cholic acid: clinical use

Prescribing considerations

• Initiation and ongoing management require an experienced hepatology or gastroenterology specialist.
• Evidence is limited because the licensed disorders are exceptionally rare.
• Use close supervision in pre-existing hepatic impairment; experience in unrelated hepatic impairment, renal impairment and older people is limited.
• Familial hypertriglyceridaemia may reduce intestinal absorption.

Contraindications and cautions

• Hypersensitivity to cholic acid or an excipient
• Concurrent phenobarbital or primidone
• The lactose-containing formulation is unsuitable in galactose intolerance, total lactase deficiency or glucose-galactose malabsorption

Monitoring

• Serum or urine bile-acid profiles, including abnormal metabolites
• Liver parameters, including ALT, GGT and hepatocellular synthetic function
• Clinical response, adherence and features suggesting excessive exposure such as persistent itching or diarrhoea
• Closer reassessment during rapid growth, intercurrent illness, pregnancy or changes from another bile-acid preparation

Clinical pharmacology

Exogenous cholic acid restores bile-acid-dependent bile flow and suppresses cholesterol 7α-hydroxylase through negative feedback, reducing hepatotoxic atypical metabolites. It undergoes enterohepatic circulation; product-specific pharmacokinetic studies are unavailable.

Formulation and product differences

• Hard capsules contain 50 mg or 250 mg cholic acid.
• The 50 mg capsule is blue and white; the 250 mg capsule is green and white.
• Both strengths contain lactose and bovine-derived gelatin; colourants differ between strengths.
• Capsules may be opened for infants and children who cannot swallow them, using the supported liquids described in the product information.

Capsule

Route: Oral

Strengths: 50 mg, 250 mg