Comparing Reduxin Met and Reduxin | Important differences

Updated: 04/23/2021 15:12:57

Expert: Abramova Tsilya

Description of the product Reduxin and Reduxin Met

Reduxin based on sibutramine and MCC is available in capsules. This is a prescription medicine for the treatment of excess body weight. Actions: anorexigenic and enterosorbing.

Reduxin Met is an improved version of the drug. Available in tablets and capsules, which are sold in one package. Tablets contain metformin, capsules contain sibutramine.

Reduxin and Reduxin Met have a similar effect and have the same indications and contraindications. They are distinguished by their method of application, dosage and cost. Reduxin Met has an additional property – hypoglycemic.

Sibutramine is a medicinal substance that affects the feeling of satiety. It reduces the need to eat. MCC is a sorbent with a detoxification effect. Microcrystalline cellulose binds and removes toxic substances and allergens.

Metformin is a hypoglycemic substance that does not lead to hypoglycemia in healthy people. It stimulates glycogen synthesis and has a beneficial effect on metabolism. Taking this remedy leads to a gradual weight loss or it remains stable.

Both drugs are potent drugs that can only be used for strict indications for the treatment of obesity. They cannot be used for weight loss without concomitant diseases. The drugs have many contraindications and side symptoms.

Research and effectiveness

When using the drug Reduxin for the treatment of obesity, positive results are observed within 4 weeks. Loss of body weight occurs mainly due to adipose tissue. The drug is well tolerated. While taking the medication, patients experience a decrease in hunger and a reduction in the number of unplanned snacks.

Therapy with Reduxin in most cases achieves the desired effect in metabolic syndrome. When combined with lifestyle changes, treatment becomes more effective.

Source: “Experience of using the drug Reduxin in patients with metabolic syndrome.” Butrova S.A. Obesity and metabolism. 2007.

Contraindications

Restrictions on the use of Reduxin:

1. hypersensitivity to the composition;
2. mental illness;
3. organic causes of excess weight, such as hypothyroidism;
4. generalized tics;
5. CVD diseases;
6. thyrotoxicosis;
7. bulimia, anorexia;
8. hypertension;
9. severe kidney and liver pathologies;
10. pregnancy, before 18 and after 65 years;
11. prostate hyperplasia;
12. drug and alcohol addiction;
13. angle-closure glaucoma.

Reduxin Met additionally has the following restrictions for use:

1. diabetic coma;
2. exacerbation of chronic diseases;
3. previous surgery, trauma;
4. hypocaloric diet;
5. 48 hours before and after x-rays using iodine-containing products;
6. history of lactic acidosis.

Drugs are used with caution for any diseases of the kidneys and liver. The risk group includes elderly patients and people engaged in heavy physical labor.

There is not enough information about the use of the drug during pregnancy. Therefore, Reduxin in any variation is contraindicated for pregnant women. Treatment with the drug is prohibited during breastfeeding.

Side effects

The side effects of these drugs are somewhat different, which is due to the metformin content in the latter. This substance can cause lactic acidosis, changes in taste, dyspeptic symptoms, and skin reactions.

Sibutramine, which is present in both drugs, causes the following side symptoms:

1. dry mucous membranes, headache, insomnia, paresthesia, anxiety;
2. loss of appetite, intestinal disorders, constipation, exacerbation of hemorrhoids;
3. rapid heartbeat, tachycardia, increased blood pressure, increased heart rate;
4. increased sweating.

Other possible adverse reactions have been identified during post-marketing experience. Cases of arrhythmia, urinary retention, impotence, and uterine bleeding have been described. Taking the drug can lead to central nervous system disorders such as suicidal thoughts, mania, and memory impairment.

Dosage

Reduxin is taken once a day, 1 capsule. The initial dose is 10 mg, which can be increased to 15 mg. The course lasts up to 3 months. Maximum duration is 12 months.

Reduxin Met tablets and capsules are taken at the same time. The initial dose is 850 mg metformin and 10 mg sibutramine. The dosage can be increased to 2 tablets at a time.

In case of an overdose of metformin, lactic acidosis develops. The patient is hospitalized. When consuming a large dose of sibutramine, symptoms such as headache, tachycardia, increased blood pressure, and dizziness are observed. For treatment, gastric lavage is performed, activated charcoal and other symptomatic medications are prescribed.

Who is it suitable for?

Reduxin is used strictly as prescribed by a doctor for alimentary obesity with a BMI of 20 kg/m2 or more, as well as for obesity in combination with diabetes mellitus.

Reduxin Met has the same indications. It is also prescribed when there are risk factors for diabetes and when lifestyle changes have failed to achieve glycemic control.

Reduxin Met, tab. 850 mg + capsules (10 mg+158.5) mg, tablets and capsules set, 90 pcs.

Lactic acidosis.

