Composition, form of production and packaging
Capsules number 2 in blue; the contents of the capsules are white or white powder with a slightly yellowish tint of color.
1 caps.
sibutramine hydrochloride monohydrate 10 mg
cellulose microcrystalline 158.5 mg
[PRING] calcium stearate.
The composition of the shell of the capsule: dye titanium dioxide, dye azorubin, dye patented blue, gelatin.
10 pieces. - Cellular outline packaging (aluminum / PVC) (3) - cardboard packs.
10 pieces. - Cellular outline packaging (aluminum / PVC) (6) - cardboard packs.
10 pieces. - Cellular outline packaging (aluminum / PVC) (1) - cardboard packs.
10 pieces. - Cellular outline packaging (aluminum / PVC) (4) - cardboard packs.
Tablets are white or white in color, oval, biconvex, with a risk on one side.
1 tab.
metformin (in the form of hydrochloride) 850 mg
10 pieces. - Cellular outline packaging (aluminum / PVC) (3) - cardboard packs.
10 pieces. - Cellular outline packaging (aluminum / PVC) (6) - cardboard packs.
10 pieces. - Cellular outline packaging (aluminum / PVC) (2) - cardboard packs.
10 pieces. - Cellular outline packaging (aluminum / PVC) (4) - cardboard packs.
60 pcs. - Cellular outline packaging (aluminum / PVC) (3) - cardboard packs.
60 pcs. - Cellular outline packaging (aluminum / PVC) (6) - cardboard packs.
60 pcs. - Cellular outline packaging (aluminum / PVC) (2) - cardboard packs.
60 pcs. - Cellular outline packaging (aluminum / PVC) (4) - cardboard packs.
The set is packed in a pack of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2014.
PHARMACHOLOGIC EFFECT
Reduxin В® Met contains two separate medicines in one package: a hypoglycemic agent for oral administration of the biguanide group in the dosage form of the metformin tablet, 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 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-HT 1 , 5-HT 1A , 5-HT 1B , 5-HT 2C ), adrenergic (? 1 ,? 2 , ? 3 , ? 1 ,? 2 ), dopamine (D 1 , D 2 ), muscarinic. histamine (H 1 ), 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
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%. C max in plasma is approximately 2 Ојg / ml or 15 Ојmol 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.
T 1/2 is approximately 6.5 hours.
Pharmacokinetics in special clinical cases
In patients with renal insufficiency T 1/2 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). C max is achieved after 1.2 hours (sibutramine), 3-4 hours (active metabolites). Simultaneous food intake lowers C max 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. T 1/2 of 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 insufficiency
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
- to reduce body weight with alimentary obesity with a body mass index of 27 kg / m 2 and more in combination with type 2 diabetes mellitus and dyslipidemia.
DOSING MODE
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 В® Meth 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 therapy 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, since in the ratio of a longer period of taking sibutramip, the effectiveness data and there is no security.
Treatment with Reduxin В® The metric should 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 EFFECT
Determination of the frequency of side effects: very often (> 1/10), often (? 1/100, <1/10), infrequently (? 1/1000, <1/100), rarely (? 1/10000, <1 / 1000), very rarely (<1/10 000). Side effect is presented in order of decreasing importance.
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 should 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).
Use Reduxin В® Meth in patients with elevated blood pressure: see the section "Contraindications" and "Special instructions."
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
- hypersensitivity to the components of the drug;
- diabetic ketoacidosis, diabetic precoma, diabetic coma;
- renal dysfunction (CC less than 60 ml / min);
- impaired liver function;
- acute conditions at which there is a risk of developing a violation of kidney function: dehydration (with diarrhea, vomiting), severe infectious diseases, shock;
- cardiovascular diseases (in the anamnesis and now) 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 the brain blood circulation);
uncontrolled arterial hypertension (blood pressure (BP) above 145/90 mm Hg);
- Clinically expressed 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;
- an angle-closure glaucoma;
- extensive surgery and trauma (when insulin therapy is indicated);
- lactic acidosis (including in the anamnesis);
- established pharmacological or drug dependence;
- pregnancy and the period of breastfeeding;
- age under 18 and over 65;
- a period of at least 48 hours before and within 48 hours after radioisotope or X-ray studies with the introduction of iodine-containing contrast media;
- compliance with the 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's syndrome (generalized tics);
- simultaneous administration of MAO inhibitors (eg, phentermine, fenfluramine, dexfenfluramine, ethylamphetamine, ephedrine) or their use for 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 AND LACTATION
Since there is not yet a sufficiently convincing amount of research regarding the safety of sibutramine exposure to the fetus, this drug is contraindicated during pregnancy. Women who are of reproductive age, while taking Reduxin В® Met, should use contraceptives.
