Reduxin Met tabs 850mg #60 + caps 15mg #30

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Reduxin Met - a combined drug designed to reduce weight, weight loss. Reduxin Met contains two separate medicines in one package: a hypoglycemic agent for the oral administration of a biguanide group in a tablet dosage form of metformin, and an agent for treating obesity in a capsule dosage form containing sibutramine and microcrystalline cellulose.

Metformin

Oral hypoglycemic agent from the biguanide group. reduces hyperglycemia, without leading to the development of hypoglycemia. Unlike derivatives of sulfonylurea, it does not stimulate insulin secretion and does not cause hypoglycemic effect in healthy individuals. Increases the sensitivity of peripheral receptors to insulin and the utilization of glucose by cells. It inhibits gluconeogenesis in the liver. Delays the absorption of carbohydrates in the intestine. Metformin stimulates the synthesis of glycogen, affecting 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, low-density lipoproteins and triglycerides.
On the background of taking metformin, the patient's body weight either remains stable or moderately decreases.

Sibutramine

It is a prodrug and shows its effect in vivo due to metabolites (primary and secondary amines) inhibiting the reuptake of monoamines (serotonin, norepinephrine and dopamine). An increase in the content of neurotransmitters in the 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. By indirectly activating betas-adrenergic receptors. sibutramine affects the brown adipose tissue. The decrease in body weight is accompanied by an increase in the concentration of high-density lipoprotein (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-HT1, 5-HT1A, 5-HT1B, 5-HT2C), adrenergic (β1, β2, β3, α1, α2), dopamine (D1, D2), muscarinic. histamine (H1), benzodiazepine and glutamate NMDA receptors.

Microcrystalline cellulose

It is an enterosorbent, it possesses sorption properties and nonspecific detoxification action.
Binds and removes from the body various microorganisms, the products of their vital functions, 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 efficacy of the combination used in patients with overweight and type 2 diabetes mellitus.

Pharmacokinetics of Reduxin Met

Metformin

Suction. After taking the drug inside, metformin is completely absorbed from the digestive tract. With simultaneous intake of food, absorption of metformin is reduced and delayed. Absolute bioavailability is 50-60%. Cmax in plasma is approximately 2 μg / ml or 15 μmol and is achieved after 2.5 hours.
Distribution. Metformin is quickly distributed into the tissues of the body. Virtually does not bind to plasma protein.
Metabolism. To a very small extent, is exposed to metabolism.
Excretion. It is excreted by the kidneys. The clearance of metformin in healthy individuals is 400 ml / min (4 times more than CC), which indicates active tubular secretion. T1 / 2 is approximately 6.5 hours.

Pharmacokinetics in special clinical cases

In patients with renal insufficiency, T1 / 2 increases, there is a risk of cumulation of metformin in the body.

Sibutramine

Suction. After oral administration, it is rapidly absorbed from the digestive tract by at least 77%. At the "primary passage" through the liver undergoes biotransformation under the influence of the isoenzyme CYP3A4 with the formation of two active metabolites (monodesmethylsibutramine (M1) and didesselmethylsibutramine (M2)). After taking a single dose of 15 mg, the maximum concentration in the blood (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 achieved after 1.2 hours (sibutramine), 3-4 hours (active metabolites). Simultaneous food intake lowers Cmax metabolites by 30% and increases the time it takes to reach 3 hours without changing the area under the concentration-time curve (AUC).
Distribution. Quickly distributed to tissues. The connection with proteins 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 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 with the formation of inactive metabolites, which are excreted mainly by the kidneys.
T1 / 2 sibutramine - 1.1 h, M1 - 14 h, M2 - 16 h.

Pharmacokinetics in special clinical cases

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 adults.
Renal failure. Renal failure does not affect the AUC of the active metabolites M1 and M2, except for the M2 metabolite in patients with terminal stage of renal failure who are on dialysis.
Liver failure. In patients with moderate hepatic insufficiency after a single intake of sibutramine AUC, active metabolites M1 and M2 are 24% higher than in healthy individuals.

Indications for use

Set Reduxin Met is designed to reduce body weight with alimentary obesity with a body mass index of 27 kg / m2 and more in combination with type 2 diabetes and dyslipidemia.

