Close
New

Medscape is available in 5 Language Editions – Choose your Edition here.

 

ursodiol (Rx)Brand and Other Names:Actigall, Urso Forte

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsules

  • 300mg

tablets

  • 250mg
  • 500mg
more...

Gallstone Dissolution

8-10 mg/kg/d PO divided q8-12hr PO; not to exceed 300 mg/dose 

Maintenance: 250 mg PO HS x6 months

Primary Biliary Cirrhosis

13-15 mg/kg/d PO divided PO with food 

Cystic Fibrosis Liver Disease (Orphan)

Indicated for treatment of cystic fibrosis liver disease

Orphan indication sponsor

  • Asklepion Pharmaceuticals, LLC; 5200 Maryland Way; Brentwood, TN 37027

Dosage Forms & Strengths

capsules

  • 300mg

tablets

  • 250mg
  • 500mg
more...

Biliary Atresia (Off-Label)

10-15 mg/kg PO qDay

Next

Interactions

Interaction Checker

ursodiol and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            Sort by :  
             activity indicator 
            Previous
            Next

            Adverse Effects

            >10%

            Headache

            Dizziness

            Diarrhea

            Dyspepsia

            Nausea/vomiting

            Back pain

            Upper respiratory tract infection

            1-10%

            Alopecia

            Rash

            Hyperglycemia

            Flatulence

            Peptic ulcer

            Urinary tract infection

            Leukopenia

            Thrombocytopenia

            Cholecystitis

            >1%

            Fatigue

            Abdominal pain

            Thrombocytopenia

            Pruritus

            Angioedema

            Peripheral edema

            Biliary pain

            Postmarketing Reports

            Hepatobiliary disorders: Jaundice (or aggravation of pre-existing jaundice)

            Abnormal laboratory tests: Increased ALT, AST, alkaline phosphatase, bilirubin, gamma-GT

            Previous
            Next

            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

            Previous
            Next

            Pregnancy & Lactation

            Pregnancy Category: B

            Lactation: unknown if excreted in breast milk; use caution

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

            more...
            Previous
            Next

            Pharmacology

            Mechanism of Action

            Naturally-occurring bile acid; reduces cholesterol secretion from the liver; reduces the fractional reabsorption of cholesterol by the intestines.

            Absorption

            Bioavailability: 90%

            Onset: Initial response for gallstone dissolution is 3-6 months

            Distribution

            Protein Bound: 70%

            Metabolism

            Taken up rapidly by the liver, conjugated with glycine or taurine, and excreted in the bile

            Nonabsorbed ursodiol passes into the colon where it is 7-dehydroxylated to lithocholic acid (an intermediary compound, sometimes formed, is called chenodiol); chenodiol is then dehydroxylated to lithocholic acid

            Metabolites: Glyco-ursodeoxycholic acid, tauro-ursodeoxycholic acid, 7-keto-lithocholic acid (inactive); lithocholic acid (inactive) is formed from the 7-hydroxylation of ursodiol and chenodiol; a small portion is metabolized to sulfated lithocholic acid conjugates which are excreted in bile & eliminated in feces

            Elimination

            Excretion: Mainly in feces

            Previous
            Next

            Images

            Previous
            Next

            Formulary

            FormularyPatient Discounts

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
            Add or Remove Plans
            Plans for
            Select State:
            Non-Medicare PlansMedicare Plans

            Select a box to add or remove a plan.

            Select a class to view formulary status for similar drugs

            Additional Offers
            Email to Patient

            From:

            To:

            The recipient will receive more details and instructions to access this offer.

            By clicking send, you acknowledge that you have permission to email the recipient with this information.

            Email Forms to Patient

            From:

            To:

            The recipient will receive more details and instructions to access this offer.

            By clicking send, you acknowledge that you have permission to email the recipient with this information.

            Previous
             
             
             
            All material on this website is protected by copyright, Copyright © 1994-2016 by WebMD LLC. This website also contains material copyrighted by 3rd parties.