INDICATIONS AND USAGE:
Orlistat is indicated for obesity management including weight loss and weight maintenance when used in conjunction with a reduced-calorie diet. Orlistat is also indicated to reduce the risk for weight regain after prior weight loss. Orlistat is indicated for obese patients with an initial body mass index (BMI) ≥ 30 kg/m 2 or ≥ 27 kg/m 2 in the presence of other risk factors (eg, hypertension, diabetes, dyslipidemia).
The BMI is calculated by dividing weight in kilograms by height in meters squared. For example, a person who weighs 180 lbs and is 5’5” would have a BMI of 30.
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.
Commonly Observed (based on first year and second year data - Orlistat 120 mg three times a day versus placebo):
Gastrointestinal (GI) symptoms were the most commonly observed treatment-emergent adverse events associated with the use of Orlistat in the seven double-blind, placebo-controlled clinical trials and are primarily a manifestation of the mechanism of action.
These and other commonly observed adverse reactions were generally mild and transient, and they decreased during the second year of treatment. In general, the first occurrence of these events was within 3 months of starting therapy. Overall, approximately 50% of all episodes of GI adverse events associated with orlistat treatment lasted for less than 1 week, and a majority lasted for no more than 4 weeks. However, GI adverse events may occur in some individuals over a period of 6 months or longer.
Discontinuation of Treatment
In controlled clinical trials, 8.8% of patients treated with Orlistat discontinued treatment due to adverse events, compared with 5.0% of placebo-treated patients. For Orlistat, the most common adverse events resulting in discontinuation of treatment were gastrointestinal.
Incidence in Controlled Clinical Trials
The following is a list of other treatment-emergent adverse events from seven multicenter, double-blind, placebo-controlled clinical trials that occurred at a frequency of ≥ 2% among patients treated with Orlistat 120 mg three times a day.
Gastrointestinal System: Abdominal Pain/Discomfort, Nausea, Infectious Diarrhea, Rectal Pain/Discomfort, Tooth Disorder, Gingival Disorder, Vomiting.
Respiratory System: Influenza, Upper Respiratory Infection, Lower Respiratory Infection, Ear, Nose & Throat Symptoms.
Musculoskeletal System: Back Pain, Pain Lower Extremities, Arthritis, Myalgia, Joint Disorder, Tendonitis.
Central Nervous System: Headache, Dizziness.
Body as a Whole: Fatigue, Sleep Disorder.
Skin & Appendages: Rash, Dry Skin.
Reproductive (Female): Menstrual Irregularity, Vaginitis.
Urinary System: Urinary Tract Infection.
Psychiatric Disorder: Psychiatric Anxiety, Depression.
Hearing & Vestibular Disorders: Otitis.
Cardiovascular Disorders: Pedal Edema.
Other Clinical Studies or Postmarketing Surveillance
Rare cases of hypersensitivity have been reported with the use of Orlistat. Signs and symptoms have included pruritus, rash, urticaria, angioedema, bronchospasm and anaphylaxis. Very rare cases of bullous eruption, increase in transaminases and in alkaline phosphatase, and exceptional cases of hepatitis that may be serious have been reported. No causal relationship or physiopathological mechanism between hepatitis and orlistat therapy has been established. Reports of decreased prothrombin, increased INR and unbalanced anticoagulant treatment resulting in change of hemostatic parameters have been reported in patients treated concomitantly with orlistat and anticoagulants.
In clinical trials in obese diabetic patients, hypoglycemia and abdominal distension were also observed.
Preliminary data from an Orlistat and cyclosporine drug interaction study indicate a reduction in cyclosporine plasma levels when Orlistat was coadministered with cyclosporine.
In clinical trials with Orlistat in adolescent patients ages 12 to 16 years, the profile of adverse reactions was generally similar to that observed in adults.
Single doses of 800 mg Orlistat 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 Orlistat 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 orlistat should be rapidly reversible.
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. The daily intake of fat, carbohydrate, and protein should be distributed over three main meals. If a meal is occasionally missed or contains no fat, the dose of Orlistat can be omitted.
Because Orlistat has been shown to reduce the absorption of some fat-soluble vitamins and beta-carotene, patients should be counseled to take a multivitamin containing fat-soluble vitamins to ensure adequate nutrition. The supplement should be taken at least 2 hours before or after the administration of Orlistat, such as at bedtime.
Doses above 120 mg three times a day have not been shown to provide additional benefit.
Based on fecal fat measurements, the effect of Orlistat is seen as soon as 24 to 48 hours after dosing. Upon discontinuation of therapy, fecal fat content usually returns to pretreatment levels within 48 to 72 hours.
The safety and effectiveness of Orlistat beyond 4 years have not been determined at this time.
Box of 20,90 Capsules.