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Author: Kristina Lobanovskaya, doctor, practicing nutritionist Article updated: 11/10/2020
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Excess weight is not only an aesthetic problem, first of all it is a serious harm to human health. Obese people are at risk of developing diseases such as hypertension, diabetes, heart attack, stroke and many others. How can you determine when it’s time to think about losing weight if everyone’s idea of an ideal figure is different? There is a medical indicator - BMI or body mass index. It is calculated by dividing weight in kilograms by height in centimeters, and then square the resulting number. BMI shows whether a person’s weight is normal and whether it needs to be reduced or increased.
For people with a body mass index of more than 28 kg/m2, which is already considered obesity, the drug “Xenalten”, which belongs to the class of lipase inhibitors, has been developed. It blocks the absorption of fats and indirectly reduces calorie intake.
Active substance and components
The weight loss medicine “Xenalten” is produced in Russia at the Obolenskoye pharmaceutical enterprise. The drug is sold in blue or white capsules, inside of which granular powder with the active substance is visualized.
The active pharmaceutical substance of the drug "Xenalten" is orlistat. The medicine helps digest, dissolve and separate fats. 1 capsule contains 120 mg of active ingredient.
Additional substances in the composition of the drug:
- Microcrystalline cellulose;
- Sodium dodecyl sulfate;
- Crystalline mineral talc;
- Sorbent polyvinylporrilidone;
- Disintegrant sodium starch glycolate;
- Titanium dioxide dye;
- Synthetic blue dye;
- Collagen gelatin.
The product is available in contour blisters of 7 and 21 pcs. The records are packed in cardboard boxes of 1, 2, 3, 6 and 12 pcs.
Xenalten
Active substance:
Orlistat* (Orlistat*)
Pharmgroup:
Other lipid-lowering drugs
Average price in pharmacies
Name | Manufacturer | average price |
Xenalten 0.12 n42 caps | OBOLENSKOYE | 780.00 |
Xenalten 0.12 n84 caps | OBOLENSKOYE | 1462.00 |
Analogs for the active substance:Allie Xenical Orlistat Orsoten Orsoten slim |
How the drug works
"Xenalten" is a peripherally acting drug that inactivates enzymes that break down fats to prevent their absorption. Orlistat begins to work in the small intestine and stomach, where it combines with enzymes. As a result, the breakdown of fats, which enter the gastrointestinal tract in the form of triglycerides, is inhibited.
Thanks to the mechanism of action of orlistat, fats are not absorbed, the amount of calories consumed decreases, and the body begins to use up available resources. A few days after the start of therapy, an increased fat content in the feces is observed. The weight loss process begins. The instructions for the drug "Xenalten" indicate that fat absorption is reduced by approximately 30%.
The degree of absorption of orlistat is small. 8 hours after taking the capsule, the concentration of the active substance in the blood and lymph is not observed. The duration of action on the body is short, which makes the drug extremely safe in the fight against excess weight.
“Xenalten” is broken down in the gastrointestinal tract and converted into inactivated metabolic products. 2 hours after taking the tablets, the concentration of the active substance decreases by 50%. Orlistat is excreted primarily in feces and bile.
Beneficial features
Doctors prescribe Xenalten to people who, for various reasons, have not been able to lose weight on their own and who have a history of other risk factors (high blood pressure or dyslipidemia). How exactly does it help reduce excess weight? While taking these capsules, the body will absorb approximately half the calories from the total amount received from food. The drug blocks the absorption of fats during the digestive process, resulting in an energy deficiency. This phenomenon triggers the mechanism for generating energy from your own fat reserves, which also has a positive effect on body weight and volume. Taking Xenalten for weight loss can be compared in effect to following a low-calorie diet. But if you actually combine a course of treatment with certain dietary restrictions, the result in the form of a decrease in body weight will not be long in coming.
Additional influence
The indirect effect of Xenalten is associated with a decrease in blood cholesterol levels and an increase in sensitivity to the hormone insulin. Thanks to this, patients with diabetes have the opportunity to reduce the dosage of medications that correct blood sugar levels.
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For a healthy person, lowering insulin will help you lose weight by converting carbohydrates into energy and preventing excess glucose from turning into fat. This effect of orlistat helps to reduce internal fat deposits in the abdomen and waist.
Patients with a confirmed diagnosis of diabetes mellitus should discuss the issue with an endocrinologist before starting treatment with Xenalten!
