Obecol 10
Form: Tablet
Strength: 10mg
Generic Name: Obeticholic Acid
Company: Popular Pharmaceuticals Ltd.
MRP:৳ 55.0 (Box=10)
Per Piece: ৳ 5.50
Is Antibiotic: No
Indications
Obecol 10 is used to treat adult patients with primary biliary cholangitis (PBC) who do not have cirrhosis or have compensated cirrhosis, and who do not show signs of portal hypertension. Obecol 10 can be used with ursodeoxycholic acid (UDCA) when UDCA alone doesn’t work or as a single treatment for patients who cannot tolerate UDCA.
Pharmacology
Obeticholic acid works by activating the Farnesoid X Receptor (FXR) found in the liver and intestines. FXR helps control bile acid levels, inflammation, fibrosis, and metabolism. When FXR is activated, Obecol 10 reduces bile acid levels inside liver cells, and helps transport bile acids out of the liver. This reduces the amount of bile acid circulating in the body while encouraging the flow of bile.
In a trial, Obeticholic acid increased FGF-19 levels, which helps in bile acid balance. Obecol 10 also reduced two types of bile acids, cholic acid and chenodeoxycholic acid, though the significance of these results is unclear.
Even at 10 times the usual dose, Obeticholic acid does not affect the heart’s electrical activity in a way that is clinically concerning.
Dosage & Administration
Important instructions: Before starting treatment, doctors should check if the patient has severe liver disease (decompensated cirrhosis) or signs of portal hypertension (such as ascites or varices), as Obecol 10 is not recommended for these patients.
Recommended Dosage: For patients with PBC who do not have cirrhosis or have compensated cirrhosis and no signs of portal hypertension, the usual dose is:
– Start with 5 mg once daily for the first 3 months.
– If needed, increase the dose to 10 mg daily after 3 months for those who haven’t shown enough improvement in liver function.
Monitoring: Patients should be regularly checked for side effects and response to treatment. If any signs of liver failure or portal hypertension appear, the medication should be stopped immediately.
If pruritus (itching) becomes unbearable, options include using antihistamines or bile acid-binding agents, reducing the dose, or temporarily stopping the treatment.
Interaction
Obeticholic acid can interact with bile acid binding resins (like cholestyramine) and may lower its effectiveness. If both medications are used, take Obeticholic acid at least 4 hours before or after the bile acid binder.
Obecol 10 may also affect blood-thinning medication like warfarin, so the dose of warfarin might need adjustment while using Obeticholic acid.
Care should be taken when using Obeticholic acid with medications that are processed by the CYP1A2 enzyme, like theophylline and tizanidine, as Obeticholic acid can increase their effects.
Avoid using Obeticholic acid with drugs that block bile salt transport, like cyclosporine, as Obecol 10 may cause problems with bile acid accumulation in the liver.
Contraindications
Obecol 10 is not recommended for patients with:
- Severe liver disease (decompensated cirrhosis)
- Compensated cirrhosis with signs of portal hypertension
- Complete blockage of the bile duct
Side Effects
Common side effects include itching, tiredness, and stomach discomfort. Less common effects include rash, joint pain, sore throat, dizziness, constipation, abnormal thyroid levels, and skin inflammation.
Pregnancy & Lactation
Obecol 10 is not clear whether Obeticholic acid is safe to use during pregnancy. Animal studies showed no harm to the baby, but the effects in humans are not well known.
There is no information on whether Obeticholic acid passes into breast milk. Mothers should consider the benefits of breastfeeding along with any potential risks to the baby.
Precautions & Warnings
Some patients with cirrhosis may experience worsening liver function or even liver failure while using Obeticholic acid. Obecol 10 is essential to monitor these patients closely, especially for signs of portal hypertension or liver complications.
Severe itching has been reported in some patients, and liver function should be regularly checked.
Overdose Effects
Overdosing on Obeticholic acid may increase the risk of liver problems, such as jaundice, ascites, and portal hypertension. Serious effects have been reported in patients who received doses higher than recommended.
Therapeutic Class
Liver disease treatment (biliary cholangitis).
Storage Conditions
Store below 30°C, away from light and moisture. Keep out of reach of children.
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