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Orlistat for obesity and weight loss management
Xenical is the world's most popular weight loss medication.
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Orlistat, the active ingredient of Xenical, does not affect the body's metabolism to cause weight loss. Instead, Xenical diet pills achieve weight loss by using the existing fat from the body. By taking Xenical with each meal (3 times daily), these diet pills allow one third of the fat to pass through the body undigested, aiding in weight loss. You can buy it in our online pharmacy. No prescription required.
Prescribing Information Xenical
orlistat 120mg capsule
XENICAL 12Omg capsules have a turquoise cap and turquoise body with imprint of XENICAL ROCHE 120 on both the cap and body.
XENICAL is a potent, specific and long acting inhibitor of gastrointestinal lipases. It exerts its therapeutic activity in the lumen of the stomach and small intestine by forming a covalent bond with the active serine site of the gastric and pancreatic lipases. The inactivated enzyme is thus unable to hydrolyse dietary fat, in the 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 Systemic absorption is therefore not needed for activity.
Single and repeated dose toxicity studies in rodents and dogs have demonstrated a similar pattern of dose related effects across species, none of which is considered relevant to the recommended use in man.
No orlistat associated mutagenicity or genotoxicity has been observed in a standard battery of five different short-term assays.
Carcinogenicity studies in rats and mice have not shown a carcinogenic potential for orlistat at doses up to 1000mg/kg/day and 1500mg/kg/day respectively. These doses are 18Z and 125 times the daily human dose calculated on a body surface area (mg/m') basis. There was a decreased incidence of mammary fibroadenoma in female rats in the high dose group. No orlistat associated adverse effects were observed in Segment I, II and III reproductive toxicity studies at doses ranging 62-241 times the recommended clinical dose.
Studies in normal weight and obese volunteers have shown that the extent of absorption of orlistat was minimal. Plasma concentrations of intact orlistat were non-measurable ( < 5 mg/ml) eight hours following oral administration of orlistat. In general, at therapeutic doses, detection of intact orlistat in plasma was sporadic and concentrations were extremely low (< 10 mg/ml or 0.02 pM), without evidence of accumulation, and consistent with negligible absorption.
The volume of distribution cannot be determined because orlistat is minimally absorbed and has no defined systemic pharmacokinetics. In vitro orlistat is >99'/o bound to plasma proteins (lipoproteins and albumin were the major binding proteins). Orlistat minimally partitions into erythrocytes.
Based on animal data, it is likely that the metabolism of orlistat occurs mainly within the qastrointestinal wall. Based on a study in obese patients, of the minute fraction of the dose that was absorbed systematically, two major metabolites, M1 (4-member lactone ring hydrolysed) and M3 (M1 with N-formyl leucine moiety cleaved), accounted for approximately 42% of the total plasrna concentration. M1 arid M3 have an open E-lactone ring and extremely weak lipase inhibitory activity (1000 and 2500 fold less than orlistat receptively). In view of this low inhibitory activity and the low plasma levels al therapeutic doses (average of 26 mg/ml and 108 mg/ml respectively), these metabolites are considered to be pharmacologically inconsequential.
Studies in normal weight and obese subjects have shown that faecal excretion
of the unabsorbed substance was the major route of elimination. Approximately
97% of the administered dose was excreted in faeces and 83% of that as unchanged
The cumulative renal excretion of total orlistat-related materials was < 2% of the given dose. The time to reach complete excretion (faecal plus urinary) was 3 to 5 days. The disposition of orlistat appeared to be similar between normal weight and obese volunteers. Orlistat, M1 and M3 are all subject to biliary excretion.
XENICAL is indicated for long-term treatment of significantly obese patients, including patients with risk factors associated with obesity, in conjunction ion with a mildly hypocaloric diet. XENICAL is effective in long-term weight control (weight loss, weight maintenance and prevention of weight regain). Treatment with XENICAL results in an improvement of risk factors and comorbidities associated with obesity, including hypercholesterolemia non-insulin-dependent diabetes mellitus (NIDDM), impaired glucose tolerance, hyperinsulinemia, hypertension and in a reduction of visceral fat.
Dosage and Adminstration
The recommended dose of XENICAL is one I 20mg capsule with each main meal (
during or up to one hour after the meal). If a meal is missed or contains no fat,
the dose of XENICAL may be omitted. The therapeutic benefits of XENICAL (including
weight control and improvement of risk factors) are continued with long-term
The patient should be on a nutritionally balanced, mildly hypocaloric diet that contains approximately 30% of calories from fat. It is recommended that the diet should t>e rich in fruit and vegetables The daily intake of fat, carbohydrate and protein should be distributed over three main meals. Doses above 120mg three times daily have not been shown to provide additional benefit. No dose adjustment is necessary for the geriatric patient. Based on faecal fat measurements, the effect of XENICAL is seen as soon as Z4 to 48 hours after dosing. Upon discontinuation of therapy, faecaI fat content usually returns to pre-treatment levels, within 48 to 72 hours.