Lactic acidosis is a rare but serious (high mortality unless promptly treated) complication that may occur due to accumulation of metformin. Cases of lactic acidosis when taking metformin occurred mainly in diabetic patients with severe renal failure. Other associated risk factors should be taken into account, such as decompensated diabetes mellitus, ketosis, prolonged fasting, alcoholism, liver failure and any condition associated with severe hypoxia. This may help reduce the incidence of lactic acidosis.

The risk of developing lactic acidosis should be taken into account when nonspecific signs appear, such as muscle cramps accompanied by dyspeptic symptoms, abdominal pain and severe asthenia. Lactic acidosis is characterized by acidotic shortness of breath, abdominal pain and hypothermia followed by coma. Diagnostic laboratory parameters are a decrease in blood pH (less than 7.25), lactate content in the blood plasma over 5 mmol/l, increased anion gap and lactate/pyruvate ratio. If metabolic acidosis is suspected, stop taking the drug and consult a doctor immediately.

Surgical operations.

The use of the drug Reduxin® Met should be discontinued 48 hours before planned surgical operations and can be continued no earlier than 48 hours after, provided that during the examination renal function was found to be normal.

Kidney function.

Since metformin is excreted by the kidneys, before starting to take the drug Reduxin® Met and regularly thereafter, it is necessary to determine creatinine Cl: at least once a year in patients with normal renal function and 2–4 times a year in elderly patients, as well as in patients with Creatinine Cl on NGN.

Particular caution should be exercised in case of possible impairment of renal function in elderly patients and the simultaneous use of antihypertensive drugs, diuretics or NSAIDs. Patients are advised to continue to follow a diet with even carbohydrate intake throughout the day. Overweight patients are recommended to continue to follow a hypocaloric diet (but not less than 1000 kcal/day).

It is recommended that routine laboratory tests be performed regularly to monitor diabetes mellitus.

It is recommended to exercise caution when using the drug Reduxin® Met in combination with insulin or other hypoglycemic agents (including sulfonylurea derivatives, repaglinide).

Treatment with Reduxin® Met should be carried out as part of complex therapy for weight loss under the supervision of a physician with practical experience in the treatment of obesity. Complex therapy includes both changing diet and lifestyle, as well as increasing physical activity. An important component of therapy is to create the prerequisites for persistent changes in eating behavior and lifestyle, which are necessary to maintain the achieved weight loss even after drug therapy is discontinued. As part of therapy with Reduxin® Met, patients need to change their lifestyle and habits in such a way as to ensure that the achieved weight loss is maintained after completion of treatment. Patients should be clear that failure to comply with these requirements will lead to repeated weight gain and repeated visits to their doctor.

In patients taking the drug Reduxin® Met, it is necessary to measure blood pressure and heart rate. During the first 3 months of treatment, these parameters should be monitored every 2 weeks and then monthly. If during two consecutive visits an increase in resting heart rate ≥10 beats/min or SBP/dBP ≥10 mmHg is detected, treatment should be discontinued. In patients with arterial hypertension whose blood pressure is ≥145/90 mm during antihypertensive therapy. Hg this control must be carried out particularly carefully and, if necessary, at shorter intervals. In patients whose blood pressure exceeded 145/90 mmHg twice during repeated measurements, treatment with Reduxin® Met should be suspended (see section “Side effects”, From the cardiovascular system

).

The use of metformin is contraindicated in acute heart failure and CHF with unstable hemodynamic parameters. In patients with CHF, taking the drug Reduxin® Met increases the risk of developing hypoxia and renal failure; such patients require regular monitoring of heart and kidney function. In patients with sleep apnea syndrome, blood pressure must be monitored especially carefully.

The simultaneous administration of drugs that increase the QT interval requires special attention. These drugs include H1 receptor blockers (astemizole, terfenadine); antiarrhythmic drugs that increase the QT interval (amiodarone, quinidine, flecainide, mexiletine, propafenone, sotalol); gastrointestinal motility stimulator cisapride; pimozide, sertindole and tricyclic antidepressants. This also applies to conditions that can lead to an increase in the QT interval, such as hypokalemia and hypomagnesemia (see “Interactions”).

The interval between taking MAO inhibitors (including furazolidone, procarbazine, selegiline) and Reduxin® Met should be at least 2 weeks. Although a link has not been established between taking sibutramine and the development of primary pulmonary hypertension, given the well-known risk of drugs in this group, with regular medical monitoring it is necessary to pay special attention to symptoms such as progressive dyspnea (breathing difficulty), chest pain and swelling in the legs.

If you miss a dose of Reduxin® Met, you should not take a double dose of the drug at the next dose; it is recommended to continue taking the drug according to the prescribed regimen.

The duration of taking Reduxin® Met should not exceed 1 year.

When taking sibutramine and other SSRIs together, there is an increased risk of bleeding. In patients predisposed to bleeding or taking drugs that affect hemostasis or platelet function, sibutramine should be used with caution.

Although there is no clinical evidence of addiction to sibutramine, the patient's history of drug dependence should be assessed and attention should be paid to possible signs of drug abuse.

