Indications - Obeticholic Acid is indicated for the treatment of primary biliary cholangitis (PBC) in combination with Ursodeoxycholic Acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA, cholestatic liver disease & non-alcoholic fatty liver disease (NAFLD) including non-alcoholic steatohepatitis (NASH).
Dosage & Administration - Starting Dosage The recommended starting dosage of Obeticholic Acid is 5 mg orally once daily. Dosage Titration If an adequate reduction in alkaline phosphatase (ALP) and/or total bilirubin has not been achieved after 3 months of Obeticholic Acid 5 mg once daily and the patient is tolerating Obeticholic Acid, increase the dosage of Obeticholic Acid to 10 mg once daily. Maximum Dosage The maximum recommended dosage of Obeticholic Acid is 10 mg once daily.
Side Effects - The most common side effects of Obeticholic Acid include: Pruritus, Fatigue & Stomach pain and discomfort. Other common side effects include rash, arthralgia (joint pain), oropharyngeal pain (pain in the middle part of the throat), dizziness, constipation, abnormal thyroid function, and eczema (inflammation of the skin).
Contraindications - Contraindicated in patients known to have hypersensitivity to the drug or any of its components & in patients with complete biliary obstruction.
Others - Pregnancy & Lactation The limited available human data on the use of Obeticholic Acid during pregnancy are not sufficient to inform a drug-associated risk.There is no information on the presence of Obeticholic Acid in human milk, the effects on the breast-fed infant or the effects on milk production.
Tablet Livacol 5 mg
- Brand Name - Livacol 5
- Generic Name - Obeticholic Acid
- Doges From - Tablet
- Strength - 5 mg
- Pack Size - 20s
- Manufacture - Square Pharmaceutical Ltd.
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