Cholic acid (Oral)

Cholic acid, also known under US brand names Chobham and Orphacol, is used in people with bile acid-related disorders and works by normalizing the production of bile acid in the body.

Overview

Cholic acid is a bile acid that is used in the treatment of patients who suffer from bile acid synthesis disorders, which are caused by a single enzyme defect. It is also used in the treatment of patients who suffer from peroxisomal disorders and show symptoms of steatorrhea, liver disease or those who struggle to absorb fat-soluble vitamins. This medication is only available via prescription from your doctor and is available in the dosage form of capsules for oral consumption.

Condition(s) treated

  • Deficiency of bile acids due to peroxisomal disorder
  • Deficiency of bile acids due to inborn synthetic defect

Type of medicine

  • Capsules for oral consumption

Side effects

Along with its intended effects, cholic acid can produce some unwanted side effects, including those of a serious nature. The following side effects have been listed in terms of more common and less common.

If you experience any of the following side effects, you should seek medical attention urgently.

More common

  • Chills
  • Dizziness
  • Clay-colored stools
  • Dark urine
  • Stomach or abdominal pain
  • Diarrhea
  • Fever
  • Headache
  • General feeling of weakness or tiredness
  • Rash or itching
  • Loss of appetite
  • Light-colored stools
  • Vomiting of blood
  • Continuing stomach pain
  • Nausea
  • Unpleasant breath odor
  • Vomiting
  • Yellow skin or eyes

Less common

  • Cloudy or bloody urine
  • Difficult, painful or burning urination
  • Dark urine
  • Bladder pain
  • Frequent urge to urinate
  • Side or lower back pain

Some of the side effects associated with the consumption of cholic acid usually don't need urgent medical attention. Rather, you will find that these side effects reduce as your body adjusts to the new medication that you are taking. If your side effects are bothering your daily life, you should contact your doctor or a health care professional, as they may be able to suggest some ways to reduce or prevent these side effects. Remember, you can report all side effects, regardless of their severity, to the FDA on 1-800-FDA-1088.

Less common

  • Difficulty with swallowing
  • Chest pain
  • General feeling of illness or discomfort
  • Heartburn
  • Burning, tingling, numbness or painful sensations
  • Skin lesions
  • Burning or pain in the throat
  • Ulcers, sores, or white spots on the tongue, lips or inside the mouth
  • Weakness in the hands, arms, feet or legs
  • Awkwardness or unsteadiness

Dosage

The final dosage of any medication will depend on a variety of factors, including your age, height, weight, the condition you are being treated for, the severity of your condition and how you reacted to the first dose of the medication.

The typical adult dose for those suffering with a bile acid synthesis disorder:

  • The initial dose is from 10-15 kg/mg taken orally, once daily. It may be divided into a split dose (two doses).
  • The typical pediatric dose for bile acid synthesis disorders:
  • The initial dose is 10-15 kg/mg, taken orally once daily, and it can be divided into a split dose.
  • Patients who suffer with concomitant familial hypertriglyceridemia:
  • The initial dose is 11-17 kg/mg taken orally daily, or divided into a split dose.

Maintenance dose:

This will be the lowest dose possible that still maintains liver function. It will be dependent on the individual.

Dosing needs to be determined by monitoring of laboratory values and clinical response in the patient. Patients should be monitored more frequently during any periods of concomitant disease, rapid growth or during pregnancy. Concurrent elevations of ALT and serum gamma-glutamyltransferase could indicate an overdose of cholic acid.

Never change your dosage without prior orders from your doctor.

What happens if I miss a dose?

If you miss a dose, take it as soon as you remember. However, if it's almost time for your next scheduled dose, then you should skip it, instead. Don't take any extra drugs to rectify the missed dose.

Administration guide

Make sure you take the medication with food. Take this medication around one hour before or four to six hours (or at as great an interval as possible) after taking an aluminum-based antacid or bile acid resin.

You should not chew or crush capsules. For those who are unable to swallow the capsules whole, you may open them up and mix them with 15 - 30 ml of breast milk, infant formula or apple puree, or a soft food, such a mashed potatoes. To prepare, hold the capsule over the food or liquid and twist the capsule gently until the contents fall out. You should then stir the contents for 30 seconds. They will not dissolve but will remain as a fine granule. Take the mixture immediately.

Interactions

Interactions can happen between drugs, which can reduce the effectiveness of either drug or cause side effects, some potentially fatal. Therefore, it's important that you give your doctor a list of all the medication you are currently taking, including any vitamins or herbal remedies. You should also inform them of your past medical history and any illnesses that may run in the family. Sometimes, it is unavoidable that two drugs, which do produce an interaction, need to be used together. Under these circumstances, your doctor will closely monitor you and may make alternative suggestions.

