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Xenical - instructions for use, analogs, reviews and release forms (capsules 120 mg) drugs to treat obesity and weight loss in adults, children and pregnancy. Composition

Xenical - instructions for use, analogs, reviews and release forms (capsules 120 mg) drugs to treat obesity and weight loss in adults, children and pregnancy. Composition

In this article, you can read the instructions for using the drug Xenical. There are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors of specialists on the use of Xenical in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Xenical with available structural analogues. Use for the treatment of obesity and weight loss, combined with diet in adults, children, as well as during pregnancy and lactation. Composition of the preparation.

 

Xenical - a powerful, specific and reversible inhibitor of gastrointestinal lipases, which has a long-lasting effect. Its therapeutic effect is carried out in the lumen of the stomach and small intestine and consists in the formation of a covalent bond with the active serine portion of the gastric and pancreatic lipases. The inactivated enzyme loses its ability to break down the food fats that come in the form of triglycerides, to sucking free fatty acids and monoglycerides. Since uncleaved triglycerides are not absorbed, the resulting decrease in the intake of calories into the body leads to a decrease in body weight. Thus, the therapeutic effect of the drug is carried out without absorption into the systemic bloodstream.

 

Judging by the results of fat content in feces, the action of Orlistat (the active substance of the drug Xenical) begins 24-48 hours after ingestion. After the drug is withdrawn, the fat content in the stool after 48-72 hours usually returns to the level that occurred before the start of therapy.

 

Efficiency

 

Patients with obesity

 

In clinical trials, patients taking orlistat had a greater weight loss compared to patients on diet therapy.The decrease in body weight began already within the first 2 weeks after the beginning of treatment and lasted from 6 to 12 months even in patients with a negative response to diet therapy. For 2 years, there was a statistically significant improvement in the profile of metabolic risk factors associated with obesity. In addition, compared to taking placebo, there was a significant decrease in the amount of fat in the body. Orlistat is effective in preventing repeated weight gain. A re-set of body weight, no more than 25% of the lost weight, was observed in about half of the patients, and half of these patients did not observe repeated weight gain or even further decrease.

 

Patients with obesity and type 2 diabetes mellitus

 

In clinical studies lasting from 6 months to 1 year in patients with overweight or obesity and type 2 diabetes taking orlistat, there was a large loss of body weight compared to patients treated only with diet therapy. The loss of body weight occurred mainly due to a decrease in the amount of fat in the body.It should be noted that before the study, despite the use of hypoglycemic agents, patients often had insufficient glycemic control. However, during the treatment with orlistat, a statistically and clinically significant improvement in glycemic control was observed. In addition, against the background of orlistat therapy, there was a decrease in doses of hypoglycemic agents, insulin concentrations, and a decrease in insulin resistance.

 

Reducing the risk of developing type 2 diabetes in obese patients

 

In a 4-year clinical study, orlistat significantly reduced the risk of developing type 2 diabetes (approximately 37% compared with placebo). The degree of risk reduction was even more significant in patients with initial impairment of glucose tolerance (approximately 45%). In the treatment group, orlistat, there was a greater loss of body weight compared to the placebo group. Maintaining the body weight at a new level was observed throughout the study period. Moreover, compared with placebo in patients receiving orlistat therapy, there was a significant improvement in the profile of metabolic risk factors.

 

Pubertal obesity

 

In a clinical study of 1 year duration in adolescents with obesity, a decrease in the body mass index was observed with Xenical when compared with the placebo group, where there was even an increase in the body mass index. In addition, patients of the orlistat group had a decrease in fat mass, as well as waist and hip circumference as compared to the placebo group. Also, patients who received orlistat therapy had a significant reduction in diastolic blood pressure compared with the placebo group.

 

Preclinical safety data

 

According to the preclinical data, additional risks for patients concerning the safety profile, toxicity, genotoxicity, carcinogenicity and reproductive toxicity were not revealed. In studies on animals, there was also no teratogenic effect. In connection with the lack of a teratogenic effect in animals, it is unlikely to be detected in humans.

 

Structure of the preparation

 

Orlistat + excipients + gelatin capsule shell.

