Product image of Orphacol (Cholic Acid) supplied by GNH India

Orphacol

Active Ingredient:
Cholic Acid
Origin:
EU

Orphacol (Cholic Acid)

Cholic acid, the active ingredient in Orphacol, is a bile acid presented as a pharmaceutical‑grade oral formulation for oral use. It is used to treat inherited bile acid synthesis disorders and primary bile acid deficiency in pediatric and adult patients.

GNH India supplies Orphacol as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, transplant centres and pharmacies worldwide, ensuring quality‑assured product availability across global markets. The company adheres to stringent manufacturing standards and provides regulatory support for import and distribution.

Manufacturer / TM Owner

Theravia

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Indications & Clinical Uses

Orphacol (cholic acid) is used in disorders of bile acid metabolism to restore a normal bile acid pool.

  • Bile acid synthesis disorders: restores deficient endogenous bile acids and improves fat digestion.
  • Primary bile acid deficiency: replaces missing cholic acid to support normal hepatic function.
  • Post‑cholecystectomy supplementation: aids in the digestion of dietary fats after gallbladder removal.

How It Works

  • Cholic acid is a primary bile acid that directly supplements the endogenous bile acid pool. After oral administration it is absorbed in the intestine, conjugated in the liver and secreted into bile, where it activates the farnesoid X receptor (FXR) and promotes micelle formation. This enhances emulsification and absorption of dietary lipids and fat‑soluble vitamins, and normalizes feedback regulation of bile acid synthesis.

Side Effects

Adverse reactions to Orphacol are generally related to gastrointestinal tolerance and, rarely, to systemic hypersensitivity.

Common Side Effects

  • Diarrhea: loose stools occurring after initiation.
  • Nausea: feeling of sickness or urge to vomit.
  • Abdominal pain: cramping or discomfort in the stomach area.
  • Flatulence: increased intestinal gas.

Serious or Rare Side Effects

  • Hepatotoxicity: elevated liver enzymes indicating liver injury.
  • Anaphylaxis: severe allergic reaction with rash, swelling, and breathing difficulty.
  • Pancreatitis: inflammation of the pancreas presenting with severe abdominal pain.

Precautions & Warnings

When prescribing Orphacol, clinicians should consider several safety precautions to minimize risk.

  • Monitor liver function: obtain baseline and periodic liver enzyme tests.
  • Assess for gallstone disease: avoid use in patients with active gallstones as it may alter bile composition.
  • Use caution in malabsorption syndromes: evaluate gastrointestinal tolerance before chronic therapy.
  • Avoid in known hypersensitivity: discontinue if allergic reactions occur.
  • Store at room temperature: keep in original container, protect from moisture and light.

Avoid Interactions

Cholic acid may interact with other medicines that affect bile acid metabolism or absorption.

Major Interactions (Avoid)

  • Bile acid sequestrants: bind cholic acid and markedly reduce its absorption.
  • Fat‑soluble vitamin supplements: may have impaired absorption when taken concurrently.
  • Antacids (aluminum or magnesium): can alter gastric pH and affect cholic acid uptake.

Moderate Interactions (Monitor Closely)

  • Statins: concurrent use may require liver function monitoring.
  • Rifampin: enzyme induction may change cholic acid metabolism.
  • Warfarin: possible alteration of INR, necessitating coagulation monitoring.

Frequently Asked Questions

Orphacol contains cholic acid, a primary bile acid used to replace deficient endogenous bile acids in patients with inherited bile acid synthesis disorders and primary bile acid deficiency. By restoring a normal bile acid pool, it helps improve digestion and absorption of dietary fats and fat‑soluble vitamins.

Cholic acid supplements the natural bile acid pool. After oral intake it is absorbed, conjugated in the liver and secreted into bile where it activates the farnesoid X receptor (FXR). This activation promotes micelle formation, enhances lipid emulsification, and normalizes feedback control of bile acid synthesis.

The dosage of Orphacol is individualized. A qualified prescriber determines the appropriate amount based on the patient’s age, weight, severity of the bile acid disorder, and clinical response. No fixed dosing regimen is provided in public literature.

Safety data for cholic acid during pregnancy and lactation are limited. It should only be used if the potential benefit to the mother outweighs any possible risk to the fetus or infant. Clinicians should discuss potential risks and monitor both mother and child closely.

To order Orphacol, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide, and will request trade or institutional credentials. The team then replies with pricing, availability, shipping details (including cold‑chain if required) and necessary import documentation.

The most common alternative for bile acid replacement is ursodeoxycholic acid (UDCA). While UDCA is primarily used for cholestatic liver diseases, cholic acid directly replaces the missing primary bile acid, offering a more physiological restoration of the bile acid pool in genetic synthesis disorders. Choice depends on the specific disorder and physician assessment.

Orphacol should be stored at room temperature, below 25 °C. Keep the product in its original packaging, protect it from moisture and direct light, and ensure the container is tightly closed to maintain stability.

Orphacol is administered orally. The powder is typically reconstituted in water or a suitable liquid as directed by the prescriber and taken with or without food, depending on individual tolerance and therapeutic guidance.

Serious risks include hepatotoxicity, manifested by elevated liver enzymes, and rare hypersensitivity reactions such as anaphylaxis. Pancreatitis has also been reported. Patients should be instructed to seek immediate medical attention if they experience severe abdominal pain, jaundice, rash, swelling, or breathing difficulties.

Orphacol should be avoided in individuals with known hypersensitivity to cholic acid or any excipients in the formulation. It is also contraindicated in patients with active gallstone disease where alteration of bile composition could exacerbate symptoms.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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