Aili Orlistat Capsules

1. Indications and Usage
Obesity Management: Indicated for the management of obesity, including patients with risk factors such as hypertension, diabetes, or dyslipidemia.
Weight Control: Used in conjunction with a slightly hypocaloric diet to treat obesity and prevent weight regain.
2. Dosage and Administration
Adults: The usual dosage is 1 capsule (120 mg) per dose, 3 times daily, taken with water during or up to 1 hour after each main meal.
Missed Doses: If a meal is skipped or consists of fat-free food, the dose should be omitted.
Pediatric Use: For adolescents (12–18 years), the usual dosage is 1 capsule (120 mg) 3 times daily, taken with water during or up to 1 hour after each main meal.
3. Mechanism of Action
Lipase Inhibition: Orlistat acts locally in the stomach and intestines by irreversibly binding to gastric and pancreatic lipases.
Fat Malabsorption: This inhibition prevents the hydrolysis of dietary triglycerides into free fatty acids and monoglycerides, resulting in approximately 30% of ingested fat remaining undigested and being excreted in the feces.
4. Safety and Warnings
Adrenal Insufficiency: There have been post-marketing reports of adrenal insufficiency in patients taking orlistat, presenting with symptoms such as fatigue, malaise, weakness, nausea, vomiting, and hypotension.
Hepatic Injury: Rare cases of severe hepatic injury have been reported. Patients should be advised to be alert for symptoms such as jaundice, dark urine, or pruritus.
Pregnancy and Lactation: Not recommended for pregnant or breastfeeding women, or for women of childbearing age who are not using effective contraception.
Constitutional Disorders: Should be used with caution in patients with chronic malabsorption syndrome or cholestasis.
5. Adverse Reactions and Clinical Research
Gastrointestinal Effects: The most common adverse reactions are gastrointestinal, including flatus with discharge, fecal incontinence, fecal spotting, and oily stools. These effects are dose-dependent and occur primarily when the diet contains excess fat.
Other Adverse Effects: Headache, dizziness, fatigue, and menstrual irregularities have also been reported.
6. Drug Interactions
Cyclosporine: Orlistat may significantly decrease the plasma concentration of cyclosporine. Cyclosporine should be administered at least 2 hours before or after taking orlistat.
Levothyroxine: Orlistat may reduce the absorption of levothyroxine. Patients should be monitored for hypothyroidism, and the dosage of levothyroxine may need to be adjusted.
Antiepileptics: There have been reports of decreased serum concentrations of antiepileptic drugs (e.g., phenytoin, valproate).
Vitamin Absorption: Orlistat may reduce the absorption of fat-soluble vitamins (A, D, E, K). Patients should take a multivitamin supplement containing these vitamins at least 2 hours before or after taking orlistat.
7. Pharmaceutical Information
Active Ingredient: Orlistat.
Strength: Typically 60 mg or 120 mg per capsule.
Appearance: Hard gelatin capsules with a white or yellowish powder.
Storage: Store below 25°C in a dry place. Keep out of reach of children.
Shelf Life: 24 months.