Actigall

Name: Actigall

What Is Ursodiol (Actigall and Urso)?

Ursodiol is a prescription drug that's used to treat and prevent gallstones (hardened deposits of digestive fluid that can form in the gallbladder).

It's sold under the brand names Actigall and Urso.

This medicine is also used to treat primary biliary cirrhosis (an autoimmune disorder that affects the liver) and chronic liver disease.

In addition, it's sometimes used to help prevent organ rejection following a liver transplant.

Ursodiol is a bile acid that's naturally found in the body. It works by reducing the production of cholesterol and dissolving it in bile, so that it can't form stones.

The Food and Drug Administration (FDA) approved ursodiol in 1987. It's manufactured by different pharmaceutical companies.

Ursodiol Warnings

Before taking Ursodiol, tell your doctor if you have, or have ever had:

  • Any disease of the liver, gallbladder, pancreas, or bile duct
  • A bile duct blockage
  • Allergies to medications

Ursodiol must be taken for several months to have an effect. You may need to take the medicine for up to two years.

Continue to take ursodiol even if you feel well. Don't stop using the medicine without first talking to your doctor.

Your doctor will probably want to order frequent tests to check your body's response to ursodiol. Keep all appointments with your doctor's office and laboratory.

This drug should be used with extreme caution in children. Safety and effectiveness haven't been confirmed in this age group.

Pregnancy and Ursodiol

Ursodiol isn't believed to harm a fetus. Still, talk to your doctor if you're pregnant or plan to become pregnant during your treatment.

It's not known whether ursodiol passes into breast milk or could hurt a nursing baby. Talk to your doctor before breastfeeding while taking this medicine.

Uses

Ursodiol is used to dissolve certain types of gallstones, to prevent gallstones from forming in obese patients who are losing weight rapidly, and to treat a certain type of liver disease (primary biliary cirrhosis). Ursodiol is a bile acid.

What is the most important information I should know about Actigall (ursodiol)?

You should not use ursodiol if you have an obstruction in your liver or gallbladder.

Before Using Actigall

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of ursodiol in the pediatric population. Safety and efficacy have not been established.

Geriatric

No information is available on the relationship of age to the effects of ursodiol in geriatric patients.

Pregnancy

Pregnancy Category Explanation
All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Ascites (accumulation of fluid in the abdominal or stomach cavity) or
  • Bleeding varices (veins that enlarge and bleed) or
  • Hepatic encephalopathy (brain disease due to liver failure) or
  • Liver damage (from not having a certain chemical in your liver to break down a substance called lithocholate) or
  • Liver transplant—Use with caution. May make these conditions worse.
  • Biliary tract blockage—Should not be used in patients with this condition.
  • Biliary tract problems or
  • Pancreatitis (swelling or inflammation of the pancreas)—These conditions may make it necessary to have surgery since treatment with ursodiol would take too long.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Alternative therapies

Watchful Waiting

Watchful waiting has the advantage that no therapy may ever be required. For patients with silent or minimally symptomatic stones, the rate of development of moderate-to-severe symptoms or gallstone complications is estimated to be between 2% and 6% per year, leading to a cumulative rate of 7 to 27% in 5 years. Presumably the rate is higher for patients already having symptoms.

Cholecystectomy

For patients with symptomatic gallstones, surgery offers the advantage of immediate and permanent stone removal, but carries a high risk in some patients. About 5% of cholecystectomized patients have residual symptoms or retained common duct stones. The spectrum of surgical risk varies as a function of age and the presence of disease other than cholelithiasis.

Mortality Rates for Cholecystectomy in the U.S. (National Halothane Study, JAMA 1966; 197:775-8) 27,600 Cholecystectomies (Smoothed Rates) Deaths/1000 Operations***
Age (Yrs)
   
   
Cholecystectomy
   
   
Cholecystectomy
+ Common Duct Exploration
Low Risk Patients*
        Women 0 - 49 .54 2.13
  50 - 69 2.80 10.10
       
        Men 0 - 49 1.04 4.12
  50 - 69 5.41 19.23
       
High Risk Patients**      
        Women 0 - 49 12.66 47.62
  50 - 69 17.24 58.82
       
        Men 0 - 49 24.39 90.91
  50 - 69 33.33 111.11
* In good health or with moderate systemic disease.
** With severe or extreme systemic disease.
*** Includes both elective and emergency surgery.

Women in good health or who have only moderate systemic disease and are under 49 years of age have the lowest surgical mortality rate (0.054); men in all categories have a surgical mortality rate twice that of women. Common duct exploration quadruples the rates in all categories. The rates rise with each decade of life and increase tenfold or more in all categories with severe or extreme systemic disease.

Actigall Food Interactions

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain food. In the case of Actigall, there are no specific foods that you must exclude from your diet when receiving this medication.

Inform MD

Before taking Actigall, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

  • are allergic to Actigall or to any of its ingredients
  • have or have had diseases of the liver, gallbladder, pancreas, or bile duct
  • are pregnant or breastfeeding

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Actigall and Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X - are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Actigall falls into category B. There are no well-done studies that have been done in humans with Actigall. In animal studies, pregnant animals were given this medication and the babies did not show any medical issues related to this medication.

Warnings

Contraindications

Hypersensitivity

Gallstone complication requiring surgery

Known hepatocyte or bile ductal abnormalities, inflammatory bowel disease

Calcified gallstones, bile acid allergy, chronic hepatic disease

Billiary gastrointestinal fistula

Patients requiring cholecystectomy

Cautions

Only use in radiolucent, non calcified, high cholesterol content gallstone

Chronic liver disease

Liver function tests (gamma-GT, alkaline phosphatase, AST, ALT) and bilirubin levels should be monitored q3months x3 months after start of therapy, and q6months thereafter

Gallbladder stone dissolution may take several months

50% of cases have stone recurrence in 5 yr

In Summary

Common side effects of Actigall include: back pain. Other side effects include: arthralgia, alopecia, arthritis, and pharyngitis. See below for a comprehensive list of adverse effects.

Ursodiol Identification

Substance Name

Ursodiol

CAS Registry Number

128-13-2

Drug Class

Bile Acids and Salts

Cholagogues and Choleretics

Cholic Acids

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