Obeticholic Acid is indicated for the treatment of primary biliary cholangitis (PBC) in adults.
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It is not known if alcohol interacts with FXR 5mg Tablet
If you are pregnant, it is advisable to consult your doctor before taking FXR 5mg Tablet. Limited information is available about the use of this medication during pregnancy, so the potential risks and benefits should be discussed with your healthcare provider.
For breastfeeding mothers, it is recommended to consult your doctor. Your healthcare provider will determine whether FXR 5mg Tablet can be taken while breastfeeding, considering the potential impact on both the mother and the breastfed infant.
FXR 5mg Tablet is generally safe for driving if prescribed. However, if you experience dizziness as a side effect of the medication, it is advised to avoid driving or operating heavy machinery to ensure
If you have kidney impairment or any concerns related to your kidney function, it is advisable to consult your doctor.
Individuals with liver impairment or concerns related to their liver function should consult their doctor. Dose adjustments may be necessary, and your healthcare provider can provide guidance on the appropriate use of FXR 5mg Tablet in such cases. It's important to inform your doctor if you have or have liver cirrhosis.
Primary biliary cirrhosis
Obeticholic Acid works by decreasing the production of bile in the liver and promoting the removal of bile from your liver.
Primary biliary cholangitis (PBC), formerly known as primary biliary cirrhosis, is an autoimmune liver disease characterized by progressive damage to the small bile ducts in the liver. These tiny tubes, known as bile ducts, are responsible for transporting bile, a digestive fluid produced by the liver, to the small intestine. Bile plays a crucial role in the digestion and absorption of dietary fats.
In PBC, the body's immune system mistakenly targets and damages the bile ducts, leading to their inflammation and destruction. As a result, bile accumulates in the liver, causing a range of problems, including liver damage and scarring (fibrosis) over time. This continuous damage to the liver can eventually lead to cirrhosis, which is characterized by extensive scarring and impaired liver function.
PBC is considered an autoimmune disease because the immune system's attack on the bile ducts is an abnormal immune response. The exact cause of PBC is not fully understood, but genetic, environmental, and immunological factors likely play a role in its development.
Patients with PBC may experience various symptoms, including fatigue, itching (pruritus), dry eyes and mouth (Sjögren's syndrome), and, in more advanced stages, complications of liver cirrhosis. Early diagnosis and treatment are crucial to manage the condition and prevent further liver damage.
The primary treatment for PBC is ursodeoxycholic acid (UDCA), which helps manage symptoms and slow disease progression. Obeticholic acid, as described earlier, is another medication that may be used in combination with UDCA or as monotherapy in cases where UDCA is not effective or tolerated.
Regular monitoring and management of PBC are essential to maintain liver health and improve the quality of life for affected individuals.
Obeticholic acid's mechanism of action involves activating the Farnesoid X receptor (FXR), which is a nuclear receptor found in the liver and gut. FXR plays a vital role in regulating various pathways, including those related to bile acids, inflammation, fibrosis, and metabolism. When obeticholic acid activates FXR, it triggers several changes in the body:
Adult Dose:
Administration:
Obeticholic Acid is contraindicated in patients with complete biliary obstruction.
There is insufficient human data on the use of Obeticholic Acid during pregnancy to establish the risk associated with the drug. There is no information on the presence of Obeticholic Acid in human milk, its effects on breastfed infants, or its impact on milk production.
Store between 15°C and 30°C in a dry, light-protected place. Keep it out of reach of children.
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