The use of the drug in patients with prediabetes is recommended in the presence of additional risk factors for the development of overt type 2 diabetes mellitus, which include age less than 60 years, BMI more than 30 kg/m2, a history of gestational diabetes mellitus, a family history of diabetes mellitus in first-degree relatives, increased concentration of triglycerides, decreased concentration of HDL cholesterol, arterial hypertension.

Impact on the ability to drive vehicles and machinery.

Taking the drug Reduxin® Met may limit the ability to drive vehicles and machines. During the period of use of the drug Reduxin® Met, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Reduxin met 850 mg No. 60 tab + 15 mg + 153.5 mg No. 30 caps set in Izhevsk

- hypersensitivity to the components of the drug;
- diabetic ketoacidosis, diabetic precoma, diabetic coma;

- impaired renal function (creatinine clearance less than 45 ml/min);

- liver dysfunction;

- acute conditions in which there is a risk of developing renal dysfunction: dehydration (with diarrhea, vomiting), severe infectious diseases, shock;

- cardiovascular diseases (in history and at present): ischemic heart disease (myocardial infarction (MI), angina pectoris), chronic heart failure in the stage of decompensation, occlusive diseases of peripheral arteries, tachycardia, arrhythmia, cerebrovascular diseases (stroke, transient cerebrovascular accidents) );

— uncontrolled arterial hypertension (BP above 145/90 mmHg);

- clinically pronounced manifestations of acute and chronic diseases that can lead to the development of tissue hypoxia (including respiratory failure, acute heart failure, chronic heart failure with unstable hemodynamic parameters, acute MI);

— chronic alcoholism, acute ethanol poisoning;

- thyrotoxicosis;

- benign prostatic hyperplasia;

- pheochromocytoma;

- angle-closure glaucoma;

— extensive surgical operations and injuries (when insulin therapy is indicated);

- lactic acidosis (including history);

— established pharmacological or drug dependence;

- pregnancy;

- lactation period (breastfeeding);

— age up to 18 years;

— age over 65 years;

- a period of less than 48 hours before and within 48 hours after radioisotope or x-ray studies with the introduction of iodine-containing contrast agent;

— adherence to a hypocaloric diet (less than 1000 kcal/day);

- presence of organic causes of obesity (for example, hypothyroidism);

- serious eating disorders (anorexia nervosa or bulimia nervosa);

- mental illness;

— Gilles de la Tourette syndrome (generalized tics);

- simultaneous use of MAO inhibitors (for example, phentermine, fenfluramine, dexfenfluramine, ethylamphetamine, ephedrine) or their use within 2 weeks before taking sibutramine and 2 weeks after stopping it; other drugs acting on the central nervous system that inhibit serotonin reuptake (for example, antidepressants, antipsychotics); sleeping pills containing tryptophan, as well as other centrally acting drugs for weight loss or the treatment of mental disorders.

The drug should be prescribed with caution in the following conditions: chronic circulatory failure; diseases of the coronary arteries (including a history), except for coronary artery disease (MI, angina pectoris); glaucoma, except angle-closure glaucoma; cholelithiasis; arterial hypertension (controlled and with a history); neurological disorders, including mental retardation and seizures (including history); epilepsy; mild to moderate renal dysfunction; renal failure (creatinine clearance 45-59 ml/min); history of motor and verbal tics; tendency to bleeding, blood clotting disorders; taking medications that affect hemostasis or platelet function; persons over 60 years of age who perform heavy physical work, which is associated with an increased risk of developing lactic acidosis.

Distinctive features of the drug "Reduxin" and its side effects

Due to the fact that these two drugs contain the component sibutramine, which has an extremely positive effect on the process of losing weight, the drug "Reduxin", as well as its closest analogue - "Reduxin Met", can be called powerful anorexigenic substances . They can be called such because they have a strong effect on the central nervous system. Another property that makes these two drugs similar to each other may also be the fact that they are distributed only by prescription. This state of affairs is explained by the fact that these two drugs are addictive and that is why its use must necessarily have a certain medical justification.

The existence of the drug “Reduxin” has been known for quite a long period of time and now this remedy can be considered a standard, and not some extended version, which is the drug “Reduxin Met”. As its distinctive features, contraindications may be perceived, of which in the case of this medication there is a whole list.

By the way, due to such a large number of them, the use of “Reduxin” can be considered appropriate only if the benefit of the composition provided in this drug is higher than the harm that would be caused specifically by excess weight. As for contraindications, from their total number, a variety of mental illnesses, glaucoma, hypertension, pregnancy, obesity, and so on should be highlighted.

Reduxin Met capsules 10 mg + 158.5 mg No. 30 + tablets 850 mg No. 60

A country

Russia
The country of production may vary depending on the batch of goods. Please check with the operator for detailed information when confirming your order.

