Chenodiol (Page 3 of 3)

DRUG ABUSE AND DEPENDENCE

Overdosage

Accidental or intentional overdoses of Chenodiol have not been reported. One patient tolerated 4 gm/day (58 mg/kg/day) for six months without incident.

DOSAGE AND ADMINISTRATION

The recommended dose range for Chenodiol 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

Body Weight

Recommended Tablets

per Day

Dose Range

(mg/kg)

Lbs.
Kgs.
100-130
45-58

3

17-13
131-185
59-75

4

17-13
186-200
76-90

5

18-14
201-235
91-107

6

18-14
236-275
108-125

7

18-14

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 Chenodiol administration. Under NCGS guidelines, if a minor, usually transient elevation (1½ 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 elevation 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 Chenodiol and usually reoccur on challenge.

Serum cholesterol should be monitored at six-month intervals. It may be advisable to discontinue Chenodiol if cholesterol rises above the acceptable age-adjusted limit for 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 Chenodiol 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; Chenodiol 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 Chenodiol. A prophylactic dose 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.

HOW SUPPLIED

Chenodiol is available as white film-coated 250 mg tablets imprinted “MP” on one side and “250” on the other side and are offered in bottles of 100 tablets (NDC 79739-7121-1).

Store at 20o C to 25o C (68o F to 77o F) [see USP Controlled Room Temperature].

Dispense in a tight container.

Manufactured by: Nexgen Pharma, Inc., Irvine, CA 92606, USA

Rev. 08/2020

LABEL PRINCIPAL DISPLAY PANEL

Chenodiol, 100-count, Container Label

Chenodiol Container Label 100-count
(click image for full-size original)
CHENODIOL
chenodiol tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:79739-7121
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHENODIOL (CHENODIOL) CHENODIOL 250 mg
Product Characteristics
Color WHITE (White to Off-White) Score no score
Shape ROUND Size 10mm
Flavor Imprint Code MP;250
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:79739-7121-1 1 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091019 10/22/2009
Labeler — LGM Pharma Solutions, LLC (117549198)

Revised: 08/2020 LGM Pharma Solutions, LLC

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