Othera
Generic Name
Orlistat
Manufacturer
Incepta Pharmaceuticals Ltd.
Country
Bangladesh
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Description
Overview of the medicine
Orlistat is an anti-obesity medication that prevents the absorption of fats from the human diet by acting as a lipase inhibitor. It is used in conjunction with a reduced-calorie diet for weight loss and to help prevent weight regain.
Uses & Indications
Dosage
Adults
120 mg capsule three times daily with each main meal (during or up to one hour after the meal).
Elderly
No specific dose adjustment is required in elderly patients.
Renal_impairment
No specific dose adjustment is required in patients with renal impairment, but caution is advised due to limited data.
How to Take
Take one capsule three times a day with each main meal that contains fat. The capsule should be taken immediately before, during, or up to one hour after the meal. If a meal is missed or contains no fat, the dose can be omitted.
Mechanism of Action
Orlistat acts by inhibiting gastrointestinal lipases (gastric and pancreatic lipases), enzymes that break down dietary fat. This inhibition prevents the hydrolysis of dietary triglycerides into absorbable free fatty acids and monoglycerides. As a result, approximately 30% of dietary fat is not absorbed and is excreted in the feces, leading to a caloric deficit and weight loss.
Pharmacokinetics
Onset
Effects on fat absorption begin within 24-48 hours.
Excretion
The primary route of excretion is via feces (approximately 97% of the administered dose), with only minimal renal excretion (less than 2%).
Half life
Terminal half-life of systemically absorbed orlistat is 1-2 hours.
Absorption
Minimal systemic absorption (less than 1%). The primary site of action is the gastrointestinal lumen.
Metabolism
Primarily metabolized in the gastrointestinal wall to two major metabolites (M1 and M3), which are inactive.
Side Effects
Contraindications
- Chronic malabsorption syndrome
- Cholestasis
- Hypersensitivity to orlistat or any component of the formulation
Drug Interactions
Warfarin
Can affect absorption of fat-soluble vitamins, including vitamin K, potentially altering INR. Monitor INR closely.
Amiodarone
Reduced absorption of amiodarone has been reported. Monitor for decreased efficacy of amiodarone.
Cyclosporine
Reduced plasma levels of cyclosporine have been observed. Administer cyclosporine at least 3 hours after orlistat.
Levothyroxine
Reduced absorption of levothyroxine. Administer levothyroxine at least 4 hours before or after orlistat.
Fat-soluble vitamins (A, D, E, K)
Absorption may be decreased. Advise patients to take a multivitamin supplement containing fat-soluble vitamins at least 2 hours before or after orlistat or at bedtime.
Storage
Store 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 with no significant adverse findings. If a significant overdose occurs, it is recommended that the patient be observed for 24 hours. Any systemic effects attributable to orlistat are likely to be rapidly reversible.
Pregnancy & Lactation
Pregnancy: Orlistat is not recommended for use during pregnancy. Lactation: It is not known whether orlistat is excreted in human milk. Caution should be exercised when administered to a nursing woman.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 to 36 months
Availability
Available in all pharmacies in Bangladesh
Approval Status
Approved by DGDA, FDA
Patent Status
Generic available, patent expired
Clinical Trials
Numerous clinical trials have demonstrated the efficacy and safety of orlistat in promoting weight loss and improving metabolic parameters in overweight and obese individuals.
Lab Monitoring
- Liver function tests (if symptoms of hepatic dysfunction occur)
- INR (for patients on warfarin)
- Lipid profile (for overall cardiovascular risk assessment)
Doctor Notes
- Emphasize the importance of dietary fat restriction and regular exercise alongside orlistat therapy for optimal results.
- Advise patients about potential gastrointestinal side effects and how to manage them (e.g., adhering to a low-fat diet).
- Recommend a daily multivitamin supplement containing fat-soluble vitamins.
- Monitor for signs of liver injury and drug interactions with cyclosporine, warfarin, and levothyroxine.
Patient Guidelines
- Follow a nutritionally balanced, reduced-calorie diet containing approximately 30% of calories from fat.
- Take a multivitamin supplement containing fat-soluble vitamins (A, D, E, K) at least 2 hours before or after orlistat, or at bedtime.
- If you miss a meal or your meal contains no fat, you may omit your dose of orlistat.
- Report any signs of liver injury (e.g., yellow eyes or skin, dark urine, severe stomach pain) to your doctor immediately.
Missed Dose Advice
If a dose is missed by more than one hour after a main meal, the missed dose should be omitted, and the next dose should be taken at the usual time. Do not take a double dose to make up for a missed one.
Driving Precautions
Orlistat is not expected to affect the ability to drive or operate machinery.
Lifestyle Advice
- Combine orlistat treatment with a healthy lifestyle, including a balanced diet and regular physical activity.
- Set realistic weight loss goals and discuss them with your healthcare provider.
- Maintain adequate hydration.
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Global Brand Names
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