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.

Weight/Dosage Guide

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 (1½ to 3 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 known 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 month intervals. It may be advisable to discontinue Chenodal (chenodiol tablets) if cholesterol rises above the acceptable age-adjusted limit for a given patient.

Oral cholecystograms or ultrasonograms are recommended 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 longer is greatly reduced; Chenodal (chenodiol tablets) should be discontinued it 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 o monitor for recurrence, keeping in mind that radiolucency and gallbladder function should be established before starting another course of Chenodal (chenodiol tablets). A prophylactic dosage 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.