Urso 250

Ursodiol is a naturally-occurring bile acid that is made by the liver in humans and is secreted in small quantities into bile. It is used to dissolve and prevent cholesterol gallstones and to treat primary biliary cirrhosis, a disease of the liver. Ursodiol blocks the enzyme in the liver that produces cholesterol and thereby decreases production of cholesterol by the liver and the amount of cholesterol in bile. It also reduces the absorption of cholesterol from the intestine. By decreasing the concentration of cholesterol in bile, ursodiol prevents the formation and promotes the dissolution of cholesterol-containing gallstones. The mechanism by which it acts in primary biliary cirrhosis is not clear. The FDA approved ursodiol in December 1987.

Before taking ursodiol,

• tell your doctor and pharmacist if you are allergic to ursodiol, bile acids, or any other drugs.
• tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially antacids that contain aluminum (Amphojel, Gaviscon, Maalox, Mylanta, others), cholestyramine (LoCHOLEST, Prevalite, Questran), clofibrate (Atromid-S), colestipol (Colestid), medications that lower lipid or cholesterol levels, medications that contain estrogen (including birth control pills), and vitamins and herbal products.
• tell your doctor if you have or have ever had disease of the liver, gallbladder, pancreas, or bile duct.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking ursodiol, call your doctor.

Take Urso 250 exactly as prescribed.

Urso 250 comes in oral tablet form and is taken 2 to 4 times a day.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Urso 250 at the same time.

If you take too much Urso 250, call your healthcare provider or local Poison Control Center or seek emergency medical attention right away.

If Urso 250 is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose if suspected, seek emergency medical attention.

• Store Urso 250 at room temperature.
• Keep this and all medications out of the reach of children.

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

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.

It is important that your doctor check your progress at regular visits. Blood tests will have to be done every few months while you are taking this medicine to make sure that the gallstones are dissolving and your liver is working properly.

Check with your doctor immediately if severe abdominal or stomach pain, especially toward the upper right side, or severe nausea and vomiting occur. These symptoms may mean that you have other medical problems or that your gallstone condition needs your doctor's attention.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Urso 250 while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Dizziness.
• Back pain.
• Loose stools (diarrhea).
• Hard stools (constipation).
• Upset stomach or throwing up.
• Belly pain or heartburn.
• Muscle or joint pain.
• Signs of a common cold.
• Hair loss.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

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.