Anti-obesity medication central action.
Sibutramine, [Cellulose microcristallic]
1 caps. It contains:
sibutramine hydrochloride monohydrate 10 mg;
microcrystalline cellulose 158.5 mg.
The composition of the capsule shell :
colorant titanium dioxide, dye azorubin, patent blue dye, gelatin.
To reduce body weight in 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 caused by overweight (type 2 diabetes mellitus / non-insulin / or dyslipoproteinemia).
– the presence of organic causes of obesity (e.g., hypothyroidism);
– serious eating disorders (anorexia nervosa or bulimia nervosa);
– mental illnesses;
– Gilles de la Tourette syndrome (generalized tics);
– simultaneous MAO inhibitors (e.g., phentermine, fenfluramine, dexfenfluramine, ethylamphetamine, ephedrine), or their use for 2 weeks prior to drug Reduxine destination; the use of other drugs acting on the central nervous system (e.g., antidepressants, antipsychotics); drugs prescribed for sleep disorders, containing tryptophan and other central acting drugs to reduce body weight;
– coronary heart disease, decompensated chronic heart failure, congenital heart disease, peripheral arterial occlusive disease, tachycardia, arrhythmia, cerebrovascular disease (stroke, transient ischemic attacks);
– uncontrolled hypertension (blood pressure above 145/90 mm Hg);
– severe hepatic dysfunction;
– severe renal dysfunction;
– benign prostatic hyperplasia;
– closure glaucoma;
– the established drug, drug or alcohol addiction;
– lactation (breast feeding);
– child and adolescence to 18 years;
– old age over 65 years;
– established hypersensitivity to sibutramine or to other components of the preparation.
Precautions should be prescribed for the following conditions: a history arrhythmia, chronic circulatory insufficiency, coronary artery disease (including history), cholelithiasis, hypertension (controlled and history), neurological disorders, including mental retardation and convulsions (including history) of the liver and / or kidney mild to moderate severity, verbal and motor tics history.
Side effects, depending on the effects on organs and organ systems in the following order (often – > 10%, sometimes – 1-10%, rarely – < 1%).
On the part of the central nervous system 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.
With the cardiovascular system: sometimes – tachycardia, palpitations, increased blood pressure, vasodilatation. There is a moderate recovery of blood pressure alone at 1-3 mmHg and a moderate increase in heart rate by 3-7 beats per minute. In some cases, are not excluded more pronounced increase in blood pressure and heart rate. Clinically significant changes in blood pressure and heart rate are recorded primarily in the beginning of treatment (during the first 4-8 weeks).
From the digestive system: often – loss of appetite, constipation; sometimes – nausea, exacerbation of hemorrhoids. A tendency to constipation in the early days should be monitored for the evacuation function of the intestine. If you experience constipation receiving end and take a laxative. In rare cases, abdominal pain, paradoxically increased appetite, transient increase in liver enzymes.
Dermatologic reactions: sometimes – sweating; in rare cases – pruritus, Henoch-Schönlein purpura (bleeding into the skin).
On the part of the whole body: in a few cases are described following clinically significant undesirable effects: dysmenorrhoea, edema, flu syndrome, thirst, rhinitis, acute interstitial nephritis, bleeding, thrombocytopenia.
Reactions to the cancellation, such as headache or increased appetite, are rare. There is no evidence that observed after treatment withdrawal, cancellation or mood disorder syndrome.
In most cases, side effects occur at the beginning of treatment (first 4 weeks). Their severity and frequency over time weakens. Side effects are generally not heavy and reversible.
How to accept, acceptance rate and dosage
Reduxine appointed interior 1 time / day. The dose is determined individually, depending on tolerability and clinical effectiveness. The recommended starting dose – 10 mg, with poor tolerance can receive 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, and combined with the meal.
If within 4 weeks of starting treatment is not achieved weight loss of 5% or more, the dose increased to 15 mg / day. Reduxine Duration of therapy should not exceed 3 months in patients who respond poorly to therapy (i.e. which, during 3 months of treatment fails to reduce the weight by 5% from the initial body weight). Treatment should not be continued if, for further treatment, the patient again adds to 3 kg body weight (achieved after reduction of body weight) or more.
The total duration of therapy should not exceed 2 years, because with regard to a longer period of receiving sibutramine data on efficacy and safety are absent.
Reduxine therapy should spend doctor who has experience treating obesity. The drug should be combined with diet and exercise.
Sibutramine, [Cellulose microcristallic]
Microsomal oxidation inhibitors, including inhibitors isozyme 3A4 of cytochrome P450 (including ketoconazole, erythromycin, cyclosporin) increase in plasma concentration of metabolites of sibutramine with an increase in heart rate and clinically unimportant increase the interval QT. Rifampicin, antibiotics of the macrolide, phenytoin, carbamazepine, phenobarbital and dexamethasone may accelerate metabolism of sibutramine. Simultaneous use of several drugs that increase serotonin in the blood, can lead to serious interactions. The so-called serotonin syndrome may occur in rare cases while applying Reduxine 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.
When simultaneous administration of sibutramine and ethanol there were no adverse effects amplification ethanol. However, alcohol is absolutely not compatible with the recommended dietary measures taking sibutramine.
Reduxine should be used only in those cases where all the non-pharmacological interventions to reduce weight are ineffective – if the body weight reduction within 3 months was less than 5 kg.
Reduxine treatment should be carried out as part of combination therapy for weight loss under medical supervision, with practical experience in the treatment of obesity.
Complex obesity therapy includes both the change in diet and lifestyle, as well as increased physical activity. An important component of therapy is to create prerequisites to permanent change in eating habits and lifestyle that are necessary to preserve the achieved weight loss after discontinuation of drug therapy. Patients should be under the therapy with Reduxine change your lifestyle and eating habits so that after completion of treatment to ensure preservation of the achieved weight loss. Patients need to be clear about that non-compliance will lead to re-weight gain and repeated appeals to the doctor.
Patients taking Reduxine, 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 treatment blood pressure above 145/90 mm Hg), this control must be carried out very carefully and, if necessary, at shorter intervals. Patients whose blood pressure measurements at repeated twice higher than the level of 145/90 mmHg Reduxine drug treatment should be suspended.
Special attention should be given co-administration of drugs that increase the QT interval. These drugs include blockers of histamine H1-receptor (astemizole, terfenadine); antiarrhythmic drugs that 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 the background conditions which are risk factors for increasing the interval QT (hypokalemia, hypomagnesemia).
The interval between the reception and Reduxine MAO inhibitors should be at least 2 weeks.
Association between 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 Reduxine drug may limit the patient’s ability to drive vehicles and management mechanisms.
Pregnancy and lactation
The drug should not be used during pregnancy due to lack of sufficient number of safety studies on the effects of sibutramine on the fetus.
Women of childbearing age while receiving Reduxine should use contraceptives.
Reduxine should not be used during breastfeeding.
There are very limited data about sibutramine overdose. In case of overdose, the patient should seek medical advice.
Symptoms: increased severity of side effects. Specific signs of overdose are unknown.
Treatment: administration of activated charcoal, gastric lavage, symptomatic therapy, with an increase in blood pressure and tachycardia – appointment of beta-blockers. Any 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 a supportive symptomatic therapy if necessary. The effectiveness of forced diuresis or hemodialysis has not been established.