FXR 5 mg (Tablet)
Unit Price: ৳ 30.00 (3 x 10: ৳ 900.00)
Strip Price: ৳ 300.00
Medicine Details
| Category | Details |
|---|---|
| Generic | Obeticholic acid |
| Company | Beacon pharmaceuticals plc |
| Also available as |
Indications
- Treatment of primary biliary cholangitis in adult patients
- Treatment in combination with ursodeoxycholic acid (UDCA)
- Monotherapy in patients unable to tolerate UDCA
Mechanism of Action
- Agonist for Farnesoid X Receptor (FXR)
- Regulator of bile acid, inflammatory, fibrotic, and metabolic pathways
- Decreases intracellular hepatocyte concentrations of bile acids
- Promotes choleresis and reduces hepatic exposure to bile acids
Pharmacodynamics
- Increase in concentrations of FGF-19
- Reduction in concentrations of cholic acid and chenodeoxycholic acid
Cardiac Electrophysiology
- No clinically relevant prolongation of QT interval at maximum recommended dose
Dosage & Administration
- Important Dosage and Administration Instructions
- Recommended Dosage Regimen
- Monitoring to Assess Safety
- Management of Patients with Intolerable Pruritus
- Dosage reduction and temporary interruption for intolerable pruritus
Interaction
- Interactions with Bile Acid Binding Resins
- Interactions with Warfarin
- Interactions with CYP1A2 Substrates
- Avoid concomitant use of inhibitors of Bile Salt Efflux Pump
Contraindications
- Decompensated cirrhosis or prior decompensation event
- Compensated cirrhosis with evidence of portal hypertension
- Complete biliary obstruction
Side Effects
- Pruritus
- Fatigue
- Stomach pain and discomfort
- Rash
- Joint pain
- Oropharyngeal pain
- Dizziness
- Constipation
- Abnormal thyroid function
- Eczema
Pregnancy & Lactation
- Limited available human data on use during pregnancy
- No observed developmental abnormalities or fetal harm in animal studies
- No information on presence in human milk or effects on breastfed infant
Precautions & Warnings
- Hepatic Decompensation and Failure in PBC Patients with Cirrhosis
- Severe pruritus management and evaluation
- Reduction in HDL-C and monitoring
Use in Special Populations
- Limited safety and effectiveness in pediatric patients
- Geriatric Use observations
- Hepatic Impairment precautions and contraindications
Overdose Effects
- Increase in hepatic adverse reactions
- Observation and supportive care for 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