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How to drink reduxin meth dosage. Reduxin met instructions for use

Compound

1 caps.
sibutramine hydrochloride monohydrate 10 mg; 15 mg
cellulose microcrystalline 158.5 mg

1 tab.
metformin (as hydrochloride) 850 mg

pharmachologic effect

Enterosorbent, anorexigenic, hypoglycemic.

Reduxin® Met contains two separate medicines in one package: a hypoglycemic agent for oral administration of the biguanide group in the dosage form of a tablet - Metformin, and an agent for the treatment of obesity in the dosage form of a capsule containing sibutramine and microcrystalline cellulose.

Indications

- to reduce body weight in alimentary obesity with a body mass index of 27 kg / m2 or more in combination with diabetes 2 types and dyslipidemia.

Contraindications for use

- hypersensitivity to the components of the drug;

- diabetic ketoacidosis, diabetic precoma, diabetic coma;

- impaired renal function (CC less than 60 ml / min);

- impaired liver function;

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

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

- uncontrolled arterial hypertension (blood pressure (BP) above 145/90 mm Hg);

- clinical manifestations of acute and chronic diseases, which can lead to the development of tissue hypoxia (including respiratory failure, heart failure, acute MI);

- chronic alcoholism, acute ethanol poisoning;

- thyrotoxicosis;

- benign prostatic hyperplasia;

- pheochromocytoma;

- angle-closure glaucoma;

- extensive surgical operations and trauma (when insulin therapy is indicated);

- lactic acidosis (including history);

- Established pharmacological or drug dependence;

- pregnancy and lactation;

- age up to 18 years and over 65 years;

- a period of at least 48 hours before and within 48 hours after radioisotope or X-ray studies with the introduction of an iodine-containing contrast agent;

- compliance with a hypocaloric diet (less than 1000 kcal / day);

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

- serious eating disorders - anorexia nervosa or bulimia nervosa;

- mental illness;

- Gilles de la Tourette's 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 the end of his use of other drugs that act on the central nervous system, inhibiting reverse capture serotonin (eg, antidepressants, antipsychotics); sleeping pills containing tryptophan, as well as other centrally acting drugs for weight loss or the treatment of mental disorders.

With caution, the drug should be prescribed under the following conditions: arrhythmias in history; chronic circulatory failure; diseases of the coronary arteries (including history), except for coronary heart disease (MI, angina pectoris); glaucoma other than angle-closure glaucoma; cholelithiasis; arterial hypertension (controlled and history); neurological disorders, including mental retardation and seizures (including history); epilepsy; impaired renal function of mild and moderate severity; history of motor and verbal tics; tendency to bleeding, bleeding disorders; taking drugs 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.

Dosing regimen

The recommended starting dose is 1 tablet containing 850 mg of metformin and one capsule containing 10 mg of sibutramine. 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 food intake.

It is necessary to monitor the dynamics of changes in the concentration of glucose in the blood and the dynamics of weight loss. If after one to two weeks the optimal values of blood glucose concentration are not reached, the dose of metformin should be increased to 2 tablets.

The usual maintenance dose of metformin is 1700 mg daily. 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 tablet in the evening.

If within 4 weeks from the start of treatment a decrease in body weight by 2 kg is not achieved, then 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 enough to therapy, i.e. who within 3 months of treatment fail to achieve a decrease in body weight by 5% of the baseline. Treatment should not be continued if, during further therapy, after the achieved weight loss, 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 in relation to a longer period of taking sibutramip.

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.

Side effect

Frequency detection side effects: very often (>1/10), often (≥1/100,<1/10), нечасто (≥1/1000, <1/100), редко (≥1/10000, <1/1000), очень редко (<1/10 000). Побочное действие представлено в порядке снижения значимости.

Metformin

From the side of metabolism and nutrition: very rarely - lactic acidosis; with prolonged use, a decrease in the absorption of vitamin B12 is possible. A decrease in vitamin B12 concentration should be taken into account in patients with megaloblastic anemia. From the nervous system: often - a violation of taste.

From the digestive tract: 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. Slow dose escalation may improve gastrointestinal tolerance.

On the part of the skin and subcutaneous tissues: very rarely skin reactions such as erythema, itching, rash.

On the part of the liver and biliary tract: very rarely - a violation of liver function, hepatitis, after the abolition of metformin, these adverse events completely disappear.

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 impact on organs and organ systems, are presented in the following order: very often (> 1/10), often (> 1/100,<1/10).

From the side of the central nervous system: very common side effects are dry mouth and insomnia, headache, dizziness, anxiety, paresthesia, and a change in taste are often noted.

Since the cardiovascular system: tachycardia, palpitations, increased blood pressure, vasodilation are common.

On the part of the digestive system: loss of appetite and constipation are very often observed, often nausea and exacerbation of hemorrhoids. With a tendency to constipation in the early days, it is necessary to control the evacuation function of the intestine. If constipation occurs, stop taking and take a laxative.

On the part of the skin: increased sweating is often noted. 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, Shenlein-Genoch purpura (bleeding into the skin), convulsions, thrombocytopenia, transient increase in the activity of "liver" enzymes in the blood.

From the side of the cardiovascular system. There is a moderate rise in blood pressure at rest by 1-3 mm Hg. and a moderate increase in heart rate of 3-7 beats per minute. In some cases, a more pronounced increase in blood pressure and an increase in heart rate are not excluded. Clinically significant changes in blood pressure and pulse are recorded mainly at the beginning of treatment (in the first 4-8 weeks).

The use of Reduxin® Met in patients with elevated blood pressure: see the section "Contraindications" and "Special Instructions".

During post-marketing studies of sibutramine, additional adverse reactions have been described, listed below by organ system:

From the side of the cardiovascular system: atrial fibrillation.

From the immune system: hypersensitivity reactions (from moderate skin rashes and urticaria to angioedema (angioedema) and anaphylaxis).

Mental disorders: psychosis, states of suicidal thinking, suicide and mania. If such conditions occur, the drug must be discontinued.

From the nervous system: convulsions, short-term memory impairment.

On the part of the organ of vision: blurred vision ("veil before the eyes").

From the gastrointestinal tract: diarrhea, vomiting.

From the skin and subcutaneous tissue: alopecia.

From the side of the kidneys and urinary tract: urinary retention.

On the part of the genital organs and mammary gland: ejaculation / orgasm disorders, impotence, menstrual disorders, uterine bleeding.

Terms of dispensing from pharmacies

On prescription.

Storage conditions

In a place protected from light at a temperature not exceeding 25 ° C. The drug should be stored out of the reach of children.

Best before date

3 years (tablets 3 years, capsules 3 years).

