Product Overview of Obeticholic Acid Tablet
Obeticholic Acid is a prescription liver disease medicine used primarily in the treatment of Primary Biliary Cholangitis (PBC), a chronic autoimmune liver condition. It is often prescribed for patients who have an inadequate response or intolerance to ursodeoxycholic acid (UDCA).
🔬 Product Information of Obeticholic Acid Tablet
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Generic Name: Obeticholic Acid
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Dosage Form: Tablet
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Category: Hepatology / Liver Disease Medicine
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Therapeutic Class: Farnesoid X Receptor (FXR) Agonist
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Route of Administration: Oral
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Prescription Status: Prescription Only
🧬 Mechanism of Action
Obeticholic Acid is a selective FXR agonist that helps regulate bile acid synthesis and transport in the liver. By reducing bile acid accumulation, it improves liver function and slows disease progression in patients with PBC.
🩺 Indications / Uses
Obeticholic Acid is used in:
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Primary Biliary Cholangitis (PBC)
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Patients with inadequate response to UDCA
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Patients intolerant to ursodeoxycholic acid
(Treatment should be initiated and monitored by a liver specialist.)
💊 Dosage & Administration
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Dosage is determined by a healthcare professional
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Taken orally, usually once daily
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Can be taken with or without food
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Dose adjustment may be required in hepatic impairment
⚠️ Always follow the prescribed dosage and medical advice.
⚠️ Possible Side Effects
Common side effects may include:
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Pruritus (itching)
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Fatigue
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Abdominal discomfort
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Joint pain
Serious side effects (rare):
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Worsening liver function
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Severe itching requiring treatment modification
👉 Contact a doctor if severe or persistent side effects occur.
🚫 Precautions & Warnings
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Not recommended in decompensated cirrhosis
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Regular liver function monitoring required
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Use with caution in advanced liver disease
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Pregnancy and breastfeeding: use only if prescribed
🔄 Drug Interactions
May interact with:
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Bile acid sequestrants
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Warfarin
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Certain cholesterol-lowering medicines
Always inform your doctor about all medications you are taking.
📦 Storage Instructions
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Store below 30°C
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Protect from light and moisture
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Keep out of reach of children
🌍 International Market Information
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Prescription-only hepatology medicine
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Suitable for regulated and semi-regulated markets
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Export subject to destination country regulatory approval
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Documentation available as per importer requirements
Frequently Asked Questions (FAQ)
What is Obeticholic Acid used for?
It is used to treat primary biliary cholangitis (PBC), a chronic liver disease.Is Obeticholic Acid a steroid?
No, it is an FXR agonist, not a steroid.Can Obeticholic Acid replace UDCA?
It is used when UDCA is ineffective or not tolerated.
