Obeliva 10mg Tablet is used alone or in combination with treatment for certain liver diseases (primary biliary cholangitis-PBC). This disease slowly destroys the bile ducts in the liver. When bile ducts are damaged, harmful substances can build up in the bile and scar the liver.
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Obeticholic Acid is categorized as a Farnesoid X-receptor agonist, and it is employed in the treatment of primary biliary cirrhosis, also known as primary biliary cholangitis. This condition is an autoimmune disease that results in damage to the bile ducts in the liver. Biliary cirrhosis, in turn, leads to the accumulation of bile in the liver, causing liver damage.
Obeliva 10mg Tablet contains 'Obeticholic acid' as its active ingredient, which enhances liver function by reducing the production and buildup of bile within the liver, increasing the removal of bile from the liver, and reducing inflammation. These mechanisms collectively contribute to the treatment of primary biliary cirrhosis.
It is essential to adhere to your doctor's prescribed regimen when taking Obeticholic Acid. In some instances, you may experience common side effects, including stomach pain, tiredness, dizziness, constipation, and palpitations. Most of these side effects are typically mild and resolve gradually over time. Nevertheless, if these side effects persist or worsen, it is advisable to consult your doctor.
It is not known if alcohol interacts with Obeliva 10mg Tablet. Consult your doctor if you have any concerns.
Please consult your doctor if you are pregnant, as limited information is available regarding the usage of Obeliva 10mg Tablet during pregnancy.
Consult your doctor if you are breastfeeding; your doctor will decide whether Obeliva 10mg Tablet can be taken by breastfeeding mothers or not.
Obeliva 10mg Tablet does not affect your ability to drive. However, you are advised to omit driving if you experience dizziness.
Please consult your doctor if you have kidney impairment or any concerns regarding this.
Dose adjustment may be needed. Please consult your doctor if you have a liver impairment or any concerns regarding this. Inform your doctor if you have/had liver cirrhosis.
Primary biliary cirrhosis.
Obeliva 10mg Tablet helps improve liver function by reducing the production and build-up of bile in the liver and reduces inflammation, thereby helping treat primary biliary cirrhosis.
Primary biliary cholangitis (PBC), previously known as primary biliary cirrhosis, is an autoimmune liver disease characterized by damage to the bile ducts within the liver. These bile ducts are small channels responsible for carrying bile, a digestive fluid produced by the liver. Bile is essential for the digestion and absorption of dietary fats in the small intestine.
In PBC, the autoimmune response targets the bile ducts, leading to inflammation and gradual destruction of these ducts. This autoimmune attack compromises the normal flow of bile from the liver to the small intestine. As a result, several important events occurred:
Bile Accumulation: Due to the impaired flow of bile, it accumulates within the liver.
Inflammation: The accumulation of bile within the liver leads to inflammation.
Liver Damage: Over time, the persistent inflammation and bile buildup can cause damage to liver cells and surrounding tissue. This damage can lead to fibrosis, cirrhosis (scarring of the liver), and impaired liver function.
The condition is referred to as "cholangitis" because it involves inflammation of the bile ducts (cholangio-) within the liver. While "cirrhosis" is in the former name, it is now referred to as "cholangitis" to better reflect the primary nature of the disease, which centers on the bile ducts.
PBC is a chronic and progressive condition. If left untreated, it can lead to advanced liver disease. Early diagnosis and appropriate medical management, such as the use of medications like obeticholic acid, can help slow the progression of the disease and manage its symptoms.
Obeticholic acid activates the farnesoid X receptor (FXR), a nuclear receptor found in the liver and gut. FXR plays a crucial role in regulating various pathways, including those related to bile acids, inflammation, fibrosis, and metabolism. When FXR is activated by obeticholic acid, several important processes occur:
Reduction of Bile Acid Concentrations: FXR activation leads to a decrease in the concentration of bile acids within hepatocytes (liver cells). This is achieved by reducing the de novo (newly synthesized) production of cholesterol within the liver.
Increased Bile Acid Transport: FXR activation also increases the transport of bile acids out of hepatocytes, promoting their removal from the liver.
Limiting Hepatic Bile Acid Exposure: These combined strategies help limit the total amount of bile acids circulating within the liver. This reduction in hepatic bile acid exposure can be beneficial, as excessive bile acid buildup in the liver can lead to liver damage.
The recommended dosage regimen for Obeticholic Acid is as follows:
Starting Dosage: The initial recommended dose is 5 mg orally taken once daily. This is intended for adult patients who have either not achieved an adequate biochemical response to an appropriate dosage of Ursodeoxycholic Acid (UDCA) for a minimum of one year or those who are intolerant to UDCA.
Dosage Titration: If there is no adequate reduction in alkaline phosphatase (ALP) and/or total bilirubin levels after three months of taking Obeticholic Acid at 5 mg once daily, and the patient is tolerating the medication well, the dosage of Obeticholic Acid should be increased to 10 mg once daily.
Maximum Dosage: The highest recommended dose of Obeticholic Acid is 10 mg once daily.
Management of Patients with Intolerable Pruritus on Obeticholic Acid: For individuals who experience intolerable itching (pruritus) while taking Obeticholic Acid, the following steps can be considered:
If you are also taking certain cholesterol-lowering medications, such as cholestyramine or colestipol, take Obeticholic Acid at least 4 hours before or after taking these cholesterol-lowering products. Taking them together may affect the absorption of Obeticholic Acid.
The little human data on Obeticholic Acid consumption during pregnancy is insufficient to establish a drug-associated danger. There is no information on Obeticholic Acid's presence in human milk, its effects on breastfed infants, or its impact on milk production.
Hepatic decompensation and even fatal cases have been reported in patients with primary biliary cholangitis (PBC) who have decompensated cirrhosis or fall into Child-Pugh Class B or C hepatic impairment when they were prescribed obeticholic acid more frequently than the recommended starting dosage of 5 mg once weekly. Therefore, it is essential to strictly adhere to the prescribed dosing schedule to minimize the risk of these severe hepatic complications.
To ensure patient safety, it is crucial to closely monitor individuals taking obeticholic acid for any elevations in liver enzymes and to assess the risk factors associated with hepatic decompensation, such as worsening renal function and dehydration.
Clinical trials have demonstrated a dose-response relationship for liver-related adverse reactions, which may include jaundice, worsening ascites, and primary biliary cholangitis flare. These adverse reactions are more likely to occur when the prescribed dose exceeds 10 mg per day. It is imperative to stay within the recommended dosage range and avoid exceeding it to prevent these adverse reactions.
Regarding lactation, it is currently uncertain whether obeticholic acid is present in human breast milk. If a mother's clinical condition necessitates the use of the medication, it is advisable to carefully consider the potential developmental and health benefits of breastfeeding for the infant. This decision should be made while taking into account any potential adverse effects of the drug on the breastfed infant or the underlying maternal condition.
Store in a cool and dry place away from sunlight
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