 

Pharmacokinetics

 

In volunteers with normal body weight and obesity, the systemic effect of the drug is minimal.Judging from the data obtained in the experiment on animals, the metabolism of orlistat occurs mainly in the intestinal wall. Studies in individuals with normal and overweight showed that the main way of elimination is to remove the non-sucking drug with feces. With feces about 97% of the dose of the drug was withdrawn, 83% in the form of unchanged orlistat. The total renal excretion of all substances structurally associated with orlistat is less than 2% of the dose taken. Time to complete elimination of the drug from the body (with feces and urine) is 3-5 days. The ratio of pathways for orlistat in volunteers with normal and overweight was the same.

 

Indications

  • Long-term therapy of obese patients or patients with excessive body weight, incl. associated with obesity risk factors, combined with a moderately hypocaloric diet;
  • in combination with hypoglycemic drugs (metformin, derivatives of sulfonylureas and / or insulin) or a moderately hypocaloric diet in patients with type 2 diabetes with excessive body weight or obesity.

 

Forms of release

 

Capsules 120 mg.

 

The drug in the form of tablets or solution currently does not exist, it is possible that Xenical in this form is a fake.

 

Instructions for use and how to use them

 

Long-term therapy for obese patients or overweight patients, including those who are associated with obesity risk factors, in combination with a moderately hypocaloric diet in adults and children over 12 years of age, the recommended dose of orlistat is one 120 mg capsule with each major meal time of meal or not later than an hour after a meal).

 

In combination with hypoglycemic drugs (metformin, derivatives of ulfonylureas and / or insulin) or moderately hypocaloric diet in patients with type 2 diabetes with overweight or obesity: in adults, the recommended dose of orlistat is one 120 mg capsule with each main meal (during meal or not later than an hour after a meal).

 

If food intake is missed or if the food does not contain fat, Xenical can also be taken.

 

The drug should be taken in combination with a balanced, moderately hypocaloric diet containing no more than 30% of calories in the form of fats.The daily intake of fats, carbohydrates and proteins must be divided into three main methods.

 

Increasing the dose of orlistat more than the recommended (120 mg 3 times a day) does not lead to an increase in its therapeutic effect.

 

The efficacy and safety of Xenical in patients with impaired liver and / or kidney function, as well as in elderly and children (under 12 years) have not been studied, so taking this medication is not recommended for these categories of individuals.

 

Side effect

  • oily discharge from the rectum;
  • the emission of gases with a certain amount of detachable;
  • imperative urges for defecation;
  • steatorrhea;
  • more bowel movements;
  • loose stools;
  • flatulence;
  • pain or discomfort in the abdomen.

 

Their frequency increases with an increase in the fat content in the diet. Patients should be informed about the possibility of occurrence of adverse reactions from the gastrointestinal tract and teach how to eliminate them by better adherence to the diet, especially regarding the amount of fat contained in it. The use of a low-fat diet reduces the likelihood of side effects on the part of the gastrointestinal tract and thereby helps patients to monitor and regulate the consumption of fats.

 

As a rule, these adverse reactions are mild and transient. They appeared at early stages of treatment (in the first 3 months), and in most patients there was not more than one episode of such reactions.

 

When treating with Xenical, the following undesirable effects also occur:

  • "a soft chair;
  • pain or discomfort in the rectum;
  • fecal incontinence;
  • bloating;
  • damage to teeth;
  • defeat of gums;
  • headache;
  • upper respiratory tract infection;
  • infections of the lower respiratory tract;
  • urinary tract infections;
  • dysmenorrhea;
  • anxiety;
  • weakness;
  • hypoglycemic conditions;
  • itching;
  • rash;
  • hives;
  • angioedema;
  • bronchospasm;
  • anaphylaxis;
  • rectal bleeding;
  • diverticulitis;
  • pancreatitis.

 

Contraindications

  • syndrome of chronic malabsorption;
  • cholestasis;
  • hypersensitivity to the drug or any other components contained in the capsule.

 

Application in pregnancy and lactation

 

The drug category B.

 

In studies of reproductive toxicity in animals, the teratogenic and embryotoxic effect of the drug was not observed. In the absence of a teratogenic effect in animals, one should not expect a similar effect in humans.However, due to the lack of clinical data, Xenical should not be given to pregnant women.

 

Excretion of Xenical with breast milk has not been studied, so it should not be taken during breastfeeding.

 

special instructions

 

Xenical is effective in terms of long-term control of body weight (reduction in body weight and its maintenance at a new level, prevention of repeated weight gain). Treatment with Xenical leads to an improvement in the profile of risk factors and diseases associated with obesity, including hypercholesterolemia, type 2 diabetes, impaired glucose tolerance, hyperinsulinemia, arterial hypertension, and a reduction in visceral fat.

