Orphacol (Cholic Acid)

Orphacol (cholic acid) is used to address disorders of bile acid deficiency and related fat malabsorption conditions.

• Bile acid deficiency: restores deficient bile acids, improving fat digestion.
• Fat malabsorption: enhances emulsification of dietary fats, increasing nutrient absorption.
• Cholesterol gallstone dissolution: reduces cholesterol saturation in bile, aiding dissolution of cholesterol gallstones.

• Cholic acid acts as a primary bile acid that replaces endogenous bile acids lacking in the enterohepatic circulation. By integrating into micelles, it lowers the critical micellar concentration, promotes the emulsification of dietary lipids, and facilitates the enzymatic breakdown and intestinal absorption of fats and fat‑soluble vitamins.

Adverse reactions may occur with oral cholic acid therapy.

Common Side Effects

• Abdominal discomfort: mild pain or cramping in the stomach area.
• Diarrhea: increased loose stools, often transient.
• Nausea: sensation of unease or urge to vomit.
• Flatulence: excess gas production.
• Constipation: reduced bowel movements.
• Headache: mild to moderate head pain.

Serious or Rare Side Effects

• Allergic reactions: rash, urticaria, or angioedema.
• Hepatic enzyme elevation: increased ALT or AST levels.
• Severe abdominal pain: persistent or worsening pain.
• Pancreatitis: inflammation of the pancreas, presenting with intense abdominal pain.
• Cholestasis: impaired bile flow leading to jaundice.
• Anaphylaxis: rare, life‑threatening systemic reaction.

Before initiating therapy, consider the following precautions.

• Assess bile acid status: evaluate deficiency prior to prescribing.
• Monitor nutritional status: watch for changes in fat‑soluble vitamin levels.
• Hepatic impairment: use with caution in patients with liver disease.
• Hypersensitivity: avoid in individuals with known allergy to cholic acid.
• Pregnancy and lactation: safety not established; consult a healthcare professional.
• Store at ambient temperature: keep in the original container, protect from moisture and light.

Cholic acid may interact with other medicines; review the following.

Major Interactions (Avoid)

• Bile acid sequestrants (e.g., cholestyramine): bind cholic acid and markedly reduce its absorption.
• Certain antibiotics (e.g., rifampin): may alter gut flora affecting bile acid metabolism.

Moderate Interactions (Monitor Closely)

• Warfarin: changes in vitamin K absorption could affect anticoagulation control.
• Oral contraceptives: altered enterohepatic recycling may modify hormone levels.
• Statins: potential impact on cholesterol metabolism.
• Fat‑soluble vitamin supplements: monitor for excess or deficiency.
• Other bile acid preparations: additive effects on bile composition.