Reduxin Met is a combination drug for overweight correction and lowering blood glucose levels. The therapeutic effect of a drug is a component of the pharmacological effects of its individual components. Metformin is a tableted antidiabetic drug used in non-insulin dependent diabetes mellitus, lowers glucose levels without dropping it below the physiological norm. It differs from sulfonylurea derivatives by the lack of the ability to stimulate the production of insulin, which is a significant advantage, because. the drug does not cause hypoglycemia in healthy people. Sensitizes receptors of peripheral tissues in relation to insulin. Improves the uptake of glucose by cells. Interferes with the process of glucose formation from non-carbohydrate compounds in the liver. Interferes with the absorption of carbohydrates in the digestive tract. Intensifies glycogenesis by activating the enzyme glycogen synthase. Expands the possibilities of transport proteins of cell membranes to transport glucose into the cell for its subsequent utilization. Improves lipid profile by lowering total and "bad" cholesterol, as well as triglycerides. Metformin leads to either stabilization or weight loss in the patient. Sibutramine is a prodrug. Pharmacological activity is shown by its metabolites - primary and secondary amines, which suppress the reuptake of neuronal serotonin, norepinephrine and dopamine. An increase in the concentration of the above neurotransmitters causes the activation of the corresponding receptors, as a result of which a feeling of fullness develops and there is no need for additional food intake, and heat production increases. Sibutramine activates beta-3-adrenergic receptors, thereby affecting brown fat. Weight loss is accompanied by an increase in the concentration of “good” cholesterol in the blood and an improvement in the lipid profile.

Microcrystalline cellulose is a substance that binds exogenous and endogenous substances in the digestive tract by adsorption. Acts as a non-specific detoxifier. It binds and ensures the elimination from the body of various microbes, traces of their vital activity, external and internal toxins, substances that cause allergies, chemicals alien to living organisms that are not naturally included in the biotic cycle, metabolic products that cause toxicosis. The combined use of all three components of the drug increases the severity of the therapeutic response in patients in whom diabetes mellitus is accompanied by overweight. Following oral administration, metformin is well absorbed from the gastrointestinal tract. The presence of food content in the gastrointestinal tract slows down the rate and reduces the degree of absorption of metformin. Its peak plasma concentration is recorded 2.5 hours after ingestion. Elimination from the body is carried out by the kidneys. The half-life is 6.5 hours. Sibutramine is quite fully - not less than 77% - absorbed in the digestive tract. In the liver, it undergoes metabolic transformations with the formation of active metabolites. Elimination from the body is carried out mainly with urine. Metformin tablets and sibutramine capsules are taken simultaneously once a day in the morning with breakfast. If within three months of the drug course the patient's weight has decreased by less than 5%, treatment is stopped. If, during the course of the drug course, the patient, after the initial weight loss, again added 3 or more kg, the treatment is also stopped. The maximum duration of the drug course is 1 year. During treatment, you must follow the diet recommended by the doctor and exercise. During the drug course, blood pressure monitoring should be organized.

Pharmacology

Reduxin ® Met contains two separate medicines in one package: a hypoglycemic agent for oral use of the biguanide group in the dosage form of a tablet - metformin, and a drug for the treatment of obesity in a capsule dosage form containing sibutramine and microcrystalline cellulose.

Metformin

Oral hypoglycemic drug from the group of biguanides. 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 carriers. In addition, it has a beneficial effect on lipid metabolism: it reduces the content of total cholesterol, low-density lipoprotein and triglycerides.

While taking metformin, the patient's body weight either remains stable or moderately decreases.

Sibutramine

It is a prodrug and exerts 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 5HT-serotonin and adrenergic receptors, which contributes to an increase in satiety and a decrease in the need for food, as well as an increase in thermal production. Indirectly activating betaz-adrenergic receptors. Sibutramine acts on brown adipose tissue. Weight loss is accompanied by an increase in the concentration of high-density lipoproteins (HDL) in the blood serum and a decrease in the amount of triglycerides. total cholesterol, low density lipoprotein (LDL) and uric acid. Sibutramine and its metabolites do not affect the release of monoamines, do not inhibit monoamine oxidase (MAO): they do not have affinity for a large number of neurotransmitter receptors, including serotonin (5-HT 1, 5-HT 1A, 5-HT 1B, 5-HT 2C), adrenergic (β 1 , β 2 , β 3 , α 1 , α 2), dopamine (D 1 , D 2), muscarinic. histamine (H 1), benzodiazepine and glutamate NMDA receptors.

Cellulose microcrystalline

It is an enterosorbent, has sorption properties and a non-specific detoxification effect. It 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 some metabolic products and metabolites responsible for the development of endogenous toxicosis.

The simultaneous use of metformin and sibutramine with microcrystalline cellulose increases the therapeutic efficacy of the combination used in patients with overweight and type 2 diabetes mellitus.

Pharmacokinetics

Metformin

Suction

After taking the drug inside, metformin is quite completely absorbed from the gastrointestinal tract. With simultaneous intake of food, the absorption of metformin is reduced and delayed. Absolute bioavailability is 50-60%. C max in plasma is approximately 2 μg / ml or 15 μmol and is reached after 2.5 hours.

Distribution

Metformin is rapidly distributed into body tissues. Practically does not bind to plasma proteins.

Metabolism

It is metabolized to a very small extent.

breeding

Excreted by the kidneys. Metformin clearance in healthy individuals is 400 ml / min (4 times more than CC), which indicates active tubular secretion.

T 1/2 is approximately 6.5 hours.

In patients with renal insufficiency T 1/2 increases, there is a risk of accumulation of metformin in the body.

Sibutramine

Suction

After oral administration, it is rapidly absorbed from the gastrointestinal tract 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 concentration in the blood (C max) 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 achieved after 1.2 hours (sibutramine), 3-4 hours (active metabolites). Simultaneous food intake lowers 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

It is quickly distributed on fabrics. Protein binding is 97% (sibutramine) and 94% (M1 and M2). The equilibrium concentration of active metabolites in the blood is reached within 4 days after the start of treatment and is approximately 2 times higher than the concentration in 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. T 1/2 sibutramine - 1.1 h, M1 - 14 h, M2 -16 h.

Pharmacokinetics in special clinical situations

Currently available limited data do not indicate the existence of clinically significant differences in pharmacokinetics in men and women.

Pharmacokinetics in the elderly

Pharmacokinetics in elderly healthy individuals (mean age 70 years) is similar to that in young people.

kidney failure

Renal failure has no effect on the AUC of the active metabolites M1 and M2, except for the M2 metabolite in dialysis patients with end-stage renal disease.

Liver failure

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

Release form

Capsules No. 2 blue; the contents of the capsules are white or white with a slightly yellowish tint powder.

Excipients: calcium stearate.

The composition of the capsule shell: titanium dioxide dye, azorubine dye, patent blue dye, gelatin.

10 pieces. - blister packs (aluminum/PVC) (1) - cardboard packs.

White or post white tablets, oval, biconvex, scored on one side.

10 pieces. - blister packs (aluminum/PVC) (3) - cardboard packs.
10 pieces. - cellular contour packings (aluminum/PVC) (6) - packs of cardboard.
10 pieces. - blister packs (aluminum/PVC) (2) - cardboard packs.
10 pieces. - blister packs (aluminum/PVC) (4) - cardboard packs.
60 pcs. - blister packs (aluminum/PVC) (3) - cardboard packs.
60 pcs. - cellular contour packings (aluminum/PVC) (6) - packs of cardboard.
60 pcs. - blister packs (aluminum/PVC) (2) - cardboard packs.
60 pcs. - blister packs (aluminum/PVC) (4) - cardboard packs.

The set is packed in a cardboard box.

Dosage

If within 4 weeks from the start of treatment a decrease in body weight by 2 kg is not achieved, then 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 enough to therapy, i.e. who within 3 months of treatment fail to achieve a decrease in body weight by 5% of the baseline. Treatment should not be continued if, during further therapy, after the achieved weight loss, 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 in relation to a longer period of taking sibutramip.

