Chenodal
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Questions & Answers
Side Effects & Adverse Reactions
Safe use of chenodiol depends upon selection of patients without
pre-existing liver disease and upon faithful monitoring of serum
aminotransferase levels to detect drug-induced liver toxicity. Aminotransferase
elevations over three times the upper limit of normal have required
discontinuation of chenodiol in 2% to 3% of patients. Although clinical and
biopsy studies have not shown fulminant lesions, the possibility remains that an
occasional patient may develop serious hepatic disease. Three patients with
biochemical and histologic pictures of chronic active hepatitis while on
chenodiol, 375 mg/day or 750 mg/day, have been reported. The biochemical
abnormalities returned spontaneously to normal in two of the patients within 13
and 17 months; and after 17 months’ treatment with prednisone in the third.
Follow-up biopsies were not done; and the causal relationship of the drug could
not be determined. Another biopsied patient was terminated from therapy because
of elevated aminotransferase levels and a liver biopsy was interpreted as
showing active drug hepatitis.
One patient with sclerosing cholangitis, biliary cirrhosis and history of
jaundice died during chenodiol treatment for hepatic duct stones. Before
treatment, serum aminotransferase and alkaline phosphate levels were over twice
the upper limit of normal; within one month they rose to over 10 time normal.
Chenodiol was discontinued at seven weeks, when the patient was hospitalized
with advanced hepatic failure and E. coli peritonitis; death ensued at the eight
week. A contribution of chenodiol to the fatal outcome could not be ruled
out.
Epidemiologic studies suggest that bile acids might contribute to human colon
cancer, but direct evidence is lacking. Bile acids, including chenodiol and
lithocholic acid, have no carcinogenic potential in animal models, but have been
shown to increase the number of tumors when administered with certain know
carcinogens. The possibility that chenodiol therapy might contribute to colon
cancer in otherwise susceptible individuals cannot be ruled out.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Chenodal (chenodiol tablets) is indicated for patients with radiolucent stones in well-opacifying gallbladders, in whom selective surgery would be undertaken except for the presence of increased surgical risk due to systemic disease or age. The likelihood of successful dissolution is far greater if the stones are floatable or small. For patients with nonfloatable stones, dissolution is less likely and added weight should be given to the risk that more emergent surgery might result form a delay due to unsuccessful treatment. Safety of use beyond 24 months is not established. Chenodiol will not dissolve calcified (radiopaque) or radiolucent bile pigment stones.
History
There is currently no drug history available for this drug.
Other Information
Chenodiol is the non-proprietary name for chenodeoxycholic acid,
a naturally occurring human bile acid. It is a bitter-tasting white powder
consisting of crystalline and amorphous particles freely soluble in methanol,
acetone and acetic acid and practically insoluble in water. Its chemical name is
3α, 7α-dihydroxy-5β-cholan-24-oic acid (C24H40O4), it has a molecular weight of
392.58, and its structure is shown below;
Chenodiol film-coated tablets for oral administration contain 250 mg of
chenodiol.
Inactive ingredients: pregelatinized starch; silicon dioxide;
microcrystalline cellulose, sodium starch glycollate; and magnesium stearate;
the thin-film coating contains: opadry YS-2-7035 [consisting of methylcellulose
and glycerin] and sodium lauryl sulfate
Sources
Chenodal Manufacturers
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Manchester Pharmaceuticals Inc.
![Chenodal (Chenodiol) Tablet, Film Coated [Manchester Pharmaceuticals Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Chenodal | Manchester Pharmaceuticals Inc.
The recommended dose range for Chenodal (chenodiol tablets) is 13 to 16 mg/kg/day in two divided doses, morning and night, starting with 250 mg b.i.d. the first two
weeks and increasing by 250 mg/day each week thereafter until the recommended or maximum tolerated dose is reached. If diarrhea occurs during dosage buildup or
later in treatment, it usually can be controlled by temporary dosage adjustment until symptoms abate, after which the previous dosage usually is tolerated.
Dosage less than 10 mg/kg usually is ineffective and may be associated with increased risk of cholecystectomy, so is not recommended.
The optimal frequency of monitoring liver function tests is not known. It is suggested that serum aminotransferase levels should be monitored monthly for the
first three months and every three months thereafter during Chenodal (chenodiol tablets) administration. Under NCGS guidelines, if a minor, usually transient elevations
(1 ½ to3 three times the upper limit of normal) persisted longer than three to six months. Chenodiol was discontinued and resumed only after the
aminotransferase level returned to normal; however, allowing the elevations to persist over such an interval is not know to be safe. Elevations over three
times the upper limit of normal require immediate discontinuation of Chenodal (chenodiol tablets) and usually reoccur on challenge.
Serum cholesterol should be monitored at six months intervals. It may be advisable to discontinue Chenodal (chenodiol tablets) if cholesterol rises above the acceptable
age-adjusted limit for given patient.
Oral cholecystograms or ultrasonograms are recommend at six to nine month intervals to monitor response. Complete dissolutions should be confirmed by a
repeat test after one to three months continued Chenodal (chenodiol tablets) administration. Most patients who eventually achieve complete dissolution will show partial (or
complete) dissolution at the first on-treatment test. If partial dissolution is not seen by nine to 12 months, the likelihood of success of treating loner is
greatly reduced; Chenodal (chenodiol tablets) should be discontinued if there is no response by 18 months. Safety of use beyond 24 months is not established.
Stone recurrence can be expected within five years in 50% of cases. After confirmed dissolution, treatment generally should be stopped. Serial
cholecystograms or ultrasonograms are recommended to monitor for recurrence, keeping in mind that radiolucency and gallbladder function should be established
before starting another course of Chenodal (chenodiol tablets). A prophylactic doses is not established; reduced doses cannot be recommended; stones have recurred on 500
mg/day. Low cholesterol or carbohydrate diets, and dietary bran, have been reported to reduce biliary cholesterol; maintenance of reduced weight is
recommended to forestall stone recurrence.
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