Obetic
Generic Name
Obeticholic Acid
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
Loading images...
Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| obetic 5 mg tablet | ৳ 30.00 | ৳ 300.00 |
Description
Overview of the medicine
Obetic-5-mg-tablet contains Obeticholic Acid, which is used to treat primary biliary cholangitis (PBC) in adults. It is typically prescribed in combination with ursodeoxycholic acid (UDCA) for patients who have an inadequate response to UDCA, or as monotherapy for adults who cannot tolerate UDCA.
Uses & Indications
Dosage
Adults
Initial dose is 5 mg orally once daily. After 6 months, if tolerated and with inadequate response, the dose may be increased to 10 mg once daily. For patients with moderate to severe hepatic impairment (Child-Pugh B or C), the starting dose is 5 mg once weekly, which may be increased to 10 mg once weekly after 6 months if tolerated and with inadequate response.
Elderly
No specific dose adjustment is required for elderly patients.
Renal_impairment
For patients with moderate to severe renal impairment (eGFR 15 to <60 mL/min/1.73 m²), a starting dose of 5 mg twice weekly should be considered. Further dose adjustments are based on tolerability and response.
How to Take
Take Obetic-5-mg-tablet orally with or without food. Administer at the same time each day.
Mechanism of Action
Obeticholic Acid is a selective agonist for the farnesoid X receptor (FXR), a nuclear receptor expressed in the liver and intestine. Activation of FXR reduces the synthesis of bile acids in the liver and promotes their excretion, thereby improving bile flow and reducing the accumulation of toxic bile acids.
Pharmacokinetics
Onset
Effects on liver enzymes are typically observed within weeks of initiating therapy.
Excretion
Primarily eliminated via the feces as both unconjugated and conjugated metabolites. Less than 3% is excreted in the urine.
Half life
The effective half-life of obeticholic acid is approximately 24-48 hours.
Absorption
Rapidly absorbed after oral administration, with peak plasma concentrations occurring at approximately 1-2 hours.
Metabolism
Undergoes extensive metabolism in the liver by conjugation with glycine and taurine. It is also deconjugated by gut bacteria, leading to enterohepatic recirculation.
Side Effects
Contraindications
- Complete biliary obstruction.
Drug Interactions
Warfarin
Co-administration with obeticholic acid may increase the International Normalized Ratio (INR). Monitor INR and adjust warfarin dose as needed.
UGT1A4 Substrates (e.g., Rifampin)
UGT1A4 inducers like rifampin may reduce systemic exposure to obeticholic acid. Avoid co-administration if possible, or monitor for reduced efficacy of obeticholic acid.
CYP1A2 Substrates (e.g., Theophylline, Tizanidine)
Obeticholic acid is a weak inhibitor of CYP1A2. Exercise caution if co-administering with CYP1A2 substrates with a narrow therapeutic index.
Bile Acid Sequestrants (e.g., Cholestyramine, Colestipol)
May reduce the absorption of obeticholic acid. Administer obeticholic acid at least 4-6 hours before or 4-6 hours after taking bile acid sequestrants, or as directed by your physician.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
There is no specific antidote for obeticholic acid overdose. In case of overdose, symptomatic and supportive treatment should be initiated. Contact a poison control center for further guidance.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is unknown if obeticholic acid is excreted in human milk; therefore, breastfeeding is not recommended during treatment.
Side Effects
Contraindications
- Complete biliary obstruction.
Drug Interactions
Warfarin
Co-administration with obeticholic acid may increase the International Normalized Ratio (INR). Monitor INR and adjust warfarin dose as needed.
UGT1A4 Substrates (e.g., Rifampin)
UGT1A4 inducers like rifampin may reduce systemic exposure to obeticholic acid. Avoid co-administration if possible, or monitor for reduced efficacy of obeticholic acid.
CYP1A2 Substrates (e.g., Theophylline, Tizanidine)
Obeticholic acid is a weak inhibitor of CYP1A2. Exercise caution if co-administering with CYP1A2 substrates with a narrow therapeutic index.
Bile Acid Sequestrants (e.g., Cholestyramine, Colestipol)
May reduce the absorption of obeticholic acid. Administer obeticholic acid at least 4-6 hours before or 4-6 hours after taking bile acid sequestrants, or as directed by your physician.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
There is no specific antidote for obeticholic acid overdose. In case of overdose, symptomatic and supportive treatment should be initiated. Contact a poison control center for further guidance.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is unknown if obeticholic acid is excreted in human milk; therefore, breastfeeding is not recommended during treatment.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Usually 24 to 36 months from the date of manufacture, specific to manufacturer's guidelines.
Availability
Pharmacies, Hospitals
Approval Status
FDA Approved
Patent Status
Patented
Clinical Trials
Clinical trials are ongoing to evaluate obeticholic acid for other indications such as non-alcoholic steatohepatitis (NASH) with liver fibrosis, though it did not receive FDA approval for NASH as of recent updates.
Lab Monitoring
- Liver function tests (ALT, AST, ALP, total bilirubin) should be performed at baseline and periodically (e.g., every 3 months for the first year, then as clinically indicated) during treatment.
- INR should be monitored regularly in patients concomitantly receiving warfarin.
Doctor Notes
- Careful monitoring of liver function tests (ALT, AST, ALP, total bilirubin) is crucial, especially during dose titration and in patients with hepatic impairment.
- Assess patients for signs and symptoms of worsening liver function, including ascites, encephalopathy, and jaundice. Discontinue if liver decompensation occurs.
- Counsel patients on the importance of reporting severe pruritus, and manage with anti-pruritic medications if necessary.
Patient Guidelines
- Take the medicine exactly as prescribed by your doctor.
- Do not stop taking Obetic-5-mg-tablet without consulting your doctor, as this may worsen your liver condition.
- Report any new or worsening symptoms, especially severe itching, yellowing of skin/eyes, or severe abdominal pain, to your doctor immediately.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Obeticholic acid may cause dizziness. Patients should be cautious when driving or operating machinery until they know how the medication affects them.
Lifestyle Advice
- Maintain a healthy diet and lifestyle.
- Avoid alcohol consumption as advised by your healthcare provider, especially if you have liver disease.
- Stay hydrated by drinking plenty of fluids.
Alternative Medicines in Bangladesh
Similar medicines available in the market
Global Brand Names
International brand names for this medicine. Click a brand to search for detailed information.
Other Medicines in Obetic Brand
Other medicines available under the same brand name
