About Gastroenterology

Glossary

URSO Forte® Scored Tablets

 What is URSO Forte® Scored?

You may have heard the term "URSO" before. URSO is short for "ursodiol," which is a naturally occurring bile acid. URSO Forte® Scored (pronounced er-so for-tay) is an ursodiol tablet that is used to treat Primary Biliary Cirrhosis (PBC), a cholestatic liver disease. Now available as a scored tablet, URSO Forte® Scored can be broken into halves, which allows for dosing flexibility, reduced pill burden and cost savings.

 How may URSO Forte® Scored 500mg Tablets make my treatment easier?

Dosing Flexibility – New scored URSO Forte® Scored Tablets allow you to easily create the exact dose your doctor has prescribed by either splitting a tablet in half or by combining a whole tablet with a half tablet. Your physician now has the ability to increase or decrease your dose depending on your response to therapy.

Reduced Pill Burden – Because URSO Forte® is scored (meaning it’s easily split in half) you may be able to take fewer tablets to achieve the same dose of medication. For example, a patient prescribed 750mg of ursodiol would need to take one and half tablets of URSO Forte® Scored (500mg + 250mg =750mg). That same patient would need to take 3 tablets of URSO 250® to fulfill the same dose (250mg + 250mg + 250mg = 750mg).

Cost Savings – URSO Forte® Scored costs less (mg per mg) than URSO 250®1. Only one prescription is needed to fulfill any dosing requirement.

Confidence – URSO Forte® Scored Tablets offer the same efficacy and safety you have trusted for years.

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Make Dosing a Snap!

 How should I split my URSO Forte® Scored 500mg Tablets?

URSO Forte® Scored tablets can be broken with your hands or by using a tablet cutter.

To break URSO Forte® Scored tablets with your hands:

  1. Place the tablet on a flat surface with the scored section on top.
  2. Hold the tablet with your thumbs placed close to the scored part of the tablet (groove).
  3. Apply gentle pressure and snap the tablet segments apart (segments breaking incorrectly should not be used).

The segments should be swallowed unchewed, with water. Holding the segments in the mouth or chewing them may reveal a bitter taste. Due to the bitter taste, broken halves should be stored separately.


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To break URSO Forte® Scored with a tablet cutter:

  1. Place the tablet scored side up into the slot beneath the blade. Make sure the groove is lined up with the blade.
  2. Push the blade down onto the pill.
  3. Press firmly to make sure it cuts through the tablet fully.
  4. Always store broken halves separate from full tablets.

Talk to you doctor about obtaining a free URSO Forte® Scored tablet cutter.

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Primary Biliary Cirrhosis (PBC), a Cholestatic Liver Disease

 What is cholestatic liver disease?

Cholestatic liver disease is characterized by a reduction or stoppage of bile flow in the liver.2 Bile is a fluid produced by the liver that aids in the digestion and absorption of fats and the removal of certain waste products from the body.3 When bile does not flow properly it can build up and become toxic to the liver.2 Primary Biliary Cirrhosis (PBC) is an autoimmune type of cholestatic liver disease in which the ducts in the liver that drain bile (bile ducts) are slowly destroyed.2 Cholestatic liver disease is often characterized by:

Immunologic or toxic injury of bile ducts4,5

Retention of bile acid in liver cells

Impaired bile secretion or obstruction of bile flow

Aggrevation of bile duct injury

Liver cell damage

Fibrosis and/or cirrhosis

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 How does URSO Forte® Scored help treat Primary Biliary Cirrhosis (PBC), a cholestatic liver disease? URSO Forte® Scored may help treat PBC, a cholestatic liver disease, in part by changing the makeup of the bile acid pool so that the circulating bile salts are less toxic. This decreases the harmful bile acids associated with PBC related liver damage, thereby slowing the progression of the disease. URSO Forte® Scored tablets may help reduce liver cell death.5

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 Advantages of Ursodiol Tablets

More of the product is absorbed by the body.

