Chenodal (chenodiol) dosing, indications, interactions, adverse effects, and more

Sections

Sections chenodiol
Dosing & Uses
Interactions
Adverse Effects
Warnings
Pregnancy
Pharmacology
Images
Patient Handout
Formulary

Dosing & Uses

AdultPediatric

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

Combination 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

Interaction Checker

Enter a drug name and chenodiol

No Results

No Interactions Found

Interactions Found

Contraindicated

Serious - Use Alternative

Significant - Monitor Closely

Minor

All Interactions Sort By:

Due to system maintenance, the drug interactions feature you are attempting to access is temporarily unavailable. Please try again later.

>10%

Diarrhea (30-40%)

Biliary 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

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

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.

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

BRAND	FORM.	UNIT PRICE	PILL IMAGE
Chenodal oral -	250 mg tablet

Patient Handout

A Patient Handout is not currently available for this monograph.

Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

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

Create Your List of Plans

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.

View explanations for tiers and restrictions

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.

Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.

[CLOSE WINDOW]

Sections chenodiol
Dosing & Uses
Interactions
Adverse Effects
Warnings
Pregnancy
Pharmacology
Images
Patient Handout
Formulary

chenodiol (Rx)