Duoliv 5 mg (Tablet)
Unit Price: ৳ 30.00 (1 x 10: ৳ 300.00)
Strip Price: ৳ 300.00
Medicine Details
| Category | Details |
|---|---|
| Generic | Obeticholic acid |
| Company | Eskayef pharmaceuticals ltd |
| Also available as |
Indications
- Treatment of adult patients with primary biliary cholangitis (PBC)
- Indicated for patients with or without cirrhosis
- In combination with ursodeoxycholic acid (UDCA)
- Monotherapy for patients unable to tolerate UDCA
Pharmacology
- Obeticholic acid is an agonist for Farnesoid X Receptor (FXR)
- Regulates bile acid, inflammatory, fibrotic, and metabolic pathways
- Decreases intracellular hepatocyte concentrations of bile acids
- Increases transport of bile acids out of hepatocytes
- Promotes choleresis, reducing hepatic exposure to bile acids
Dosage & Administration
- Recommended starting dosage of 5 mg once daily
- May increase to a maximum dosage of 10 mg once daily
- Requires monitoring for biochemical response and tolerability
- Management of patients with intolerable pruritus
Interaction
- Bile Acid Binding Resins may reduce the absorption and efficacy of Duoliv
- Warfarin coadministration may necessitate INR monitoring
- May increase exposure to CYP1A2 substrates with narrow therapeutic index
- Avoid concomitant use of inhibitors of the Bile Salt Efflux Pump
Contraindications
- Decompensated cirrhosis or a prior decompensation event
- Compensated cirrhosis with evidence of portal hypertension
- Complete biliary obstruction
Side Effects
- Common side effects include pruritus, fatigue, stomach pain, rash, joint pain, dizziness, constipation, abnormal thyroid function, and eczema
Pregnancy & Lactation
- Limited human data available on use during pregnancy
- No information on presence of obeticholic acid in human milk
- Consider potential risks against benefits for breastfeeding mothers
Precautions & Warnings
- Hepatic decompensation and failure reported in PBC patients with cirrhosis
- Severe pruritus management strategies and clinical evaluation
- Dose-dependent reduction in HDL-C levels observed
- Safety and effectiveness not established in pediatric patients
- Considerations for geriatric use and hepatic impairment
Use in Special Populations
- Safety and effectiveness not established in pediatric patients
- No overall differences in safety or effectiveness observed in geriatric use
- Contraindicated in patients with hepatic impairment
Overdose Effects
- Dose-dependent increase in hepatic adverse reactions observed in clinical trials
- Serious hepatic adverse reactions reported postmarketing
- Careful observation and supportive care recommended 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