Obeticholic Acid

Is the active ingredient.

Treatment of primary biliary cholangitis (PBC) in adults with inadequate response to ursodeoxycholic acid.

Treatment of nonalcoholic steatohepatitis (NASH) with bridging fibrosis or advanced fibrosis (F3, F4).

Obetiace 10mg Tablet (Obeticholic Acid) is a farnesoid X receptor (FXR) agonist. By activating FXR, it modulates bile acid synthesis, reduces hepatic inflammation, and improves liver fibrosis. The exact mechanisms contributing to its efficacy in PBC and NASH are still being investigated, but the FXR activation plays a central role.

Store at 20°C to 25°C (68°F to 77°F). Protect from moisture.

Dosage and frequency should be determined by a healthcare professional and may vary depending on the condition being treated and the patient's response.

PBC: Typically starts with a low dose and is gradually increased as tolerated.

NASH: Follow the prescribing information provided by your physician.

Itching

Fatigue

Nausea

Diarrhea

Headache

Increased cholesterol levels (particularly LDL cholesterol)

Elevated liver enzymes

Pruritus (severe itching)

Elevated blood pressure

Gallstones

Increased risk of infections

Alcohol Consumption

Alcohol consumption may exacerbate liver damage; discuss alcohol intake with your doctor.



While Driving or operating Machinery

Obeticholic acid may cause fatigue and dizziness; avoid driving or operating machinery if affected.



Pregnant & Breastfeeding Women

Not recommended during pregnancy or breastfeeding; consult your doctor about contraception.



Children

Not approved for use in children.



Kidney

Use caution in patients with moderate to severe kidney disease; may require dose adjustment.



Liver

Use caution in patients with pre-existing liver disease; monitor liver function regularly.

Please consult your doctor or pharmacist for specific references and package insert information.