Obeticholic Acid

Dosage Forms Available

• Obeticholic Acid is available for use via the oral route in the form of tablets.

Age and Dose Restrictions

• This medicine is intended for use in adults. Its safety and efficacy have not been established in paediatric patients.

Contraindications

• Obeticholic Acid is contraindicated in patients with complete biliary obstruction.

• It should also not be used by patients with a history of chronic liver disease or prior decompensation.

Other Medications to Avoid

• Obeticholic acid can interact with medications affecting liver enzymes (such as rifampin, ketoconazole), anticoagulants (such as warfarin, dabigatran), and medications affecting bile acid levels (such as cholestyramine, colesevelam).

Overdose and Missed Dose

• An overdose of Obeticholic Acid may lead to liver injury, jaundice, worsening ascites, and primary biliary cholangitis flares. If you suspect an overdose, inform your doctor immediately.

• If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular schedule.

Management of Side Effects

Most side effects are temporary and generally harmless and resolve when discontinuing this medicine. However, if you experience any severe side effects or worsening of any of the symptoms, please consult your doctor.

• Drinking plenty of fluids can help manage constipation.

• Resting or reducing activity can help manage fatigue.

• For itching, over-the-counter creams or lotions can provide temporary relief.

Use in Driving and Operating Machinery

• Obeticholic Acid may cause dizziness. If you experience this side effect, avoid driving or operating heavy machinery until you feel well enough.

Use in Pregnancy and Lactation

• The use of this medicine during pregnancy or breastfeeding is not recommended without a doctor's advice. It is best to consult your doctor before taking this medication if you are pregnant or nursing.

Caution in Other Conditions

• Patients with moderate or severe liver impairment (Child-Pugh B or C) should exercise caution when taking Obeticholic Acid.

Special Dietary and Lifestyle Recommendations

• Regular monitoring of liver function is recommended for patients taking Obeticholic Acid.

• Patients should maintain a balanced diet with a sufficient intake of proteins, vitamins, and minerals to support liver health.

• It is advised to avoid activities that may lead to further liver damage, such as excessive alcohol consumption.

• Regular physical activity can help maintain general health and well-being.