Active substance

Metformin + Sibutramine + Microcrystalline cellulose

pharmachologic effect

Reduxin® Met contains two separate drugs in one package: a hypoglycemic agent for oral administration of the biguanide group in a tablet dosage form - metformin, and a drug for the treatment of obesity in a capsule dosage form containing sibutramine and microcrystalline cellulose. Metformin. An oral hypoglycemic drug from the biguanide group, reduces hyperglycemia without leading to the development of hypoglycemia. Unlike sulfonylurea derivatives, it does not stimulate insulin secretion and does not cause a hypoglycemic effect in healthy individuals. Increases the sensitivity of peripheral receptors to insulin and the utilization of glucose by cells. Inhibits gluconeogenesis in the liver. Delays the absorption of carbohydrates in the intestines. Metformin stimulates glycogen synthesis by acting on glycogen synthase. Increases the transport capacity of all types of membrane glucose transporters. In addition, it has a beneficial effect on lipid metabolism: it reduces the content of total cholesterol, LDL and triglycerides. While taking metformin, the patient's body weight either remains stable or decreases moderately. Sibutramine. It is a prodrug and exhibits its effect in vivo due to metabolites (primary and secondary amines) that inhibit the reuptake of monoamines (serotonin, norepinephrine and dopamine). An increase in the content of neurotransmitters in synapses increases the activity of central serotonin 5HT receptors and adrenoreceptors, which increases the feeling of satiety and reduces the need for food, as well as an increase in thermal production. By indirectly activating β3-adrenergic receptors, sibutramine acts on brown adipose tissue. A decrease in body weight is accompanied by an increase in the concentration of HDL in the blood serum and a decrease in the amount of triglycerides, total cholesterol, LDL and uric acid. Sibutramine and its metabolites do not affect the release of monoamines and do not inhibit MAO; do not have affinity for a large number of neurotransmitter receptors, including serotonin (5-HT1, 5-HT1A, 5-HT1B, 5-HT2C), adrenergic receptors (β1, β2, β3, β1, β2), dopamine (D1 , D2), muscarinic, histamine (H1), benzodiazepine and glutamate NMDA receptors. Microcrystalline cellulose. It is an enterosorbent, has sorption properties and a nonspecific detoxification effect. Binds and removes from the body various microorganisms, their metabolic products, toxins of exogenous and endogenous nature, allergens, xenobiotics, as well as an excess of certain metabolic products and metabolites responsible for the development of endogenous toxicosis. The simultaneous use of metformin and sibutramine with microcrystalline cellulose increases the therapeutic effectiveness of the combination used in patients with excess body weight and type 2 diabetes mellitus.

Indications for use

- to reduce body weight in alimentary obesity with a body mass index of 27 kg/m2 or more in combination with type 2 diabetes mellitus and dyslipidemia; — to reduce body weight in alimentary obesity with a body mass index of more than 30 kg/m2 in patients with prediabetes and additional risk factors for developing type 2 diabetes mellitus, in whom lifestyle changes did not allow them to achieve adequate glycemic control.

Mode of application

The drug is taken orally. Tablets and capsules should be taken in the morning at the same time, without chewing and with a sufficient amount of liquid (1 glass of water) in combination with meals. The recommended starting dose is 1 tablet containing 850 mg of metformin and 1 capsule containing 10 mg of sibutramine. You should monitor the dynamics of changes in blood glucose concentrations and the dynamics of body weight loss. If after 1-2 weeks the optimal blood glucose concentrations are not achieved, the dose of metformin should be increased to 2 tablets. The usual maintenance dose of metformin is 1700 mg/day. The maximum daily dose of metformin is 2550 mg. To reduce side effects from the gastrointestinal tract, the daily dose of metformin can be divided into 2 doses. For example, take 1 tablet. in the morning and 1 tab. In the evening. If within 4 weeks from the start of treatment a reduction in body weight of 2 kg is not achieved, the dose of sibutramine is increased to 15 mg/day. Treatment with Reduxin® Met should not last more than 3 months in patients who do not respond well to therapy, i.e. who fail to achieve a 5% reduction in body weight from baseline within 3 months of treatment. Treatment should not be continued if, with further therapy after the achieved reduction in body weight, the patient again gains 3 kg or more in body weight. The duration of treatment should not exceed 1 year, since there are no data on efficacy and safety for a longer period of taking sibutramine. Treatment with Reduxin® Met should be carried out in combination with diet and exercise under the supervision of a physician with practical experience in the treatment of obesity. For diabetes mellitus, the usual dose is 850-1700 mg/day of metformin and 10-15 mg/day of siubtramine. In the morning you should take 1 tablet at a time. metformin and 1 caps. sibutramine. If it is necessary to increase the dose of metformin to 1700 mg, take an additional 1 tablet in the evening. metformin. It is recommended to regularly conduct glycemic monitoring to assess the need for further use of the drug and dose adjustment of metformin. The duration of use of the drug for type 2 diabetes mellitus and prediabetes should not exceed 1 year, since there is no data on effectiveness and safety regarding a longer period of taking sibutramine. In the future, it is recommended to switch to metformin monotherapy.

