Reduxin, 90 pcs., 15 mg, hard gelatin capsules
Reduxin® should be used only in cases where all non-drug measures for weight loss are ineffective - if the weight loss over 3 months is less than 5 kg.
Treatment with Reduxin® 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.
Complex therapy includes both changing diet and lifestyle, as well as increasing physical activity.
An important component of therapy is to create the prerequisites for persistent changes in eating behavior and lifestyle, which are necessary to maintain the achieved weight loss even after drug therapy is discontinued. As part of therapy with Reduxin®, patients need to change their lifestyle and habits in such a way as to ensure that the achieved weight loss is maintained after completion of treatment.
Patients should be clear that failure to comply with these requirements will lead to repeated weight gain and repeated visits to their doctor.
In patients taking Reduxin®, 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 consecutive visits an increase in resting heart rate ≥10 beats/min or SBP/dBP ≥10 mmHg is detected. Art., it is necessary to stop treatment. Patients with arterial hypertension whose blood pressure level is above 145/90 mm Hg during antihypertensive therapy. Art., this control should be carried out especially carefully and, if necessary, at shorter intervals. Patients whose blood pressure exceeded 145/90 mmHg twice during repeated measurements. Art., treatment with Reduxin® should be o).
In patients with sleep apnea syndrome, blood pressure must be monitored especially carefully.
The simultaneous administration of drugs that increase the QT interval requires special attention. These drugs include histamine H1 receptor blockers (astemizole, terfenadine); antiarrhythmic drugs that increase the QT interval (amiodarone, quinidine, flecainide, mexiletine, propafenone, sotalol); gastrointestinal motility stimulator cisapride; pimozide, sertindole and tricyclic antidepressants. This also applies to conditions that can lead to an increase in the QT interval (hypokalemia and hypomagnesemia - see “Interaction”).
The interval between taking MAO inhibitors (including furazolidone, procarbazine, selegiline) and Reduxin® should be at least 2 weeks.
Although no connection has been established between taking Reduxin® and the development of primary pulmonary hypertension, given the well-known risk for drugs in this group, with regular medical monitoring it is necessary to pay special attention to symptoms such as progressive dyspnea (breathing difficulty), chest pain and swelling legs
If you miss a dose of the drug Reduxin®, you should not take a double dose of the drug at the next dose; it is recommended to continue taking the drug according to the prescribed regimen.
The duration of taking Reduxin® should not exceed 1 year.
When taking sibutramine and other serotonin reuptake inhibitors together, there is an increased risk of bleeding. In patients predisposed to bleeding or taking drugs that affect hemostasis or platelet function, sibutramine should be used with caution.
Although there is no clinical evidence of addiction to sibutramine, the patient's history of drug dependence should be assessed and attention should be paid to possible signs of drug abuse.
Impact on the ability to drive vehicles and machinery. Taking the drug Reduxin® may limit the ability to drive vehicles and operate machinery. During the period of use of the drug Reduxin®, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
About the drug Reduxin
Lactic acidosis
Lactic acidosis is a rare but serious (high mortality unless promptly treated) complication that may occur due to accumulation of metformin. Cases of lactic acidosis when taking metformin occurred mainly in diabetic patients with severe renal failure.
Other associated risk factors should be taken into account, 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 shortness of breath, abdominal pain and hypothermia followed by coma. Diagnostic laboratory parameters are a decrease in blood pH (less than 7.25), lactate content in the blood plasma over 5 mmol/l, increased anion gap and lactate/pyruvate ratio. If metabolic acidosis is suspected, stop taking the drug and consult a doctor immediately.
Surgical operations
The use of the drug Reduxin® Forte should be discontinued 48 hours before planned surgical operations and can be continued no earlier than 48 hours after, provided that during the examination, renal function was found to be normal.
Kidney function
Since metformin is excreted by the kidneys, before starting to take the drug Reduxin® Forte and regularly thereafter, it is necessary to determine 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 in case of possible impairment of renal function in elderly patients, with simultaneous use of antihypertensive drugs, diuretics or non-steroidal anti-inflammatory drugs.
Patients are advised to continue to follow a diet with even carbohydrate intake throughout the day. Overweight patients are recommended to continue to follow a hypocaloric diet (but not less than 1000 kcal/day).
It is recommended that routine laboratory tests be performed regularly to monitor diabetes mellitus.
It is recommended to exercise caution when using Reduxin® Forte in combination with insulin or other hypoglycemic agents (including sulfonylurea derivatives, repaglinide).
