Olic 10 mg (Tablet)
Unit Price: ৳ 50.00 (1 x 10: ৳ 500.00)
Strip Price: ৳ 500.00
Medicine Details
Category | Details |
---|---|
Generic | Obeticholic acid |
Company | Acme laboratories ltd |
Also available as |
Indications
- Treatment of primary biliary cholangitis (PBC)
- Treatment without cirrhosis
- Treatment with compensated cirrhosis
- Combination therapy with ursodeoxycholic acid (UDCA)
- Monotherapy in patients unable to tolerate UDCA
Pharmacology
- Mechanism of action as Farnesoid X Receptor (FXR) agonist
- Regulation of bile acid, inflammatory, fibrotic, and metabolic pathways
- FXR activation decreases intracellular hepatocyte concentrations of bile acids
- Pharmacodynamic markers including FGF-19 and bile acid concentration changes
- No clinically relevant QT interval prolongation
Dosage & Administration
- Dosage determination based on cirrhosis severity
- Recommended starting dosage of 5mg once daily
- Dosage increase to 10mg once daily based on response
- Monitoring for biochemical response and safety
- Management of intolerable pruritus
Interaction
- Interaction with bile acid binding resins
- Interaction with warfarin
- Potential to increase exposure to CYP1A2 substrates
- Avoid concomitant use of inhibitors of the bile salt efflux pump
Contraindications
- Decompensated cirrhosis
- Compensated cirrhosis with evidence of portal hypertension
- Complete biliary obstruction
Side Effects
- Common side effects like pruritus, fatigue, stomach pain
- Other common side effects including rash, joint pain, dizziness
Pregnancy & Lactation
- Limited human data on use during pregnancy
- No observed developmental abnormalities or fetal harm in animal studies
Precautions & Warnings
- Hepatic decompensation and failure in PBC patients with cirrhosis
- Occurrence of severe pruritus and management strategies
- Reduction in HDL-C levels and monitoring for changes in lipid levels
Use in Special Populations
- Lack of established safety and effectiveness in pediatric patients
- Considerations for geriatric use and potential greater sensitivity
- Considerations for hepatic impairment and contraindications in certain cirrhosis patients
Overdose Effects
- Dose-dependent increase in hepatic adverse reactions
- Serious hepatic adverse reactions, including jaundice and portal hypertension
- Careful observation and supportive care in case of overdosage
Therapeutic Class
- Farnesoid X Receptor Agonists
Storage Conditions
- Store below 30°C
- Store in a dry place and protect from light
- Keep out of children's reach