Mode of application

Dosage of the drug Reduxin Met:
The recommended initial dose is 1 tablet containing 850 mg of metformin and I capsule containing 10 mg of sibutramine. Tablets and capsules should be taken in the morning at the same time, without chewing and drinking 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 blood glucose concentration and the dynamics of weight loss. If after one or two 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 per 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 divided doses. For example, take 1 tablet in the morning and 1 tablet in the evening.
If within 4 weeks from the beginning of treatment there is no reduction in body weight of 2 kg, the dose of sibutramine increases 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 during the 3 months of treatment can not achieve a reduction in body weight by 5% of the baseline. Treatment should not be continued if, in the further treatment after the achieved weight loss, the patient again adds 3 kg or more in the body mass.
Duration of treatment should not exceed 1 year, because in the relationship of a longer period of taking sibutramip, there is no evidence of efficacy and safety.
Treatment with Reduxin Met must be carried out in combination with diet and exercise under the supervision of a doctor who has practical experience in the treatment of obesity.

Side effects of Reduxin Met

When using the drug Reduxin Met, such side effects may occur.

Metformin.

From the side of metabolism and nutrition: very rarely - lactic acidosis; with prolonged use, it is possible to reduce the absorption of vitamin B12. Reducing the concentration of vitamin B12 must be taken into account in patients with megaloblastic anemia. From the nervous system: often - a violation of taste.
From the gastrointestinal 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 spontaneously pass. Slow increase in dose may improve gastrointestinal tolerance.
From the skin and subcutaneous tissues: very rarely skin reactions such as erythema, pruritus, rash.
From the liver and biliary tract: very rarely - a violation of liver function tests, hepatitis, after the withdrawal of metformin, these undesirable phenomena completely disappear.

Sibutramine.

Most often, side effects occur at the beginning of treatment (in the first 4 weeks). Their severity and frequency diminish over time. Side effects are generally light 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, <1/10).
From the side of the central nervous system: very frequent side effects are dry mouth and insomnia, headache, dizziness, anxiety, paresthesia, and taste change are often noted.
From the cardiovascular system: often there are tachycardia, a feeling of palpitation, increased blood pressure, vasodilation.
On the part of the digestive system: very often there is loss of appetite and constipation, often nausea and exacerbation of hemorrhoids. With a tendency to constipation in the first days, control over the evacuation function of the intestine is necessary. If there is constipation, stop taking and take a laxative.
On the part of the skin: often there is increased sweating. In single cases, the following undesirable clinically significant events are described in the treatment of sibutramine: dysmenorrhea, edema, flu-like syndrome, skin itching, back pain, abdominal pain, paradoxical appetite increase, thirst, rhinitis, depression, drowsiness, emotional lability, anxiety, irritability, nervousness, acute interstitial nephritis, bleeding, purpura Shenlen-Henoch (hemorrhages in the skin), convulsions, thrombocytopenia, transient increase in the activity of "hepatic" enzymes in the blood.
From 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 at 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).
During post-marketing studies of sibutramine, additional adverse reactions listed below for organ systems were described:
From the cardiovascular system: atrial fibrillation.
On the part of the immune system: hypersensitivity reactions (from moderate rashes on the skin and urticaria to angioedema (Quincke's edema) and anaphylaxis).
Disorders of the psyche: psychosis, states of suicidal thinking, suicide and mania. If such conditions occur, the drug should be discarded.
From the nervous system: cramps, short-term memory impairments.
From the side of the organ of vision: blurring of vision ("veil before the eyes").
From the digestive tract: diarrhea, vomiting.
From the skin and subcutaneous tissue: alopecia.
From the side of the kidneys and urinary tract: urinary retention.
From the genitals and the breast: violations of ejaculation / orgasm, impotence, menstrual irregularity, uterine bleeding.