Treatment with Reduxin® Forte 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. Complex therapy includes both changing diet and lifestyle, as well as increasing physical activity. An important component of therapy is to create the prerequisites for persistent changes in eating behavior and lifestyle, which are necessary to maintain the achieved weight loss even after drug therapy is discontinued. As part of therapy with Reduxin® Forte, patients need to change their lifestyle and habits in such a way as to ensure that the achieved weight loss is maintained after completion of treatment. Patients should be clear that failure to comply with these requirements will lead to repeated weight gain and repeated visits to their doctor.
In patients taking the drug Reduxin® Forte, it is necessary to measure blood pressure and heart rate. During the first 3 months of treatment, these parameters should be monitored every 2 weeks and then monthly. If during two consecutive visits an increase in resting heart rate ≥10 beats per minute or systolic/diastolic pressure ≥10 mmHg is detected. Art., it is necessary to stop treatment. In patients with arterial hypertension whose blood pressure is above 145/90 mm Hg during antihypertensive therapy. Art., this control should be carried out especially carefully and, if necessary, at shorter intervals. In patients whose blood pressure exceeded 145/90 mmHg twice during repeated measurements. Art., treatment with Reduxin® Forte should be suspended (see section “Side effects”, subsections “Heart disorders”, “Vascular disorders”).
In patients with sleep apnea, blood pressure must be monitored especially carefully.
The simultaneous administration of drugs that increase the QT interval requires special attention. These drugs include H1-histamine receptor blockers (astemizole, terfenadine); antiarrhythmic drugs that increase the QT interval (amiodarone, quinidine, flecainide, mexiletine, propafenone, sotalol); gastrointestinal motility stimulator 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® Forte should be at least 2 weeks.
Although a connection has not been established between taking sibutramine and the development of primary pulmonary hypertension, however, given the well-known risk of drugs in this group, with regular medical monitoring it is necessary to pay special attention to symptoms such as progressive dyspnea (breathing difficulty), chest pain and swelling in the legs .
If you miss a dose of Reduxin® Forte, you should not take a double dose of the drug at the next dose; it is recommended to continue taking the drug according to the prescribed regimen.
When taking sibutramine and other serotonin reuptake inhibitors together, there is an increased risk of bleeding. In patients predisposed to bleeding or taking drugs that affect hemostasis or platelet function, sibutramine should be used with caution.
Although there is no clinical evidence of addiction to sibutramine, the patient's history of drug dependence should be assessed and attention should be paid to possible signs of drug abuse.
Directions for use and doses
Reduxin is prescribed The dose is set individually, depending on tolerability and clinical effectiveness. The recommended starting dose is 10 mg; in case of poor tolerance, a dose of 5 mg can be taken. Capsules should be taken in the morning, without chewing and with sufficient liquid. The drug can be taken on an empty stomach or combined with meals.
If within 4 weeks from the start of treatment a reduction in body weight of 5% or more is not achieved, then the dose is increased to 15 mg/day. The duration of therapy with Reduxin should not exceed 3 months in patients who do not respond well to therapy (i.e., who fail to reduce weight by 5% of initial body weight within 3 months of treatment). Treatment should not be continued if, with further therapy (after achieving a reduction in body weight), the patient again gains 3 kg or more in body weight.
The total duration of therapy should not exceed 2 years, since there are no data on efficacy and safety for a longer period of taking sibutramine. If you miss a dose at the next dose, you should not take a double dose of the drug; It is recommended to continue taking the drug according to the prescribed regimen.
Therapy with Reduxin should Taking the drug should be combined with diet and exercise.
Contraindications
The presence of organic causes of obesity (for example, hyperthyroidism); serious eating disorders (anorexia nervosa or bulimia nervosa); mental illness; Gilles de la Tourette syndrome (generalized tics); simultaneous use of MAO inhibitors (for example, phentermine, fenfluramine, dexfenfluramine, ethylamphetamine, ephedrine) or their use within 2 weeks before prescribing Reduxin ; use of other drugs acting on the central nervous system (for example, antidepressants, antipsychotics); drugs prescribed for sleep disorders containing tryptophan, as well as other centrally acting drugs for weight loss; IHD, decompensated chronic heart failure, congenital heart defects, occlusive diseases of peripheral arteries, tachycardia, arrhythmias, cerebrovascular diseases (stroke, transient cerebrovascular accidents); uncontrolled arterial hypertension (blood pressure above 145⁄90 mmHg); thyrotoxicosis; severe liver dysfunction; severe renal dysfunction; benign prostatic hyperplasia; pheochromocytoma; angle-closure glaucoma; established drug, drug or alcohol dependence; pregnancy; lactation (breastfeeding); children and adolescents up to 18 years of age; elderly people over 65 years of age; established hypersensitivity to sibutramine or other components of the drug.