When are the tablets prescribed?
The instructions for use of Xenalten indicate that it is prescribed for weight loss.
What diseases and conditions are indications for treatment with orlistat:
- Excess body weight. Weight is considered overweight when it exceeds normal body weight by 10-20%. You can calculate the normal weight for an individual patient using simple calculations: height – 100. 100 is a variable value that changes depending on the person’s height. So at 155-165 cm 103 is subtracted, at 166-175 - 106, at 176 and above - 110. Exceeding the normal body weight by more than 20% is considered obesity.
- Obesity. The pathology is manifested by weight gain due to excess accumulation of fat deposits. To establish a diagnosis, the formula for calculating BMI (body mass index) is used: weight (kg) / height² (m). Calculation example: patient weight 98 kg, height 168. BMI = 98 / 1.68² = 34. Normal BMI is 18-25. The use of Xenalten is appropriate for patients with a body mass index above 28.
- Metabolic syndrome. The pathology is characterized by an increase in body weight due to excess accumulation of internal (abdominal) fat. At the same time, sensitivity to insulin decreases, its level in the blood increases and metabolic processes are disrupted. The condition is dangerous with the risk of developing hypertension.
The drug can be used to maintain weight after weight loss. Orlistat is allowed to be used for the following pathologies that often accompany obesity:
- Diabetes;
- Fat metabolism disorder;
- Arterial hypertension.
Measure your waist! The normal volume for women is less than 90 cm, for men - no more than 100 cm. Significant deviations from the norm indicate the accumulation of visceral fat, which forms around the internal organs. Visit an endocrinologist, nutritionist and gastroenterologist. You may need drug treatment for obesity!
Is the product effective?
A study was conducted where participants took this drug for a year. At the end of the year, experts found that most patients lost weight by 10% or even more. Many people's blood pressure has normalized, although it was previously hypertensive. The risk of diabetes mellitus has greatly decreased.
Based on these indicators, it can be assumed that the medicine performs the functions that are expected of it. Those who doubt the advisability of using this product should pay attention to the reviews of people who have used it.
Directions for use and dosage
Treatment with Xenalten occurs against the background of dietary nutrition and a calorie deficit. It is advisable to adhere to a low-calorie menu for 2 weeks before starting therapy. It is recommended to consume enough vegetables and fruits and reduce fat intake (no more than 30% of total calories). During treatment with the drug, care should be taken to ensure that the diet is balanced. This is necessary to avoid breakdowns and deterioration of health due to lack of nutrients and vitamins.
According to the instructions for use, “Xenalten” should be taken according to the following scheme:
- 1 capsule 120 mg 3 times a day an hour after meals or during meals;
- The minimum course of treatment is 3 months, the maximum is 2 years;
- If the food was low-fat, you are allowed to skip taking the medicine.
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Do not exceed the recommended dosage due to the high risk of developing undesirable consequences! In case of significant overdose (in a single dose of more than 800 mg), daily monitoring of the patient's condition is necessary. The duration of treatment is determined by the doctor individually!
Side effects
If you follow your doctor's recommendations regarding the use of the drug "Xenalten", the risk of side effects is minimal.
The most common consequences of treatment with orlistat are observed in the gastrointestinal tract:
- Stool liquefaction;
- Excessive passage of gases with oily discharge spontaneously coming out of the anus;
- False urge to defecate, accompanied by abdominal pain, colic and flatulence;
- The presence of a large amount of fatty inclusions in the stool;
- Frequent stools.
Such reactions occur in the first weeks of therapy and are mild and inconsistent. Patients noted that side effects from the gastrointestinal tract appear with increased fat consumption. Undesirable manifestations are stopped after adjusting the diet.
Some patients during treatment with Xenalten developed infectious diseases of the respiratory system, genitourinary system and inflammation of the ENT organs.
Immune reactions rarely occur:
- Skin itching, rashes and other manifestations of allergies;
- Quincke's edema;
- Bronchospastic syndrome;
- Anaphylactic shock.
In isolated cases, pathological activity of liver enzymes and an increase in alkaline phosphatase occur, which may signal overload and narrowing of the bile ducts.
In the first month of treatment, reactions from the central nervous system are possible:
- Headache;
- Dizziness;
- Problems falling asleep and deteriorating sleep quality;
- Anxiety.