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.

Overdose

Metformin

Symptoms When using metformin at a dose of 85 g (42.5 times the maximum daily dose), hypoglycemia was not observed, but the development of lactic acidosis was noted.

Significant overdose or associated risk factors may lead to the development of lactic acidosis.

Treatment: in case of signs of lactic acidosis, treatment with the drug should be stopped immediately, the patient should be urgently hospitalized and, having determined the concentration of lactate, clarify the diagnosis. 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 overdose of sibutramine. The most common adverse reactions associated with overdose: tachycardia, increased blood pressure, headache, dizziness. You should notify your doctor in case of suspected overdose.

Treatment: There is no specific treatment or specific antidotes. It is necessary to perform general measures: ensure free breathing, monitor the state of the cardiovascular system, and, if necessary, carry out supportive symptomatic therapy. Timely use of activated charcoal, as well as gastric lavage, can reduce the intake of sibutramine into 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 an overdose, you should immediately stop taking Reduxin ® Met.

Interaction

Metformin

Contraindicated combinations

Iodine-containing radiopaque agents: against the background of functional renal failure in patients with diabetes mellitus, a radiological examination using iodine-containing radiopaque agents can cause the development of lactic acidosis. Treatment with metformin should be discontinued, depending on renal function, 48 hours before or at the time of an x-ray examination using iodine-containing radiopaque agents and not resumed earlier than 48 hours after, provided that during the examination, renal function was found to be normal.

Alcohol: acute alcohol intoxication increases the risk of developing lactic acidosis, especially in the case of:

malnutrition, low-calorie diet;
liver failure.

While taking the drug, alcohol and medicines containing ethanol should be avoided.

Combinations requiring caution

Danazol: concomitant use of danazol is not recommended in order to avoid the hyperglycemic effect of the latter. If necessary, treatment with danazol and after discontinuation of the latter, a dose adjustment of metformin is required under the control of blood glucose concentration.

Chlorpromazine: when taken in high doses (100 mg per day), it increases the concentration of glucose in the blood, reducing the release of insulin. In the treatment of neuroleptics and after discontinuation of the latter, a dose adjustment of the drug is required under the control of the concentration of glucose in the blood.

Glucocorticosteroids (GCS) of systemic and local action reduce glucose tolerance, increase the concentration of glucose in the blood, sometimes causing ketosis. In the treatment of corticosteroids and after discontinuation of the latter, a dose adjustment of metformin is required under the control of blood glucose concentration.

Diuretics: concomitant use of "loop" diuretics can lead to the development of lactic acidosis due to possible functional renal failure. Metformin should not be prescribed if the CC is below 60 ml / min.

Assigned in the form of injections of beta 2-adrenergic agonists: increase the concentration of glucose in the blood due to stimulation of beta 2-adrenergic receptors. In this case, it is necessary to control the concentration of glucose in the blood. If necessary, the appointment of insulin is recommended.

With the simultaneous use of the above drugs, 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 termination.

ACE inhibitors and other antihypertensive drugs can lower blood glucose levels. If necessary, the dose of metformin should be adjusted.

With the simultaneous use of metformin with sulfonylurea derivatives, insulin, acarbose, 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 C max

Sibutramine

Inhibitors of microsomal oxidation, incl. CYP3A4 isoenzyme inhibitors (ketoconazole, erythromycin, cyclosporine, etc.) 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 content of serotonin in the blood plasma can lead to the development of a serious interaction. The so-called serotonin syndrome can develop in rare cases when sibutramine is used simultaneously with selective serotonin reuptake inhibitors (drugs for depression), with certain drugs for the treatment of migraine (sumatriptan, dihydroergotamine), with potent analgesics (pentazocine, pethidine, fentanyl) or antitussives. drugs (dextromethorphan). Sibutramine does not affect the effect of oral contraceptives.

With the simultaneous administration of sibutramine and alcohol, there was no increase in the negative effects of alcohol. However, alcohol is absolutely incompatible with the dietary measures recommended when taking sibutramine.

With simultaneous use with sibutramine of other drugs that affect hemostasis or platelet function, the risk of bleeding increases.

Drug interactions with the simultaneous use of sibutramine with drugs that increase blood pressure and heart rate are currently not fully understood. This group of drugs includes decongestants, antitussives. cold and antiallergic drugs, which include ephedrine or pseudoephedrine. Therefore, in cases of simultaneous administration of these drugs with sibutramine, caution should be exercised.

The concomitant 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 effects

Determining the frequency of side effects: very often (> 1/10), often (≥ 1/100,<1/10), нечасто (≥1/1000, <1/100), редко (≥1/10000, <1/1000), очень редко (<1/10 000). Побочное действие представлено в порядке снижения значимости.

Metformin

On the part of the skin and subcutaneous tissues: very rarely skin reactions such as erythema, itching, rash.

On the part of the liver and biliary tract: very rarely - a violation of liver function, hepatitis, after the abolition of metformin, these adverse events completely disappear.

Sibutramine

From the side of the central nervous system: very common side effects are dry mouth and insomnia, headache, dizziness, anxiety, paresthesia, and a change in taste are often noted.

Since the cardiovascular system: tachycardia, palpitations, increased blood pressure, vasodilation are common.

The use of Reduxin ® Met in patients with elevated blood pressure: see the section "Contraindications" and "Special Instructions".

During post-marketing studies of sibutramine, additional adverse reactions have been described, listed below by organ system:

From the side of the cardiovascular system: atrial fibrillation.

From the immune system: hypersensitivity reactions (from moderate skin rashes and urticaria to angioedema (angioedema) and anaphylaxis).

Mental disorders: psychosis, states of suicidal thinking, suicide and mania. If such conditions occur, the drug must be discontinued.

From the nervous system: convulsions, short-term memory impairment.

On the part of the organ of vision: blurred vision ("veil before the eyes").

From the gastrointestinal tract: diarrhea, vomiting.

From the skin and subcutaneous tissue: alopecia.

From the side of the kidneys and urinary tract: urinary retention.

On the part of the genital organs and mammary gland: ejaculation / orgasm disorders, impotence, menstrual disorders, uterine bleeding.

Indications

To reduce body weight in alimentary obesity with a body mass index of 27 kg / m 2 or more in combination with type 2 diabetes mellitus and dyslipidemia.

Contraindications

hypersensitivity to the components of the drug;
diabetic ketoacidosis, diabetic precoma, diabetic coma;
impaired renal function (CC less than 60 ml / min);
liver dysfunction;
acute conditions in which there is a risk of developing impaired renal function: dehydration (with diarrhea, vomiting), severe infectious diseases, shock;
cardiovascular diseases (history and current) coronary 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 disorders of cerebral circulation );
uncontrolled arterial hypertension (blood pressure (BP) above 145/90 mm Hg);
clinically pronounced manifestations of acute and chronic diseases that can lead to the development of tissue hypoxia (including respiratory failure, heart failure, acute MI);
chronic alcoholism, acute ethanol poisoning;
thyrotoxicosis;
benign prostatic hyperplasia;
pheochromocytoma;
angle-closure glaucoma;
major surgery and trauma (when insulin therapy is indicated);
lactic acidosis (including history);
established pharmacological or drug dependence;
pregnancy and lactation period;
age up to 18 years and over 65 years;
a period of at least 48 hours before and within 48 hours after radioisotope or X-ray studies with the introduction of an iodine-containing contrast agent;
compliance with a hypocaloric diet (less than 1000 kcal / day);
the 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);
concomitant use of MAO inhibitors (for example, phentermine, fenfluramine, dexfenfluramine, ethylamphetamine, ephedrine) or their use within 2 weeks before taking sibutramine and 2 weeks after the end of taking other drugs that act on the central nervous system that inhibit serotonin reuptake (for example, antidepressants, neuroleptics); sleeping pills containing tryptophan, as well as other centrally acting drugs for weight loss or the treatment of mental disorders.