An important clinical study has shown that more of the active ingredient in ursodiol tablets is absorbed by the body when compared to ursodiol capsules. This means that more of the active ingredient is available for the liver to use to help slow progression of PBC, a cholestatic liver disease.6

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 Studies have shown that ursodiol tablets:

May help PBC patients live longer without the need for a liver transplant7

Slow down the progression of the disease8

Reduce the frequency of esophageal varices (veins in the esophagus that enlarge and may bleed)9,10

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Treatment Tips and Information

 Take URSO Forte® Scored as prescribed.

Be sure to follow your doctor’s instructions about taking URSO Forte® Scored. Dosing is based on each patient’s needs. Keep using it according to your doctor’s instructions even if you feel better.

Continue to take URSO Forte® Scored as long as your doctor prescribes it for you. If you feel like you want to stop taking any of your medications, be sure to talk to your doctor about it. Your doctor may be able to adjust your therapy so it works better for you.

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 What are the most common side effects?

URSO Forte® Scored is generally well tolerated with few side effects. In scientific studies, the most common side effects of URSO Forte® Scored were a general feeling of weakness, high blood pressure, chest pain, severe itching, swelling in the ankles, feet, and/or legs, nausea or upset stomach, and other disorders of the stomach and small intestine. Less frequent events (< 5%) included diabetes, cyst and breast neoplasms, stomach pain, anorexia, inflammation of the esophagus, high creatinine levels, high blood glucose levels, low levels of certain white blood cells, peptic ulcer, and skin rash.8 Please contact your doctor if you experience any of these side effects.

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 Who should not take URSO Forte® Scored?

As a precaution, people who have had an allergic-type reaction to ursodiol, or to any of its ingredients, should not take URSO Forte® Scored. Also, people with complications of advanced liver disease such as variceal bleeding, hepatic encephalopathy, ascites, and those who are in need of an urgent liver transplant should receive appropriate treatment before starting on URSO Forte® Scored. Do not take this medication without first consulting your doctor if you are pregnant or breast feeding.8

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 Are there any medications that I should avoid when taking URSO Forte® Scored?

Though they may not harm you, there are certain medications that may reduce the efficacy of URSO Forte® Scored.8

Before taking URSO Forte® Scored, inform your doctor if you are taking any of the following drugs:

If you take antacids with aluminum in them or bile acid-sequestering agents (Questran), be sure to take them 2 to 3 hours before taking URSO Forte® Scored.8

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 How can I find out more?

There are many sources of information for people living with cholestatic liver disease. Your healthcare provider can recommend some helpful resources. In addition, these national organizations may benefit you:

Be sure to ask your doctor if you have further questions about URSO Forte® Scored.

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References: 1. Axcan Pharma™ WAC Price List, August 2007. 2. Clinical manifestations in liver disease. In: Berkow R, Beers MH and Fletcher AJ,et al, eds. The Merck Manual of Medical Information. Home ed. West Point, PA: Merck & Co., Inc.; 1997: 614-620. 3. .Biology of the digestive system. In: Berkow R, Beers MH and Fletcher AJ,et al, eds. The Merck Manual of Medical Information. Home ed. West Point, PA: Merck & Co., Inc.; 1997: 524-528. 4. Paumgartner G, Beuers U. Mechanisms of action and therapeutic efficacy of ursodeoxycholic acid in cholestatic liver disease. Clin Liver Dis 2004;8:67-81. 5. Angulo P. Use of ursodeoxycholic acid in patients with liver disease. Curr Gastroenterol Rep 2002;4:37-44. 6. Williams CN , Al-Knawy B, Blanchard W. Bioavailability of four ursodeoxycholic acid preparations. Aliment Pharmacol Ther 2000;14:1133-9. 7. Parés et al. Excellent long-term survival in patients with primary biliary cirrhosis and biochemical response to ursodeoxycholic acid. Gastroenterology 2006;130:715-720. 8. URSO Forte™ [package insert]. Birmingham, AL: Axcan Pharma US, Inc. 2004. 9. Lindor KD et al. Ursodeoxycholic acid delays the onset of esophageal varices in primary biliary cirrhosis. Mayo Clin Proc 1997;72:137-40. 10. Jorgensen R, Angulo P, Dickson ER, Lindor KD . Results of long-term ursodiol treatment for patients with primary biliary cirrhosis. Am J Gastroenterol 2002;97:2647-2650.