Reduxin, 15 mg+153, 5 mg capsules 60 pcs

Type 2 Diabetes, Obesity

For weight loss 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 due to excess body weight (type 2 diabetes/insulin-independent/ or dyslipoproteinemia).

Indications

For weight loss in the following conditions:

— nutritional obesity with a body mass index (BMI) of 30 kg/m2 or more;

— nutritional obesity with a BMI of 27 kg/m2 or more in combination with other risk factors caused by excess body weight (type 2 diabetes mellitus/non-insulin dependent/or dyslipoproteinemia).

Pharmacological effect

A drug for the treatment of obesity with central action.

Special instructions

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 for obesity includes both changes in diet and lifestyle, as well as increased physical activity. An important component of therapy is the creation of prerequisites for permanent changes in eating habits 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. During the first 2 months of treatment, these parameters should be monitored every 2 weeks and then monthly. In patients with arterial hypertension (whose blood pressure levels are above 145/90 mmHg during antihypertensive therapy), 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. treatment with Reduxin should be suspended.

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 stimulants (cisapride, pimozide, sertindole and tricyclic antidepressants). Caution should be exercised when using the drug against conditions that are risk factors for increasing the QT interval (hypokalemia, hypomagnesemia).

The interval between taking MAO inhibitors and Reduxin should be at least 2 weeks.

The connection between taking Reduxin and the development of primary pulmonary hypertension has not been established, 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.

Impact on the ability to drive vehicles and operate machinery

Taking the drug Reduxin may limit the patient’s ability to drive vehicles and operate machinery.

Active ingredient

Sibutramine, microcrystalline cellulose

Composition

1 caps. contains:

sibutramine hydrochloride monohydrate 15 mg;

microcrystalline cellulose 153.5 mg.

Excipients:

calcium stearate.

Composition of the capsule shell:

titanium dioxide dye,

patented blue dye,

gelatin.

Pregnancy

The drug should not be used during pregnancy due to the lack of sufficiently convincing studies on the safety of the effects of sibutramine on the fetus.

Women of childbearing age should use contraception while taking Reduxin.

Reduxin should not be used during breastfeeding.

Contraindications

– presence of organic causes of obesity (for example, hypothyroidism);

– 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 (BP above 145/90 mm Hg);

– 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;

— old age over 65 years;

– established hypersensitivity to sibutramine or other components of the drug.

The drug should be prescribed with caution in the following conditions: a history of arrhythmias, chronic circulatory failure, coronary artery disease (including a history), cholelithiasis, arterial hypertension (controlled and a history), neurological disorders, including mental retardation and convulsions (including a history), impaired liver and/or kidney function of mild to moderate severity, motor and verbal tics in anamnesis.

Side Effects

Side effects, depending on the effect on organs and organ systems, are presented in the following order (often – >10%, sometimes – 1-10%, rarely – <1%).

From the central nervous system and peripheral nervous system: often – dry mouth, insomnia; sometimes – headache, dizziness, anxiety, paresthesia, and changes in taste; in isolated cases – back pain, depression, drowsiness, emotional lability, anxiety, irritability, nervousness, convulsions.

One patient with schizoaffective disorder, which was presumed to exist before treatment, developed acute psychosis after treatment.

From the cardiovascular system: sometimes – tachycardia, palpitations, increased blood pressure, vasodilation. There is a moderate increase in blood pressure at rest by 1-3 mm Hg. and a moderate increase in heart rate of 3-7 beats per minute. In some cases, more pronounced increases in blood pressure and heart rate cannot be ruled out. Clinically significant changes in blood pressure and pulse levels are recorded mainly at the beginning of treatment (in the first 4-8 weeks).

From the digestive system: often – loss of appetite, constipation; sometimes – nausea, exacerbation of hemorrhoids. If you are prone to constipation in the first days, monitoring the evacuation function of the intestines is necessary. If constipation occurs, stop taking it and take a laxative. In isolated cases, abdominal pain, paradoxical increase in appetite, transient increase in the activity of liver enzymes.

Dermatological reactions: sometimes – sweating; in isolated cases – skin itching, Henoch-Schönlein purpura (bleeding into the skin).

From the body as a whole: in isolated cases the following undesirable clinically significant phenomena have been described: dysmenorrhea, edema, influenza-like syndrome, thirst, rhinitis, acute interstitial nephritis, bleeding, thrombocytopenia.

Withdrawal reactions such as headache or increased appetite are rare. There is no evidence that withdrawal symptoms, withdrawal symptoms or mood disturbances occur after treatment.

Most often, side effects occur at the beginning of treatment (in the first 4 weeks). Their severity and frequency weaken over time. Side effects are generally mild and reversible.

Interaction

Inhibitors of microsomal oxidation, incl. inhibitors of cytochrome P450 isoenzyme 3A4 (including ketoconazole, erythromycin, cyclosporine) increase plasma concentrations of sibutramine metabolites with an increase in heart rate and a 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 the level of serotonin in the blood can lead to the development of a serious interaction.

The so-called serotonin syndrome can develop in rare cases when Reduxin is used simultaneously with selective serotonin reuptake inhibitors (drugs for the treatment of depression), with certain drugs for the treatment of migraines (sumatriptan, dihydroergotamine), with potent analgesics (pentazocine, pethidine, fentanyl) or antitussives (dextromethorphan).

Sibutramine does not affect the effect of oral contraceptives.

When sibutramine and ethanol were taken simultaneously, there was no increase in the negative effects of ethanol. However, alcohol consumption is absolutely not combined with the dietary measures recommended when taking sibutramine.

Overdose

There are extremely limited data on sibutramine overdose. In case of overdose, the patient should consult a doctor.

Symptoms: possible increased severity of side effects. Specific signs of overdose are unknown.

Treatment: taking activated charcoal, gastric lavage, symptomatic therapy, with increased blood pressure and tachycardia – prescribing beta-blockers.

There is no special treatment or specific antidotes. It is necessary to carry out general measures: ensure free breathing, monitor the state of the cardiovascular system, and, if necessary, carry out supportive symptomatic therapy. The effectiveness of forced diuresis or hemodialysis has not been established.

Manufacturer

Biokhimik JSC, Russia