Orlinom capsules (Orlistat 120mg)

Dosage Information for Orlistat

Understanding the appropriate dosage for Orlistat is crucial for its effective use. The medication is available in different strengths and forms, with specific guidelines for both adults and pediatric patients.

Adult and Pediatric Dosage Forms and Strengths

Dosage Considerations

• Obesity Management
• Indicated in patients with pretreatment BMI greater than 30 kg/m², or BMI greater than 27 kg/m² in the presence of other risk factors or diseases (e.g., hypertension, diabetes mellitus, hyperlipidemia).
• Adult Rx (Xenical): 120 mg orally every 8 hours with each fat-containing meal (during or up to 1 hour after the meal), doses greater than 120 mg three times daily show no additional benefit.
• Over-the-Counter (OTC) (Alli): Up to 60 mg orally every 8 hours with each fat-containing meal.
• Children under 12 years: Safety and efficacy not established.
• Children 12 years and older:
  • Prescription (Xenical): 120 mg orally every 8 hours with each fat-containing meal (during or up to 1 hour after the meal), doses greater than 120 mg three times daily show no additional benefit.
  • Over-the-Counter (Alli): Up to 60 mg orally every 8 hours with each fat-containing meal.
• Only effective as an adjunct to caloric restriction, increased physical activity, and behavioral modification.

Drug Interactions with Orlistat

Drug interactions can alter how medications work or increase the risk of serious side effects. It is essential to keep a list of all your medications and share it with your healthcare provider to avoid potential interactions.

Known Interactions

Orlistat has interactions categorized by their severity:

Interaction Severity	Number of Drugs
Severe Interactions	None known
Serious Interactions	None known
Moderate Interactions	65 different drugs
Mild Interactions	21 different drugs

Specific Drug Interactions and Recommendations

• Cyclosporine: Administer cyclosporine 3 hours after Orlistat.
• Levothyroxine: Administer 4 hours apart; monitor for changes in thyroid function.
• Amiodarone oral: A pharmacokinetic study showed reduced amiodarone and desethylamiodarone systemic exposure when coadministered with Orlistat.
• Antiepileptic drugs (AEDs): Convulsions reported with coadministration of AEDs and Orlistat; monitor serum AED levels.
• Antiretroviral drugs: Loss of virological control has been reported in HIV-infected patients taking Orlistat concomitantly with antiretroviral drugs; HIV RNA levels should be frequently monitored in patients taking Orlistat and antiretroviral drugs; if HIV viral load increases, discontinue Orlistat.
• Warfarin:
  • Vitamin K absorption may be decreased with Orlistat.
  • Reports of decreased prothrombin, increased INR, and unbalanced anticoagulant treatment resulting in a change of hemostatic parameters have occurred with the coadministration of Orlistat and anticoagulants.
  • Patients on chronic stable doses of warfarin or other anticoagulants who are prescribed Orlistat should be monitored closely for coagulation parameter changes.
• Vitamin supplements:
  • Orlistat may reduce the absorption of some fat-soluble vitamins and beta-carotene.
  • Instruct the patient to take a multivitamin containing fat-soluble vitamins to ensure adequate nutrition.
  • Take the vitamin supplement at least 2 hours before or after taking Orlistat, such as at bedtime.

Administration Guidelines for Orlistat

Appropriate administration of Orlistat enhances its effectiveness and reduces the risk of side effects.

Key Administration Guidelines

• If a meal is missed or contains no fat, the Orlistat dose should be omitted.
• Daily fat intake (30% of calories), carbohydrate, and protein should be evenly distributed over 3 main meals.
• A multivitamin supplement containing vitamins A, D, E, and K is recommended to offset reduced absorption of fat-soluble vitamins.

Scenarios for Adjusted Administration

Some specific conditions necessitate an adjusted approach to Orlistat administration:

• Severe Liver Injury: Postmarketing reports have indicated cases of severe liver injury, hepatocellular necrosis, or acute hepatic failure which sometimes result in liver transplant or death.
• Hyperoxaluria or Calcium Oxalate Nephrolithiasis: Cases of oxalate nephrolithiasis and oxalate nephropathy with renal failure have been reported.
• Substantial Weight Loss: Rapid weight loss can increase the risk of cholelithiasis (gallstones).
• Organic Causes of Obesity: Exclude organic causes of obesity (e.g., hypothyroidism) before starting Orlistat therapy.
• Diet High in Fat: Increased gastrointestinal events are more likely when taking a diet high in fat (greater than 30% total daily calories from fat).
• Diabetes Mellitus: Patients should be closely monitored for blood sugar levels.
• Avoid with Eating Disorders: People with anorexia nervosa or bulimia should not use Orlistat.

Pregnancy and Lactation

Orlistat is not recommended for use during pregnancy or breastfeeding due to the potential risks involved.

• Pregnancy:
  • Do not use Orlistat in pregnancy as the risks outweigh the potential benefits.
  • Weight loss offers no potential benefit to a pregnant woman and may result in fetal harm.
  • A minimum weight gain, and no weight loss, is currently recommended for all pregnant women, including those who are already overweight or obese.
• Lactation:
  • It is not known if Orlistat is distributed in breast milk.
  • Orlistat is not recommended for use while breastfeeding.