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 an oral formulation for oral use. It assists in the physiological process of bile flow and supports the digestion and absorption of dietary fats in patients requiring bile acid supplementation.

GNH India supplies Orphacol as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, transplant centres, oncology centres, pharmacies and clinics worldwide. The company adheres to stringent quality standards and provides regulatory documentation to facilitate import and distribution across global markets.

Manufacturer / TM Owner

Theravia

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Indications & Clinical Uses

  • Orphacol, a bile acid, is employed in conditions where bile flow or composition is impaired.
  • Primary bile acid synthesis deficiency: helps restore a normal bile acid pool and improves fat absorption.
  • Cholestatic liver disease: supports bile flow and may alleviate symptoms of cholestasis.
  • Fat malabsorption due to bile acid deficiency: aids digestion of dietary fats.
  • Gallstone prevention: may reduce cholesterol saturation in bile.
  • Post‑cholecystectomy syndrome: assists in maintaining adequate bile flow.

How It Works

  • Cholic Acid acts as a primary bile acid that integrates into the enterohepatic circulation. After oral administration, it is absorbed in the intestine, returned to the liver via the portal vein, and incorporated into bile. This supplementation restores the bile acid pool, enhances micelle formation, and promotes the emulsification and enzymatic digestion of dietary lipids, facilitating their absorption.

Side Effects

Common Side Effects

  • Abdominal discomfort or cramping.
  • Diarrhea or loose stools.
  • Nausea or mild vomiting.
  • Flatulence or bloating.
  • Headache.
  • Constipation.

Serious or Rare Side Effects

  • Severe allergic reaction (anaphylaxis, rash, swelling).
  • Jaundice or marked elevation of liver enzymes.
  • Acute pancreatitis.
  • Worsening of cholestasis.
  • Hepatic failure in predisposed individuals.

Precautions & Warnings

Orphacol should be used with consideration of the following precautions:

  • Pregnancy: consult a healthcare professional before use.
  • Breastfeeding: evaluate risk versus benefit.
  • Renal impairment: monitor renal function and adjust use if necessary.
  • Existing liver disease: use under specialist supervision.
  • Potential drug interactions: review concomitant medications.
  • Store at ambient temperature: keep in original container, protect from moisture and direct sunlight.

Avoid Interactions

Major Interactions (Avoid)

  • Bile acid sequestrants: may significantly reduce cholic acid absorption.
  • Cyclosporine: increased risk of hepatotoxicity.
  • Warfarin: possible alteration of anticoagulant effect.

Moderate Interactions (Monitor Closely)

  • Oral contraceptives: may affect hormone levels.
  • Statins: monitor liver enzymes during combined therapy.

Frequently Asked Questions

Orphacol contains cholic acid, a bile acid used to support normal bile flow and improve the digestion and absorption of dietary fats. It is prescribed for patients with bile acid deficiency, certain cholestatic liver conditions, and fat malabsorption disorders where supplemental bile acids are indicated.

Cholic acid integrates into the body's enterohepatic circulation after oral intake. It replenishes the bile acid pool, enhances micelle formation, and promotes the emulsification of dietary lipids, thereby facilitating enzymatic breakdown and absorption of fats in the small intestine.

The dosage of Orphacol is individualized and set by the prescribing healthcare professional based on the patient’s condition, age, weight, and response to therapy. Specific dosing regimens are not provided here and should be obtained from a qualified prescriber.

Safety data for cholic acid in pregnancy and lactation are limited. Use of Orphacol during pregnancy or while breastfeeding should only occur after a risk‑benefit assessment by a qualified healthcare provider. The prescriber will determine if the potential benefits outweigh any possible risks.

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. After submission, the sales team will verify trade or institutional credentials, then provide pricing, availability, shipping details, and any required import documentation.

Orphacol provides cholic acid, a primary bile acid, whereas alternatives such as ursodeoxycholic acid (UDCA) are secondary bile acids with different therapeutic profiles. Cholic acid is typically used for primary bile acid deficiency, while UDCA is often employed for cholestatic liver diseases like primary biliary cholangitis. The choice depends on the specific clinical indication and physician judgment.

Store Orphacol at ambient temperature, preferably below 25 °C. Keep the product in its original packaging, protect it from moisture and direct sunlight, and ensure the container is tightly closed to maintain stability throughout its shelf life.

Orphacol is taken orally, usually with water. The exact timing (e.g., with meals or on an empty stomach) and frequency are determined by the prescribing clinician based on the patient’s therapeutic needs and tolerance.

Serious risks include severe allergic reactions such as anaphylaxis, marked liver enzyme elevations leading to jaundice, acute pancreatitis, and worsening of cholestasis in susceptible individuals. Patients should be monitored for signs of liver dysfunction, abdominal pain, or hypersensitivity and seek medical attention promptly if they occur.

Orphacol should be avoided in individuals with known hypersensitivity to cholic acid or any excipients in the formulation. Patients with severe liver failure, uncontrolled cholestasis, or those taking medications that have major contraindicated interactions (e.g., certain bile‑acid sequestrants) should not use this product without specialist guidance.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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