Urso

DRUG DESCRIPTION

URSO 250 (urso (ursodiol) diol, 250 mg) is available as a film-coated tablet for oral administration. URSO Forte (urso (ursodiol) diol, 500 mg) is available as a scored film-coated tablet for oral administration. Urso (ursodiol) diol (urso (ursodiol) deoxycholic acid, UDCA) is a naturally occurring bile acid found in small quantities in normal human bile and in larger quantities in the biles of certain species of bears. It is a bitter-tasting white powder consisting of crystalline particles freely soluble in ethanol and glacial acetic acid, slightly soluble in chloroform, sparingly soluble in ether, and practically insoluble in water. The chemical name of urso (ursodiol) diol is 3?,7?-dihydroxy-5?-cholan-24-oic (C24 H40 O4). Urso (ursodiol) diol has a molecular weight of 392.56. Its structure is shown below.

URSO (ursodiol) Structural Formula Illustration

Inactive ingredients: microcrystalline cellulose, povidone, sodium starch glycolate, magnesium stearate, ethylcellulose, dibutyl sebacate, carnauba wax, hydroxypropyl methylcellulose, PEG 3350, PEG 8000, cetyl alcohol, sodium lauryl sulfate and hydrogen peroxide.

What are the possible side effects of ursodiol (Actigall, Urso, Urso Forte)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Other less serious side effects are more likely to occur, such as:

  • fever, chills, body aches, flu symptoms;
  • stomach pain, nausea, diarrhea, constipation;
  • dizziness, tired feeling;
  • back pain;
  • runny or stuffy nose, cold symptoms; or
  • headache.

Side effects other than those listed...

Read All Potential Side Effects and See Pictures of Urso

What are the precautions when taking ursodiol (Urso)?

Before taking ursodiol, tell your doctor or pharmacist if you are allergic to it; or to other bile acids; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain gallbladder/bile duct problems (e.g., acute cholecystitis, cholangitis, biliary obstruction, gallstone pancreatitis, biliary-gastrointestinal fistula).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease (e.g., ascites, variceal bleeding, hepatic encephalopathy).

This drug...

Read All Potential Precautions of Urso


Urso Consumer (continued)

SIDE EFFECTS: Stomach upset, nausea, diarrhea, dizziness, back pain, hair loss, or cough may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: weakness, swelling of the ankles/feet, increased thirst/urination, signs of infection (e.g., fever, persistent sore throat), easy bleeding/bruising.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking ursodiol, tell your doctor or pharmacist if you are allergic to it; or to other bile acids; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain gallbladder/bile duct problems (e.g., acute cholecystitis, cholangitis, biliary obstruction, gallstone pancreatitis, biliary-gastrointestinal fistula).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease (e.g., ascites, variceal bleeding, hepatic encephalopathy).

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.


Urso Patient Information Including Side Effects

Brand Names: Actigall, Urso, Urso Forte

Generic Name: ursodiol (Pronunciation: ur so DY all)

  • What is ursodiol (Urso)?
  • What are the possible side effects of ursodiol (Urso)?
  • What is the most important information I should know about ursodiol (Urso)?
  • What should I discuss with my healthcare provider before taking ursodiol (Urso)?
  • How should I take ursodiol (Urso)?
  • What happens if I miss a dose (Urso)?
  • What happens if I overdose (Urso)?
  • What should I avoid while taking ursodiol (Urso)?
  • What other drugs will affect ursodiol (Urso)?
  • Where can I get more information?

What is ursodiol (Urso)?

Ursodiol is a bile acid that decreases the amount of cholesterol produced by the liver and absorbed by the intestines. Ursodiol helps break down cholesterol that has formed into stones in the gallbladder. Ursodiol also increases bile flow in patients with primary biliary cirrhosis.

Ursodiol is used to treat small gallstones in people who cannot have gallbladder surgery, and to prevent gallstones in overweight patients undergoing rapid weight loss. Ursodiol is also used to treat primary biliary cirrhosis.

Ursodiol is not for treating gallstones that are calcified.

Ursodiol may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of ursodiol (Urso)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Other less serious side effects are more likely to occur, such as:

  • fever, chills, body aches, flu symptoms;
  • stomach pain, nausea, diarrhea, constipation;
  • dizziness, tired feeling;
  • back pain;
  • runny or stuffy nose, cold symptoms; or
  • headache.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

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

Before taking ursodiol, tell your doctor if you are also taking cholestyramine (Questran), colestipol (Colestid), or estrogens (birth control pills or hormone replacement).

Avoid using antacids without your doctor's advice. Use only the specific type of antacid your doctor recommends. Antacids contain different medicines and some types can make it harder for your body to absorb ursodiol.

To treat gallstones, you may have to take ursodiol for several months, and not all gallstones may completely dissolve. Many people who use this medicine will develop gallstones again within 5 years after treatment with ursodiol. Talk to your doctor about your specific risks for repeated gallstones.

To be sure this medication is helping your condition, your doctor may perform ultrasound examinations of your gallbladder on a regular basis. Your liver function may also need to be tested. Do not miss any scheduled visits to your doctor.

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