Other side effects that are possible while taking Xenalten:
- ARVI;
- Pathological course of menstruation, accompanied by pain in the lower abdomen, nausea and vomiting, fever;
- Weakness, decreased activity.
An increase in the symptoms of adverse reactions and the presence of pathological conditions not noted in the instructions is a reason to immediately consult a doctor!
Instructions:
Contraindications
Hypersensitivity, chronic malabsorption syndrome, cholestasis.
Use during pregnancy and breastfeeding
There are no adequate, well-controlled studies of orlistat in pregnant women. Because data from animal testing may not always predict response in humans, orlistat is not recommended for use during pregnancy.
FDA category of effect on the fetus is B.
It is unknown whether orlistat is secreted into breast milk and should not be used in nursing women.
Side effects of the drug
Controlled clinical trials
According to seven double-blind, placebo-controlled clinical trials, in patients taking orlistat 120 mg 3 times daily with diet, during the first and second year of follow-up, the most frequent (with a frequency of ≥5%) and at least 2 times more often than in the placebo group (on the background of diet), side effects from the gastrointestinal tract were noted, which reflected the mechanism of action of the drug (see Table 3).
Table 3
Most common side effects observed in controlled clinical trials of orlistat
Side effects | 1st year of observation | 2nd year of observation | ||
Orlistat (n=1913), % | Placebo (n=1466), % | Orlistat (n=613), % | Placebo (n=524), % | |
Oily discharge from the rectum | 26,6 | 1,3 | 4,4 | 0,2 |
Emission of gases with some discharge | 23,9 | 1,4 | 2,1 | 0,2 |
Urgency to defecate | 22,1 | 6,7 | 2,8 | 1,7 |
Greasy/oily stools | 20,0 | 2,9 | 5,5 | 0,6 |
Oily stool | 11,9 | 0,8 | 2,3 | 0,2 |
Increased frequency of bowel movements | 10,8 | 4,1 | 2,6 | 0,8 |
Fecal incontinence | 7,7 | 0,9 | 1,8 | 0,2 |
These and other commonly observed adverse reactions were generally of moderate severity and transient, and their frequency decreased in the second year of treatment. In general, the first episode of side effects occurred within 3 months from the start of therapy. The duration of 50% of all gastrointestinal side effects associated with orlistat treatment was less than 1 week, in most cases no more than 4 weeks. However, gastrointestinal side effects may develop in some patients during 6 or more months of therapy.
In controlled clinical trials, 8.8% of patients taking orlistat had to stop treatment due to side effects, compared with 5% in the placebo group. In the orlistat group, treatment was most often interrupted due to gastrointestinal side effects.
Table 4 presents side effects that were observed in seven multicenter, double-blind, placebo-controlled studies in patients taking orlistat 120 mg 3 times daily in combination with diet for 2 years, with an incidence of ≥2% and greater than that in the placebo plus diet group (“-” indicates no reported incidence of the symptom ≥2% and greater than placebo).
Table 4
Side effects observed in placebo-controlled clinical trials
Body systems/Side effects | 1st year of observation | 2nd year of observation | ||
Orlistat (n=1913), % | Placebo (n=1466), % | Orlistat (n=613), % | Placebo (n=524), % | |
From the gastrointestinal tract | ||||
abdominal pain/discomfort | 25,5 | 21,4 | — | — |
nausea | 8,1 | 7,3 | 3,6 | 2,7 |
infectious diarrhea | 5,3 | 4,4 | — | — |
pain/discomfort in the rectum | 5,2 | 4,0 | 3,3 | 1,9 |
dental diseases | 4,3 | 3,1 | 2,9 | 2,3 |
gum disease | 4,1 | 2,9 | 2,0 | 1,5 |
vomit | 3,8 | 3,5 | — | — |
From the respiratory system | ||||
flu | 39,7 | 36,2 | — | — |
upper respiratory tract infections | 38,1 | 32,8 | 26,1 | 25,8 |
lower respiratory tract infections | 7,8 | 6,6 | — | — |
symptoms from ENT organs | 2,0 | 1,6 | — | — |
From the musculoskeletal system | ||||
backache | 13,9 | 12,1 | — | — |
pain in lower extremities | — | — | 10,8 | 10,3 |
arthritis | 5,4 | 4,8 | — | — |
myalgia | 4,2 | 3,3 | — | — |
joint dysfunction | 2,3 | 2,2 | — | — |
tendinitis | — | — | 2,0 | 1,9 |
From the nervous system and sensory organs | ||||
headache | 30,6 | 27,6 | — | — |
dizziness | 5,2 | 5,0 | — | — |