Application features

Use during pregnancy and lactation

Since there is still not a sufficiently convincing number of studies regarding the safety of sibutramine exposure to the fetus, this drug is contraindicated during pregnancy. Women of reproductive age should use contraceptives while taking Reduxin ® Met.

The use of Reduxin ® Met is contraindicated during breastfeeding.

Application for violations of liver function

The use of the drug is contraindicated in violations of liver function

Application for violations of kidney function

The use of the drug is contraindicated in case of impaired renal function (CC less than 60 ml / min)

Use in children

Contraindicated for use in children under 18 years of age

Use in elderly patients

Contraindicated for use in patients over 65 years of age

special instructions

lactic acidosis

Lactic acidosis is a rare but serious (high mortality in the absence of emergency treatment) complication that can occur due to the accumulation of metformin. Cases of lactic acidosis while taking metformin occurred mainly in patients with diabetes mellitus with severe renal insufficiency.

Other associated risk factors should be considered, 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.

Diagnostic laboratory indicators are a decrease in blood pH (less than 7.25), a lactate content in blood plasma over 5 mmol / l, an increased anion gap and a lactate / pyruvate ratio. If you suspect metabolic acidosis, you should stop taking the drug and consult a doctor immediately.

Surgical operations

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

Kidney function

Since metformin is excreted by the kidneys, before starting the drug Reduxin ® Met and regularly thereafter, it is necessary to determine the 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 at the lower limit of normal.

Particular caution should be exercised with possible impaired renal function in elderly patients, while the use of antihypertensive drugs, diuretics or non-steroidal anti-inflammatory drugs.

Patients are advised to continue to follow a diet with an even intake of carbohydrates throughout the day. Patients with overweight are advised to continue to follow a low-calorie diet (but not less than 1000 kcal / day).

Reduxin ® Met should be used only in cases where all non-drug measures to reduce body weight are ineffective - if the weight loss within 3 months was 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. Comprehensive therapy includes both diet and lifestyle changes and increased physical activity. An important component of therapy is the creation of prerequisites for a stable change in eating behavior and lifestyle, which are necessary to maintain the achieved weight loss even after discontinuation of drug therapy. As part of therapy with Reduxin ® Met, patients need to change their lifestyle and habits in such a way that, after completion of treatment, the achieved reduction in body weight is maintained. Patients should clearly understand that failure to comply with these requirements will lead to a repeated increase in body weight and repeated visits to the attending physician.

In patients taking Reduxin ® Met, it is necessary to measure blood pressure and heart rate. In the first 3 months of treatment, these parameters should be monitored every 2 weeks, and then monthly. If an increase in resting heart rate ≥10 beats per minute or systolic/diastolic pressure ≥10 mmHg is detected during two consecutive visits, treatment should be discontinued. In hypertensive patients whose blood pressure is above 145/90 mm Hg 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 mm Hg twice during repeated measurement, treatment with Reduxin ® Met should be suspended (see section "Side effects. Disorders of the cardiovascular system").

In patients with sleep apnea, blood pressure should be carefully monitored.

Particular attention should be paid to the simultaneous administration of drugs that increase the QT interval. These drugs include H 1 -histamine blockers (astemizole, terfenadine); antiarrhythmic drugs that increase the QT interval (amiodarone, quinidine, flecainide, mexiletine, propafenone, sotalol); gastrointestinal motility stimulant 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 "Interaction with other drugs").

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

Although the relationship between the use of sibutramine and the development of primary pulmonary hypertension has not been established, however, given the well-known risk of drugs in this group, with regular medical monitoring, special attention should be paid to symptoms such as progressive dyspnea (breathing disorder), chest pain and swelling in the legs. .

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

The duration of taking the drug Reduxin ® Met should not exceed 1 year. When co-administering sibutramine and other serotonin reuptake inhibitors, there is an increased risk of bleeding. In patients predisposed to bleeding, as well as taking drugs that affect hemostasis or platelet function, sibutramine should be used with caution.

Although there are no clinical data on addiction to sibutramine, it should be ascertained whether the patient had a history of drug dependence and pay attention to possible signs of drug abuse.

Influence on the ability to drive vehicles and mechanisms

Taking the drug Reduxin ® Met may limit the ability to drive vehicles and mechanisms. 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.

In the fight against excess weight caused by diabetes, the complex remedy "Reduxin Met" is prescribed. It is released in sets of tablets with metformin and capsules with sibutramine. Helps to reduce the feeling of hunger and slow down the absorption of carbohydrates in the intestines. Your attention is invited to a detailed instruction on the use of Reduxin Met.

Reduxin Met refers to drugs prescribed for the treatment of obesity and overweight observed against the background of type 2 diabetes mellitus. Taken orally during breakfast, be sure to drink liquid. There are two separate products in the package: this is metformin in tablets and sibutramine with cellulose in capsules.

Metformin is used to reduce hyperglycemia. The substance does not cause hypoglycemia, unlike a number of similar ones. It does not force the body to produce insulin, inhibits the absorption of carbohydrates, and helps the body eliminate glucose. Additionally, it reduces the level of cholesterol in the patient's blood. Metmorphine is necessary for stabilization or measured weight loss.

Sibutramine increases the activity of serotonin receptors, which allows the patient to feel full more quickly when eating.

At the same time, thermal production increases, and brown fat, which is actively involved in this process, is affected. Taking sibutramine, the patient quickly, but in a controlled manner, loses weight and becomes satiated faster. The need for food during therapy becomes less and less.

Microcrystalline cellulose is designed to work as an enterosorbent. It helps to remove decay products, toxins, xenobiotics and other substances from the body that interfere with the normal functioning of the digestive system. Together with sibutramine and metformin, it is prescribed for the treatment of obesity: the components complement each other, which increases the effectiveness of treatment.

Release form

The release form of the drug "Reduxin Met" is one, but very peculiar. In one package you will find both capsules and tablets. There are only two sets.

The composition of the drug in the first set:

Sibutramine hydrochloride monohydrate (10 mg) capsules.
Microcrystalline cellulose (158.5 mg) in capsules.

White tablets are packed in a cellular blister. Blue gelatin capsules with white powder inside are also packaged in blisters. The set itself is packed in a cardboard box. There are sets of 20 tablets + 10 capsules and 60 tablets + 30 capsules.

The second set includes:

Metformin hydrochloride (850 mg) tablets.
Sibutramine hydrochloride monohydrate (15 mg) capsules.
Microcrystalline cellulose (153.5 mg) in capsules.

The sets are similar to the first ones, with a lower content of active ingredients in capsules.