Interaction

Metformin. Contraindicated combinations. Iodine-containing radiocontrast agents: against the background of functional renal failure in patients with diabetes, radiological examination using iodine-containing X-ray contrast agents can cause the development of lactic acidosis. Treatment with metformin should be discontinued depending on renal function 48 hours before or during an X-ray examination using iodinated contrast agents and not resumed earlier than 48 hours after, provided that during the examination renal function was found to be normal. Combinations not recommended. Alcohol: with acute alcohol intoxication, the risk of developing lactic acidosis increases, especially in the case of: - malnutrition, following a low-calorie diet; - liver failure. While using the drug, you should avoid drinking alcohol and medications containing ethanol. Combinations requiring caution. Danazol: simultaneous use of danazol is not recommended to avoid the hyperglycemic effect of the latter. If treatment with danazol is necessary and after discontinuation of the latter, a dose adjustment of metformin is required under the control of blood glucose concentrations. Chlorpromazine: when taken in large doses (100 mg/day), it increases the concentration of glucose in the blood, reducing the release of insulin. When treated with antipsychotics and after stopping the latter, dose adjustment of the drug is required under the control of blood glucose concentrations. GCS for systemic and local use reduce glucose tolerance, increase blood glucose concentrations, sometimes causing ketosis. When treating GCS and after stopping the latter, dose adjustment of metformin is required under the control of blood glucose concentrations. Diuretics: Concomitant use of loop diuretics may lead to the development of lactic acidosis due to possible functional renal failure. Metformin should not be prescribed if CC is below 60 ml/min. Beta2-adrenergic agonists prescribed by injection: increase the concentration of glucose in the blood due to stimulation of beta2-adrenergic receptors. In this case, monitoring of blood glucose concentration is necessary. If necessary, insulin administration is recommended. When using the above drugs simultaneously, more frequent monitoring of blood glucose concentrations may be required, especially at the beginning of treatment. If necessary, the dose of metformin can be adjusted during treatment and after its cessation. ACE inhibitors and other antihypertensive drugs may decrease blood glucose concentrations. If necessary, the dose of metformin should be adjusted. When metformin is used simultaneously with sulfonylurea derivatives, insulin, acarbose, and salicylates, hypoglycemia may develop. Nifedipine increases the absorption and Cmax of metformin. Cationic drugs (amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim and vancomycin) secreted in the renal tubules compete with metformin for tubular transport systems and may lead to an increase in its Cmax. Sibutramine. Inhibitors of microsomal oxidation, incl. inhibitors of the CYP3A4 isoenzyme (ketoconazole, erythromycin, cyclosporine and others) increase plasma concentrations of sibutramine metabolites with an increase in heart rate and a clinically insignificant increase in the QT interval. Rifampicin, macrolide antibiotics, phenytoin, carbamazepine, phenobarbital and dexamethasone can accelerate the metabolism of sibutramine. The simultaneous use of several drugs that increase the level of serotonin in the blood plasma can lead to the development of serious interactions. The so-called serotonin syndrome can develop in rare cases when sibutramine is used simultaneously with selective serotonin reuptake inhibitors (drugs for the treatment of depression), certain drugs for the treatment of migraines (sumatriptan, dihydroergotamine), potent analgesics (pentazocine, pethidine, fentanyl) or antitussive drugs ( dextromethorphan). Sibutramine does not affect the effect of oral contraceptives. When taking sibutramine and ethanol simultaneously, there was no increase in the negative effects of alcohol. However, alcohol is absolutely not compatible with the dietary measures recommended when taking sibutramine. When used simultaneously with sibutramine, other drugs that affect hemostasis or platelet function increase the risk of bleeding. Drug interactions with the simultaneous use of sibutramine with drugs that increase blood pressure and heart rate have not been fully studied at present. This group of drugs includes decongestants, cough, cold, and allergy medications that contain ephedrine or pseudoephedrine. Therefore, in cases of simultaneous use of these drugs with sibutramine, caution should be exercised. The combined use of sibutramine with drugs for weight loss that act on the central nervous system or drugs for the treatment of mental disorders is contraindicated.

