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Cholic acid oral

Updated 2 Feb 2023 | Biliary composition and flow


Oral formulations of cholic acid.

Drugs List

  • cholic acid 250mg capsules
  • cholic acid 50mg capsules
  • ORPHACOL 250mg capsules
  • ORPHACOL 50mg capsules
  • Therapeutic Indications


    Inborn errors of bile acid synthesis


    The dose must be adjusted for each patient in a specialised unit according to blood and/or urine chromatographic bile acid profiles.

    The daily dose may be divided if it consists of more than one capsule in order to mimic the continuous production of cholic acid in the body, and to reduce the number of capsules that need to be taken per administration.

    The lowest dose of cholic acid that effectively reduces the bile acid metabolites to as close to zero as possible should be chosen.


    5mg/kg to 15mg/kg daily with food at the same time each day, in the morning and/or evening.

    It is recommended that the minimum dose is 50mg and that the dose is adjusted in 50mg steps, up to a maximum of 500mg daily in adults.


    Children aged over 1 month
    5mg/kg to 15mg/kg daily with food at the same time each day, in the morning and/or evening.

    It is recommended that the minimum dose is 50mg and that the dose is adjusted in 50mg steps.

    Patients with Hepatic Impairment

    The dose of cholic acid should be adjusted individually in patients with inborn errors of bile acid metabolism and hepatic impairment.

    No data regarding cholic acid treatment are available in patients with inborn errors of bile acid metabolism with hepatic impairment unrelated to their primary disease, and as such no recommendations on dosage adjustment can be made. All patients with hepatic impairment being treated with cholic acid should be monitored closely.

    Additional Dosage Information

    Familial hypertriglyceridaemia
    The cholic acid dose in patients with newly diagnosed or a family history of familial hypertriglyceridaemia may need to be elevated due to the poor absorption of cholic acid in the intestines. Doses will have to be established and adjusted as necessary. The manufacturer suggests that an elevated dose, notably higher than the 500mg daily limit for adult patients, may be required and safe.


    For infants and children who cannot swallow capsules, the capsules may be opened and the content added to infant formula or juice.


    Neonates under 1 month

    Precautions and Warnings

    Familial hypertriglyceridaemia
    Glucose-galactose malabsorption syndrome
    Hepatic impairment
    Lactose intolerance

    Treatment to be initiated and supervised by a specialist
    Contains lactose
    Monitor hepatic function
    Monitor prothrombin times
    Monitor serum and/or urine bile acid levels prior & during dose adjustment
    Discontinue if hepatic function deteriorates
    Discontinue treatment if prothrombin time does not improve within 3 months
    Familial hypertriglyceridaemia: Higher doses than 500mg daily may be needed
    Advise to avoid antacids &/or bile acid sequestrants within 5 hours of dose

    During the initiation of therapy and dose adjustment, serum and/or urine bile acid levels should be monitored intensively using suitable analytical techniques. It is recommended that monitoring takes place at least every 3 months during the first year of treatment, 6 monthly during the subsequent three years and annually thereafter.

    Liver parameters should be monitored, preferentially more frequently than serum and/or urine bile acid levels. Concurrent elevation of serum gamma glutamyltransferase (GGT), alanine aminotransferase (ALT) and/or serum bile acids above normal levels may indicate overdose. Transient elevations of transaminases at the initiation of cholic acid treatment have been observed and do not indicate the need for a dose reduction if GGT is not elevated and if serum bile acid levels are falling or in the normal range.

    Treatment with cholic acid in patients with pre-existing hepatic impairment should be given under close monitoring.

    Treatment with cholic acid should be stopped if abnormal hepatocellular function, as measured by prothrombin time, does not improve within 3 months of the initiation of cholic acid treatment for all patients. Treatment should be stopped earlier if there are clear indicators of severe hepatic failure.

    In case of persistent lack of therapeutic response to cholic acid monotherapy, other treatment options should be considered.

    Pregnancy and Lactation


    Use cholic acid with caution during pregnancy.

    The manufacturer advises that it is extremely important that pregnant women continue their therapy during pregnancy but pregnant women and their unborn children should be closely monitored.

    There is a limited amount of data (less than 20 pregnancy outcomes) from the use of cholic acid in pregnant women. The exposed pregnancies, however, showed no adverse reactions to cholic acid and resulted in normal, healthy children.

    Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.


    Cholic acid is considered safe to use during breastfeeding.

    The manufacturer advises that cholic acid may be used during breastfeeding.

    Cholic acid and its metabolites are excreted in human milk, but at therapeutic doses, no effects on the breastfed newborn/infant are anticipated.

    Side Effects

    Increase in serum transaminases


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: August 2019.

    Reference Sources

    Summary of Product Characteristics: Orphacol 50 milligram capsules. Laboratoires CTRS. Revised July 2020.

    Summary of Product Characteristics: Orphacol 250 milligram capsules. Laboratoires CTRS. Revised July 2020.

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