chenodiol (Rx)Brand and Other Names:Chenodal

 
 
 

Dosing & Uses

AdultPediatric

Dosing & Strengths

tablet

  • 250mg

Radiolucent Gallstone Dissolution

For dissolution of gallstones; effective only in the treatment of cholesterol-rich, radiolucent gallstones (not radiopaque stones) in well-opacifying gallbladders

250 mg PO BID for 2 weeks initially, then increase by 250 mg/day at weekly intervals, up to 13-18 mg/kg/day divided BID PO 

Xanthomatosis (Orphan)

Indicated for treatment of cerebrotendinous xanthomatosis

Orphan indication sponsor

  • Dr. Falk Pharma GmbH; Leinenweberstrasse 5, 9041; Freiburg, Germany
  • Sigma-Tau Pharmaceuticals, Inc; 9841 Washingtonian Blvd, Suite 500; Gaithersburg, MD 20878
  • Manchester Pharmaceuticals, Inc; 8236 Benson Ct; Fort Collins, CO 80525

Other Information

Indicated in patients whom selective surgery would be undertaken except for the presence of increased surgical risk because of systemic disease or age

Successful dissolution is more likely if the stones are floatable or small

Safety of use beyond 24 months is not established

Safety and efficacy not established

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Interactions

Interaction Checker

chenodiol and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Diarrhea (40-50%)

            Frequency Not Defined

            Abdominal cramps

            Nausea

            Vomiting

            Constipation

            Heartburn

            Flatulence

            Increased LFT's

            Increased LDL and total cholesterol

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            Warnings

            Black Box Warnings

            Not an appropriate treatment for many patients with gallstones because of potential hepatotoxicity, poor response rate in some patient subgroups, and increased rate of cholecystectomy in other subgroups

            Reserve for carefully selected patients

            Treatment must include systematic monitoring for liver function alterations

            Contraindications

            Gallstone complication requiring surgery

            Known hepatocyte or bile ductal abnormalities, inflammatory bowel dz

            Pregnancy

            Cautions

            Orphan drug status, for use in surgical high-risk patients with radiolucent stones

            Breastfeeding

            Concomitant use with clofibrate

            Hepatotoxicity

            50% of cases have stone recurrence in 5 yr

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            Pregnancy & Lactation

            Pregnancy Category: X

            Lactation: unknown whether cevimeline is distributed into breast milk, avoid using in nursing women

            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.

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            Pharmacology

            Onset: initial response for gallstone dissolution: 3-6 month

            Bioavailability: 81-100%

            Protein bound: unknown

            Excretion: mainly in feces

            Metabolism: after absorption, chenodiol is conjugated with glycine or taurine in the liver and rapidly located in the bile; conjugated chenodiol is then reabsorbed in terminal ileum and jejunum, completing the enterohepatic cycle

            Metabolites

            Lithocholic acid (inactive) is formed in the intestine by bacterial dehydroxylation of unabsorbed chenodiol; conjugated, sulfated and excreted in the bile; hepatotoxic in animals

            Ursodiol (active)

            Mechanism of Action

            Chenodiol itself is a primary acid excreted into the bile, constitutes 1/3 of total biliary bile acid; drug action on gallstone dissolution relies on negative feedback effect on the rate-limiting enzyme for synthesis of cholesterol and bile

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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
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