Ocaliva 5 mg (Tablet)
Unit Price: ৳ 30.00 (3 x 10: ৳ 900.00)
Strip Price: ৳ 300.00
Medicine Details
| Category | Details |
|---|---|
| Generic | Obeticholic acid |
| Company | Biopharma limited |
| Also available as |
Indications
- Treatment of primary biliary cholangitis in adult patients
- Treatment with or without cirrhosis
- Combination therapy with ursodeoxycholic acid
- Monotherapy in patients intolerant to UDCA
Pharmacology
- Agonist for Farnesoid X Receptor (FXR)
- Regulator of bile acid, inflammatory, fibrotic, and metabolic pathways
- Decrease in intracellular hepatocyte concentrations of bile acids
- Promotion of choleresis
- Reduction in hepatic exposure to bile acids
Dosage & Administration
- Initial dosage of 5 mg once daily for 3 months
- Maximum dosage of 10 mg once daily
- Monitoring for biochemical response and tolerability
- Management of intolerable pruritus
- Dosage adjustment for patients intolerant to 10 mg once daily
Interaction
- Bile acid binding resins may reduce absorption and efficacy
- Monitoring of INR when co-administering with warfarin
- Potential increase in exposure to CYP1A2 substrates
- Avoid concomitant use of inhibitors of bile salt efflux pump
Contraindications
- Decompensated cirrhosis (Child-Pugh Class B or C)
- Compensated cirrhosis with evidence of portal hypertension
- Complete biliary obstruction
Side Effects
- Pruritus
- Fatigue
- Stomach pain and discomfort
- Rash
- Arthralgia
- Dizziness
- Constipation
- Abnormal thyroid function
- Eczema
Pregnancy & Lactation
- Limited human data on use during pregnancy
- No information on presence in human milk
- Consideration of benefits and risks for breastfeeding mothers
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
- No established safety and effectiveness in pediatric patients
- Consideration for geriatric use
- Contraindication in hepatic impairment
Overdose Effects
- Dose-dependent increase in hepatic adverse reactions
- 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
- Protect from light
- Keep out of children’s reach