Choliva 5 mg (Tablet)
Unit Price: ৳ 30.00 (3 x 10: ৳ 900.00)
Strip Price: ৳ 300.00
Medicine Details
| Category | Details |
|---|---|
| Generic | Obeticholic acid |
| Company | Unimed unihealth pharmaceuticals ltd |
| Also available as |
Indications
- Treatment of primary biliary cholangitis in adult patients without cirrhosis
- Treatment of primary biliary cholangitis in adult patients with compensated cirrhosis without evidence of portal hypertension
- Treatment in combination with ursodeoxycholic acid (UDCA) with inadequate response to UDCA
- Monotherapy in patients unable to tolerate UDCA
Mechanism of Action
Obeticholic acid is an agonist for Farnesoid X Receptor (FXR), a key regulator of bile acid, inflammatory, fibrotic, and metabolic pathways.
Pharmacodynamic Markers
- Increase in FGF-19 concentrations
- Reduction in cholic acid and chenodeoxycholic acid concentrations
Cardiac Electrophysiology
At 10 times the maximum recommended dose, it does not prolong the QT interval to any clinically relevant extent.
Dosage & Administration
- Recommended dosage regimen for PBC patients without cirrhosis or with compensated cirrhosis
- Monitoring for biochemical response, tolerability, and progression of PBC
- Management of patients with intolerable pruritus
Interaction
- Interaction with bile acid binding resins
- Interaction with warfarin
- Potential to increase exposure to CYP1A2 substrates
- Avoiding concomitant use with 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
- Oropharyngeal pain
- 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 potential adverse effects on the breastfed infant
Precautions & Warnings
- Hepatic decompensation and failure in PBC patients with cirrhosis
- Severe pruritus management strategies
- Reduction in HDL-C and monitoring changes in serum lipid levels
Use in Special Populations
- Safety and effectiveness in pediatric patients not established
- Consideration for geriatric use
- Hepatic impairment precautions
Overdose Effects
Dose-dependent increase in hepatic adverse reactions reported in patients receiving higher dosages
Therapeutic Class
Farnesoid X Receptor Agonists
Storage Conditions
Store below 30°C in a dry place, and protect from light