Instructions for use

The drug "Reduxin Met" is prescribed for the treatment of obesity, the dosage and duration of treatment should be prescribed by the attending physician. Taking the drug should be combined with dietary nutrition and physical activity; without complex treatment, it will not be possible to achieve effective weight loss.

Do not take the drug at a temperature and infectious diseases.

The drug is taken once a day, in the morning at breakfast. Drinking a glass of water. Recommended dosage:

1 tablet and 1 capsule with 10 mg of sibutramine.
The dosage is increased to 2 tablets and 1 capsule, if there are no significant changes in the process of weight loss after 1-2 weeks.
The dosage is increased to 2 tablets and 1 capsule with 15 mg of sibutramine if there is no desired effect after 1 month from the start of treatment.

If the medications are difficult for the gastrointestinal system, the doctor can divide the intake of tablets (when the dosage is increased to two) into morning and evening. In the process of therapy, specialists must necessarily monitor the level of glucose in the blood and the dynamics of weight loss. Decisions to increase the dosage or cancel the drug are taken by the attending physician.

In the absence of side effects, therapy is carried out for at least three months.

If during this time there was no weight loss by 5% of those indicators that were noted before the start of treatment, the drug is canceled. With positive dynamics, treatment can continue for up to a year, but no more: it is not known how safe and effective longer use is, studies have not been conducted. If weight indicators begin to grow again with diet and exercise, therapy with Reduxin Met does not continue.

Contraindications

The drug "Reduxin Met" is contraindicated in the following cases:

Hypersensitivity or complete intolerance to the components of the drug.
Age under 18 and over 65.
Pregnancy or breastfeeding period in women.
The presence of alcohol or drug addiction.
Eating disorder.
The presence of mental illness, Tourette's syndrome.
Violation of the functioning of the liver and / or kidneys.
Infectious diseases and conditions that can lead to acute manifestations.
Pathologies of the cardiovascular system.
Arterial hypertension (high blood pressure that is not controlled).
Lactic acidosis (taken into account, even if it was in the past).
thyrotoxicosis.
Prostate hyperplasia in men.
Conditions in which insulin therapy is indicated.
Pheochromocytoma.
Angle-closure glaucoma.
Eating a reduced calorie diet with less than 1,000 calories per day.
Organic causes leading to obesity.

The drug is not combined with the simultaneous use of MAO inhibitors, hypnotics, antidepressants, antipsychotics.

Be sure to inform your doctor about what medications you are taking (and have taken in recent days).

Dosage

The average daily dose of metformin is 1700 mg. Maximum - 2550 mg. Maintenance therapy begins with one tablet of 850 mg, the dosage can be increased to two tablets at the discretion of the physician. The dosage of sibutramine varies strictly between 10 and 15 mg per day, the intake is also controlled by the doctor.

Side effects

Side effects for metformin and sibutramine can be different. From metformin, they manifest from the side of the central nervous system, metabolism, digestive system and skin. From sibutramine - from the side of the central nervous system, cardiovascular system, digestive system, skin. Side effects usually appear at the very beginning of treatment. When manifested, it is necessary to put your doctors in the know, but not cancel it yourself.

Side effects of metformin

taste disorder;
lactic acidosis;
absorption of vitamin B12 is reduced;
nausea, vomiting, stool disorders;
hepatitis;
itching, rash.

Side effects of sibutramine

feeling of dryness in the mouth;
insomnia;
headache;
incoordination, dizziness;
tachycardia;
increased blood pressure;
constipation;
nausea;
exacerbation of hemorrhoids;
excessive sweating;
psychosis;
mania (develops in patients with mental disorders);
menstrual irregularities;
violations in the functioning of the reproductive system.

Price

You can buy "Reduxin Met" at a price of 750 to 3500 rubles. The price is formed depending on the number of tablets and capsules in the package, on the dosage of sibutarmine in capsules, as well as on the distributor and the region of sale.

Analogues

"Reduxin Met" is expensive. Therefore, many are interested in finding similar drugs, but lower in price. Cheap analogues of "Reduxina Met":

Goldline. Contains sibutramine capsules. Reduces the feeling of hunger. The cost ranges from 1000 - 3000 rubles.
Reduxin. The same drug, but without metformin tablets in the kit. 700-2500 rubles in different pharmacies.
Reduxin Light. Dietary supplement, which does not contain sibutramine. It costs between 850-5000 rubles.

Other similar generics were previously produced, but they are now discontinued. These drugs affect only the feeling of hunger, without regulating the level of glucose in the blood, without affecting the production of insulin.

Overdose

The annotation to the drug suggests considering the consequences of an overdose separately for different drugs. With an overdose of metformin, lactic acidosis may develop. With an overdose of sibutramine, side effects increase. If these symptoms were noted, the medication should be stopped immediately.

Latin name

Active substance

ATH:

Pharmacological group

Nosological classification (ICD-10)

Compound

Set of tablets and capsules	1 set
tablets	1 tab.
active substance:
metformin hydrochloride	850 mg
Excipients: MCC - 25.5 mg; croscarmellose sodium - 51 mg; purified water - 17 mg, povidone K17 (polyvinylpyrrolidone) - 68 mg; magnesium stearate - 8.5 mg
capsules	1 caps.
active substances:
sibutramine hydrochloride monohydrate	10/15 mg
MCC	158.5/153.5 mg
Excipients: calcium stearate - 1.5 / 1.5 mg
capsule (for a dosage of 10 mg): titanium dioxide - 2%; dye azorubin - 0.0041%; dye brilliant blue - 0.0441%; gelatin - up to 100%
capsule (for a dosage of 15 mg): titanium dioxide - 2%; patented blue dye - 0.2737%; gelatin - up to 100%

Description of the dosage form

Tablets: oval, biconvex, white or almost white, scored on one side.

Capsules for a dosage of 10 mg: No. 2 blue.

Capsules for a dosage of 15 mg: No. 2 blue.

Capsule contents- white or white powder with a slightly yellowish tint.

pharmachologic effect

pharmachologic effect enterosorbent, anorexigenic, hypoglycemic.

Pharmacodynamics

The drug Reduxin ® Met contains two separate drugs in one package: a hypoglycemic agent for oral use of the biguanide group in the form of tablets - metformin and an agent for the treatment of obesity in the form of capsules, containing sibutramine and MCC in its composition.

The simultaneous use of metformin and sibutramine with MCC increases the therapeutic efficacy of the combination used in patients with overweight and type 2 diabetes mellitus.

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 carriers. 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 moderately decreases.

Sibutramine

Is a prodrug and shows 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 5-HT-serotonin and adrenergic receptors, which contributes to an increase in satiety and a decrease in the need for food, as well as an increase in thermal production. Indirectly activating beta 3-adrenergic receptors, sibutramine acts on brown adipose tissue. Weight loss 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, do not inhibit MAO; do not have affinity for a large number of neurotransmitter receptors, including serotonin (5-HT 1 -, 5-HT 1A -, 5-HT 1B -, 5-HT 2C -), adrenergic (beta 1 -, beta 2 -, beta 3 - , alpha 1 -, alpha 2 -), dopamine (D 1 -, D 2 -), muscarinic, histamine (H 1 -), benzodiazepine and glutamate NMDA receptors.

Pharmacokinetics

Metformin

Suction. After taking the drug inside, metformin is quite completely absorbed from the gastrointestinal tract. With simultaneous intake of food, the absorption of metformin is reduced and delayed. Absolute bioavailability is 50-60%. C max in plasma is approximately 2 μg / ml or 15 μmol and is reached after 2.5 hours.

