Obeliva 10 mg (Tablet)
Unit Price: ৳ 55.00 (1 x 30: ৳ 1,650.00)
Strip Price: ৳ 1,650.00
Medicine Details
| Category | Details |
|---|---|
| Generic | Obeticholic acid |
| Company | Everest pharmaceuticals ltd |
| Also available as |
Indications
- Treatment of primary biliary cholangitis (PBC) in adult patients
- Use in patients with compensated cirrhosis without evidence of portal hypertension
- Use in combination with ursodeoxycholic acid (UDCA) or as monotherapy in patients unable to tolerate UDCA
Pharmacology
- Mechanism of Action - agonist for Farnesoid X Receptor (FXR)
- FXR activation decreases intracellular hepatocyte concentrations of bile acids
- Increase in concentrations of FGF-19 from baseline to Month 12
- Reduction in concentrations of cholic acid and chenodeoxycholic acid
- No clinically relevant QT interval prolongation
Dosage & Administration
- Start with a dosage of 5 mg once daily for the first 3 months
- Increase to a maximum dosage of 10 mg once daily for adequate biochemical response
- Monitoring for biochemical response, tolerability, and PBC progression
- Management of intolerable pruritus
- Recommended dosages for different patient populations
Interaction
- Impact of bile acid binding resins on absorption and efficacy
- Impact on International Normalized Ratio (INR) when co-administering with warfarin
- Potential increase in exposure to CYP1A2 substrates
- Avoidance of concomitant use with inhibitors of Bile Salt Efflux Pump (BSEP)
Contraindications
- Decompensated cirrhosis or prior decompensation event
- Compensated cirrhosis with evidence of portal hypertension
- Complete biliary obstruction
Side Effects
- Common side effects - pruritus, fatigue, stomach pain, rash, joint pain, dizziness, constipation, abnormal thyroid function, eczema
Pregnancy & Lactation
- Limited human data available on use during pregnancy
- No information on presence in human milk or effects on the breastfed infant
Precautions & Warnings
- Hepatic decompensation and failure in PBC patients with cirrhosis
- Severe pruritus and management strategies
- Reduction in HDL-C and monitoring of serum lipid levels
Use in Special Populations
- Safety and effectiveness not established in pediatric patients
- Considerations for geriatric and hepatic impaired patients
Overdose Effects
- Dose-dependent increase in hepatic adverse reactions
- Supportive care in case of overdosage
Therapeutic Class
- Farnesoid X Receptor Agonists
Storage Conditions
- Store below 30°C in a dry place
- Protect from light
- Keep out of children’s reach