chenodiol (Rx)

Brand and Other Names:Chenodal
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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

Monotherapy: 250 mg PO q12hr for 2 weeks initially, then increase by 250 mg/day at weekly intervals, up to 13-16 mg/kg/day divided q12hr PO 

Combinatin therapy (off-label): 5-7.5 mg/kg/day PO qHS in combination with ursodeoxycholic acid, with or without adjuvant lithotripsy

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

Administration

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

and chenodiol

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 (30-40%)

            Billiary pain (10-15%)

            Increased aminotransferase (>30%)

            Frequency Not Defined

            Abdominal cramps

            Nausea

            Vomiting

            Abdominal pain

            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 disease

            Pregnancy

            Cautions

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

            Breastfeeding

            Concomitant use with clofibrate

            Hepatotoxicity

            Dose related diarrhea occurs

            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

            Metabolites

            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

            Pharmacokinetics

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

            Bioavailability: 81-100%

            Excretion: Mainly in feces (80%)

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

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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.
            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.
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            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
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