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Pronunciation |
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(kee
noe DYE
ole) |
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U.S. Brand
Names |
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Chenix® |
|
|
Generic
Available |
|
No |
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Synonyms |
|
Chenodeoxycholic Acid |
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|
Pharmacological Index |
|
Bile Acid |
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|
Use |
|
Oral dissolution of cholesterol gallstones in selected
patients |
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Pregnancy Risk
Factor |
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X |
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Contraindications |
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Presence of known hepatocyte dysfunction or bile ductal abnormalities; a
gallbladder confirmed as nonvisualizing after two consecutive single doses of
dye; radiopaque stones; gallstone complications or compelling reasons for
gallbladder surgery; inflammatory bowel disease or active gastric or duodenal
ulcer; pregnancy |
|
|
Warnings/Precautions |
|
Chenodiol is hepatotoxic in animal models including subhuman Primates;
chenodiol should be discontinued if aminotransferases exceed 3 times the upper
normal limit; chenodiol may contribute to colon cancer in otherwise susceptible
individuals |
|
|
Adverse
Reactions |
|
>10%:
Gastrointestinal: Diarrhea (mild), biliary pain
Miscellaneous: Aminotransferase increases
1% to 10%:
Endocrine & metabolic: Increases in cholesterol and LDL cholesterol
Gastrointestinal: Dyspepsia
<1%: Diarrhea (severe), cramps, nausea, vomiting, flatulence,
constipation, leukopenia, intrahepatic cholestasis, higher cholecystectomy rates
|
|
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Overdosage/Toxicology |
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Symptoms of overdose may include diarrhea; a rise in liver function tests has
been observed
No specific antidote, institute supportive therapy |
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Drug
Interactions |
|
Decreased effect: Antacids, cholestyramine, colestipol, oral
contraceptives |
|
|
Mechanism of
Action |
|
Chenodiol is a primary acid excreted into bile, normally constituting
one-third of the total biliary bile acids. Synthesis of chenodiol is regulated
by the relative composition and flux of cholesterol and bile acids through the
hepatocyte by a negative feedback effect on the rate-limiting enzymes for
synthesis of cholesterol (HMG CoA reductase) and bile acids (cholesterol 7
alpha-hydroxyl). |
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|
Usual Dosage |
|
Adults: Oral: 13-16 mg/kg/day in 2 divided doses, starting with 250 mg twice
daily the first 2 weeks and increasing by 250 mg/day each week thereafter until
the recommended or maximum tolerated dose is achieved |
|
|
Monitoring
Parameters |
|
Oral cholecystograms and/or ultrasonograms should be used to monitor
response; dissolutions of stones should be confirmed 1-3 months
later |
|
|
Test
Interactions |
|
aminotransferases,
cholesterol, LDL
cholesterol,
triglycerides,
bilirubin
(I) |
|
|
Mental Health: Effects
on Mental Status |
|
None reported |
|
|
Mental Health:
Effects on Psychiatric
Treatment |
|
May rarely produce leukopenia; use caution with clozapine and
carbamazepine |
|
|
Dental Health: Local
Anesthetic/Vasoconstrictor
Precautions |
|
No information available to require special precautions |
|
|
Dental Health:
Effects on Dental Treatment |
|
No effects or complications reported |
|
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Patient
Information |
|
Take as directed, for entire length of therapy. Medication may need to be
taken for 24 months before dissolution will occur. Avoid aluminum-based antacids
during entire course of therapy. Blood studies and x-rays studies will be
necessary during therapy. Report persistent diarrhea and gallstone attacks
(abdominal pain, nausea and vomiting, yellowing of skin or eyes).
Pregnancy/breast-feeding precautions: Inform prescriber if you are pregnant
and do not get pregnant during or for 1 month following therapy. Consult
prescriber for instruction on appropriate contraceptive measures. This drug may
cause severe fetal defects. Do not donate blood during or for 1 month following
therapy. Breast-feeding is not recommended. |
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Dosage Forms |
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Tablet, film coated: 250 mg |
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