Ursodiol Treatments

PBC research & FDA approval recommended dosing of ursodiol treatments is according to patient's weight.

Actigall, URSO 250, URSO Forte and Ursodiol are BRAND names......... Chemically all three are made from ursodiol/ursodeoxycholic acid, but they are not the same product. Each has a different FDA approved indication and fillers.

• URSO 250 mg and URSO Forte 500 mg tablets
  • Made by Anxcan Pharma, Inc. are the only ursodiol treatment product specifically for Primary Biliary Cirrhosis, as it has the FDA approved PBC indication and extensive research testing was done on the product.  URSO 250 & "New" URSO Forte made by Axcan Pharma does not have a generic.  "URSO Forte will help improve compliance, simplify dosing for many patients and may lower cost for this drug, which is the only approved product for patients with Primary Biliary Cirrhosis ("PBC")," said Keith Lindor, MD, Vice Chair, Medical Affairs for the American Liver Foundation ("ALF"), and Professor of Medicine at the Mayo Clinic. "URSO also improves survival while reducing the need for liver transplantation in these patients."
• Actigall (Ursodiol) 300 mg capsules
  • Made by Watson (previously Novartis) are indicated for patients with radiolucent, noncalcified gallbladder stones. Over the years it showed to help in slowing the progression of PBC and is prescribed by many doctors as PBC treatment.
• Ursodiol by Amide Pharm
  • Is the "generic" for Actigall.
• URSOfalk
  • Is used in most European countries and is produced by Dr. Falk Pharma in Germany.
• In Canada the name is URSO
  • It was originally called ursofalk. URSO in Canada is the same as URSO 250 here in the US. Both are produced by Axcan Pharma, Inc. URSO DS 500 mg tablets are available in Canada at this time, but have not been approved by FDA for distribution in the US yet.
• Delursan 250 mg capsule
  • Is marketed only in France.

Bioavailability of four ursodeoxycholic acid preparations by

• C. N. WILLIAMS
  • Division of Gastroenterology, Department of Medicine
• W. BLANCHARD
  • Department of Mathematics, Dalhousie University, Halifax, Nova Scotia Canada
• B. AL-KNAWY
  • Gastroenterology/Hepatology Division/Director, Endoscopy Unit, King Fahad Hospital, Riyadh, Kingdom of Saudi Arabia

Proper dosing for ursodiol treatments is confusing not only to the patients but some of the medical community. Some doctors prescribe ursodiol treatments according to the manufacturers recommended dosing instructions such as Actigall which is approved for gallstone treatment which has a dosing recommendation of 2-3 capsules per day. While this is the proper dosing for gallstones, it is most likely not the proper dose for PBC, depending on your weight. Also, some doctors do not feel it is necessary in early stage to take the full dosing recommendation. PBC Research (per Dr.Lindor, Dr. Kowdley, Axcan, etc) shows proper dosing should be based on the patient's weight to receive the full benefits of ursodiol treatments in PBC.

See URSO 250 and Actigall dosage chart.

Some doctors do not prescribed the full daily ursodiol treatment dosage upon diagnosis. They gradually increase the patient's dosage over months to avoid some of the side effects listed, especially those who already experience stomach problems.

HOW TO FIGURE THE NUMBER OF TABLETS/CAPSULES DAILY ACCORDING TO YOUR WEIGHT

13 mg multiplied by the KG divided by 250 or 300 mg equals the number of recommended dosing tablets daily according to your weight. Dose should be rounded up, not down.

First convert your pound weight into kilograms. Weight conversion table

Example dosage for person weighing 154 pounds

• Weight of 154 pounds equals 69.8532 Kilograms (70 kilograms rounded off)
• Multiplied 70 by 13 mg equals 910 mg (70 X 13 = 910)
• Divided by 250 mg for URSO 250 equals 3.64 tablets per day
• Divided by 300 mg for Actigall equals 3.03 capsules per day.
• Divided by 300 mg for generic equals 3.03 capsules per day.

IMPORTANT:  Whether you take Actigall, Generic, Ursodiol, URSO 250, URSO Forte or URSOfalk, talk to your doctor to make sure you are taking the correct dosage for full treatment benefits.  Never change your treatment plan without discussing with your doctor first.