Xenobese
Generic Name
Orlistat
Manufacturer
Leading Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
xenobese 120 mg capsule | ৳ 62.50 | ৳ 750.00 |
Description
Overview of the medicine
Xenobese 120 mg capsule is a medication used for weight loss by blocking the absorption of dietary fat in the intestine.
Uses & Indications
Dosage
Adults
120 mg capsule three times daily with each main meal (breakfast, lunch, dinner) that contains fat. The dose should be taken immediately before, during, or up to 1 hour after the meal. If a meal is missed or contains no fat, the dose should be skipped.
Elderly
No specific dosage adjustment is required for elderly patients.
Renal_impairment
No specific dosage adjustment is required for patients with renal impairment due to minimal systemic absorption.
How to Take
Take orally with water, immediately before, during, or up to 1 hour after each main meal containing fat. Swallow the capsule whole.
Mechanism of Action
Orlistat, the active ingredient in Xenobese, acts by inhibiting gastrointestinal lipases (enzymes that break down fat). This prevents the hydrolysis of dietary triglycerides into absorbable free fatty acids and monoglycerides, thereby reducing the absorption of dietary fat by approximately 30%.
Pharmacokinetics
Onset
Within 24-48 hours of first dose, affecting fat absorption.
Excretion
Mainly via feces (approximately 97% of the administered dose, with 83% as unchanged drug). Renal excretion is minimal (less than 2%).
Half life
Approximately 1-2 hours for the parent drug; approximately 14-17 hours for major metabolites (M1 and M3).
Absorption
Minimally absorbed systemically (less than 1% of the dose).
Metabolism
Primarily localized in the gastrointestinal tract wall. Systemic metabolism is negligible. Two main metabolites (M1 and M3) account for the majority of the plasma concentration.
Side Effects
Contraindications
- Chronic malabsorption syndrome.
- Cholestasis (impaired bile flow).
- Pregnancy and breastfeeding.
- Hypersensitivity to Orlistat or any component of the formulation.
Drug Interactions
Amiodarone
Decreased systemic exposure of amiodarone and desethylamiodarone.
Ciclosporin
Reduced absorption of ciclosporin. Orlistat should be administered at least 3 hours after ciclosporin.
Levothyroxine
Reduced absorption of levothyroxine. Orlistat and levothyroxine should be taken at least 4 hours apart.
Warfarin and other oral anticoagulants
Increased risk of vitamin K deficiency and potential for altered INR. Close monitoring of INR is essential.
Fat-soluble vitamins (A, D, E, K) and beta-carotene
Reduced absorption. Advise patients to take a multivitamin supplement containing these vitamins at least 2 hours before or after Orlistat, or at bedtime.
Storage
Store in a cool, dry place below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Single doses of 800 mg and multiple doses of 400 mg three times daily for 15 days have been studied in normal weight and obese subjects, showing no significant adverse events. Due to minimal systemic absorption, any systemic effects from an overdose are likely to be minor. Management should be supportive and aimed at treating any symptomatic adverse reactions.
Pregnancy & Lactation
Orlistat is contraindicated during pregnancy and breastfeeding. It is not known if Orlistat is excreted in human milk. Consult a doctor if you are pregnant, planning to become pregnant, or breastfeeding.
Side Effects
Contraindications
- Chronic malabsorption syndrome.
- Cholestasis (impaired bile flow).
- Pregnancy and breastfeeding.
- Hypersensitivity to Orlistat or any component of the formulation.
Drug Interactions
Amiodarone
Decreased systemic exposure of amiodarone and desethylamiodarone.
Ciclosporin
Reduced absorption of ciclosporin. Orlistat should be administered at least 3 hours after ciclosporin.
Levothyroxine
Reduced absorption of levothyroxine. Orlistat and levothyroxine should be taken at least 4 hours apart.
Warfarin and other oral anticoagulants
Increased risk of vitamin K deficiency and potential for altered INR. Close monitoring of INR is essential.
Fat-soluble vitamins (A, D, E, K) and beta-carotene
Reduced absorption. Advise patients to take a multivitamin supplement containing these vitamins at least 2 hours before or after Orlistat, or at bedtime.
Storage
Store in a cool, dry place below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Single doses of 800 mg and multiple doses of 400 mg three times daily for 15 days have been studied in normal weight and obese subjects, showing no significant adverse events. Due to minimal systemic absorption, any systemic effects from an overdose are likely to be minor. Management should be supportive and aimed at treating any symptomatic adverse reactions.
Pregnancy & Lactation
Orlistat is contraindicated during pregnancy and breastfeeding. It is not known if Orlistat is excreted in human milk. Consult a doctor if you are pregnant, planning to become pregnant, or breastfeeding.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
36 months from the date of manufacture.
Availability
Pharmacies, Online
Approval Status
Approved by FDA/DGDA
Patent Status
Off-patent
Clinical Trials
Orlistat has undergone extensive clinical trials demonstrating its efficacy in promoting weight loss and improving weight-related risk factors, particularly when combined with a reduced-calorie diet. Trials typically showed significant mean weight loss compared to placebo.
Lab Monitoring
- INR (International Normalized Ratio) for patients on warfarin or other oral anticoagulants.
- Liver function tests if symptoms of hepatic dysfunction (e.g., fatigue, jaundice, dark urine, itching) develop.
- Vitamin K levels, especially with long-term use.
Doctor Notes
- Emphasize the importance of dietary compliance (reduced-fat diet) for optimal efficacy and to minimize gastrointestinal side effects.
- Advise patients about the necessity of taking a daily multivitamin supplement containing fat-soluble vitamins (A, D, E, K) due to potential malabsorption.
- Counsel patients that Orlistat is an adjunct to, not a replacement for, lifestyle modifications (diet and exercise).
Patient Guidelines
- Follow a nutritionally balanced, reduced-calorie diet where approximately 30% of calories come from fat.
- Take a daily multivitamin supplement containing fat-soluble vitamins (A, D, E, K) at least 2 hours before or after Orlistat, or at bedtime.
- Be prepared for potential gastrointestinal side effects, which are usually mild and transient but can be managed by adhering to a lower-fat diet.
Missed Dose Advice
If you miss a meal or if your meal contains no fat, skip the dose for that meal. Do not take a double dose to make up for a missed one.
Driving Precautions
Xenobese has no known or anticipated effect on the ability to drive or operate machinery.
Lifestyle Advice
- Incorporate regular physical activity into your routine to enhance weight loss and overall health.
- Adopt behavioral changes regarding eating habits and portion control.
- Consult a healthcare professional for personalized dietary and exercise plans.
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