Contraindications for Reduxin Met

Contraindications to the use of the drug Reduxin Met are: hypersensitivity to the components of the drug; Diabetic ketoacidosis, diabetic precoma, diabetic coma; impaired renal function (CC less than 60 ml / min); abnormal liver function; acute conditions at which there is a risk of kidney dysfunction: dehydration (with diarrhea, vomiting), severe infectious diseases, shock; cardiovascular diseases (in the anamnesis 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 disorders of cerebral circulation ); uncontrolled arterial hypertension (blood pressure (BP) above 145/90 mm Hg); clinical manifestations of acute and chronic diseases that can lead to the development of tissue hypoxia (including respiratory failure, heart failure, acute myocardial infarction); chronic alcoholism, acute ethanol poisoning; thyrotoxicosis; benign prostatic hyperplasia; pheochromocytoma; angle-closure glaucoma; extensive surgery and trauma (when carrying out insulin therapy); lactoacidosis (including in the anamnesis); established pharmacological or drug dependence; pregnancy and the period of breastfeeding; age is 18 years and over 65; period not less than 48 hours before and within 48 hours after radioisotope or X-ray studies with the introduction of iodine-containing contrast agent; compliance with hypocaloric diet (less than 1000 kcal / day); the presence of organic causes of obesity (eg, hypothyroidism); severe eating disorders - anorexia nervosa or bulimia nervosa; mental illness; Gilles de la Tourette syndrome (generalized tics); simultaneous administration of MAO inhibitors (eg, phentermine, fenfluramine, dexfenfluramine, ethylamphetamine, ephedrine) or their use 2 weeks prior to taking sibutramine and 2 weeks after the end of its administration of other drugs acting on the CNS that inhibit serotonin reuptake (for example, antidepressants, neuroleptics); hypnotics containing tryptophan, as well as other central drugs to reduce body weight or treat psychiatric disorders.
Caution should be given to the drug under the following conditions: an arrhythmia in an anamnesis; chronic circulatory failure; diseases of the coronary arteries (including in the anamnesis), in addition to coronary heart disease (myocardial infarction, angina pectoris); glaucoma, except for closed-angle glaucoma; cholelithiasis; arterial hypertension (controlled and in anamnesis); neurological disorders, including mental retardation and convulsions (including in history); epilepsy; renal dysfunction of mild and moderate severity; motor and verbal tics in the anamnesis; propensity to bleed, bleeding disorder; taking drugs that affect hemostasis or platelet function; people over 60 years of age who perform heavy physical work, which is associated with an increased risk of developing lactic acidosis.

Pregnancy

To date, there is not a sufficiently convincing amount of research regarding the safety of sibutramine exposure to fetus, the drug Reduxin Met is contraindicated during pregnancy. Women who are of reproductive age, while taking Reduxin Met, should use contraceptives.
Contraindicated in the use of Reduxin Met during breastfeeding.

Interaction with other drugs

Metformin.

Contraindicated combinations:
Iodine-containing radiopaque: on the background of functional renal failure in diabetic patients, a radiological study using iodine-containing radiocontrast agents can cause the development of lactic acidosis.
Treatment with metformin should be canceled depending on the function of the kidneys 48 hours before or during the X-ray examination using iodine-containing radiopaque means and not to resume earlier 48 hours after, provided that during the examination the renal function was found to be normal.
Unrecommended combinations
Alcohol: with acute alcohol intoxication, the risk of developing lactic acidosis increases, especially in the case of:
- malnutrition, compliance with a low-calorie diet;
- hepatic insufficiency.
During taking the drug, you should avoid drinking alcohol and drugs containing ethanol.
Combinations that require caution
Danazol: simultaneous administration of danazol is not recommended to avoid hyperglycemia of the latter. If it is necessary to treat danazol and after stopping the latter, a dose adjustment of metformin is required under the control of the glucose concentration in the blood.
Chlorpromazine: when taken in high doses (100 mg per day) increases the concentration of glucose in the blood, reducing the release of insulin. When treating with neuroleptics and after stopping the intake of the latter, correction of the dose of the drug under the control of the concentration of glucose in the blood is required.
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 GCS, and after discontinuation of the latter, correction of the dose of metformin is required under the control of the concentration of glucose in the blood.
Diuretics: simultaneous administration of loop diuretics can lead to the development of lactic acidosis because of the possible functional renal failure. Do not administer metformin if the SC is below 60 ml / min.
Assigned as injections of beta2-adrenomimetics: increase the concentration of glucose in the blood due to stimulation of beta2-adrenoreceptors. In this case, it is necessary to monitor the concentration of glucose in the blood. If necessary, the appointment of insulin is recommended.
With the simultaneous use of the above medicines, more frequent monitoring of blood glucose concentration 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 reduce the concentration of glucose in the blood. If necessary, the dose of metformin should be adjusted.
With the simultaneous use of metformin with derivatives of sulfonylurea, insulin, acarbose, salicylates may develop hypoglycemia.
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 over the tubular transport systems and can lead to an increase in its Cmax

