Cholic acid is a bile acid. Bile acids are produced naturally in the body to aid in digestion of fats and certain nutrients.

People with bile acid disorders are unable to produce cholic acid normally. This can make it harder for the body to absorb nutrients important for health, growth, and body functioning. Abnormal bile acids can also build up in the body and become toxic to the liver.

Cholic acid is used in people with bile acid disorders. cholic acid works by normalizing bile acid production in the body.

Cholic acid may also be used for purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take with food.

Swallow the capsule whole and do not crush or chew it.

If you cannot swallow a capsule whole, open it and sprinkle the medicine into a spoonful of soft food. If you are giving cholic acid to a young child, mix the medicine with a small amount of baby formula or breast milk. Stir the mixture for 30 seconds and use it right away. Do not save the mixture for later use.

Cholic acid comes in different capsule sizes. Your dose may require that you take only 1 capsule per day or up to 8 capsules per day. Cholic acid doses are based on weight and you may need to use two different capsule sizes to make up your entire dose. Follow your doctor's dosing instructions very carefully.

The recommended dose of cholic acid increases with every few pounds gained as you grow from infancy to adulthood. Tell your doctor if you have any changes in weight.

You will need frequent medical tests.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Bile Acid Synthesis Disorders:

Initial dose: 10 to 15 mg/kg orally once a day or in 2 divided doses

Patients with Concomitant Familial Hypertriglyceridemia:
Initial dose: 11 to 17 mg/kg orally once a day or in 2 divided doses

Maintenance dose: The lowest dose that effectively maintains liver function

Comments:
-Adequacy of dosing should be determined by patient monitoring of clinical response and laboratory values; monitor more frequently during periods of rapid growth, concomitant disease, and pregnancy
-Concurrent elevations of serum gamma glutamyltransferase (GGT) and ALT may indicate cholic acid overdose.

Uses:
-For the treatment of bile acid synthesis disorders due to single enzyme defects
-As adjunctive treatment of peroxisomal disorders including Zellweger spectrum disorders in patients who exhibit manifestations of liver disease, steatorrhea, or complications from decreased fat soluble vitamin absorption.

Usual Pediatric Dose for Bile Acid Synthesis Disorders:

Initial dose: 10 to 15 mg/kg orally once a day or in 2 divided doses

Patients with Concomitant Familial Hypertriglyceridemia:
Initial dose: 11 to 17 mg/kg orally once a day or in 2 divided doses

Maintenance dose: The lowest dose that effectively maintains liver function

Comments:
-Adequacy of dosing should be determined by patient monitoring of clinical response and laboratory values; monitor more frequently during periods of rapid growth, concomitant disease, and pregnancy
-Concurrent elevations of serum gamma glutamyltransferase (GGT) and ALT may indicate cholic acid overdose.

Uses:
-For the treatment of bile acid synthesis disorders due to single enzyme defects
-As adjunctive treatment of peroxisomal disorders including Zellweger spectrum disorders in patients who exhibit manifestations of liver disease, steatorrhea, or complications from decreased fat soluble vitamin absorption.

Tell your doctor if you have ever had:

• liver disease; or

• if you also use cyclosporine.

Tell your doctor if you are pregnant or breastfeeding.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of cholic acid on the baby.

Do not give cholic acid to a child without medical advice. Cholic acid is not approved for use by anyone younger than 3 weeks old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

When you take your cholic acid dose, avoid taking other medicines by mouth at the same time. Since cholic acid aids in digestion, it can affect how well your body absorbs any other medicines you need to take. Take cholic acid at least 1 hour before or 4 to 6 hours after you take:

• cholestyramine;

• colesevelam;

• colestipol; or

• an antacid that contains aluminum--Acid Gone, Di-Gel, Gaviscon, Gelusil, Maalox, Mylagen, Mylanta, Rulox, and others.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Cholic acid may cause serious side effects. Call your doctor at once if you have:

• blood in your stools, changes in your bowel habits (such as diarrhea or constipation);

• pain or burning when you urinate; or

• liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects of cholic acid may include:

• heartburn, acid reflux;

• nausea, diarrhea, stomach pain;

• painful urination;

• general ill feeling;

• jaundice;

• skin sores; or

• numbness, tingling, or burning pain in your hands or feet.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may affect cholic acid, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.