Data from FDA - Curated by EPG Health - Last updated 04 January 2017
CONTRAINDICATIONS Chenodiol is contraindicated in the presence of know hepatocyte
Pregnancy Category X: Chenodiol may cause fetal
Hepatic lesions also occurred in neonatal baboons whose mothers had received 18 to 38 mg/kg (1 to 2 times the MRHD), all during pregnancy.
Fetal malformations were not observed.
Chenodiol is contraindicated in women who are or may become pregnant.
If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential
PRECAUTIONS Information for patients Patients should be counseled on the
Patients should be instructed on ways to
Drug interactions Bile acid sequestering agents, such as cholestyramine and colestipol, may interfere with the action of Chenodiol by reducing its absorption.
Aluminum-based antacids have been shown to absorb bile acids in_vitro and may be expected to interfere with Chenodiol in the same manner as the sequestering agents.
Estrogen, oral contraceptive and
Due to its hepatotoxicity, chenodiol can affect the pharmacodynamics of coumarin and its derivatives, causing
Patients on concommitant therapy with chenodiol and coumarin or
If prolongation of prothrombin time is observed, the coumarin dosage should be readjusted to give a prothrombin time 1?
to 2 times normal.
It has been reported that chenodiol given in
Two-year studies of lithocholic acid (a major metabolite of chenodiol) in mice (125 to 250 mg/kg/day) and
The dietary administration of Lithocholic acid to chickens is reported to cause hepatic adenomatous hyperplasia.
Pregnancy Pregnancy Category X: See CONTRAINDICATIONS. Nursing mothers It is not known whether
Because many drugs are excreted in human milk,
Pediatric use The
In most cases, these elevations were minor (1?
to 3 times the upper limit of laboratory normal) and transient,
In 2 % to 3 % of patients, SGPT levels rose to over three times the upper limit of laboratory normal, recurred on rechallenge with the drug, and required discontinuation of chenodiol treatment.
Enzyme levels have returned to normal following withdrawal of chenodiol (see WARNINGS).
Morphologic studies of liver biopsies taken before and after 9 and 24 months of treatment with chenodiol have shown that 63 % of the patients prior to chenodiol treatment had evidence of intrahepatic cholestasis.
By the ninth month of treatment, reexamination of two-thirds of the patients showed an 89 % incidence of the signs of intrahepatic cholestasis.
Two of 89 patients at the ninth month had lithocholate-like lesions in the canalicular membrane, although there were not clinical enzyme
Gastrointestinal: Dose-related diarrhea has been encountered in 30 % to 40 % of chenodiol-treated patients and may occur at any time during treatment, but is
Discontinuation of chenodiol because of
Other less frequent,
Serum Lipids: Serum total cholesterol and low-density lipoprotein (LDL) cholesterol may rise 10 % or more during administration of chenodiol:
DOSAGE AND ADMINISTRATION The
If diarrhea occurs during dosage buildup or later in treatment, it usually can be controlled by
Dosage less than
Weight/Dosage Guide Body Weight
It is suggested that serum aminotransferase levels should be monitored monthly for the first
Under NCGS guidelines, if a minor, usually transient elevations (1?
to3 three times the upper limit of normal) persisted longer than three to six months.
Elevations over three times
Serum cholesterol should be monitored at six months intervals.
It may be advisable to
Complete dissolutions should be confirmed by a repeat test after one to three months continued Chenodiol administration.
Most patients who eventually achieve
If partial dissolution is not seen by nine to 12 months, the likelihood of
Stone recurrence can be expected within five years in 50 % of cases.
After confirmed dissolution, treatment generally should be stopped.
|Date Last Revised||18-08-2009|
|Type||HUMAN PRESCRIPTION DRUG|
|Marketing authorisation holder||Nexgen Pharma, Inc.|