Obeliva 5mg Tablet is used for the treatment of a liver disease called primary biliary cirrhosis in adults.
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Obeticholic Acid is prescribed to treat primary biliary cholangitis (PBC) in individuals who have not responded well to UDCA, as well as cholestatic liver disease and non-alcoholic fatty liver disease (NAFLD), which includes non-alcoholic steatohepatitis (NASH).
It is not known if alcohol interacts with Obeticholic Acid.
Obeliva 5mg Tablet is not advisable for use during pregnancy. It is recommended to consult your doctor before taking Obeliva 5mg Tablet if you are pregnant.
It is uncertain whether Obeliva 5mg Tablet is excreted in breast milk. Prior to taking Obeticholic Acid, it is advisable to consult your doctor, especially if you are breastfeeding.
Obeliva 5mg Tablet is unlikely to affect your ability to drive or operate machinery.
Please consult your doctor if you have kidney impairment or any concerns regarding this.
Obeliva 5mg Tablet is not suitable for patients with a complete blockage of the biliary tract, which includes the liver, gall bladder, and bile ducts. It is recommended to consult your doctor before taking Obeliva 5mg Tablet, especially if you have a liver condition.
Obeticholic Acid helps improve liver function by reducing the production and build-up of bile in the liver and reducing inflammation.
Common adverse effects of Obeticholic Acid include severe itching (pruritus), fatigue, and abdominal discomfort or pain. Additional common side effects comprise skin rashes, joint pain (arthralgia), throat pain (oropharyngeal discomfort), dizziness, constipation, thyroid function changes, and skin inflammation (eczema).
Obeliva 5mg Tablet is classified under a group of medicines known as farnesoid X-receptor agonists. It is employed in the treatment of primary biliary cirrhosis, also referred to as primary biliary cholangitis. Obeliva 5mg Tablet aids in enhancing liver function by decreasing the production and accumulation of bile in the liver, ultimately reducing inflammation and contributing to the treatment of primary biliary cirrhosis.
Obeticholic Acid activates the FXR, a nuclear receptor found in the liver and gut. FXR plays a crucial role in regulating various pathways, including bile acid, inflammation, fibrosis, and metabolism. FXR activation reduces bile acid levels within liver cells by decreasing the production of cholesterol and enhancing the transport of bile acids out of the cells. These mechanisms help reduce exposure of the liver to bile acids and increase bile excretion.
The recommended starting dose of Obeticholic Acid is 5 mg taken orally once daily for adult patients who haven't adequately responded to Ursodeoxycholic Acid (UDCA) over at least one year or who cannot tolerate UDCA.
Dosage Adjustment: If there's insufficient reduction in alkaline phosphatase (ALP) and/or total bilirubin levels after three months of taking Obeticholic Acid at 5 mg daily, and if the patient is tolerating it, the dosage can be increased to 10 mg once daily.
Maximum Dosage: The highest recommended dose of Obeticholic Acid is 10 mg taken once daily.
Managing Patients with Severe Itching (Pruritus) on Obeticholic Acid: For individuals experiencing severe itching while on Obeticholic Acid, the following options can be considered:
Interactions Bile acid binding resins like cholestyramine, colestipol, or colesevelam can adsorb and inhibit bile acid absorption, potentially reducing the absorption, systemic exposure, and effectiveness of Obeticholic Acid. If taking a bile acid binding resin, Obeticholic Acid should be taken at least 4 hours before or after the resin, or at the earliest suitable interval. Warfarin: Co-administration of Obeticholic Acid and warfarin may lower the International Normalized Ratio (INR). While taking both drugs, INR should be closely monitored, and warfarin dosage adjusted as necessary to maintain it within the target range.
Narrow Therapeutic Index CYP1A2 Substrates: Obeticholic Acid may increase exposure to concurrent CYP1A2 substrates. For drugs with a limited therapeutic range that are substrates of CYP1A2, therapeutic monitoring is advised.
Obeticholic Acid should not be used by individuals with a known hypersensitivity to the medication or any of its components, or those with complete biliary obstruction.
There's limited human data on the safety of using Obeticholic Acid during pregnancy. It's unclear whether Obeticholic Acid is excreted in human breast milk, its impact on breastfed infants, or its influence on milk production.
Notable reactions to monitor include severe itching (pruritus) and reductions in low-density lipoprotein-cholesterol (HDL-C). Specialized monitoring is advised for patients experiencing these issues.
Store Obeticholic Acid in a dry place protected from light, at temperatures between 15°C to 30°C. Keep it out of reach of children.
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