Prebichol 5 

Presentation:Each tablet of Prebichol 5 contains Obeticholic Acid 5 mg.Prebichol 5 is a product of Incepta Pharmaceuticals Ltd. in Bangladesh

Indications:Prebichol (Obeticholic Acid) is indicated for the treatment of primary biliary cholangitis (PBC) in adults:  

• In combination with ursodeoxycholic acid (UDCA) in patients with an inadequate response to UDCA.  
• As monotherapy in patients unable to tolerate UDCA.  

PBC is a chronic liver disease where the bile ducts in the liver are slowly destroyed.Prebichol helps to reduce bile acid production and accumulation in the liver, thereby improving liver function and slowing down liver damage.

Dosage and Administration: The recommended starting dosage of Prebichol is 5 mg orally once daily for the first 3 months. After 3 months, if there is not an adequate reduction in alkaline phosphatase (ALP) and/or total bilirubin and the patient is tolerating the medication, the dosage may be increased to a maximum of 10 mg once daily.

Prebichol tablets can be taken with or without food.If you are also taking a bile acid-binding resin such as cholestyramine, colestipol, or colesevelam, take Prebichol at least 4 hours before or 4 hours after taking these medications, or at as long an interval as possible.  

Side Effects:The most common side effect reported with Prebichol is pruritus (itching), which can sometimes be severe.Other common side effects may include:

• Fatigue  
• Abdominal pain and discomfort  
• Rash  
• Arthralgia (joint pain)  
• Oropharyngeal pain (pain in the middle part of the throat)  
• Dizziness  
• Constipation  
• Reduced high-density lipoprotein cholesterol (HDL-C)  
• Thyroid abnormalities  
• Eczema  

Serious side effects, including worsening liver function and hepatic decompensation, have been reported, particularly in patients with cirrhosis.Contact your doctor immediately if you experience symptoms such as yellowing of the skin or eyes, dark urine, pale stools, vomiting blood, black tarry stools, swelling in the abdomen, confusion, or changes in mental status.

Precautions: Prebichol (Obeticholic Acid) is contraindicated in patients with:  

• Decompensated cirrhosis (e.g., Child-Pugh Class B or C) or a prior decompensation event.  
• Compensated cirrhosis who have evidence of portal hypertension (e.g., ascites, gastroesophageal varices, persistent thrombocytopenia).  
• Complete biliary obstruction.  

Caution should be exercised in patients with severe liver disease other than PBC. Prebichol may interact with certain medications, including bile acid-binding resins and warfarin.Inform your doctor about all the medications you are taking. Liver function tests will be monitored regularly during treatment.

Use in Pregnancy and Lactation:There is limited data on the use of Obeticholic Acid in pregnant women.Prebichol should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus. It is not known whetherObeticholic Acid is excreted in human milk. Caution should be exercised when administering Prebichol to a breastfeeding woman.

Storage:Store below 30°C in a dry place, protected from light and moisture.Keep out of reach of children.

Important Note: This information is for general knowledge and informational purposes only, and does not substitute professional medical advice. Always consult your doctor or pharmacist for specific instructions and guidance regarding your medication. They can assess your individual medical condition and provide the most appropriate advice.