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The composition of the capsule shell: dye, titanium dioxide, patent blue dye, heavy pharmachologic effect Combined preparation for the treatment of obesity, the effect of which is due to its constituent components. Sibutramine is a prodrug and exerts its effects in vivo due to metabolites (primary and secondary amines) which inhibit the reuptake of monoamines (norepinephrine, serotonin and preferably). The increase of neurotransmitters in the synapses increases the activity of central serotonin 5-HT-receptor and the adrenergic receptors, which helps to increase satiety and reduce the need for food, as well as an increase in termoproduktsii. Indirectly activating beta3-adrenergic receptors, sibutramine affects the brown adipose tissue. Weight loss accompanied by an increase in serum HDL concentration and reducing the amount of triglycerides, total cholesterol, LDL cholesterol, uric acid.
Sibutramine and its metabolites have no effect on the release of monoamines, do not inhibit MAO; It has no affinity to a large number of neurotransmitter receptors, including serotonergic (5-HT1, 5-HT1A, 5-HT1B, 5-HT2A, 5-HT2C), adrenergic receptors (beta1, beta2, beta3, alpha1, alpha2), dopamine (D1, D2), muscarinic, histamine (H1), and NMDA-benzodiazepine receptors.
Microcrystalline cellulose is enterosorbent has sorption properties and non-specific detoxification effect. Associates and displays the body of a variety of microorganisms, their metabolic products, toxins exogenous and endogenous nature, allergens, xenobiotics, as well as an excess of certain metabolic products and metabolites responsible for the development of endogenous toxicosis. Pharmacokinetics Absorption, distribution, metabolism
After oral administration Sibutramine is rapidly absorbed from the gastrointestinal tract, not less than 77%. Treated effect of «first pass» through the liver and biotransformed with participation of isoenzyme of cytochrome P450 3A4 with the formation of two active metabolites (mono and didesmetilsibutramin). After receiving a single dose of 15 mg of 4 monodesmetilsibutramina Cmax ng / mL (3.2-4.8 ng / ml) didesmetilsibutramina — 6.4 ng / ml (5.6-7.2 ng / ml). Sibutramine Cmax achieved after 1.2 hours of active metabolites -. 3-4 hours at a time reception with food decreases the Cmax of metabolites by 30% and increases the time to achieve 3 hours, without changing the AUC. It is rapidly distributed to the tissues. sibutramine binding to plasma proteins is 97%, and mono- and didesmetilsibutramina — 94%. Css active metabolites in blood is achieved within 4 days after the initiation of treatment, and about 2 times higher than the plasma levels after administration of a single dose.
T1 / 2 of sibutramine — 1.1 hours, monodesmetilsibutramina — 14 hours didesmetilsibutramina -. 16 h active metabolites are hydroxylation and conjugation with the formation of active metabolites, which are derived primarily by the kidneys. Side effects From the central and peripheral nervous system: often — dry mouth, insomnia; sometimes — headache, dizziness, anxiety, paresthesia, and changes in taste; in rare cases — back pain, depression, lethargy, emotional lability, anxiety, irritability, nervousness, convulsions.
One patient with schizoaffective disorder, which presumably existed prior to treatment, after treatment, developed acute psychosis.
Since the cardiovascular system: sometimes — tachycardia, palpitations, increased blood pressure, vasodilatation. There has been a moderate rise in blood pressure at rest for 1-3 mm Hg and moderate increase in heart rate at 3-7 bpm. In some cases it is not excluded more severe increase in blood pressure and heart rate. Clinically significant changes in blood pressure and heart rate are recorded primarily in the treatment of early (within the first 4-8 weeks).
From the digestive system: often — loss of appetite, constipation; sometimes — nausea, exacerbation of hemorrhoids. When a tendency to constipation in the early days should be monitored for the evacuation of bowel function. If you have constipation reception stop and take a laxative. In rare cases, abdominal pain, paradoxically increased appetite, transient increase in liver enzymes.
Dermatological reactions: sometimes — sweating; in rare cases — pruritus, Henoch-Schönlein purpura (bleeding into the skin). sale Properties prescription Special conditions Reduksin® should be used only in cases where all the non-pharmacological interventions to reduce weight are ineffective — if the body weight reduction for 3 months was less than 5 kg.
Treatment Reduxine should be part of an integrated therapy under medical supervision reduction in body weight, having practical experience in the treatment of obesity.
