Each film tablet contains : Obeticholic Acid Tablets 5mg
Obeticholic acid is indicated for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA. It is also used as a monotherapy in adults with PBC that are unable to tolerate UDCA.
Obeticholic acid is currently being considered for FDA approval to treat fibrosis caused by non-alcoholic liver steatohepatitis (NASH), and is likely to be approved for this indication in 2020.
Primary biliary cholangitis (PBC) is a chronic liver disease that can destroy bile ducts in the liver and may lead to cirrhosis (scarring of the liver) and liver failure. PBC is a progressive disease that may have no symptoms for many years.
Obeticholic acid is used to treat PBC in adults who have not developed liver cirrhosis. Obeticholic acid is sometimes used with another drug called ursodeoxycholic acid (UDCA)
SIDE EFFECTS :
- new or worsening feelings of weakness, tiredness, dizziness, or drowsiness;
- confusion, mood or behavior changes, slurred speech;
- severe itching;
- fever, chills, less urination.