Obeticholic Acid 10 mg Tablet: View Uses, Benefits, Side Effects, And More.

Obeticholic Acid 10 mg tablet is a prescription medication used primarily in the management of chronic liver diseases, particularly primary biliary cholangitis (PBC)—a progressive autoimmune liver condition. This tablet belongs to a class of drugs known as farnesoid X receptor (FXR) agonists, which play a vital role in regulating bile acid levels in the liver and intestines. Obeticholic acid is used alone or in combination with ursodiol to treat primary biliary cholangitis. 

In recent years, obeticholic acid 10 mg has emerged as a breakthrough treatment for patients who do not respond adequately to first-line therapies like ursodeoxycholic acid (UDCA). In this comprehensive guide, we explore everything you need to know about this medication—including its uses, benefits, side effects, dosage guidelines, and safety precautions.

What is Obeticholic Acid 10 mg?

Obeticholic acid 10 mg tablet is a synthetic bile acid analog designed to activate FXR receptors. These receptors are involved in controlling bile acid production and secretion in the liver. When activated, they help reduce bile acid accumulation, which is a key factor in liver cell damage in PBC and other cholestatic liver diseases.

The drug is FDA-approved for use in combination with UDCA in adults with an inadequate response or as monotherapy in adults who are intolerant to UDCA.

Obeticholic Acid 10 mg Uses

Understanding the obeticholic acid 10 mg uses is important for both patients and caregivers. Its primary indications include:

1. Primary Biliary Cholangitis (PBC)

This is the most common use. PBC is a chronic disease that damages the small bile ducts in the liver, leading to bile build-up, inflammation, and scarring. Obeticholic acid 10 mg Tablet helps reduce bile acid toxicity and slow disease progression.

2. Liver Function Support

For patients with impaired liver function or inflammation due to bile acid buildup, obeticholic acid helps regulate this balance by activating FXR pathways, which reduce bile acid synthesis.

3. Clinical Trials for NASH

Although not yet approved for this indication, obeticholic acid 10 mg has shown promise in clinical trials for non-alcoholic steatohepatitis (NASH)—a more severe form of non-alcoholic fatty liver disease (NAFLD). 

How Does Obeticholic Acid 10 mg Tablet Work?

The mechanism of action of obeticholic acid lies in its ability to stimulate the farnesoid X receptor (FXR). FXR is a nuclear receptor primarily found in the liver and intestines that regulates bile acid production.

By activating FXR:

• It reduces bile acid synthesis in the liver.

• Promotes bile acid excretion.

• Decreases inflammation and fibrosis (scarring) in the liver.

• Supports cholesterol and glucose metabolism.

This multifaceted approach helps protect liver cells and prevent long-term complications, such as cirrhosis or liver failure.

Benefits of Obeticholic Acid 10 mg Tablet

Patients taking obeticholic acid 10 mg tablets can experience a wide range of benefits, particularly when they do not respond well to traditional medications. Here are the most important advantages:

Improves Liver Biomarkers

The medication significantly reduces alkaline phosphatase (ALP) levels—a key marker for liver inflammation and damage in PBC.

Slows Disease Progression

Obeticholic acid helps delay the progression of PBC and reduces the risk of cirrhosis and liver failure when taken regularly.

Alternative for UDCA-Intolerant Patients

For those who cannot tolerate ursodeoxycholic acid, obeticholic acid provides a well-tolerated and effective alternative.

Supports Better Quality of Life

By controlling fatigue, itching, and other symptoms of PBC, this medication helps improve the overall well-being of patients.

Once-Daily Dosing

The convenient once-daily dose supports better adherence and long-term treatment success.

Dosage and Administration

The typical starting dose of obeticholic acid is:

5 mg once daily, which may be increased to 10 mg once daily based on patient response and tolerance.

Dosage may vary based on liver function tests and specific medical conditions. The tablets should be swallowed whole with or without food. It is important to follow your doctor's instructions precisely.

Patients with advanced liver disease or cirrhosis (Child-Pugh Class B or C) should be closely monitored, and dose adjustments may be required to prevent complications.
 

Side Effects of Obeticholic Acid 10 mg Tablet

While generally well-tolerated, obeticholic acid 10 mg tablets may cause some side effects. These can be mild, moderate, or rarely severe, depending on the individual’s response.

Common Side Effects:

• Itching (Pruritus) – the most commonly reported side effect

• Fatigue

• Abdominal pain

• Nausea

• Joint pain
   

Less Common Side Effects:

• Rash or skin irritation

• Constipation or diarrhea

• Dizziness

• Swelling in legs or ankles
   

Serious Side Effects (Rare):

• Worsening of liver function in patients with cirrhosis

• Hepatic decompensation

• Liver-related hospitalization
   

Always report any unusual or persistent symptoms to your healthcare provider. Regular liver function monitoring is essential during treatment.

Precautions and Safety Advice

If you're considering or already taking obeticholic acid 10 mg, keep the following safety guidelines in mind:

• Do not take this medication without a prescription and proper diagnosis.

• Regular liver function tests are mandatory during treatment.

• Avoid use during pregnancy or breastfeeding unless prescribed by a healthcare provider.

• Limit alcohol intake to avoid extra strain on the liver.

• Inform your doctor about all other medications and supplements to avoid potential interactions.

Why Choose Steris Healthcare For Obeticholic Acid 10 mg Tablet.

Steris Healthcare Pvt Ltd stands out as a reliable and quality-driven pharmaceutical provider, and its Obeticholic Acid 10 mg Tablet is a prime example of excellence in liver care therapeutics. This medication, primarily used for managing primary biliary cholangitis (PBC), is developed with a commitment to purity, consistency, and clinical efficacy. Manufactured in WHO-GMP-certified facilities, Steris Healthcare ensures that every tablet meets stringent quality control standards, providing patients and healthcare professionals with confidence in its safety and performance.

What truly sets Steris Healthcare apart is its patient-centric approach. The Obeticholic Acid 10 mg Tablet is formulated with bioavailability and tolerability in mind, minimizing side effects while maximizing therapeutic outcomes. It helps reduce bile acid build-up in the liver, slowing disease progression and improving liver function over time.

Moreover, Steris Healthcare is known for its affordability and accessibility, making critical medications like Obeticholic Acid more attainable across India. Their transparent labeling, responsive customer support, and adherence to regulatory standards make them a trusted choice among doctors and patients alike.