Obetic 5 mg (Tablet)
Unit Price: ৳ 30.00 (2 x 10: ৳ 600.00)
Strip Price: ৳ 300.00
Medicine Details
| Category | Details |
|---|---|
| Generic | Obeticholic acid |
| Company | Drug international ltd |
| Also available as |
Indications
- Treatment of primary biliary cholangitis (PBC)
- Treatment of adult patients without cirrhosis
- Treatment of adult patients with compensated cirrhosis
- Treatment in combination with ursodeoxycholic acid (UDCA)
- Monotherapy for patients intolerant to UDCA
Pharmacology
- Mechanism of action as an agonist for Farnesoid X Receptor (FXR)
- FXR activation decreases intracellular hepatocyte concentrations of bile acids
- Increases transport of bile acids out of the hepatocytes
- Promotes choleresis to reduce hepatic exposure to bile acids
- Pharmacodynamic markers such as FGF-19 concentrations
Dosage & Administration
- Dosage regimen for patients without cirrhosis or with compensated cirrhosis
- Monitoring to assess safety and need for discontinuation
- Management of patients with intolerable pruritus
Interaction
- Interaction with bile acid binding resins
- Interaction with warfarin
- Potential interaction with CYP1A2 substrates
- Avoid concomitant use of inhibitors of Bile Salt Efflux Pump
Contraindications
- Contraindicated in patients with decompensated cirrhosis
- Contraindicated in patients with evidence of portal hypertension
- Contraindicated in patients with complete biliary obstruction
Side Effects
- Common side effects such as pruritus, fatigue, stomach pain
- Other common side effects include rash, joint pain, dizziness, constipation, abnormal thyroid function, and eczema
Pregnancy & Lactation
- Limited available human data on use during pregnancy
- No information on the presence in human milk
- Consideration of the developmental and health benefits of breastfeeding
Precautions & Warnings
- Risk of hepatic decompensation and failure
- Potential for severe pruritus
- Potential reduction in HDL-C levels
Use in Special Populations
- Safety and effectiveness in pediatric patients not established
- No overall differences in safety or effectiveness observed in geriatric patients
- Contraindicated in patients with hepatic impairment
Overdose Effects
- Dose-dependent increase in the incidence of hepatic adverse reactions observed in clinical trials
- Serious hepatic adverse reactions reported with 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