Orlistat Capsules
Generic name:
Orlistat
Composition:
Each capsule contains:
Active ingredient:
Orlistat 120 mg
Inactive ingredients:
Avicel PH 101, Sodium starch glycolate, Sodium lauryl sulphate, Povidone and
Talc
Pharmaceutical form:
Capsules
Pharmacological actions:
Orlistat is a reversible inhibitor of lipases. It exerts its therapeutic activity in the lumen of the stomach and small intestine by forming a covalent bond with the active serine residue elte of gastric and pancreatic lipases. The inactivated enzymes ‘are thus unCll’ailable to hydrolyze dietary fat inJhe form of triglycerides into absorbable free fatty acids and monoglycerides. As undigested triglycerides are not absorbed, the resulting caloric deficit has a positive effect on weight control.
Pharmacokinetics:
Orlistat is minimally absorbed after oral doses
Indications:
Or/istat is indicated for:
-Management weight loss for obese adult and adolescents 12 years old or older.
-Weight maintenance
-To prevent regaining weight previously lost.
-Overweight patients with an initial body mass index (BMI) ~ 30 kg/m2 or ~ 27 kg/m2 if other risk factors are present (e.g: hypertension, diabetes and dyslipidernia).
Dosage and Administration:
The recommended dose of Orlistat is one 120 mg capsule three times a day with each main meal containing fat (during or up to 1 hour after the meal).
The patient should be on a nutritionally balanced, reduced-calorie diet that contains approximately 30% of calories from fat.
Pediatric Use:
The safety and efficacy of Ortistat have not been established in children below 12 years old.
Contraindications:
Orlistat is contraindicated in patients with chronic malabsorption syndrome or cholestasis, and in patients with known hypersensitivity to Orlistat or to any component of this product.
Side effects:
A gastrointestinal (GIT) effect: (steatorrhea) liquid or oily stool lasts for few weeks and minimized by reduced fat intake.
Drug Interactions:
-Orlistat may reduce the plasma concentration of cyclosporine. So, cyclosporine should be administered two hours after or before Orlistat.
-Orlistat may reduce the absorption of fat-soluble vitamins.
-Avoid use with acarbose.
Pregnancy and lactation:
Orlistat should not be taken by nursing and pregnant women (Category B).
Precautions and warnings:
Caution should be taken with patients with a history of hyperoxaluria or calcium oxalate nephrolithiasis. Absorption of fat-soluble vitamins and Beta-carotene is inhibited by Orlistat, so patients should be counseled to take a multivitamin containing fat-soluble vitamins to ensure adequate nutrition.
Package and storage:
Store at controlled room temperature 15°C – 30’C.
A box containing 1 blister of 10 capsules.
A box containing 2 blisters, each of 10 capsules.
A box containing 3 blisters, each of 10 capsules.
produced by :
Sigma pharmaceutical industries egypt s.a.e.