Using cholic acid is not recommended with any of the following medicines; however, in some cases, it may be unavoidable. If both medicines are prescribed together, your physician may alter the dosage or the frequency with which you use either one of the medications:

Cyclosporine

Using cholic acid with any of the following medicines can increase your risk of some side effects. However, the use of both drugs together may be the best option for you. Again, if both medications are given together, your doctor may alter the dose or the frequency with which you take either or both of these medications.

  • Aluminum carbonate, basic
  • Aluminum phosphate
  • Aluminum hydroxide
  • Dihydroxyaluminum aminoacetate
  • Magaldrate
  • Dihydroxyaluminum sodium carbonate

List of drugs that interact with cholic acid

You should inform your doctor if you are currently taking any of the following medicines. Your dosage of either medicine may need to be altered. The following drugs have a moderate reaction with the use of cholic acid:

  • Acetaminophen / aspirin / caffeine / aluminum hydroxide / magnesium hydroxide
  • Aluminum carbonate
  • Alginic acid / aluminum hydroxide / magnesium carbonate
  • Aluminum hydroxide
  • Aluminum hydroxide / magnesium carbonate
  • Aluminum hydroxide / calcium carbonate / aspirin / magnesium hydroxide
  • Aluminum hydroxide / magnesium hydroxide
  • Aluminum hydroxide / mineral oil
  • Aluminum hydroxide / magnesium hydroxide / simethicone
  • Aluminum hydroxide / magnesium trisilicate
  • Aminophylline / ephedrine / phenobarbital / potassium iodide
  • Aminophylline / ephedrine / guaifenesin / phenobarbital
  • Atropine / hyoscyamine / phenobarbital / scopolamine
  • Belladonna / ergotamine / phenobarbital
  • Atropine / phenobarbital
  • Cholestyramine
  • Colestipol
  • Colesevelam
  • Cyclosporine
  • Ephedrine / phenobarbital / theophylline
  • Dyphylline / ephedrine / guaifenesin / phenobarbital
  • Ephedrine / phenobarbital / potassium iodide / theophylline
  • Letrozole / ribociclib
  • Hyoscyamine / phenobarbital
  • Phenobarbital
  • Sucralfate
  • Ribociclib
  • Sorafenib
  • Tipranavir

Other medical problems that can interact with this medication

Other medical problems present in your body could affect the use of cholic acid. Ensure you inform your doctor if you have any other medical problems, especially:

  • Familial hypertriglyceridemia or history of this illness: patients who suffer from this condition may need a higher dose of cholic acid.
  • Liver disease: patients with liver disease should exercise caution as cholic acid may make this condition worse.

Medications that are known to interact with cholic acid

You should inform your doctor if you are currently taking or have taken the following drugs.

  • Aluminum carbonate
  • Acetaminophen
  • Aluminum hydroxide
  • Colestipol
  • Atropine / phenobarbital
  • Cholestyramine
  • Belladonna / ergotamine / phenobarbital
  • Colesevelam
  • Cyclosporine
  • Dyphylline / ephedrine / guaifenesin / phenobarbital
  • Hyoscyamine / phenobarbital
  • Ephedrine / phenobarbital / potassium iodide / theophylline
  • Letrozole / ribociclib
  • Ribociclib
  • Phenobarbital
  • Sorafenib
  • Tipranavir
  • Sucralfate

Warnings

Use in pediatric patients

Studies that have been performed have not shown any pediatric-specific problems that could limit the useful nature of cholic acid in children three weeks of age and above. Studies have not been done on infants younger than three weeks.

Women who are breastfeeding

There have been no adequate studies in women for determining any risk to infants when using this medicine during breastfeeding. You should, with the guidance of your doctor, weigh up the potential benefits against the potential risks before choosing to take this drug whilst breastfeeding.

Women who are pregnant

This drug has been used without harmful effects and has not been assigned a warning under the US FDA pregnancy category. If taking this medication whilst pregnant, you should be monitored frequently during the pregnancy.

Use in geriatric patients

No appropriate studies have been conducted on the relationship of age to the effects of cholic acid, so there are no geriatric-specific problems that have been noted to date.

Storage

  • Always store this medication in a closed container away from direct light, heat, and moisture at room temperature. Ensure you prevent it from freezing.
  • Keep out of the reach of children.
  • Do not keep medicine you no longer need or medicine that is out of date.
  • Do pour any drugs down the drain or flush any drugs down the toilet unless you have been given instructions to do so. You need to dispose of this drug correctly once it is no longer needed. You should contact your nearest pharmacist for advice or more details on how to discard of your drug safely.

Summary

When used correctly, cholic acid (oral) is successful in treating patients with bile acid synthesis disorders. Due to the interactions possible, you should always remember to inform your doctor of any medications you are currently taking, including herbal products and vitamins. Patients should report any symptoms or signs of liver impairment.

They should also speak to their healthcare provider or doctor if they intend on becoming pregnant, have fallen pregnant or are currently breastfeeding. You should also inform your doctor of your entire past medical history, as some medications can interact with other illnesses. Failure to reveal this information could result in adverse side effects, some of which could being debilitating.