Hepaticand/or Renal Impariment
Dose adjustment is not required.
Children below the age of 18 years
The safety and efficacy of XENICAL in children have not been established.
XENICAL is contraindicated in patients with chronic malabsorption syndrome and in patients with known hypersensitivity to orlistat or any of the other components contained in the capsule.
Warnings And Precautions
No serious adverse reactions or safety hazards related to the use of XENICAL have been reported to date during large, long-term clinical trials (3300 patients treated with XENICAL for up to 2 years) (see Adverse Effects). Patients should be advised to adhere to dietary guidelines (see Dosage and Administration). The possibility of experiencing gastrointestinal events (see Adverse Effects) may increase when XENICAL is taken with a diet high in fat (e.g. in a 2000 calorie/day diet, >30% of calories from fat equates to >67g of fat) The daily intake of fat should be distributed over three main meals. If XENICAL is taken with any one meal very high in fat, the possibility of gastrointestinal effects may increase.
Use during pregnancy and lactation
The safety of XENICAL has not been established in pregnant women. In animal reproductive studies no embryotoxic or teratogenic effects were observed that were considered to be associated with XFNICAI. However, because animal studies are not always predictive of human response, XENICAL should not be used during pregnancy unless the potential benefit outweighs the potential risk. XI-NICAI should not be taken by nursing women, because it is not known whether XENICAL is secreted in human milk, unless the potential benefit outweighs the potential risk.
Effect on ability to drive and use machines
No effects on the patient's ability to drive and use machines have been reported.
The safety of orlistat has not been established beyond two years. Adverse.
reactions to XENICAL are largely gastrointestinal in nature and related to the
pharmacological effect of the substance on preventing the absorption of ingested
fat (see Actions). Commonly observed events are oily spotting, flatus with
discharge, faecal urgency, fatty/oily stool, oily evacuation, increased
defecation and faecal incontinence.
The incidence of these increases the higher the fat content of the diet and thus faeces. Patients should be counseled as to the possibility of gastrointestinal effects occurring and how best to handle them such as reinforcing the diet, particularly the percentage of fat it contains. Consumption of a diet low in fat will decrease the likelihood of experiencing adverse gastrointestinal events and this may help patients monitor and regulate their fat intake. In clinical studies, these pharmacological effects were not considered an impediment to continuation of therapy. These adverse reactions are generally mild and transient. Gastrointestinal events occurred early in treatment (within 3 months) and most patients experienced only one episode. On y 3% of patients experienced more than two episodes of any one adverse. event.
In a clinical programme with over 4,000 patients treated for up to Z years, there were a total of 11 reports of breast cancer, all in women 45 years of age or older. There were 10 reports of breast cancer in the XENICAL treated subgroups (N=1063) and 1 in the placebo subgroup (N=579!. The total number of patients reporting breast cancer was small but the, imbalance seen warranted further evaluation. All study patients 45 years of age or older were followed up and all available data were thorough y reviewed by independent clinical experts in the fields of oncology, pathology, radiology and epiderniology. Follow up revealed two more patients with breast cancer in a XENICAL group and two more in the placebo group.
For 6 of the XENICAL patients, mammograms were available from before XENICAL treatment had commenced and in 4 of these 6 it was possible to detect the lesion when the mammogram was re-examined. Most cancers found were 25mm in diameter and, as it takes 8 to 12 years for a cancer to grow from a single cell to 10mm, it is clear that most tumors were pre-existing. A specific marker found in 9 tumors suggests the lesion was at least 5 years old. Of the 1Z patients treated with XENICAL 1ZOmg, 60mg or 30mg found to have breast cancer, 9 had tumors which were proved to have been pre-existing. Of the 3 patients treated with placebo who were found to have breast cancer, one tumor was proven to have been pre-existing.
In summary, there were 3 cases of breast cancer possibly related to therapy in patients in the XFNICAL treatment groups (N=1063) and Z cases possibly related to therapy in patients in the placebo treatment group (N=579). Epidemiological data suggest that if XENICAL were a promoter of cancer, one would expect to see other cancers, and if it were an enhance one would expect to see increased growth around existing tumors. In neither case was this found. A tabulation of the data is as follows:
Breast Cancer Cases
|Treatment Group||Sub Group (N) Women >45years||Actual||Expected||Add F/U||Pre-existing||Possibly Related|