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

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