Distribution. Metformin is rapidly distributed into body tissues. Practically does not bind to plasma proteins.

Metabolism. It is metabolized to a very small extent.

Withdrawal. Excreted by the kidneys. Metformin clearance in healthy individuals is 400 ml / min (4 times more than Cl creatinine), which indicates active tubular secretion. T 1/2 is approximately 6.5 hours.

Special clinical cases

In patients with renal insufficiency T 1/2 increases, there is a risk of accumulation of metformin in the body.

Sibutramine

Suction. After oral administration, it is rapidly absorbed from the gastrointestinal tract by at least 77%. During the initial 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, C max Ml is 4 ng / ml (3.2-4.8 ng / ml), M2 - 6.4 ng / ml (5.6-7.2 ng / ml). Cmax is achieved after 1.2 hours (sibutramine), 3-4 hours (active metabolites). Simultaneous food intake lowers C max metabolites by 30% and increases T max by 3 hours without changing AUC.

Distribution. It is quickly distributed on fabrics. Communication with proteins is 97 (sibutramine) and 94% (Ml and M2). C ss of active metabolites in the blood is achieved within 4 days after the start of treatment and is approximately 2 times higher than the plasma concentration 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. T 1/2 sibutramine - 1.1 h, Ml - 14 h, M2 - 16 h.

Special clinical cases

Floor. Currently available limited data do not indicate the existence of clinically significant differences in pharmacokinetics in men and women.

Elderly age. Pharmacokinetics in elderly healthy individuals (mean age 70 years) is similar to that in young people.

Renal failure. Renal insufficiency does not affect the AUC of the active metabolites Ml and M2, except for the M2 metabolite in patients with end-stage renal disease who are on dialysis.

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

Indications for Reduxin® Met

For weight loss in the following conditions:

alimentary obesity with a BMI of 27 kg / m 2 or more in combination with type 2 diabetes mellitus and dyslipidemia.

alimentary obesity with a BMI over 30 kg/m 2 in patients with prediabetes and additional risk factors for type 2 diabetes mellitus in whom lifestyle changes did not allow adequate glycemic control to be achieved.

Contraindications

hypersensitivity to the components of the drug;

diabetic ketoacidosis, diabetic precoma, diabetic coma;

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

liver dysfunction;

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

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

uncontrolled arterial hypertension (BP above 145/90 mm Hg - see "Special Instructions");

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 myocardial infarction);

chronic alcoholism, acute ethanol poisoning;

thyrotoxicosis;

benign prostatic hyperplasia;

pheochromocytoma;

angle-closure glaucoma;

major surgery and trauma (when insulin therapy is indicated);

lactic acidosis (including history);

established pharmacological or drug dependence;

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

compliance with a hypocaloric diet (less than 1000 kcal / day);

the 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 administration of MAO inhibitors (including phentermine, fenfluramine, dexfenfluramine, ethylamphetamine, ephedrine) or their use within 2 weeks before taking sibutramine and 2 weeks after the end of its administration, other drugs acting on the central nervous system that inhibit serotonin reuptake ( for example, antidepressants), neuroleptics, tryptophan-containing sleeping pills, and other centrally acting drugs for weight loss or the treatment of psychiatric disorders;

pregnancy;

the period of breastfeeding;

age up to 18 and over 65 years.

Carefully: chronic circulatory failure; diseases of the coronary arteries (including history), except for coronary heart disease (myocardial infarction, angina pectoris); glaucoma other than angle-closure glaucoma; cholelithiasis; arterial hypertension (controlled and in history); neurological disorders, including mental retardation and seizures (including history); epilepsy; impaired renal function of mild and moderate severity; renal failure (Cl creatinine 45-59 ml / min); history of motor and verbal tics; tendency to bleeding, bleeding disorders; taking drugs that affect hemostasis or platelet function; patients over 60 years of age who perform heavy physical work, which is associated with an increased risk of developing lactic acidosis.

Use during pregnancy and lactation

Since there is still not a sufficiently convincing number of studies regarding the safety of sibutramine exposure to the fetus, this drug is contraindicated during pregnancy.

Women with preserved reproductive potential while taking the drug Reduxin ® Met should use contraceptives.

The use of the drug Reduxin ® Met is contraindicated during breastfeeding.

Side effects

Determining the frequency of side effects: very often (≥1 / 10); often (≥1/100,<1/10); нечасто (≥1/1000, <1/100); редко (≥1/10 000, <1/1000); очень редко (<1/10000). Побочное действие представлено в порядке снижения значимости.

Metformin

From the side of metabolism and nutrition: very rarely - lactic acidosis; with prolonged use, a decrease in the absorption of vitamin B 12 is possible. A decrease in vitamin B 12 concentration should be taken into account in patients with megaloblastic anemia.

From the side of the central nervous system: often - a violation of taste.

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 disappear spontaneously); very rarely - a violation of liver function, hepatitis, after the abolition of metformin, these adverse events completely disappear. Slow dose escalation may improve gastrointestinal tolerance.

From the side of 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.

From the side of the central nervous system: very often - dry mouth and insomnia, headache, dizziness, anxiety, paresthesia, and a change in taste are often noted.

From the CCC: often - tachycardia, palpitations, vasodilation, increased blood pressure (moderate rise in blood pressure at rest by 1-3 mm Hg and a moderate increase in heart rate by 3-7 beats / min). In some cases, a more pronounced increase in blood pressure and an increase in heart rate are not excluded. Clinically significant changes in blood pressure and pulse are recorded mainly at the beginning of treatment (in the first 4-8 weeks). The use of the drug Reduxin ® Met in patients with elevated blood pressure - see "Contraindications" and "Special Instructions".

From the digestive system: very often - loss of appetite and constipation, often nausea and exacerbation of hemorrhoids. With a tendency to constipation in the early days, it is necessary to control the evacuation function of the intestine. If constipation occurs, stop taking and take a laxative.

From the side of 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, Shenlein-Genoch purpura (bleeding into the skin), convulsions, thrombocytopenia, transient increase in liver enzymes in the blood.

During post-marketing studies of sibutramine, additional adverse reactions have been described, listed below by organ system.

From the CCC: flickering arrhythmia.

Allergic reactions: hypersensitivity reactions (from moderate skin rashes and urticaria to angioedema (Quincke's edema) and anaphylaxis).

From the side of the central nervous system: psychosis, states of suicidal thinking, suicide and mania, short-term memory impairment, convulsions. If such conditions occur, the drug must be discontinued.

From the sense organs: blurred vision (veil before the eyes).

From the digestive system: diarrhea, vomiting.

From the side of the skin: alopecia.

From the urinary system: urinary retention.

From the reproductive system: ejaculation / orgasm disorders, impotence, menstrual irregularities, uterine bleeding.

Interaction

Metformin

Contraindicated combinations

Iodine-containing radiopaque agents. Against the background of functional renal failure in patients with diabetes mellitus, a radiological examination using iodine-containing radiopaque agents can cause the development of lactic acidosis. Treatment with metformin should be discontinued, depending on renal function, 48 hours before or at the time of an x-ray examination using iodine-containing radiopaque agents and not resumed earlier than 48 hours after, provided that during the examination, renal function was found to be normal.

