Choliva 5mg Tablet

Uses:

• Treats primary biliary cholangitis in adults

How does Choliva 5mg Tablet work?

Choliva 5mg Tablet works by reducing the production and build-up of bile in the liver and also reduces the inflammation of the liver. Therefore, as a result, it helps to improve liver function.

Side Effects of Choliva 5mg Tablet

Common side effects include pruritus, fatigue, stomach pain, discomfort, rashes, joint pain, oropharyngeal discomfort, dizziness, constipation, altered thyroid function, and eczema.

Quick Suggestions:

• PBC is much more common in women, with women accounting for about 90% of PBC cases. The reason for this sex difference is not fully understood.
• PBC is most likely to occur in individuals between the ages of 30 and 60 years old. It is less common in younger individuals and older adults.
• There appears to be a genetic component to PBC. If you have a family member who has or has PBC, your risk of developing the condition may be increased. This suggests a possible genetic predisposition.
• PBC is more common in people of northern European descent. However, it can affect individuals of all races and ethnic backgrounds.
• Researchers believe that genetic factors, in combination with certain environmental factors, may trigger the development of PBC. These environmental factors can include:
• Certain infections, such as urinary tract infections, have been considered as potential triggers for PBC. However, the exact relationship between infections and PBC is still under investigation.
• Smoking has been suggested as a potential environmental factor that may increase the risk of PBC. Smoking is known to have various negative effects on health, and it may contribute to the development of autoimmune conditions like PBC.
• Exposure to certain toxic chemicals or environmental toxins has been considered a possible risk factor for PBC. However, more research is needed to establish a direct link between specific toxins and the development of the condition.

Indications:

Obeticholic Acid is used to treat several conditions, including:

1. Primary biliary cholangitis (PBC) in individuals who have had a poor response to UDCA (ursodeoxycholic acid).
2. Cholestatic liver disease.
3. Non-alcoholic fatty liver disease (NAFLD), including non-alcoholic steatohepatitis (NASH).

Pharmacology:

Obeticholic Acid activates the farnesoid X receptor (FXR), a nuclear receptor found in the liver and gut. FXR plays a critical role in bile acid, inflammatory, fibrotic, and metabolic pathways. FXR activation reduces bile acid concentrations within hepatocytes by limiting de novo cholesterol production and increasing bile acid transport out of hepatocytes. These mechanisms reduce hepatic bile acid exposure and increase choleresis.

Dosage & Administration

• Starting Dosage: The recommended starting dosage is 5 mg orally once daily for adult patients who have not responded adequately to an appropriate dosage of UDCA for at least 1 year or are intolerant to UDCA.
• Dosage Titration: If there is no adequate reduction in alkaline phosphatase (ALP) and/or total bilirubin after 3 months of 5 mg once daily, and the patient tolerates the medication, the dosage can be increased to 10 mg once daily.
• Maximum Dosage: The maximum recommended dosage is 10 mg once daily.
• Management of Patients with Intolerable Pruritus: Options for patients with intolerable pruritus include adding an antihistamine or bile acid binding resin, reducing the dosage to 5 mg every other day for those intolerant to 5 mg once daily, or reducing the dosage to 5 mg once daily for those intolerant to 10 mg once daily. Temporary interruption of dosing for up to 2 weeks, followed by restarting at a reduced dosage, can also be considered.

Interaction

• Bile acid binding resins may reduce the absorption, systemic exposure, and efficacy of obeticholic acid.
• When taken together with warfarin, obeticholic acid can decrease the International Normalized Ratio (INR). Adjust the warfarin dosage as needed.
• Obeticholic acid may increase the exposure to concomitant CYP1A2 substrates with a limited therapeutic index.

Contraindications

Obeticholic Acid should not be used by patients with known hypersensitivity to the medicine or any of its components, as well as those with total biliary obstruction.

Pregnancy & Lactation

There is insufficient human data to establish the drug-associated risk of Obeticholic Acid consumption during pregnancy. Additionally, there is no information on its presence in human milk, its effects on breastfed infants, or its impact on milk production.

Precautions & Warnings

Specialized monitoring is required for adverse reactions to the liver, such as pruritus and low-density lipoprotein-cholesterol reduction (HDL-C).

Storage Conditions

Store Obeticholic Acid at 15°C to 30°C in a dry, light-protected location, and keep it out of children's reach.