Adiponil

 120 mg Capsule
Incepta Pharmaceuticals Ltd.
Unit Price: ৳ 40.00 (2 x 10: ৳ 800.00)
Strip Price: ৳ 400.00
Indications
  • Obesity Management: Treatment of obesity in adults with a body mass index (BMI) ≥30 kg/m² or ≥27 kg/m² with associated risk factors (e.g., hypertension, diabetes, dyslipidemia).
  • Weight Loss and Weight Maintenance: As an adjunct to a reduced-calorie diet and increased physical activity for long-term weight management.
  • Off-label: Use in pediatric patients (≥12 years) for obesity under specialist supervision (varies by region).
  • Prevention of Weight Gain: Following initial weight loss in obese patients.
Dosage & Administration
  • Route: Oral.
  • Adults:
    • 120 mg capsule three times daily with each main meal containing fat (during or up to 1 hour after eating).
  • Pediatrics:
    • Safety and efficacy not well established for children under 12 years; specialist use may vary.
  • Elderly:
    • No dose adjustment required; use cautiously considering comorbidities.
  • Renal/Hepatic Impairment:
    • Use with caution; no specific dose adjustment recommended but monitor closely in severe impairment.
  • Duration:
    • Treatment duration depends on clinical response; evaluate effectiveness after 12 weeks and discontinue if less than 5% weight loss.
Mechanism of Action (MOA)

Orlistat is a potent, selective, and reversible inhibitor of gastric and pancreatic lipases. By inhibiting these lipases in the gastrointestinal tract, orlistat prevents the hydrolysis of dietary triglycerides into absorbable free fatty acids and monoglycerides. Consequently, approximately 30% of dietary fat is excreted undigested in the feces, leading to decreased caloric intake and weight loss.

Pharmacokinetics
  • Absorption: Systemic absorption is minimal (<1%), acting locally in the gastrointestinal lumen.
  • Distribution: Due to minimal systemic absorption, distribution is negligible.
  • Metabolism: Metabolized in the gastrointestinal tract to inactive metabolites.
  • Elimination: Excreted primarily in feces; minimal renal excretion.
Pregnancy Category & Lactation
  • Pregnancy: Classified as FDA pregnancy category X (contraindicated). Use is not recommended during pregnancy due to potential fetal harm and lack of benefit.
  • Lactation: Limited data available; caution advised. Consider risk-benefit before use during breastfeeding.
Therapeutic Class
  • Anti-obesity agent; gastrointestinal lipase inhibitor.
Contraindications
  • Known hypersensitivity to orlistat or any component.
  • Chronic malabsorption syndrome (e.g., inflammatory bowel disease).
  • Cholestasis (bile flow obstruction).
  • Pregnancy.
  • Concomitant use with cyclosporine (due to absorption interference).
Warnings & Precautions
  • Risk of fat-soluble vitamin deficiencies; supplementation with vitamins A, D, E, and K recommended.
  • Monitor for signs of liver injury; rare reports of severe hepatic events.
  • Use cautiously in patients with a history of kidney stones or pancreatitis.
  • May cause gastrointestinal adverse effects that can affect compliance.
  • Monitor glucose control in diabetic patients, as weight loss can affect insulin or oral hypoglycemic requirements.
Side Effects
  • Common (Gastrointestinal): Oily spotting, flatus with discharge, fecal urgency, fatty/oily stools, increased defecation, abdominal pain, and flatulence. These typically occur shortly after initiation and improve over time.
  • Serious (Rare): Severe liver injury, cholestasis, hypersensitivity reactions, kidney stones.
  • Other: Headache, respiratory tract infections.
Drug Interactions
  • May reduce absorption of fat-soluble vitamins; separate vitamin supplementation by at least 2 hours.
  • Reduces absorption of cyclosporine; concurrent use contraindicated or requires careful monitoring.
  • May interfere with levothyroxine absorption; separate administration by at least 4 hours.
  • Potential interaction with warfarin and other anticoagulants; monitor INR.
  • No significant CYP450 enzyme involvement.
Recent Updates or Guidelines
  • Guidelines emphasize combination with lifestyle modification for efficacy.
  • Monitoring for liver function recommended after reports of rare hepatic injury.
  • Not recommended for use beyond 1 year without re-evaluation of risk-benefit.
  • Some guidelines highlight pediatric use under specialist supervision.
Storage Conditions
  • Store at controlled room temperature between 20°C and 25°C (68°F to 77°F).
  • Protect from moisture and light.
  • Keep container tightly closed.
  • Do not freeze.
Available Brand Names