 

When used in combination with such hypoglycemic drugs as metformin, sulfonylureas and / or insulin in patients with type 2 diabetes who are overweight (body mass index (BMI) ≥28 kg / m2) or obese (BMI ≥30 kg / m2 ), Xenical in combination with a moderately hypocaloric diet provides an additional improvement in the compensation of carbohydrate metabolism.

 

In clinical studies in most patients, concentrations of Vitamins A, D, E,K and betakaren for four years of orlistat therapy remained within the normal range. To ensure adequate intake of all nutrients, multivitamins can be prescribed.

 

The patient should receive a balanced, moderately hypocaloric diet containing no more than 30% of calories in the form of fats. We recommend eating rich in fruits and vegetables. The daily intake of fats, carbohydrates and proteins must be divided into three main methods.

 

The likelihood of GI adverse reactions may increase if Xenical is taken amid a diet rich in fats (for example, 2000 kcal / day, of which more than 30% is fat, which is about 67 g of fat). Daily intake of fat should be divided into three main methods. If Xenical is taken with food, very rich in fat, the likelihood of gastrointestinal reactions increases.

 

In patients with type 2 diabetes mellitus, a decrease in body weight when treated with Xenical is accompanied by an improvement in the compensation of carbohydrate metabolism, which may or may require a reduction in the dose of hypoglycemic drugs (for example, sulfonylurea derivatives).

 

Drug Interactions

 

No interaction with amitriptyline, atorvastatin, biguanides, digoxin, fibrates, fluoxetine, losartan, phenytoin, oral contraceptives, phentermine, pravastatin, warfarin, Nifedipine GITS (gastrointestinal therapeutic system) and slow release nifedipine, Sibutramine or alcohol (based on studies of interactions between drugs). However, it is necessary to monitor the rates of MNO with concomitant therapy with Warfarin or other oral anticoagulants.

 

With simultaneous admission with the drug Xenical, there was a decrease in absorption of vitamins D, E and beta-carotene. If multivitamins are recommended, they should be taken no less than 2 hours after taking Xenical or before bedtime.

 

With the simultaneous administration of the drug Xenical and cyclosporine, a decrease in plasma concentrations of cyclosporine was noted, therefore, a more frequent determination of the concentrations of cyclosporine in plasma with simultaneous administration of cyclosporine and Xenical is recommended.

 

With oral administration of Amiodarone during therapy with Xenical, the systemic exposure of amiodarone and desethylamiodarone decreased by 25-30%However, in connection with the complex pharmacokinetics of amiodarone, the clinical significance of this phenomenon is not clear. Addition of Xenical to prolonged therapy with amiodarone may lead to a decrease in the therapeutic effect of amiodarone (no studies have been performed).

 

It is necessary to avoid simultaneous administration of Xenical and acarbose, due to the lack of pharmacokinetic data.

 

With the simultaneous administration of orlistat and antiepileptic drugs, cases of seizures developed. Causal relationship between the development of seizures and orlistat therapy is not established. However, patients should be monitored for possible changes in the frequency and / or severity of the convulsive syndrome.

 

Analogues of the drug Xenical

 

Structural analogs for the active substance:

  • Allie;
  • Xenalten;
  • Orlimax;
  • Orlistat;
  • Orsotene;
  • Orsoten Slim.

Similar medicines:

Other medicines:

