Generic Name: Ursodiol Brand Name(s): Generics only. No brands available. Avability: Rx Pregnancy Category: B

Uses

What is Ursodiol used for?

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.

How should I take Ursodiol?

Take this medication exactly as directed by your doctor. Dosage is based on your medical condition and response to therapy. Do not increase your dose or take this medication more often without your doctor’s approval. Your condition will not improve any faster, and the risk of serious side effects may be increased.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.

How do I store Ursodiol?

Ursodiol is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Ursodiol in the bathroom or the freezer. Tablets that are broken in half can be kept at room temperature for up to 28 days. If you split your tablets, keep them separate from any whole tablets.

There may be different brands of Ursodiol that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Ursodiol down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Ursodiol?

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).

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.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Ursodiol during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Ursodiol. Ursodiol is pregnancy risk category B according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Ursodiol?

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.

Tell your doctor right away 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.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Ursodiol?

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: aluminum-containing antacids, birth control pills, cholesterol medications (e.g., cholestyramine, clofibrate, colestipol), estrogen.

Ursodiol may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Ursodiol?

Ursodiol may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

This drug may make you dizzy. Alcohol or marijuana can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana.

What health conditions may interact with Ursodiol?

Ursodiol may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

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

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Ursodiol.

What is the dose of Ursodiol for an adult?

Usual Adult Dose for Biliary Cirrhosis

Tablets: 13 to 15 mg/kg/day orally in 2 to 4 divided doses with food

Approved indication: For treatment of patients with primary biliary cirrhosis

Usual Adult Dose for Gallbladder Disease

Capsules:

Gallbladder stone dissolution: 8 to 10 mg/kg/day orally in 2 or 3 divided doses

Gallstone prevention: 300 mg orally twice a day

Approved indications:

-For dissolution of gallstones in patients with radiolucent, noncalcified gallbladder stones less than 20 mm in greatest diameter who are not candidates for cholecystectomy due to increased surgical risk (e.g., systemic disease, advanced age, idiosyncratic reaction to general anesthesia) or who refuse surgery

-For gallstone prevention in obese patients undergoing rapid weight loss

What is the dose of Ursodiol for a child?

Usual Pediatric Dose for Gallbladder Disease (Not approved by FDA)

Some experts recommend:

Parenteral nutrition-induced cholestasis in neonates:

Treatment: 30 mg/kg/day orally in 3 divided doses; some centers divide in 2 daily doses

Prevention:

With initiation of parenteral nutrition: 5 mg/kg/day orally in 4 divided doses beginning on day of life 3

With initiation of enteral feeding: Increase dose to 10 mg/kg/day orally in 4 divided doses.

When full enteral feedings reached: Increase dose to 20 mg/kg/day orally in 4 divided doses.

Biliary atresia:

Infants: 10 to 15 mg/kg orally once a day

Treatment of TPN-induced cholestasis:

Infants and children: 30 mg/kg/day orally in 3 divided doses

Improvement in the hepatic metabolism of essential fatty acids in cystic fibrosis:

Children: 30 mg/kg/day orally in 2 divided doses

How is Ursodiol available?

Ursodiol is available in the following dosage forms and strengths:

  • Oral capsule,
  • Oral tablet.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Ursodiol, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

 

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: November 13, 2018 | Last Modified: November 13, 2018

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