Alcohol. In acute alcohol intoxication, the risk of developing lactic acidosis increases, especially in case of malnutrition, low-calorie diets and liver failure. While taking the drug, alcohol and drugs containing ethanol should be avoided.

Combinations requiring caution

Danazol. The simultaneous use of danazol is not recommended in order to avoid the hyperglycemic effect of the latter. If necessary, treatment with danazol and after discontinuation of the latter, a dose adjustment of metformin is required under the control of blood glucose concentration.

Chlorpromazine. When taken in high doses (100 mg per day), it increases the concentration of glucose in the blood, reducing the release of insulin. In the treatment of neuroleptics and after discontinuation of the latter, a dose adjustment of the drug is required under the control of the concentration of glucose in the blood.

GCS of systemic and local action reduce glucose tolerance, increase the concentration of glucose in the blood, sometimes causing ketosis. In the treatment of corticosteroids and after discontinuation of the latter, a dose adjustment of metformin is required under the control of blood glucose concentration.

Diuretics. Simultaneous use of loop diuretics can lead to the development of lactic acidosis due to possible functional renal failure. Metformin should not be prescribed if Cl creatinine is below 60 ml / min.

Assigned in the form of injections of beta 2-adrenergic agonists. Increase the concentration of glucose in the blood due to stimulation of beta 2-adrenergic receptors. In this case, it is necessary to control the concentration of glucose in the blood. If necessary, the appointment of insulin is recommended.

ACE inhibitors and other antihypertensive drugs. May lower blood glucose levels. If necessary, the dose of metformin should be adjusted.

Concomitant use of metformin with sulfonylurea derivatives, insulin, acarbose, salicylates possible development of hypoglycemia.

Nifedipine. Increases absorption and C max 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 can lead to an increase in its C max .

Sibutramine

Inhibitors of microsomal oxidation, incl. CYP3A4 isoenzyme inhibitors (including ketoconazole, erythromycin, cyclosporine). They increase the concentration of sibutramine metabolites in the blood plasma with an increase in heart rate and a clinically insignificant increase in the QT interval.

Rifampicin, macrolide antibiotics, phenytoin, carbamazepine, phenobarbital, and dexamethasone. May accelerate the metabolism of sibutramine.

Simultaneous application several drugs that increase the content of serotonin in the blood plasma, can lead to the development of a serious interaction. In rare cases, the simultaneous use of sibutramine with SSRIs (drugs for the treatment of depression), certain drugs for the treatment of migraine (sumatriptan, dihydroergotamine), potent analgesics (pentazocine, pethidine, fentanyl) or antitussive drugs (dextromethorphan) may develop a so-called. serotonin syndrome.

Sibutramine does not affect the action oral contraceptives.

Alcohol. With the simultaneous administration of sibutramine and alcohol, there was no increase in the negative effects of alcohol. However, alcohol is absolutely incompatible with the dietary measures recommended when taking sibutramine.

When used simultaneously with sibutramine other drugs that affect hemostasis or platelet function increases the risk of bleeding.

Drug interactions with the simultaneous use of sibutramine with drugs that increase blood pressure and heart rate, is currently not well understood. This group of drugs includes decongestants, antitussives, colds and antiallergic drugs, which include ephedrine or pseudoephedrine. Therefore, in cases of simultaneous administration of these drugs with sibutramine, caution should be exercised.

Co-administration of sibutramine with drugs for weight loss, acting on the central nervous system, or drugs for the treatment of mental disorders contraindicated.

Dosage and administration

inside. Metformin tablets and sibutramine 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 food intake.

It is necessary to monitor the dynamics of changes in the concentration of glucose in the blood and the dynamics of weight loss. If after 1-2 weeks the optimal values of glucose concentration in the blood are not reached, 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 table. in the morning and 1 tab. in the evening. If within 4 weeks from the start of treatment a decrease in body weight by 2 kg is not achieved, then 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 enough to therapy, i.e. who within 3 months of treatment fail to achieve a decrease in body weight by 5% of the baseline. Treatment should not be continued if, during further therapy, after the achieved weight loss, 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.

In prediabetes, the usual dose is 850–1700 mg/day of metformin and 10–15 mg/day of sibutramine.

If it is necessary to increase the dose of metformin to 1700 mg, an additional 1 table should be taken in the evening. metformin. It is recommended to regularly conduct glycemic control to assess the need for further use of the drug and dose adjustment of metformin.

The duration of use of the drug in type 2 diabetes mellitus and prediabetes should not exceed 1 year, since there are no data on efficacy and safety for a longer period of taking sibutramine. In the future, it is recommended to switch to metformin monotherapy.

Overdose

Metformin

Symptoms when using metformin at a dose of 85 g (42.5 times the maximum daily dose): no hypoglycemia was observed, however, the development of lactic acidosis was noted. Significant overdose or associated risk factors may lead to the development of lactic acidosis.

Treatment: in the event of signs of lactic acidosis, treatment with the drug should be stopped immediately, the patient should be urgently hospitalized and, having determined the concentration of lactate, clarify the diagnosis. 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 overdose of sibutramine.

Symptoms: tachycardia, increased blood pressure, headache, dizziness. You should notify your doctor in case of suspected overdose.

Treatment: there is no specific treatment or specific antidotes. It is necessary to perform general measures - to ensure free breathing, to monitor the state of the cardiovascular system, and, if necessary, to carry out supportive symptomatic therapy. Timely administration of activated charcoal, as well as gastric lavage, can reduce the intake of sibutramine into 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 an overdose, you should immediately stop taking the drug Reduxin ® Met.

special instructions

lactic acidosis. Lactic acidosis is a rare but serious (high mortality in the absence of emergency treatment) complication that can occur due to metformin accumulation. Cases of lactic acidosis while taking metformin occurred mainly in patients with diabetes mellitus with severe renal insufficiency. Other associated risk factors should be considered, 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 dyspnea, abdominal pain, and hypothermia followed by coma. Diagnostic laboratory indicators are a decrease in blood pH (less than 7.25), a lactate content in blood plasma over 5 mmol / l, an increased anion gap and a lactate / pyruvate ratio. If you suspect metabolic acidosis, you should stop taking the drug and consult a doctor immediately.

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

Kidney function. Since metformin is excreted by the kidneys, before taking the drug Reduxin ® Met and regularly thereafter, it is necessary to determine Cl creatinine: at least 1 time per year in patients with normal renal function and 2-4 times a year in elderly patients, as well as in patients with Cl creatinine for NGN.

Particular caution should be exercised with possible impaired renal function in elderly patients, the simultaneous use of antihypertensive drugs, diuretics or NSAIDs. Patients are advised to continue to follow a diet with an even intake of carbohydrates throughout the day. Patients with overweight are advised to continue to follow a low-calorie diet (but not less than 1000 kcal / day).

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. Comprehensive therapy includes both diet and lifestyle changes and increased physical activity. An important component of therapy is the creation of prerequisites for a stable change in eating behavior and lifestyle, which are necessary to maintain the achieved weight loss even after discontinuation of drug therapy. As part of therapy with Reduxin ® Met, patients need to change their lifestyle and habits in such a way that, after completion of treatment, the achieved reduction in body weight is maintained. Patients should clearly understand that failure to comply with these requirements will lead to a repeated increase in body weight and repeated visits to the attending physician.

