Lowet Capsule

Orlistat

Indications

Adults: Lowet 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 with Lowet should be discontinued after 12 weeks in patients who have not lost at least 5% of their body weight as measured at the start of drug therapy.

Adolescents (12 years & older): Obese adolescents should be treated with Lowet only if an adequate reduction of body weight cannot be achieved by means of diet & increased physical activity. Treatment with Lowet should be considered in particular if complications of obesity are present.

Pharmacology

Orlistat is a potent, specific and long-acting lipase inhibitor. It exerts its therapeutic activity in the lumen of the stomach and upper small intestine by forming a covalent bond with the active serine site of gastric and pancreatic lipases. The inactivated enzyme is thus rendered unable to hydrolyze dietary fats in the form of triglycerides into absorbable free fatty acids and monoglycerides. As undigested triglycerides can not be absorbed, a caloric deficit arises which has a positive effect on weight control. Systemic absorption of orlistat is therefore not needed for the activity. At the recommended therapeutic dose of 120 mg three times a day, orlistat inhibit dietary fat absorption by approximately 30%.

Dosage & Administration

The recommended dose of Orlistat is one 120 mg 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 of Orlistat should be omitted. Doses of Orlistat above 120 mg three times daily have not been shown to provide additional benefits. The effect of Orlistat results in an increase in fecal fat 24-48 hours after dosing. Upon discontinuation of therapy, fecal fat content usually returns to pretreatment levels within 48-72 hours.

The safety & efficacy of Orlistat were investigated in clinical studies lasting up to 4 years. The recommended dose of Orlistat for adolescents is as same as adults.

Special dosage instruction: The tolerability and efficacy of Orlistat have not been studied in elderly patients, or patients with hepatic and/ or renal impairments.

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Interaction

Reduction in cyclosporine plasma levels when Lowet was coadministered with cyclosporine. Lowet inhibited absorption of a vitamin E acetate supplement. The effect of Lowet on the absorption of supplemental vitamin D, vitamin A, and nutritionally-derived vitamin K is not known. Hypothyroidism has been reported in patients treated concomitantly with Lowet and levothyroxine. Patients treated concomitantly with Lowet and levothyroxine should be monitored for changes in thyroid function. Administer levothyroxine and Lowet at least 4 hours apart. Vitamin K absorption may be decreased with Lowet. Patients on chronic stable doses of warfarin who are prescribed Lowet should be monitored closely for changes in coagulation parameters. Convulsions have been reported in patients treated concomitantly with Lowet and antiepileptic drugs. Patients should be monitored for possible changes in the frequency and/or severity of convulsions.

Contraindications

Orlistat is contraindicated in patients with chronic malabsorption syndrome, in patients with cholestasis and in patients who are hypersensitive to orlistat or to any of the other ingredients of the capsules.

Side Effects

Common: Undesirable effects of Lowet are largely gastrointestinal in nature. Common gastrointestinal side effects are oily spotting from the rectum, flatulence, fecal urgency, oily or fatty stool, abdominal discomfort etc.

Rare: Influenza, anxiety. headache, fatigue etc may rarely occur in some patients. Rare cases of hypersensitivity have been reported. Main clinical symptoms are pruritus, exanthema, urticaria, angioedema and anaphylaxis.

Pregnancy & Lactation

Pregnancy: Orlistat is Pregnancy Category X drug. Orlistat is contraindicated during pregnancy, because weight loss offers no potential benefit to a pregnant woman and may result in fetal harm. A minimum weight gain, and no weight loss, is currently recommended for all pregnant women, including those who are already overweight or obese, due to the obligatory weight gain that occurs in maternal tissues during pregnancy. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard of maternal weight loss to the fetus.

Lactation: It is not known if Orlistat is present in human milk. Caution should be exercised when Orlistat is administered to a nursing woman.

Precautions & Warnings

Organic causes of obesity (e.g. hypothyroidism) should be excluded before prescribing Lowet. Lowet and cyclosporine should not be coadministered. Cyclosporine should be taken at least 2 hours before or after Lowet in patients taking both drugs. Cyclosporine level should be measured and frequently monitored.

In clinical trial, the decrease in body weight with Lowet therapy was less in type II diabetic patients than in non-diabetic patients. Antidiabetic drug treatment should be closely monitored during Lowet therapy. Because of the improvement in glycemic control, the dose of oral antidiabetics or of insulin may need to be adjusted.

Patients should be advised to adhere to the dietary recommendations. The probability of occurrence of gastrointestinal side effects may increase when Lowet is taken with a fatty meal. The daily intake of fat should be distributed between three main meals. Patients should be strongly encouraged to take a multivitamin supplement that contains fat soluble vitamins to ensure adequate nutrition because Lowet has been shown to reduce the absorption of some fat soluble vitamins & beta-carotene. In addition, the levels of vitamin D & beta carotene may be low in obese patients compared with non-obese patients.

Overdose Effects

Single doses of 800 mg Lowet and multiple doses of up to 400 mg three times a day for 15 days have been studied in normal-weight and obese subjects without significant adverse findings. Should a significant overdose of Lowet occur, it is recommended that the patient be observed for 24 hours. Based on human and animal studies, systemic effects attributable to the lipase-inhibiting properties of Lowet should be rapidly reversible.

Therapeutic Class

Appetite suppressant drugs/Anti-obesity drugs

Storage Conditions

Store in cool & dry place below 30°C, protect from light & moisture. Keep out of reach of children.