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Cholic Acid

Medically reviewed by Drugs.com. Last updated on Sep 22, 2020.

Pronunciation

(KOE lik AS id)

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule, Oral:

Cholbam: 50 mg, 250 mg

Brand Names: U.S.

  • Cholbam

Pharmacologic Category

  • Bile Acid

Pharmacology

Cholic acid, a primary bile acid, enhances bile flow and provides the physiologic feedback inhibition of bile acid synthesis to maintain bile acid homeostasis.

Absorption

Absorbed by passive diffusion along the gastrointestinal tract. Patients with concomitant familial hypertriglyceridemia may have poor absorption.

Metabolism

Hepatic; conjugated by bile acid- enzymes. Conjugated cholic acid is secreted into bile. It is reabsorbed in the ileum, and enters another cycle of enterohepatic circulation.

Excretion

Feces

Use: Labeled Indications

Bile acid synthesis disorders: Treatment of bile acid synthesis disorders due to single enzyme defects (SEDs).

Peroxisomal disorders: Adjunctive treatment of peroxisomal disorders (PDs) in patients who exhibit manifestations of hepatic disease, steatorrhea, or complications from decreased fat soluble vitamin absorption.

Limitations of use: Safety and effectiveness of cholic acid on extrahepatic manifestations of bile acid synthesis disorders due to SEDs or PDs have not been established.

Contraindications

There are no contraindications listed in the manufacturer's labeling.

Dosing: Adult

Bile acid synthesis disorders: Oral: 10 to 15 mg/kg (once daily or in 2 divided doses); administer 11 to 17 mg/kg (once daily or in 2 divided doses) in patients with concomitant familial hypertriglyceridemia.

Peroxisomal disorders: Oral: 10 to 15 mg/kg (once daily or in 2 divided doses); administer 11 to 17 mg/kg (once daily or in 2 divided doses) in patients with concomitant familial hypertriglyceridemia.

Dosing: Pediatric

Bile acid synthesis disorders or peroxisomal disorders (eg, Zellweger spectrum disorders): Infants, Children, and Adolescents: Oral: 10 to 15 mg/kg/day once daily or in divided doses twice daily; round dose to nearest available capsule sizes (50 mg or 250 mg). Allow 3 months of treatment to assess therapeutic effect (eg, clinical response parameters: LFTs, bilirubin, PT/INR, steatorrhea); use the lowest dose that effectively maintains liver function; discontinue if hepatic function does not improve within 3 months of starting treatment.

Dosing adjustment for familial hypertriglyceridemia (including newly diagnosed or family history of): Note: Patients with hypertriglyceridemia have malabsorption of cholic acid requiring 10% higher doses: Infants, Children, and Adolescents: Oral: 11 to 17 mg/kg/day once daily or in divided doses twice daily; round dose to nearest available capsule sizes (50 mg or 250 mg).

Administration

Oral: Administer (once daily or in 2 divided doses) with food; do not crush or chew capsules. Take at least 1 hour before or 4 to 6 hours after bile acid binding resin or aluminum-based antacid.

For patients unable to swallow capsules, contents may be mixed with 15 to 30 mL of infant formula, expressed breast milk, or soft food such as mashed potatoes or apple puree. Stir for 30 seconds and administer immediately. Capsule contents will remain as fine granules in the milk or food and will not dissolve.

Dietary Considerations

Administer with food.

Storage

Store at 20°C to 25°C (69°F to 77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F).

Drug Interactions

Aluminum Hydroxide: May decrease the absorption of Cholic Acid. Management: Administer cholic acid at least 1 hour before or 4 to 6 hours after administration of any aluminum hydroxide-containing products to minimize the potential for a significant interaction. Consider therapy modification

Bile Acid Sequestrants: May decrease the absorption of Cholic Acid. Management: Administer cholic acid at least 1 hour before or 4 to 6 hours after administration of any bile acid-binding products to minimize the potential for a significant interaction. Consider therapy modification

BSEP/ABCB11 Inhibitors: May decrease the excretion of Cholic Acid. Management: Avoid the use of bile salt efflux pump inhibitors with cholic acid. If such a combination cannot be avoided, monitor serum transaminases (eg, AST, ALT) and bilirubin closely. Consider therapy modification

Sevelamer: May decrease the absorption of Cholic Acid. Management: Administer cholic acid at least 1 hour before or 4 to 6 hours after administration of any bile acid-binding products, such as sevelamer, to minimize the potential for a significant interaction. Consider therapy modification

Sucralfate: May decrease the absorption of Cholic Acid. Management: Administer cholic acid at least 1 hour before or 4 to 6 hours after administration of aluminum-containing products such as sucralfate to minimize the potential for a significant interaction. Consider therapy modification

Adverse Reactions

>10%:

Gastrointestinal: Cholestasis (≤14%, exacerbation)

Hepatic: increased serum bilirubin ( ≤14%), increased serum transaminases ( ≤14%)

1% to 10%:

Central nervous system: Malaise (≤1%), peripheral neuropathy (≤1%)

Dermatologic: Skin lesion (≤1%)

Gastrointestinal: Diarrhea (1% to 2%), abdominal pain (≤1%), intestinal polyps (≤1%), nausea (≤1%), reflux esophagitis (≤1%)

Genitourinary: Urinary tract infection (≤1%)

Hepatic: Hepatic disease (6%, exacerbation), jaundice (≤1%)

<1%, postmarketing, and/or case reports: Cholelithiasis (3β-HSD deficient patient)

Warnings/Precautions

Disease-related concerns:

• Hepatic impairment: Monitor liver function tests (eg, aspartate aminotransferase [AST], alanine aminotransferase [ALT], gamma glutamyltransferase [GGT], alkaline phosphatase [ALP], bilirubin and INR) monthly for the first 3 months. Discontinue if hepatic function does not improve within 3 months of starting treatment, if complete biliary obstruction develops, or if there are persistent clinical or laboratory indicators of worsening hepatic function or cholestasis; continue to monitor hepatic function and consider restarting a lower dose when parameters return to baseline. Concurrent elevations of GGT and ALT may indicate cholic acid overdose.

Other warnings/precautions:

• Experienced physician: Treatment should be initiated and monitored by an experienced hepatologist or pediatric gastroenterologist.

Monitoring Parameters

Monitor AST, ALT, GGT, ALP, bilirubin and INR every month for the first 3 months, every 3 months for the next 9 months, every 6 months during the next 3 years, and annually thereafter. Monitor more frequently during periods of rapid growth, concomitant disease, and pregnancy.

Pregnancy Considerations

Animal reproduction studies have not been conducted. Information related to the use of cholic acid during pregnancy is limited. Tests of hepatic function should be monitored closely.

A registry is available for women exposed to cholic acid during pregnancy. Patients or their health care provider should call 844-202-6262 to enroll.

Patient Education

What is this drug used for?

• It is used to treat certain bile acid problems caused by single enzyme defects (SEDs).

• It is used to treat peroxisomal disorders like Zellweger spectrum disorders.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Diarrhea

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Liver problems like dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or yellow skin.

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.