Sibutramine

Inhibitors of microsomal oxidation, incl. inhibitors of the isoenzyme CYP3A4 (ketoconazole, erythromycin, cyclosporine, etc.) increase the plasma concentrations of sibutramine metabolites with increased heart rate and 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 serotonin levels in blood plasma can lead to the development of serious interaction. The so-called serotonin syndrome can develop in rare cases with the simultaneous use of sibutramine with selective serotonin reuptake inhibitors (drugs for the treatment of depression), with some medications for the treatment of migraine (sumatriptan, dihydroergotamine), with potent analgesics (pentazocine, pethidine, fentanyl) or antitussive 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 effect of alcohol. However, alcohol is absolutely not compatible with the recommended dietary measures when taking sibutramine.
With the simultaneous use with sibutramine other drugs that affect hemostasis or platelet function, the risk of bleeding increases.
Drug interaction with the simultaneous use of sibutramine with drugs that raise blood pressure and heart rate, is currently not fully understood. This group of drugs includes decongestants, antitussives. anti-cold and antiallergic drugs, which include ephedrine or pseudoephedrine. Therefore, in cases of simultaneous administration of these drugs with sibutramine, care should be taken.
Joint use of sibutramine with drugs for weight loss, acting on the central nervous system, or drugs for the treatment of mental disorders is contraindicated.

Overdose

Symptoms in the use of metformin at a dose of 85 g (42.5 times the maximum daily dose) did not show hypoglycemia, but there was a development of lactic acidosis.
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 urgently hospitalized and, having determined the concentration of lactate, clarify the diagnosis. The most effective measure for excretion from the body of lactate and metformin is hemodialysis.
Conduct also symptomatic treatment.
There are extremely limited data on the overdose of sibutramine. The most common adverse reactions associated with overdose: tachycardia, increased blood pressure, headache, dizziness. You should notify your doctor if there is an alleged overdose.
Treatment: there is no special treatment and no specific antidotes. It is necessary to carry out general measures: to ensure free breathing, to observe the state of the cardiovascular system, and also, if necessary, to carry out maintenance symptomatic therapy. Timely application 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 assigned beta-blockers. The effectiveness of forced diuresis or hemodialysis is not established.
In case of an overdose, you should immediately cancel the use of Reduxin Met.

Storage conditions

Preparation Reduxin Met should be stored in a dark place at a temperature of no higher than 25 ° C. The drug should be stored in places inaccessible to children. Shelf life - 3 years (tablets 3 years, capsules 3 years).

Form of issue

Set Reduxin Met is produced:
Capsules number 2; 10 mg, 15 mg. For 10 pcs.
Tablets - 850 mg. For 10pcs, 60 pcs.

Composition of Reduxin Met

1 capsule Reduxin Met contains: sibutramine hydrochloride monohydrate 15 mg; cellulose microcrystalline 158.5 mg.
Excipients: calcium stearate.
The composition of the shell of the capsule: dye titanium dioxide, dye azorubin, dye patented blue, gelatin.
1 tablet Reduxin Met contains: metformin (in the form of hydrochloride) 850 mg.

