Choliva 10 mg (Tablet)
Unit Price: ৳ 55.00 (1 x 10: ৳ 550.00)
Strip Price: ৳ 550.00
Medicine Details
| Category | Details |
|---|---|
| Generic | Obeticholic acid |
| Company | Unimed unihealth pharmaceuticals ltd |
| Also available as |
Indications
- Treatment of primary biliary cholangitis in adult patients
Dosage & Administration
- Initial dosage of 5 mg once daily for the first 3 months
- Increase to a maximum dosage of 10 mg once daily after 3 months if necessary
Mechanism of Action
- Obeticholic acid is an agonist for Farnesoid X Receptor (FXR)
- Key regulator of bile acid, inflammatory, fibrotic, and metabolic pathways
Pharmacodynamic Markers
- FGF-19 concentrations increased by 173%
- Cholic acid and chenodeoxycholic acid concentrations reduced by 2.7 and 1.4 micromolar respectively
Pharmacological Effects
- Decrease in intracellular hepatocyte concentrations of bile acids
- Promotion of choleresis to reduce hepatic exposure to bile acids
Recommended Monitoring
- Routine monitoring of patients for biochemical response, tolerability, and progression of PBC
- Closely monitor patients with compensated cirrhosis and concomitant hepatic disease for new evidence of portal hypertension
Management of Intolerable Pruritus
- Consider adding antihistamine or bile acid-binding resin
- Reduce or temporarily interrupt Obeticholic acid dosing if necessary
Interaction with Bile Acid Binding Resins
- Take Choliva at least 4 hours before or after taking bile acid binding resins
Interaction with Warfarin
- Monitor INR and adjust warfarin dosage as needed when co-administering with Choliva
Interaction with CYP1A2 Substrates
- May increase exposure to CYP1A2 substrates with a narrow therapeutic index
- Therapeutic monitoring is recommended when co-administered with Choliva
Contraindications
- Decompensated or prior decompensation cirrhosis
- Compensated cirrhosis with evidence of portal hypertension
- Complete biliary obstruction
Common Side Effects
- Pruritus
- Fatigue
- Stomach pain and discomfort
- Rash
- Joint pain
- Dizziness
- Constipation
- Abnormal thyroid function
- Eczema
Pregnancy & Lactation
- Limited human data on use during pregnancy
- No information on presence in human milk
- Consider benefits vs. potential adverse effects on the breastfed infant
Precautions & Warnings
- Hepatic decompensation and failure has been reported in patients with cirrhosis
- Severe pruritus may require medical intervention
- Reduction in HDL-C levels observed in some patients
Use in Special Populations
- No established safety and effectiveness in pediatric patients
- No overall differences in safety or effectiveness observed in elderly patients
- Extra caution needed in patients with hepatic impairment
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