CHENODAL Film-coated tablet (2021)

Βιβλιογραφική αναφορά

Συγγραφείς

Retrophin, Inc.

Λέξεις κλειδιά

68974-876

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BOXED WARNING SECTION

SPECIAL NOTE Because of the potential hepatoxicity of chenodiol, poor response rate in some subgroups of chenodiol treated patients, and an increased rate of a need for cholecystectomy in other chenodiol ...

1. Description

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 ...

2. Clinical Pharmacology

At therapeutic doses, chenodiol suppresses hepatic synthesis of both cholesterol and cholic acid, gradually replacing the latter and its metabolite, deoxycholic acid in an expanded bile acid pool. These ...

3. Indications and Usage

Chenodiol 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 ...

4. Contraindications

Chenodiol is contraindicated in the presence of know hepatocyte dysfunction or bile ductal abnormalities such as intrahepatic cholestasis, primary biliary cirrhosis or sclerosing cholangitits (see Warnings); ...

5. Warnings

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 ...

6.2. Information for Patients

Patients should be counseled on the importance of periodic visits for liver function tests and oral cholecystograms (or ultrasonograms) for monitoring stone dissolution; they should be made aware of the ...

6.4. 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 ...

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

A two-year oral study of chenodiol in rats failed to show a carcinogenic potential at the tested levels of 15 to 60 mg/kg/day (1 to 4 times the maximum recommended human dose, MRHD). It has been reported ...

6.7. Pregnancy

Pregnancy Category X: See CONTRAINDICATIONS.

6.9. Nursing Mothers

It is not known whether chenodiol is excreted in human mild. Because many drugs are excreted in human milk, caution should be exercised when chenodiol is administered to a nursing mother.

6.10. Pediatric Use

The safety and effectiveness of chenodiol in children have not been established.

7. Adverse Reactions

Hepatobiliary Dose-related serum aminotransferase (mainly SGPT) elevations, usually not accompanied by rises in alkaline phosphatase or bilirubin, occurred in 30% or more of patients treated with the recommended ...

9. 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.

10. 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 ...

11. How Supplied

Chenodal (chenodiol tablets) is available as white film-coated 250 mg tablets imprinted MP on one side and 250 on the other in bottles of 100, NDC 68974-876-40. Manufactured for: Retrophin, Inc., San Diego, ...

12. Storage and handling

Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container.