Contraindicated in the use of Reduxin В® Met during breastfeeding.
APPLICATION FOR FUNCTIONS OF THE LIVER
Contraindicated use of the drug for violations of kidney function (KK less than 60 ml / min)
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Contraindicated use of the drug for violations of liver function
APPLICATION FOR CHILDREN
Contraindicated in children under 18 years of age
APPLICATION IN ELDERLY PATIENTS
Contraindicated in patients older than 65 years
SPECIAL INSTRUCTIONS
Lactic acidosis
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), lactate 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 Reduxin В® Meth should be discontinued 48 hours before 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 preparation Reduxin В® 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 CC at the lower limit of normal.
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 advisable to use caution when using Reduxin В® Met in combination with insulin or other hypoglycemic agents (including sulfonylureas, repaglinide).
Reduxine В® Met should be used only in those cases where all non-drug measures to reduce body weight ineffective - if the body weight decrease during the 3 months was less than 5 kg. Treatment with Reduxine В® Met should be carried out within the framework of a comprehensive therapy for weight loss under medical supervision, with practical experience in the treatment of obesity. Complex therapy includes both the change in diet and lifestyle, as well as increased physical activity. An important component of therapy is to create prerequisites for persistent changes in eating and lifestyle choices that are necessary to maintain the achieved weight loss after discontinuation of drug therapy. Patients should be under the therapy with Reduxine В®Met to change their lifestyle and habits so that after completion of treatment to ensure preservation of the achieved weight reduction. 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.
Patients taking Reduxine В® 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 the two consecutive visits revealed an increase in heart rate at rest? 10 bpm or systolic / diastolic pressure? 10 mmHg, it is necessary to stop treatment. Patients with hypertension whose antihypertensive therapy on the background of blood pressure above 145/90 mmHg, the control must be carried out very carefully and, if necessary, at shorter intervals. Patients whose blood pressure measurements at repeated twice higher than 145/90 mm Hg, treatment with Reduxine В®Met should be suspended (see. Section "Side effect. Violations of the cardiovascular system").
In patients with sleep apnea syndrome particular care to control blood pressure.
Special attention should be given co-administration of drugs that increase the QT interval. These drugs include H 1 histamine blockers (astemizole, terfenadine); antiarrhythmic drugs that increase the interval QT (quinidine, amiodarone, flecainide, mexiletine, propafenone, sotalol.); GI motility stimulant cisapride; pimozide, sertindole, and tricyclic antidepressants. This applies to the conditions which can lead to an increase in QT interval, such as hypokalemia and hypomagnesemia. (See. Section "Interaction with other drugs").
The interval between the reception of MAO inhibitors (including furazolidone, procarbazine, selegiline) and drug Reduxine В® Mw should be at least 2 weeks.
Although not established an association between sibutramine and the development of primary pulmonary hypertension, however, given the well-known risk of drugs of this group, with regular medical monitoring is necessary to pay special attention to symptoms such as progressive dyspnea (breathing problems), chest pain and swelling in the legs .
Omitting dose Reduxine В® Met should not be taken in the next intake double dose, it is recommended to continue further reception of a prescribed drug scheme.
The duration of ingestion Reduxine В®Met should not exceed 1 year. When co-administered sibutramine and other serotonin reuptake inhibitors are at 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 clinical data on addiction to sibutramine no, you should find out if there was any in the patient's history of drug addiction, and pay attention to possible signs of drugs of abuse.
Impact on the ability to drive vehicles and mechanisms
Admission drug Reduxine В® Met may limit the ability to drive vehicles and mechanisms. During the period of preparation Reduxine В® Met must be careful when driving and occupation of other potentially hazardous activities that require high concentration and psychomotor speed reactions.
OVERDOSE
Metformin
Symptoms with metformin at the dose of 85 g (42.5 times the maximum daily dose) hypoglycemia was not observed, but it was noted the development of lactic acidosis.
A significant overdose or associated risk factors can lead to the development of lactic acidosis.
Treatment: in case of signs of lactic acidosis, drug treatment must be stopped immediately, the patient hospitalized immediately and determine 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.
sibutramine
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 in case of suspected overdose.
Treatment: no special treatment and specific antidotes exist. It is necessary to carry out common activities: to provide free breathing, monitor the health of the cardiovascular system, as well as to implement supportive symptomatic therapy if necessary. Timely use of activated charcoal and gastric lavage can reduce the intake of sibutramine. Patients with high blood pressure and tachycardia can be assigned to beta-blockers. The effectiveness of forced diuresis or hemodialysis is not established.