Side effect

Determination of the frequency of side effects: very often (? 1/10), often (? 1/100, Metformin. From the metabolic side: very rarely - lactic acidosis; with long-term use, a decrease in the absorption of vitamin B12 is possible. A decrease in the concentration of vitamin B12 must be taken into account in patients with megaloblastic anemia. From the nervous system: often - taste disturbance. From the digestive system: very often - nausea, vomiting, diarrhea, abdominal pain, lack of appetite (most often these symptoms occur during the initial period of treatment and in most cases resolve spontaneously); very rarely - abnormal liver function tests, hepatitis (after discontinuation of metformin, these adverse effects completely disappear). Slowly increasing the dose can improve gastrointestinal tolerability. From the skin: very rarely - skin reactions such as erythema, itching , rash Sibutramine Most often, side effects occur at the beginning of treatment (in the first 4 weeks).Their severity and frequency weaken over time. Side effects are generally mild and reversible. Side effects, depending on the effect on organs and organ systems, are presented in the following order: very often (? 1/10), often (? 1/100, From the nervous system: very often - dry mouth and insomnia; often - headache, dizziness, anxiety, paresthesia, as well as changes in taste. From the cardiovascular system: often - tachycardia, palpitations, increased blood pressure, vasodilation. There is a moderate increase in blood pressure at rest by 1-3 mm Hg and moderate an increase in pulse by 3-7 beats/min. In some cases, a more pronounced increase in blood pressure and an increase in heart rate cannot be ruled out. Clinically significant changes in blood pressure and heart rate are recorded mainly at the beginning of treatment (in the first 4-8 weeks). From the digestive system: very often - loss of appetite, constipation; often - nausea, exacerbation of hemorrhoids. If you are prone to constipation in the first days, control of the evacuation function of the intestines is necessary. If constipation occurs, stop taking the drug and take a laxative. From the skin: often - increased sweating. In isolated cases, the following clinically significant adverse events have been described during treatment with sibutramine: dysmenorrhea, edema, flu-like syndrome, skin itching, back pain, abdominal pain, paradoxical increase in appetite, thirst, rhinitis, depression, drowsiness, emotional lability, anxiety, irritability, nervousness, acute interstitial nephritis, bleeding, Henoch-Schönlein purpura (bleeding into the skin), convulsions, thrombocytopenia, transient increase in the activity of liver enzymes in the blood. Use of the drug Reduxin® Met in patients with high blood pressure - see sections “Contraindications” and “Special instructions”. During post-marketing studies of sibutramine, additional adverse reactions were described, listed below by organ system. From the cardiovascular system: atrial fibrillation. Allergic reactions: hypersensitivity reactions (from mild skin rashes and urticaria to angioedema (Quincke's edema) and anaphylaxis). Mental disorders: psychosis, states of suicidal ideation, suicide and mania, short-term memory impairment, seizures. If such conditions occur, the drug must be discontinued. From the nervous system: psychosis, states of suicidal ideation, suicide and mania, short-term memory impairment, convulsions. If such conditions occur, the drug must be discontinued. From the side of the organ of vision: blurred vision (“veil before the eyes”). From the digestive system: diarrhea, vomiting. From the skin: alopecia. From the urinary system: urinary retention. From the reproductive system: ejaculation/orgasm disorders, impotence, menstrual irregularities, uterine bleeding.

Contraindications

- hypersensitivity to the components of the drug; - diabetic ketoacidosis, diabetic precoma, diabetic coma; - impaired renal function (creatinine clearance less than 45 ml/min); - liver dysfunction; - acute conditions in which there is a risk of developing renal dysfunction: dehydration (with diarrhea, vomiting), severe infectious diseases, shock; - cardiovascular diseases (in history and at present): ischemic heart disease (myocardial infarction (MI), angina pectoris), chronic heart failure in the stage of decompensation, occlusive diseases of peripheral arteries, tachycardia, arrhythmia, cerebrovascular diseases (stroke, transient cerebrovascular accidents) ); — uncontrolled arterial hypertension (BP above 145/90 mmHg); - clinically pronounced manifestations of acute and chronic diseases that can lead to the development of tissue hypoxia (including respiratory failure, acute heart failure, chronic heart failure with unstable hemodynamic parameters, acute MI); — chronic alcoholism, acute ethanol poisoning; - thyrotoxicosis; - benign prostatic hyperplasia; - pheochromocytoma; - angle-closure glaucoma; — extensive surgical operations and injuries (when insulin therapy is indicated); - lactic acidosis (including history); — established pharmacological or drug dependence; - pregnancy; - lactation period (breastfeeding); — age up to 18 years; — age over 65 years; - a period of less than 48 hours before and within 48 hours after radioisotope or x-ray studies with the introduction of iodine-containing contrast agent; — adherence to a hypocaloric diet (less than 1000 kcal/day); - presence of organic causes of obesity (for example, hypothyroidism); - serious eating disorders (anorexia nervosa or bulimia nervosa); - mental illness; — Gilles de la Tourette syndrome (generalized tics); - simultaneous use of MAO inhibitors (for example, phentermine, fenfluramine, dexfenfluramine, ethylamphetamine, ephedrine) or their use within 2 weeks before taking sibutramine and 2 weeks after stopping it; other drugs acting on the central nervous system that inhibit serotonin reuptake (for example, antidepressants, antipsychotics); sleeping pills containing tryptophan, as well as other centrally acting drugs for weight loss or the treatment of mental disorders. The drug should be prescribed with caution in the following conditions: chronic circulatory failure; diseases of the coronary arteries (including a history), except for coronary artery disease (MI, angina pectoris); glaucoma, except angle-closure glaucoma; cholelithiasis; arterial hypertension (controlled and with a history); neurological disorders, including mental retardation and seizures (including history); epilepsy; mild to moderate renal dysfunction; renal failure (creatinine clearance 45-59 ml/min); history of motor and verbal tics; tendency to bleeding, blood clotting disorders; taking medications that affect hemostasis or platelet function; persons over 60 years of age who perform heavy physical work, which is associated with an increased risk of developing lactic acidosis.