Reviews (14):
Guests
obsyd
Xenical really removes fat.The chair becomes liquid and very fat, this muck remains everywhere - on the toilet, on the underpants, only you go and you are afraid to do it. You really stop eating because of fear that diarrhea will catch up in a crowded place. So the drug really helps, with the same result you can and use. I refused to accept it, since it is not known how much more nervous system could sustain.
Guests
Jane
I accept Alli (Orlistat 60 mg) for two years already. I must adhere to a diet of 1200 kkal per day, a multiple (divided) food. Weight (for two years) decreased from 113 kg to 71 kg (total - 42 kg) and continues to decline slowly. Do not eat fat - there will be no side effect (you do not have to suffer because of diarrhea or any other unpleasant phenomena). Be sure to take vitamins, and, of course, exercise. For example, an hour a day walking at an average pace. The skin does not hang because of the first slow weight loss, and secondly - a little physical exertion. In general, weight loss is a big and hard work - I wish everyone patience and good luck.
Guests
Snezana
The drug causes intestinal steatorria due to impaired absorption of fats.
Guests
Nastya
Not so long ago I, like many "slivers" bought into advertising this drug, which took a little more than six months. Yes, in the first months of admission Xenical could not rejoice - I lost weight quickly, despite some discomfort. After she began to notice that the nails began to disintegrate, but she did not associate with the drug. But here after 4 months, when already my hair caught not that strands, whole bunches, and on the skin there was a terrible rash, I really was scared. Conclusion - xenical can not be used on a regular basis, constantly, and it is necessary to beware of the so-called "undesirable" phenomena - they can bring it to the hospital bed. I'm on it put a fat point.
Guests
Eugene
I took xenical one year ago. Yes, the chair became more frequent and liquid, but that already flowed - this was not. To me, so as not to have such effects, it was enough to give up pork and other fatty foods. However, I took only six months - I was enough to throw off my extra 18 kg. While weight keeps - I try to support sports and a diet. Because I think that all the same pills are an extreme option.
Guests
Dinka
So do not eat fat in tons, and nothing will come out and flow out. I was eating normally when taking xenical, everything was fine, only the first day there was a little increased gas formation. So, maybe it was not even from the pills.
Guests
Gloria
I took Xenical on the appointment of an endocrinologist. I was told for many years that you just have a constitution, a broad bone, and so on. And it turned out that it was necessary to find a competent doctor to tell me that I have problems with hormones. I underwent a course of treatment, stabilized my hormonal background, in parallel propyl Xenical. Now I feel comfortable, with the growth of 165 cm I weigh 58 kg. I feed myself as usual, not that one grass, I eat bread and even sweet, just like from the beginning of the course of starting the fats themselves to reduce in the diet, and got used to it.
Guests
Marina
I read at one time reviews and myself decided to drink xenical. I do not regret a bit. Became a slender for some four months. From 73 to 61 kg lost weight, so it is with the growth of 167 cm. Now it is not even ashamed to wear a separate swimsuit in the summer).
Guests
viola
Before delivery, I was very slender. While on the retention of pregnancy lay, I was stuffed with hormones to the ears, that's weight and crawled up. After birth, she became 20 kg heavier. The friend the doctor to me ksenikal advised, has spent on drink it a floor of year and on 18 kg has grown thin. And then I can do it myself).
Guests
Yegorovna
I have to be lazy - any sport is absolutely contraindicated for me. After the operation on the spine, you can not run or practice fitness, only gymnastics. Which is not to lose weight at all, but to maintain my well-being. After the operation, I recovered very much, I lead a sedentary lifestyle and such consequences. Therefore, pills help me lose weight. Refused those that reduce the appetite, began to take xenalten, it helps not to digest fats. The result is also very noticeable for me, if not for the pill, it would be quite tight.
Guests
Alla
A horrible tool for losing weight !!! The girlfriend has advised, as after delivery I was strongly distributed in breadth, and the endocrinologist has told or said after analyzes, that problems any does not see and it is necessary to eat less, though the character of a delivery has not changed also I do not feed a breast. In general, I turned around for a month and tried it.You can not tell what began with the body! The gases were moving in a continuous sequence, it felt as though they had gathered there all their lives and were only waiting for me to start taking this xenical. In the society (first of all mine) it became intolerable, I just did that I asked to go to the toilet to let out excess air. On the third day there was still diarrhea, yes such that from a toilet bowl to not wash. It is said that so fat comes out. I do not know what kind of fat there was, but on the scales for a week of reception the same figures. So thanks. I do not intend to take this drug and I do not advise others!
Guests
Galiya
Girls, when you take orlistat preparations, you need to diversify the diet with vitamins and minerals, do not you tell a dietician or your doctor, or do you prescribe pills to yourself ?! T-t-t at me any problems was not special, probably business in an individual intolerance. Yes, in a big way went fat, if it leaned on pork or mayonnaise salads. The first week of 3 times a day could go. Saw 3 months ksenalten, this is an analog of xenical, but cheaper, Russian. In the autumn I repeat.
Guests
Olga
Dissatisfied. I drink the second package, the result is 0. It seems that positive feedback is advertising.
Guests
Alesya
Dorogovat Xenical.

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