Adiponil 120

Indications

Adults: Adiponil is recommended alongside a mildly hypocaloric diet for the management of obesity in patients with a body mass index (BMI) greater than 30 kg/m², as well as in overweight individuals (BMI over 28 kg/m²) who have associated health risks such as type II diabetes, hyperlipidemia, or hypertension. Treatment with Adiponil should be stopped after 12 weeks if the patient has not achieved at least a 5% reduction in body weight from the baseline.

Adolescents (12 years and older): For obese adolescents, Adiponil should only be considered if weight loss cannot be attained through diet and increased physical activity. This treatment is especially important if obesity-related complications are present.

Pharmacology

Adiponil contains orlistat, a potent, long-acting lipase inhibitor. It functions in the stomach and upper small intestine by forming a covalent bond with the active site of gastric and pancreatic lipases, rendering them inactive. As a result, dietary fats, particularly triglycerides, remain undigested and unabsorbed, leading to a caloric deficit that aids in weight management. At a therapeutic dose of 120 mg taken three times daily, orlistat reduces dietary fat absorption by approximately 30%.

Dosage & Administration

The recommended dosage of Orlistat is one 120 mg capsule taken just before, during, or within one hour after each main meal. If a meal is missed or contains no fat, the dose should be skipped. Higher doses (beyond 120 mg three times daily) do not yield additional benefits. Patients typically see an increase in fecal fat within 24-48 hours post-dosing, which usually normalizes within 48-72 hours after stopping the medication.

Orlistat has been studied for safety and efficacy in clinical trials lasting up to four years. The recommended dose for adolescents mirrors that for adults.

Special Dosage Instructions: The effects of Orlistat in elderly patients or those with liver and/or kidney impairments have not been thoroughly studied.

Always consult with a healthcare professional before using this medication.

Interactions

Co-administration of Adiponil with cyclosporine may reduce cyclosporine plasma levels. It also inhibits the absorption of vitamin E acetate, while the impact on vitamins D, A, and K remains unclear. Patients on levothyroxine should be monitored for thyroid function changes when taking Adiponil, with a recommendation to space the administration of these medications by at least four hours. Additionally, patients taking warfarin should be closely observed for any changes in coagulation parameters, and those on antiepileptic drugs should be monitored for any increase in seizure activity.

Contraindications

Orlistat is contraindicated for individuals with chronic malabsorption syndrome, cholestasis, or those allergic to orlistat or any of its components.

Side Effects

Common Side Effects: Most side effects associated with Adiponil are gastrointestinal, including oily spotting, flatulence, fecal urgency, oily stools, and abdominal discomfort.

Rare Side Effects: Less commonly reported effects include influenza, anxiety, headache, and fatigue. Rare hypersensitivity reactions may occur, presenting as itching, rashes, hives, swelling, and anaphylaxis.

Pregnancy & Lactation

Pregnancy: Orlistat is classified as a Category X drug and is contraindicated during pregnancy due to potential harm to the fetus from maternal weight loss. Pregnant women, regardless of their weight status, are advised to gain weight appropriately.

Lactation: It is unclear whether Orlistat is excreted in human milk; caution is recommended when administering this medication to nursing mothers.

Precautions & Warnings

Before prescribing Adiponil, it is crucial to rule out organic causes of obesity, such as hypothyroidism. Co-administration with cyclosporine is not advised; it should be taken at least two hours apart. In patients with type II diabetes, weight loss may be less significant than in non-diabetics, necessitating careful monitoring of antidiabetic medications during treatment. A balanced diet is essential, as gastrointestinal side effects may increase with fatty meals. Patients are encouraged to take a multivitamin supplement to mitigate the reduced absorption of fat-soluble vitamins.

Overdose Effects

Studies have shown that single doses of up to 800 mg and multiple doses of 400 mg three times daily for 15 days did not produce significant adverse effects. In case of an overdose, monitoring for 24 hours is recommended. The lipase-inhibiting effects are typically reversible based on both human and animal studies.

Therapeutic Class

Appetite suppressants / Anti-obesity medications

Storage Conditions

Store in a cool, dry place below 30°C, away from light and moisture. Keep out of reach of children.