Overdose

Metformin. Symptoms When using metformin at a dose of 85 g (42.5 times the maximum daily dose), no hypoglycemia was observed, but the development of lactic acidosis was noted. Significant overdose or associated risk factors can lead to the development of lactic acidosis. Treatment: if signs of lactic acidosis appear, treatment with the drug must be stopped immediately, the patient must be urgently hospitalized and, after determining the lactate concentration, the diagnosis must be clarified. The most effective measure for removing lactate and metformin from the body is hemodialysis. Symptomatic treatment is also carried out. Sibutramine. There are extremely limited data on sibutramine overdose. The most common adverse reactions associated with overdose: tachycardia, increased blood pressure, headache, dizziness. The patient should notify his or her physician in the event of a suspected overdose. Treatment: There is no special treatment or specific antidotes. It is necessary to carry out general measures: ensure free breathing, monitor the state of the cardiovascular system, and, if necessary, carry out supportive symptomatic therapy. Timely use of activated carbon, as well as gastric lavage, can reduce the intake of sibutramine in the body. Patients with high blood pressure and tachycardia can be prescribed beta-blockers. The effectiveness of forced diuresis or hemodialysis has not been established. In case of overdose, you should immediately stop taking Reduxin® Met.

special instructions

Lactic acidosis.
Lactic acidosis is a rare but serious (high mortality unless promptly treated) complication that may occur due to accumulation of metformin. Cases of lactic acidosis when taking metformin occurred mainly in diabetic patients with severe renal failure. Other associated risk factors should be taken into account, such as decompensated diabetes mellitus, ketosis, prolonged fasting, alcoholism, liver failure and any condition associated with severe hypoxia. This may help reduce the incidence of lactic acidosis. The risk of developing lactic acidosis should be taken into account when nonspecific signs appear, such as muscle cramps accompanied by dyspeptic symptoms, abdominal pain and severe asthenia. Lactic acidosis is characterized by acidotic shortness of breath, abdominal pain and hypothermia followed by coma. Diagnostic laboratory parameters are a decrease in blood pH (less than 7.25), lactate content in the blood plasma over 5 mmol/l, increased anion gap and lactate/pyruvate ratio. If metabolic acidosis is suspected, stop taking the drug and consult a doctor immediately. Surgical operations. The use of the drug Reduxin® Met should be discontinued 48 hours before planned surgical operations and can be continued no earlier than 48 hours after, provided that during the examination renal function was found to be normal. Kidney function. Since metformin is excreted by the kidneys, before starting to take the drug Reduxin® Met and regularly thereafter, it is necessary to determine CC: at least once a year in patients with normal renal function, and 2-4 times a year in elderly patients, as well as in patients with CC is at the lower limit of normal. Particular caution should be exercised in case of possible impairment of renal function in elderly patients, with simultaneous use of antihypertensive drugs, diuretics or NSAIDs. Patients are advised to continue to follow a diet with even carbohydrate intake throughout the day. Overweight patients are recommended to continue to follow a hypocaloric diet (but not less than 1000 kcal/day). It is recommended that routine laboratory tests be performed regularly to monitor diabetes mellitus. It is recommended to exercise caution when using Reduxin® Met in combination with insulin or other hypoglycemic agents (including sulfonylurea derivatives, repaglinide). Reduxin® Met should be used only in cases where all non-drug measures for weight loss are ineffective - if the weight loss over 3 months is less than 5 kg. Treatment with Reduxin® Met should be carried out as part of complex therapy for weight loss under the supervision of a physician with practical experience in the treatment of obesity. Complex therapy includes both changing diet and lifestyle, as well as increasing physical activity. An important component of therapy is to create the prerequisites for persistent changes in eating behavior and lifestyle, which are necessary to maintain the achieved weight loss even after drug therapy is discontinued. As part of therapy with Reduxin® Met, patients need to change their lifestyle and habits in such a way as to ensure that the achieved weight loss is maintained after completion of treatment. Patients should be clear that failure to comply with these requirements will lead to repeated weight gain and repeated visits to their doctor. In patients taking Reduxin® Met, it is necessary to measure blood pressure and heart rate. During the first 3 months of treatment, these parameters should be monitored every 2 weeks and then monthly. If during two consecutive visits an increase in resting heart rate ≥10 beats/min or systolic/diastolic pressure ≥10 mmHg is detected, treatment should be discontinued. In patients with arterial hypertension, whose blood pressure is higher than 145/90 mmHg during antihypertensive therapy, this control should be carried out especially carefully and, if necessary, at shorter intervals. In patients whose blood pressure exceeded 145/90 mmHg twice during repeated measurements, treatment with Reduxin® Met should be suspended (see section “Side Effects”).

The use of metformin is contraindicated in acute heart failure and in chronic heart failure with unstable hemodynamic parameters. In patients with chronic heart failure, taking the drug Reduxin® Met increases the risk of developing hypoxia and renal failure; such patients require regular monitoring of heart and kidney function.

In patients with sleep apnea syndrome, blood pressure must be monitored especially carefully.

