Xenobese 120 mg

Description

Indications:

• Adults: Xenobese is indicated in conjunction with a mildly hypocaloric diet for the treatment of obese patients with a body mass index (BMI) >30 kg/m² and overweight patients (BMI >28 kg/m²) with associated risk factors such as type II diabetes, hyperlipidemia, and hypertension. Treatment should be discontinued after 12 weeks if the patient has not lost at least 5% of their body weight.
• Adolescents (12 years & older): Obese adolescents should use Xenobese only if bodyweight reduction cannot be achieved by diet and increased physical activity. Treatment should be considered particularly if complications of obesity are present.

Use as per a registered physician’s recommendation.

Pharmacology: Orlistat, the active ingredient in Xenobese, is a potent lipase inhibitor. It works by forming a covalent bond with the active site of gastric and pancreatic lipases, preventing the hydrolysis of dietary fats into absorbable fatty acids and monoglycerides. As a result, approximately 30% of dietary fat is not absorbed. This leads to a caloric deficit, helping with weight management. No systemic absorption of Orlistat is required for its action.

Dosage & Administration:

• The recommended dose is 120 mg (one capsule) to be taken immediately before, during, or up to one hour after each main meal.
• If a meal is missed or contains no fat, the dose should be omitted.
• Doses above 120 mg three times daily have not shown additional benefits.
• Orlistat’s effect results in an increase in fecal fat 24-48 hours after dosing, and the fecal fat content usually returns to pretreatment levels within 48-72 hours upon discontinuation.
• The recommended dose for adolescents is the same as for adults.

Special Dosage Instructions: The tolerability and efficacy of Orlistat in elderly patients or those with hepatic and/or renal impairments have not been studied.

Use as per a registered physician’s recommendation.

Interactions:

• Cyclosporine plasma levels may decrease when coadministered with Xenobese.
• Xenobese may inhibit the absorption of vitamin E acetate supplements. Its effect on vitamin D, A, and K absorption is not known.
• Patients on levothyroxine should be monitored for changes in thyroid function, and the two drugs should be taken at least 4 hours apart.
• Vitamin K absorption may decrease with Xenobese, so patients on warfarin should be monitored closely for changes in coagulation parameters.
• Patients on antiepileptic drugs should be monitored for potential changes in convulsion frequency and severity.

Contraindications:

• Chronic malabsorption syndrome
• Cholestasis
• Hypersensitivity to Orlistat or any of its ingredients

Side Effects:

• Common: Gastrointestinal issues such as oily spotting, flatulence, fecal urgency, oily stools, and abdominal discomfort.
• Rare: Influenza, anxiety, headache, fatigue, and hypersensitivity reactions such as pruritus, exanthema, urticaria, angioedema, and anaphylaxis.

Pregnancy & Lactation:

• Pregnancy: Xenobese is contraindicated during pregnancy as weight loss can harm the fetus. A minimum weight gain is recommended during pregnancy, and the drug should not be used during this time.
• Lactation: It is unknown whether Orlistat is present in human milk. Caution is advised when administered to breastfeeding women.

Precautions & Warnings:

• Organic causes of obesity (e.g., hypothyroidism) should be ruled out before prescribing Xenobese.
• Xenobese and cyclosporine should not be coadministered, and cyclosporine levels should be frequently monitored.
• In patients with type II diabetes, monitoring of antidiabetic drug therapy is essential as Xenobese may improve glycemic control and require adjustments to insulin or oral antidiabetics.
• Patients should follow dietary recommendations carefully. Taking Xenobese with fatty meals may increase the likelihood of gastrointestinal side effects.
• A multivitamin supplement containing fat-soluble vitamins is recommended as Xenobese reduces the absorption of fat-soluble vitamins and beta-carotene.

Overdose Effects:

• No significant adverse effects were observed with doses up to 800 mg as a single dose or 400 mg three times daily for 15 days in normal-weight and obese subjects.
• In the event of an overdose, patients should be observed for 24 hours. Systemic effects are expected to be rapidly reversible.

Therapeutic Class: Appetite-suppressant drugs/Anti-obesity drugs

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