Integrated treatment of obesity includes both changes in diet and lifestyle, and increasing physical activity. An important component of therapy is to create prerequisites to permanent changes in eating habits and lifestyle, which are necessary to preserve the achieved weight loss after discontinuation of drug therapy. Patients should be under the therapy with Reduksin® change their lifestyle and habits so that after completion of treatment to ensure preservation of the achieved weight loss. Patients should clearly understand that failure to comply with these demands will lead to re-weight gain and repeated appeals to the doctor.
Patients taking Reduksin®, necessary to measure blood pressure and heart rate. In the first 2 months of treatment, these parameters should be monitored every 2 weeks, and then monthly. In patients with hypertension (which on the background of antihypertensive therapy, blood pressure above 145/90 mm Hg), this control should be carried out very carefully and, if necessary, at shorter intervals. Patients whose blood pressure measured twice during the second level higher than 145/90 mm Hg Reduksin® drug treatment should be suspended.
Special attention should be given co-administration of drugs that increase the QT interval. These medications include blockers of histamine H1 receptors (astemizole, terfenadine); antiarrhythmic drugs, increase the interval QT (amiodarone, quinidine, flecainide, mexiletine, propafenone, sotalol); GI motility stimulants (cisapride, pimozide, sertindole, and tricyclic antidepressants). Caution should be observed when using the drug on a background of conditions that are risk factors for increasing the interval QT (hypokalemia, hypomagnesemia).
The interval between the reception of MAO inhibitors and Reduxine should be at least 2 weeks.
Communication between the reception Reduxine and primary pulmonary hypertension has not been established, 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.
Effects on ability to drive vehicles and management mechanisms
Admission Reduksin® drug may limit the patient’s ability to drive vehicles and management mechanisms. testimony To reduce the body weight at the following conditions:
— Alimentary obesity with a body mass index (BMI) of 30 kg / m2 or more
— Alimentary obesity with a BMI of 27 kg / m2 or more in combination with other risk factors, due to excess body weight (type 2 diabetes mellitus / non-insulin / or dislipoproteinemia). Contraindications — Availability of organic causes of obesity (eg hypothyroidism);
— Serious eating disorders (anorexia nervosa or bulimia nervosa);
— Mental illnesses;
— Gilles de la Tourette syndrome (generalized tics);
— Simultaneous reception of MAO inhibitors (eg, phentermine, fenfluramine, dexfenfluramine, ethylamphetamine, ephedrine) or use within 2 weeks prior to the appointment of the drug Reduksin®; the use of other drugs acting on the CNS (such as antidepressants, antipsychotics); drugs prescribed and sleep disorders, containing tryptophan and other central acting drugs to reduce body weight;
— Uncontrolled hypertension (blood pressure above 145/90 mm Hg); Drug interactions Microsomal oxidation inhibitors, including isoenzyme 3A4 inhibitors of cytochrome P450 (including ketoconazole, erythromycin, cyclosporin) increase in the plasma concentration of sibutramine metabolites with increased heart rate and clinically unimportant increase QT interval. Rifampicin, antibiotics from the macrolide group, phenytoin, carbamazepine, phenobarbital, and dexamethasone may accelerate sibutramine metabolism. Simultaneous use of several drugs that increase serotonin in the blood, can lead to serious interactions. The so-called serotonin syndrome may develop in rare cases, the concomitant use of Reduxine with selective serotonin reuptake inhibitors (drugs for the treatment of depression), with some drugs for migraine treatment (sumatriptan, dihydroergotamine), a potent analgesics (pentazocine, pethidine, fentanyl) or antitussive drugs (dextromethorphan). Sibutramine has no effect on the effect of oral contraceptives. Dosage Reduksin® appointed interior 1 time / Dose set individually, depending on tolerability and clinical efficacy. The recommended initial dose — 10 mg, with poor tolerance can be received at a dose of 5 mg. The capsules should be taken in the morning, without chewing and drinking plenty of fluids. The drug can be taken on an empty stomach or with a meal mix. If within 4 weeks of starting treatment is not achieved weight loss of 5% or more, the dose increased to 15 mg / Reduxine Duration of therapy should not exceed 3 months in patients who are not adequately respond to the therapy (i.e., in which within 3 months of treatment fails to reduce the weight by 5% from the initial body weight). Treatment should not be continued, if further treatment (after the weight loss reached) adds new patient body weight of 3 kg or more. The total duration of treatment should not exceed 2 years, because with regard to a longer period of receiving sibutramine data on efficacy and safety are absent. Therapy should conduct Reduxine doctor who has experience treating obesity. The drug should be combined with diet and exercise.