In patients taking the drug Reduxin ® Met, it is necessary to measure blood pressure and heart rate. In the first 3 months of treatment, these parameters should be monitored every 2 weeks and then monthly. If during two visits in a row an increase in resting heart rate ≥10 bpm or SBP/dBP ≥10 mmHg is detected. , it is necessary to stop treatment. In patients with arterial hypertension, in whom, against the background of antihypertensive therapy, blood pressure ≥145/90 mm. Hg this control must be carried out with particular care and, if necessary, at shorter intervals. In patients in whom blood pressure twice, when measured twice, exceeded 145/90 mm Hg. , treatment with Reduxin ® Met should be suspended (see section "Side effects", From the side of the SSS).

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

Particular attention should be paid to the simultaneous administration of drugs that increase the QT interval. These drugs include H1-receptor blockers (astemizole, terfenadine); antiarrhythmic drugs that increase the QT interval (amiodarone, quinidine, flecainide, mexiletine, propafenone, sotalol); gastrointestinal motility stimulant 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 "Interaction").

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, special attention should be paid to symptoms such as progressive dyspnea (breathing disorder), chest pain and swelling in the legs.

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

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

Although there are no clinical data on addiction to sibutramine, it should be ascertained whether the patient had a history of drug dependence and pay attention 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 / m 2, a history of gestational diabetes mellitus, a family history of diabetes mellitus in first-line relatives , increased concentration of triglycerides, reduced concentration of HDL cholesterol, arterial hypertension.

Influence on the ability to drive vehicles and mechanisms. Taking the drug Reduxin ® Met may limit the ability to drive vehicles and mechanisms. 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.

Release form

Set: tablets 850 mg + capsules 10 mg + 158.5 mg; tablets 850 mg + capsules 15 mg + 153.5 mg.

10, 20, 25, 30 or 60 tab. Metformin in a blister pack made of PVC film and printed lacquered aluminum foil. 7, 10, 14 or 15 caps. sibutramine + MCC in a blister pack made of PVC film and printed lacquered aluminum foil. 7, 10, 14, 15, 28, 30, 60, 90, 120, 150, 160 or 180 caps. sibutramine + MCC in a polymer container for drugs. 10, 20, 25, 30, 40, 50, 60, 100 or 120 tab. Metformin in a polymer can for drugs. 1 jar containing metformin tablets and 1 container containing sibutramine + MCC capsules, or 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20 or 22 blister packs containing tablets metformin, and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or 11 blister packs containing sibutramine + MCC capsules, respectively, are placed in a cardboard pack.

Manufacturer

Terms of dispensing from pharmacies

On prescription.

Storage conditions of the drug Reduxin® Met

In a place protected from light, at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life of the drug Reduxin® Met

3 years tab., 3 years caps.

Do not use after the expiry date stated on the packaging.

Weight loss is a topical issue. Many of the fair sex, in their quest to get a dream figure, resort to the use of special preparations. Of course, they are not very useful for health, but the result can be very fast, which cannot be achieved simply by nutrition and exercise.

Description of the drug

Its price is slightly higher than the usual "Reduksin". Metformin, according to manufacturers, can solve the problem of obesity resulting from diabetes, as it makes the receptors more sensitive to insulin, provoking the excretion of glucose. Both drugs are identical in terms of use.

By following the rules prescribed by the instructions, you can significantly and safely reduce body weight. However, it should be noted that the price of this drug is very high, which does not make it widely available.

Key Features

So, the main features of the two drugs are:

Both drugs have an anorexigenic effect.
According to reviews, "Reduxin Met" is an improved and supplemented version of "Reduxin".
Both drugs eliminate the need for food on a psychological level.
Both are sorbents for the intestines.

Mode of application

With a body mass index of more than 28, it is an unequivocal indication for taking Reduxin Met. This is especially true if obesity is accompanied by diabetes and dyslipidemia (impaired fat metabolism).

One package of the drug contains two types of tablets. The initial dosage of the drug should be one and one capsule of sibutramine. Tablets are taken at the same time in the morning during breakfast. Using "Reduxin Met" (reviews of experts remind of this), it is important to control blood sugar levels. If glucose levels after several weeks of administration have reached optimal values, then the dosage of metformin can be doubled.

The normal daily dose of metformin is 1700 mg, but should not exceed 2550 mg. In order not to cause side effects, metformin is divided into morning and evening.

If during the first month the weight has not decreased by more than two kilograms, then the daily dosage of sibutramine is increased to 15 mg. Apply, judging by the reviews, "Reduxin Met" for more than four months is not recommended for those whose weight is reduced slowly. It is not worth repeating the course if, after refusing the drug, the lost weight quickly returned. The drug must be combined with a balanced diet and exercise.

Side effects

Metformin can cause the following side effects:

From the gastrointestinal tract: loss of appetite, nausea, vomiting, diarrhea, stomach cramps. These symptoms appear at the beginning of therapy and disappear by themselves with an increase in dosage.
On the part of metabolism: lactic acidosis, a decrease in the level of vitamin B12.
From the side of the liver: hepatitis and liver failure are rarely possible.
Allergic reactions: itching, rash, erythema. This is confirmed by doctors' reviews of Reduxin Met.

Sibutramine can cause the following conditions:

From the side of the cardiovascular system: hypertension, palpitations.
From the side of the central nervous system: insomnia, headaches, dry mouth, changes in taste sensations.
On the part of digestion: nausea, loss of appetite, constipation, exacerbation of hemorrhoids.

Contraindications

Judging by the reviews, "Reduxin Met" cannot be used if the patient has:

Intolerance to the components of the drug.
Allergic reactions.
Diabetic coma, ketoacidosis, precoma.
Uncontrolled hypertension.
Liver dysfunction.
Arrhythmia, ischemia, tachycardia, heart failure and other pathologies of the cardiovascular system.
Alcoholism in a chronic form.
Hyperplasia of the prostate.
Angle-closure glaucoma.
thyrotoxicosis.
Pheochromocytoma.
Lactic acidosis.
Surgical interventions.
Drug addiction.
Pregnancy and lactation.
Hypothyroidism (endocrine disease).
Eating disorder.
Tourette syndrome.
Reception of MAO inhibitors.
Mental illness.
Taking sleeping pills with tryptophan.

Reception with caution

Arrhythmia.
Insufficient circulation.
Glaucoma.
Hypertension.
Epilepsy.
Motor and verbal tics.
Renal failure.
Age over 55 years.
neurological disorders.

Interaction with other drugs

Metformin should not be used in the following combinations:

With alcohol, as the risk of lactic acidosis increases sharply.
With iodine-containing contrast agents for x-ray examination (may also lead to lactic acidosis).

With caution, it is necessary to combine the following drugs with metformin:

Chlorpromazine. Increases the amount of glucose by stopping the release of insulin. This requires dose adjustment.
Danazol. It also has a hyperglycemic effect, which reduces the effect of metformin.
Diuretics. When taken simultaneously with metformin, they cause lactic acidosis and renal failure.
Glucocorticosteroids. They cause an increase in blood glucose levels.

If you still decide to combine the above drugs, then you need to frequently check your blood sugar levels, especially at the beginning of the reception. "Nifedipine" increases the absorption of metformin. Antihypertensive drugs lower glucose levels.