Livadox 5 mg (Tablet)
Unit Price: ৳ 30.00 (3 x 10: ৳ 900.00)
Strip Price: ৳ 300.00
Medicine Details
| Category | Details |
|---|---|
| Generic | Obeticholic acid |
| Company | Jenphar bangladesh ltd |
| Also available as |
Indications
- Treatment of primary biliary cholangitis (PBC)
- Treatment for adult patients
- Combination therapy with ursodeoxycholic acid (UDCA)
- Monotherapy for patients unable to tolerate UDCA
- Treatment for patients with compensated cirrhosis
- Treatment for patients without evidence of portal hypertension
Pharmacology
- Mechanism of Action: FXR agonist
- Regulator of bile acid, inflammatory, fibrotic, and metabolic pathways
- Decreases intracellular hepatocyte concentrations of bile acids
- Suppresses de novo synthesis of bile acids
- Increased transport of bile acids out of hepatocytes
- Promotes choleresis
- Reduces hepatic exposure to bile acids
- Increases concentrations of FGF-19
- Reduces concentrations of cholic acid and chenodeoxycholic acid
- Non-prolongation of QT interval
Dosage & Administration
- Recommended for PBC patients without cirrhosis or with compensated cirrhosis
- Dosage of 5 mg once daily for the first 3 months
- Dosage increase to a maximum of 10 mg once daily if inadequate response to UDCA
- Monitoring for biochemical response, tolerability and progression of PBC
- Management of intolerable pruritus
- Dosage reduction or interruption for intolerable pruritus
Interaction
- Interaction with bile acid binding resins
- Interaction with warfarin
- Potential increase in exposure to CYP1A2 substrates
- Avoid concomitant use of inhibitors of BSEP
- Need for monitoring serum transaminases and bilirubin
Contraindications
- Contraindicated in decompensated cirrhosis patients
- Contraindicated in compensated cirrhosis patients with evidence of portal hypertension
- Contraindicated in patients with complete biliary obstruction
Side Effects
- Common side effects include pruritus, fatigue, stomach pain and discomfort
- Other side effects include rash, arthralgia, oropharyngeal pain, dizziness, constipation, abnormal thyroid function, and eczema
Pregnancy & Lactation
- Limited human data on use during pregnancy
- No developmental abnormalities or fetal harm observed in animal studies
- No information on presence in human milk or effects on the breastfed infant
Precautions & Warnings
- Risk of hepatic decompensation and failure in PBC patients with cirrhosis
- Reported cases of severe pruritus
- Reduction in HDL-C levels in some patients with PBC
- Considerations for pediatric, geriatric, and hepatic impairment use
Use in Special Populations
- Safety and effectiveness not established in pediatric patients
- Considerations for geriatric use
- Hepatic impairment concerns
Overdose Effects
- Dose-dependent increase in hepatic adverse reactions observed
- Serious hepatic adverse reactions reported postmarketing
- Patients should be observed and supportive care administered 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