daily dose depends on body weight and is approx. 2 to 6 capsules(approx. 10‐15 mg/kg body weight).
    • The following regimen is recommended:
Bodyweight Daily dose Morning Evening
34 to 50 kg 1 capsule - 1
51 to 70 kg 2 capsules - 2
71 to 100 kg 3 capsules 1 2
Over 100 kg 4 capsules 2 2

 

 

Publications

1-Documents Section

1 Single Dose vs Multiple Dose in Cholestatic Liver Disease (J Hepatol 1996)


2 Tolerability of High Doses UDCA 20 & 30 mg per kg daily in PSC (J Hepatol 2008)


3 500 mg UDCA once Daily & Gall Stone Prophylaxis (Ann Surg 2003)


4 500 mg UDCA b.i.d. IBD Colorectal Cancer (Anticancer Res 2004)


5 500 mg UDCA once daily + Colchicine in PBC (Aliment Pharmacol Ther 2000)


6 UDCA 15 mg per kg daily in IHCP (Liver Int 2005)


7 UDCA Comparative Bioavailability 250, 500 & 750 mg (Aliment Pharmacol Ther 2000)

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