In case of overdose, immediately stop taking the Reduxine В® Met.
DRUG INTERACTION
Metformin
is contraindicated in combination
Iodinated X-ray contrast media: on the background of functional renal failure in patients with diabetes radiological examination using iodine-containing contrast media can induce the development of lactic acidosis. Treatment with metformin to cancel depending on renal function for 48 h before or at the time of X-ray studies using iodinated contrast media, and not to resume previously after 48 hours, with the proviso that the survey renal function was considered normal.
Unrecommended combinations
Alcohol : in acute alcohol intoxication increases the risk of lactic acidosis, particularly in the case of:
- insufficient supply, compliance with a low-calorie diet;
- hepatic insufficiency.
During treatment to avoid intake of alcohol and drugs containing ethanol.
Combinations requiring caution
Danazol: not recommended for concomitant use of danazol to avoid hyperglycemic action of the latter. If necessary, treatment with danazol and after discontinuation of the latter requires dose adjustment of metformin under the control of blood glucose concentration.
chlorpromazine:when taken in large doses (100 mg daily) increases the concentration of glucose in the blood, reducing insulin release. When neuroleptic treatment and after discontinuation of the past required dose correction under the control of blood glucose concentration.
Glucocorticosteroids (GCS) systemic and topical 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 require dose adjustment of metformin under the control of blood glucose concentration.
Diuretics: simultaneous reception of "loop" diuretics may lead to the development of lactic acidosis due to possible functional renal failure. It should appoint metformin if QA is lower than 60 ml / min.
Assign a beta injection2 -adrenomimetiki: increase the concentration of glucose in the blood due to stimulation of beta 2 adrenoreceptor. In this case it is necessary to control the concentration of blood glucose. If necessary, the appointment of insulin is recommended.
With simultaneous use of the above drugs may require more frequent monitoring of blood glucose concentration, especially at the beginning of treatment. If necessary metformin dose can be adjusted during the treatment and after its termination.
ACE inhibitors and other antihypertensive drugs can reduce the blood glucose concentration. If necessary, adjust the dose of metformin.
With simultaneous use of metformin with sulfonylureas, insulin, acarbose, salicylates may develop hypoglycemia.
Nifedipine increases the absorption and the C max of metformin.
Cationic drugs(amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, and vancomycin), secreted in the renal tubules, compete with metformin for canalicular transport systems, and may lead to an increase in its C max
Sibutramine
inhibitors mikrosomalnogo oxidation , in Vol. h. inhibitors isoenzyme CYP3A4 (ketoconazole, erythromycin, cyclosporin, etc.) increase in plasma concentration of metabolites of sibutramine with an increase in heart rate and clinically unimportant increase QT interval.
Rifampicin, antibiotics of the macrolide , phenytoin, carbamazepine, phenobarbital and dexamethasone may accelerate metabolism of sibutramine.
Simultaneous use of several drugs that increase blood plasma serotonin may lead to serious interactions. The so-called serotonin syndrome may occur in rare cases, while the use of sibutramine with selective serotonin reuptake inhibitors (drugs for treating depression), with some drugs for treating migraine (sumatriptan, dihydroergotamine), a potent analgesics (pentazocine, pethidine, fentanyl) or antitussive drugs (dextromethorphan). Sibutramine does not affect the action of oral contraceptives.
At the same time taking sibutramine and alcoholThere was no amplification of negative effects of alcohol. However, alcohol is absolutely not compatible with the recommended dietary measures taking sibutramine.
While the use of sibutramine other drugs affecting hemostasis or platelet function, increased risk of bleeding.
Drug interaction while the use of sibutramine with drugs that increase the heart rate and blood pressure , are currently not fully understood. This group of drugs include decongestants, antitussives. cough and allergy medicines, which contain ephedrine or pseudoephedrine. Therefore, in the case of simultaneous reception of these drugs with sibutramine caution.
The combined use of drugs with sibutramine to reduce body weight acting on the CNS, or drugs to treat psychiatric disorders contraindicated.
TERMS OF RELEASE FROM PHARMACY
On prescription.
TERMS AND CONDITIONS OF STORAGE
In the dark place at a temperature of no higher than 25 В° C. The drug should be stored out of the reach of children. Shelf life - 3 years (3 years tablets, capsules, 3 years).
Sibutramine belongs to the list of potent substances approved by the Decree of the Government of the Russian Federation of 29.12.2007. No. 964.