anxiety | 4,7 | 2,9 | 2,8 | 2,1 |
depression | — | — | 3,4 | 2,5 |
otitis | 4,3 | 3,4 | 2,9 | 2,5 |
Body as a whole | ||||
fatigue | 7,2 | 6,4 | 3,1 | 1,7 |
sleep disturbance | 3,9 | 3,3 | — | — |
From the skin | ||||
rash | 4,3 | 4,0 | — | — |
dry skin | 2,1 | 1,4 | — | — |
From the genitourinary system | ||||
irregular menstrual cycle | 9,8 | 7,5 | — | — |
vaginitis | 3,8 | 3,6 | 2,6 | 1,9 |
urinary tract infections | 7,5 | 7,3 | 5,9 | 4,8 |
Others | ||||
swelling of the feet | — | — | 2,8 | 1,9 |
Other clinical studies and post-marketing experience
There have been rare reports of hypersensitivity reactions to orlistat, including pruritus, rash, urticaria, angioedema, bronchospasm and anaphylaxis.
Very rare cases of bullous rash, increased activity of transaminases and alkaline phosphatase, as well as isolated, possibly serious cases of hepatitis have been described.
In the post-marketing period, cases of pancreatitis have been reported (a cause-and-effect relationship with taking orlistat or pathophysiological mechanisms of development have not been established).
In clinical studies in patients with type 2 diabetes, the nature and frequency of adverse events were comparable to those in people without diabetes who were overweight and obese.
Precautionary measures
Before prescribing orlistat, an organic cause of obesity, such as hypothyroidism, should be excluded.
During treatment, a balanced low-calorie diet is recommended, in which fats provide no more than 30% of calories. The likelihood of developing side effects from the gastrointestinal tract increases with high fat content in food (more than 30% of daily calories). The daily intake of fats, carbohydrates and proteins should be distributed between three main meals. Because orlistat reduces the absorption of some fat-soluble vitamins, patients should take a multivitamin containing fat-soluble vitamins to ensure adequate intake. In addition, vitamin D and beta-carotene levels may be lower in obese patients than in non-obese individuals. Multivitamins should be taken 2 hours before or 2 hours after taking orlistat, for example at bedtime. Taking orlistat in doses exceeding 120 mg 3 times a day does not provide additional effect. In patients taking orlistat and cyclosporine concomitantly, more frequent monitoring of cyclosporine plasma levels is required.
In patients who did not receive prophylactic vitamin supplements, at two or more consecutive visits to the doctor during the first and second years of treatment with orlistat, a decrease in plasma vitamin levels was recorded in the following percentage of cases (data in the placebo group are indicated in parentheses): vitamin A 2, 2% (1%), vitamin D 12.0% (6.6%), vitamin E 5.8% (1%), beta-carotene 6.1% (1.7%). In some patients, urinary oxalate levels may increase with orlistat. As with other weight loss medications, orlistat may be abused in some groups of patients (such as anorexia nervosa or bulimia).
Induction of weight loss by orlistat may be combined with improved metabolic control of diabetes mellitus, which will require a reduction in doses of oral hypoglycemic agents (sulfonylurea derivatives, metformin, etc.) or insulin.
special instructions
The degree of obesity is assessed by body mass index (BMI), which is calculated using the formula: BMI = M/P2, where M is body weight, kg; P—height, m.
Storage conditions of the drug
List B.: In a place protected from moisture, at a temperature not exceeding 25 °C.
When a drug is prohibited
Contraindications for the use of Xenalten listed in the instructions for the drug:
- Individual intolerance to components;
- Cholestatic syndrome (insufficient flow of bile into the duodenum);
- Impaired absorption of nutrients, macroelements and vitamins;
- Age up to 18 years.
Due to insufficient research, diet pills with orlistat should not be taken during pregnancy or breastfeeding. In addition, treatment with Xenalten reduces the intake of fat-soluble nutrients, which is undesirable during pregnancy.
Xenalten is used with caution and only under the supervision of a physician for the following pathologies:
- Oxalaturia (excessive excretion of oxalic acid salts in urine);
- Deposition of kidney stones.
