Ursodeoxycholic acid also known as ursodiol, originally used to help dissolve gallstones in patients who do not want or can not have gallbladder surgery. It is also used to prevent gallstones from forming in overweight patients. Later, it was learned ursodiol could help slow the progression of primary biliary cholangitis (PBC) patients. Ursodiol and new medication Ocaliva are the only treatment to help slow the progression of PBC.
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 Cholangitis, as it has the FDA approved PBC indication and extensive research testing was done on the product. URSO 250 & “New” URSO Forte are made by 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 Cholangitis (“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.
There are generic available for both Urso 250/forte and Actigall.
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.
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 and 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 the patient’s 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. 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.
Dosage chart for Urso 250, Actigall and Generic. Correct treatment dosage for PBC is based on patient’s weight. Urso 250 by Axcan Pharma is the only ursodiol treatment with FDA approval specifically for PBC 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
|Body Weight lbs||Body Weight kg||Daily Patient Dose||URSO 250 Low Dose||URSO 250 High Dose||Actigall Low Dose||Actigall High Dose|
|13 mg/kd/d||15 mg/kd/d||# Tablets||# Tablets||# Caps||# Caps|