Obetic 10 mg (Tablet)
Unit Price: ৳ 55.00 (1 x 10: ৳ 550.00)
Strip Price: ৳ 550.00
Medicine Details
| Category | Details |
|---|---|
| Generic | Obeticholic acid |
| Company | Drug international ltd |
| Also available as |
Indications
- Treatment of primary biliary cholangitis in adult patients
- Indicated for patients without cirrhosis
- Indicated for patients with compensated cirrhosis and no evidence of portal hypertension
- Can be used in combination with ursodeoxycholic acid (UDCA) with inadequate response to UDCA
- Can be used as monotherapy in patients unable to tolerate UDCA
Pharmacology
- Obeticholic acid is an agonist for Farnesoid X Receptor (FXR)
- FXR activation decreases intracellular hepatocyte concentrations of bile acids
- Promotes choleresis, reducing hepatic exposure to bile acids
- Associated with an increase in concentrations of FGF-19
- Reduces concentrations of cholic acid and chenodeoxycholic acid
- Does not prolong the QT interval at recommended doses
Dosage & Administration
- Healthcare providers should determine decompensated cirrhosis before initiation
- Recommended starting dosage of 5 mg once daily for the first 3 months
- Maximum dosage of 10 mg once daily for patients with inadequate response
- Monitoring for biochemical response, tolerability, and progression of PBC
- Management strategies for intolerable pruritus
- Dosage reduction and interruption strategies for intolerable pruritus
Interaction
- Bile acid binding resins can reduce absorption and efficacy of Obeticholic acid
- Warfarin coadministration requires monitoring and dosage adjustment
- Obeticholic acid may increase exposure to CYP1A2 substrates with narrow therapeutic index
- Avoid concomitant use of inhibitors of the 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
- Arthralgia
- Oropharyngeal pain
- Dizziness
- Constipation
- Abnormal thyroid function
- Eczema
Pregnancy & Lactation
- Limited 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
- Reduction in HDL-C
- Monitoring of serum lipid levels during treatment
- Consider risks vs. benefits for patients not responding to treatment
Use in Special Populations
- Pediatric use not established
- No overall differences observed in geriatric patients
- Hepatic impairment contraindicated
Overdose Effects
- Dose-dependent increase in hepatic adverse reactions
- Serious hepatic adverse reactions reported in some patients who received recommended dosage
- Careful observation and supportive care recommended 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