"Xenalten" is not effective if the cause of obesity is hypothyroidism (lack of thyroid hormones). Before starting treatment, the doctor must exclude pathology.
Drug interactions
Xenalten is not recommended for use in patients undergoing treatment with cyclosporine. If, in the opinion of the doctor, this combination is unavoidable, the immunosuppressant should be taken 2 hours before or 2 hours after meals. Additionally, blood monitoring is required to control the accumulation of cyclosporine.
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With simultaneous treatment with orlistat and indirect blood thinning drugs, monitoring of coagulogram parameters is necessary.
"Xenalten" reduces the absorption of vitamins A, E, K by 30%. If your doctor prescribes additional vitamins, you should take them 2 hours after taking orlistat or before bed.
"Xenalten" increases the absorption of drugs to lower blood cholesterol levels, which may require a reduction in the dosage of the latter. Orlistat helps reduce insulin, so treatment adjustments may be necessary in patients with diabetes.
There is a possibility of decreased bioavailability of oral contraceptives. To prevent unwanted pregnancy, women taking OCs are recommended to additionally use barrier methods of contraception.
The simultaneous use of Xenalten and drugs for the treatment of arrhythmia with the active substance amiodarone is permissible only with the permission of the attending physician.
additional information
"Xenalten" does not affect the level of concentration and does not reduce visual acuity. The drug is allowed to be used by patients who are employed in industries that require increased attention and who drive vehicles.
Drinking alcohol during treatment with drugs containing orlistat does not affect the bioavailability and mechanism of action of the drugs.
Patients who did not take vitamin complexes during treatment were diagnosed with symptoms of vitamin deficiency.
If after 3 months of treatment with Xenalten the patient’s body weight has decreased by less than 5%, the doctor decides to discontinue the drug due to the lack of positive dynamics.
pharmachologic effect
Xenalten is an inhibitor of gastrointestinal lipases. The main active ingredient, orlistat, inhibits the action of the pancreatic enzyme lipase, which prevents the breakdown of fats in the gastrointestinal tract, which prevents their absorption. One or two days after taking the capsule, the concentration of fat in the stool increases.
Xenalten for weight loss provides not only effective control of body weight, but also reduces the depot of fat in the body.
Cost and analogues
You can buy Xenalten at pharmacies. The cost of the drug depends on the number of capsules in the package and ranges from 620 to 2300 rubles.
Structural analogues of "Xenalten" are:
- Orlistat. Produced in Germany, India and China. The cost of the drug is from 500 to 2000 rubles, depending on the number of tablets and. Manufacturer: Switzerland. The price of the drug is 700-3500 rubles.
- "Orsoten." Russian drug, a complete analogue of Xenalten. Cost - 500-2500 rubles.
- "Listata". Manufacturer: Russia. Price - 600-3000 rubles.
“Xenalten” and “Orsoten” are considered cheap analogues of imported drugs containing orlistat.
Conclusion
On weight-loss forums, reviews about the drug “Xenalten” are mostly positive. Patients note a noticeable weight loss and an improvement in overall well-being. The effectiveness of the medicine covers possible side effects, which disappear over time or after adjusting the diet.
“Xenalten” is not a dietary supplement or a miracle diet pill! This is a serious drug, the use of which is permissible only with the permission of a doctor, if indicated and after careful study of the instructions for use.
Are diets and exercises necessary while taking the drug?
The question arises - how to eat properly so that taking the medicine is beneficial and does not harm the body?
The main thing when using Xenalten is not to go to extremes. An overly strict diet may give quick results, but it can be harmful to the body. In addition, strict dietary restrictions can lead to breakdowns, during which excess weight will be gained again.
Not following a diet at all is also wrong. Pills alone cannot transform your figure into an ideal one. If you refuse any restrictions, then even the medicine will not cope with the intake of large amounts of high-calorie food into the body.
The diet should change gradually. Giving up unhealthy or high-calorie foods should not happen all at once. To make it easier to cope with giving up your favorite foods, you should pay attention to a variety of low-calorie recipes on the Internet. Among them there is a tasty replacement for junk food.
As for various exercises and sports, moderation is important in this area as well. First of all, it is important that the actions are not a burden and bring pleasure. Gradually, achievements can be achieved in this area if you do not demand instant changes from the body.