Additionally

Lactic acidosis is a rare but serious (high mortality in the absence of emergency treatment) complication, which may occur due to the cumulation of metformin. The cases of lactic acidosis with metformin were developed mainly in diabetic patients with severe renal insufficiency.
Other associated risk factors, such as decompensated diabetes mellitus, ketosis, prolonged fasting, alcoholism, liver failure and any condition associated with severe hypoxia, should be considered.
This can help reduce the incidence of lactic acidosis.
The risk of developing lactic acidosis when nonspecific signs appear, such as muscle cramps, accompanied by dyspeptic symptoms, abdominal pain and severe asthenia, should be considered. 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 the blood plasma above 5 mmol / l, an increased anion gap and a lactate / pyruvate ratio. If you suspect a metabolic acidosis, stop taking the medication and consult a doctor immediately.
Surgical operations. The use of the Reduxin Met drug 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.
Function of the kidneys. Since metformin is excreted by the kidneys, before starting the preparation Reduxin Met and regularly in the subsequent it is necessary to determine QA: 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 QC at the lower limit of the norm.
Care should be taken if there is a possible impairment of kidney function in elderly patients, while using antihypertensive drugs, diuretics or non-steroidal anti-inflammatory drugs.
Patients are encouraged to continue to follow a diet with an even intake of carbohydrates throughout the day. Patients with excessive body weight should continue to observe a hypocaloric diet (but not less than 1000 kcal / day).
It is recommended that regular laboratory tests be performed on a regular basis to control diabetes mellitus.
It is recommended to use caution when applying Reduxin Met in combination with insulin or other hypoglycemic agents (including sulfonylurea derivatives, repaglinide).
Reduxin Met should be used only in those cases when all non-medicamentous measures to reduce body weight are ineffective - if the decrease in body weight during 3 months was less than 5 kg. Treatment with Reduxin Met must be carried out as part of a comprehensive therapy for weight loss under the supervision of a doctor who has practical experience in the treatment of obesity. Complex therapy includes both changing diet and lifestyle, and increasing physical activity.
An important component of therapy is the creation of the prerequisites for a persistent change in eating behavior and lifestyle that are necessary to maintain the achieved weight loss and after the abolition of drug therapy. Patients need to change their lifestyle and habits within the framework of therapy with the Reduxin Met drug in such a way that after the treatment is completed, the achieved reduction in body weight should be maintained. Patients should clearly realize that failure to comply with these requirements will lead to a second increase in body weight and repeated calls to the treating 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 there is an increase in the heart rate at rest ≥10 beats per minute or systolic / diastolic pressure ≥ 10 mmHg during two consecutive visits, discontinue treatment. In patients with hypertension who have arterial blood pressure above 145/90 mm Hg on the background of antihypertensive therapy, this control should be carried out particularly carefully and, if necessary, at shorter intervals. In patients who have twice the arterial blood pressure for repeated measurement of 145/90 mm Hg, treatment with Reduxin Met must be suspended.
In patients with sleep apnea syndrome, blood pressure must be carefully monitored.
Special attention should be paid to the simultaneous administration of drugs that increase the QT interval. These drugs include H1-histamin blockers (astemizole, terfenadine); antiarrhythmic drugs that increase the QT interval (amiodarone, quinidine, flecainide, mexiletine, propafenone, sotalol); motility stimulator of the gastrointestinal tract 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.
The interval between the intake of MAO inhibitors (including furazolidone, procarbazine, selegiline) and Reduxin Met must be at least 2 weeks.
Although there is no relationship between sibutramine intake and primary pulmonary hypertension, however, given the generally known risk of drugs in this group, with regular medical supervision, special attention should be paid to symptoms such as progressive dyspnea (breathing disorder), chest pain and swelling on the legs .
If you miss a dose of Reduxin Met, you should not take a double dose of the drug in the next dose, it is recommended that you continue taking the drug as prescribed.
Duration of reception of the drug Reduxin Met should not exceed 1 year. With the joint administration of sibutramine and other serotonin reuptake inhibitors, there is an increased risk of bleeding. In patients who are prone to bleeding, as well as taking drugs that affect hemostasis or platelet function, sibutramine should be used with caution.
Although clinical data on addiction to sibutramine are not available, it should be ascertained whether there has been a history of drug dependence in the patient's history and pay attention to possible signs of drug abuse.
The use of Reduxin Met may limit the ability to drive vehicles and mechanisms. During the period of use of the Reduxin Met preparation, care must be taken when driving vehicles and engaging in other potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

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