Obetic-10 10 mg Tablet

Obetic-10 10 mg tablet by Drug International Ltd. is a medicine that contains Obeticholic Acid. In Bangladesh, it is mainly used for adults with primary biliary cholangitis when prescribed by a specialist, usually when ursodeoxycholic acid alone has not worked well enough or cannot be tolerated.

Obeticholic Acid works by activating the farnesoid X receptor, which helps reduce bile acid production and improve bile flow in the liver. A key caution is that it can cause serious liver-related harm in people with advanced or decompensated liver disease, so liver status must be assessed before and during treatment.

• Treatment of primary biliary cholangitis in adults, in combination with ursodeoxycholic acid when response to ursodeoxycholic acid is inadequate.
• Treatment of primary biliary cholangitis in adults as monotherapy when ursodeoxycholic acid cannot be tolerated.

Adult dosing must be individualised by the prescribing doctor according to liver condition, current medicines, tolerability, and treatment response. It is usually taken by mouth once daily in suitable patients, with possible dose adjustment after assessment. People with cirrhosis or any signs of liver decompensation need specialist evaluation, and this medicine may be unsuitable or require a different approach. Do not start, stop, or change the dose without medical advice.

• Common: itching or worsening itching, tiredness, abdominal discomfort or pain, rash, joint pain, dizziness, constipation, and throat or mouth discomfort.
• May affect blood lipids, including a reduction in HDL cholesterol.
• Serious: worsening jaundice, dark urine, swelling of the abdomen or legs, confusion, vomiting blood, black stools, severe persistent itching, liver decompensation, liver failure, or severe allergic reaction. Seek urgent medical help if these occur.

Use extra caution in people with any history of cirrhosis, portal hypertension, ascites, variceal bleeding, hepatic encephalopathy, worsening jaundice, complete or severe bile duct blockage, or abnormal liver tests. Liver function and symptoms should be monitored regularly during treatment. Use this medicine only under the guidance of a registered doctor or pharmacist.

• Bile acid binding resins such as cholestyramine, colestipol, or colesevelam can reduce absorption; they are usually taken several hours apart if both are prescribed.
• Warfarin effect may be altered; INR should be monitored closely when treatment is started or changed.
• Medicines mainly metabolised by CYP1A2, such as theophylline or tizanidine, may need monitoring because exposure can increase.
• Tell the doctor about all prescription medicines, over-the-counter medicines, herbal products, and liver or cholesterol treatments before use.

• Known hypersensitivity to obeticholic acid or any component of the tablet.
• Complete biliary obstruction.
• Primary biliary cholangitis with decompensated cirrhosis or a previous decompensation event such as ascites, variceal bleeding, or hepatic encephalopathy.
• Compensated cirrhosis with evidence of portal hypertension, such as gastroesophageal varices or persistent low platelet count, unless a specialist determines otherwise according to current guidance.

There is limited human information on use during pregnancy, so it should be used only if the expected benefit justifies the potential risk and the prescriber considers it necessary. It is not known whether obeticholic acid passes into human breast milk; breastfeeding patients should discuss the benefits and risks with their doctor before use.

Store tablets at room temperature in a dry place, protected from moisture and direct light. Keep out of the reach of children and do not use after the expiry date printed on the pack.