Obecol 10 mg (Tablet)
Unit Price: ৳ 55.00 (1 x 10: ৳ 550.00)
Strip Price: ৳ 550.00
Medicine Details
Category | Details |
---|---|
Generic | Obeticholic acid |
Company | Popular pharmaceuticals ltd |
Also available as |
Indications
- Treatment of primary biliary cholangitis (PBC) in adult patients without cirrhosis
- Treatment of PBC in adult patients with compensated cirrhosis without evidence of portal hypertension
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
- 173% increase in concentrations of FGF-19 at 12 months
- Reduction in cholic acid and chenodeoxycholic acid concentrations at 12 months
Dosage & Administration
- Start with 5 mg once daily for the first 3 months
- May increase to a maximum of 10 mg once daily based on response
- Monitor patients for biochemical response and tolerability
- Management strategies for intolerable pruritus
Interaction
- Interacts with bile acid binding resins
- Interacts with warfarin
- May increase exposure to CYP1A2 substrates
- Interaction with inhibitors of BSEP
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
- Rash
- Arthralgia
- Oropharyngeal pain
- Dizziness
- Constipation
- Abnormal thyroid function
- Eczema
Pregnancy & Lactation
- Insufficient human data for use during pregnancy
- 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 strategies
- Reduction in HDL-C monitoring
Use in Special Populations
- Safety and effectiveness not established in pediatric patients
- No overall differences in safety or effectiveness in geriatric patients
- Contraindicated in patients with hepatic impairment
Overdose Effects
- Dose-dependent increase in hepatic adverse reactions in clinical trials
- Careful observation and supportive care 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