The simultaneous administration of drugs that increase the QT interval requires special attention. These drugs include histamine H1 receptor blockers (astemizole, terfenadine); antiarrhythmic drugs that increase the QT interval (amiodarone, quinidine, flecainide, mexiletine, propafenone, sotalol); gastrointestinal motility stimulator cisapride; pimozide, sertindole and tricyclic antidepressants. This also applies to conditions that can lead to an increase in the QT interval, such as hypokalemia and hypomagnesemia. (see section "Drug interactions").

The interval between taking MAO inhibitors (including furazolidone, procarbazine, selegiline) and Reduxin® Met should be at least 2 weeks.

Although a connection has not been established between taking sibutramine and the development of primary pulmonary hypertension, however, given the well-known risk of drugs in this group, with regular medical monitoring it is necessary to pay special attention to symptoms such as progressive dyspnea (breathing difficulty), chest pain and swelling in the legs .

If you miss a dose of Reduxin® Met, you should not take a double dose of the drug at the next dose; it is recommended to continue taking the drug according to the prescribed regimen.

The duration of taking Reduxin® Met should not exceed 1 year.

When taking sibutramine and other serotonin reuptake inhibitors together, there is an increased risk of bleeding. In patients predisposed to bleeding or taking drugs that affect hemostasis or platelet function, sibutramine should be used with caution.

Although there is no clinical evidence of addiction to sibutramine, the patient's history of drug dependence should be assessed and attention should be paid to possible signs of drug abuse.

The use of the drug in patients with prediabetes is recommended in the presence of additional risk factors for the development of overt type 2 diabetes mellitus, which include: age less than 60 years, body mass index more than 30 kg/m2, history of gestational diabetes mellitus, family history of diabetes mellitus in first-degree relatives line of kinship, increased triglyceride concentrations, decreased HDL cholesterol concentrations, arterial hypertension.

Impact on the ability to drive vehicles and machinery

Taking the drug Reduxin® Met may limit the ability to drive vehicles and machines. During the period of use of the drug Reduxin® Met, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Dispensing conditions in pharmacies

On prescription

Reduxin Forte tablets 850+10 mg 30 pcs. in Zelenograd

Metformin

Suction.

After taking the drug orally, metformin is quite completely absorbed from the gastrointestinal tract (GI tract). With simultaneous food intake, the absorption of metformin is reduced and delayed. Absolute bioavailability is 50-60%. The maximum plasma concentration (Cmax) is approximately 2 µg/ml or 15 µmol and is achieved after 2.5 hours.

Distribution.

Metformin is quickly distributed in body tissues. Practically does not bind to plasma proteins.

Metabolism.

Metabolized to a small extent.

Excretion.

Excreted by the kidneys.
Metformin clearance in healthy people is 400 ml/min (4 times higher than creatinine clearance (CC)), indicating active tubular secretion. The half-life (T1/2) is approximately 6.5 hours. Pharmacokinetics in special clinical situations:
In patients with renal failure:

T1/2 increases, there is a risk of metformin accumulation in the body.

Sibutramine

Suction.

After oral administration, it is quickly absorbed from the gastrointestinal tract (GIT) by at least 77%. During the “primary passage” through the liver, it undergoes biotransformation under the influence of the CYP3A4 isoenzyme with the formation of two active metabolites (monodesmethylsibutramine (M1) and didesmethylsibutramine (M2)). After taking a single dose of 15 mg, the maximum blood concentration (Cmax) of monodesmethylsibutramine (M1) is 4 ng/ml (3.2-4.8 ng/ml), didesmethylsibutramine (M2) - 6.4 ng/ml (5.6 -7.2 ng/ml). Cmax is reached after 1.2 hours (sibutramine), 3-4 hours (active metabolites). Simultaneous food intake reduces the Cmax of metabolites by 30% and increases the time to reach it by 3 hours, without changing the area under the concentration-time curve (AUC).

Distribution.

Quickly distributed in tissues. Protein binding is 97% (sibutramine) and 94% (M1 and M2). The equilibrium concentration of active metabolites in the blood is achieved within 4 days after the start of treatment and is approximately 2 times higher than the concentration in the blood plasma after taking a single dose.

Metabolism and excretion.

Active metabolites undergo hydroxylation and conjugation to form inactive metabolites, which are excreted primarily by the kidneys.
The half-life of sibutramine is 1.1 hours, M1 - 14 hours, M2 -16 hours. Pharmacokinetics in special clinical situations
The limited data currently available do not indicate the existence of clinically significant differences in pharmacokinetics between men and women.

Pharmacokinetics in the elderly.

Pharmacokinetics in elderly healthy individuals (average age 70 years) are similar to those in young people.

Kidney failure.

Renal impairment does not affect the AUC of the active metabolites M1 and M2, except for the M2 metabolite in patients with end-stage renal disease on dialysis.

Liver failure.

In patients with moderate hepatic impairment, after a single dose of sibutramine, the AUC of active metabolites M1 and M2 is 24% higher than in healthy individuals.