Reduxin caps 15mg #60

Instruction for Reduxin

Reduxin is a central action for the treatment of obesity.

Release form and composition

Dosage form Reduxin - capsules: size No. 2, blue or blue; contents - powder of white or white-yellowish color (10 pieces each in blister packs, 3 or 6 packs in a pack of cardboard).
Active substances and their content:
    Capsules of blue color: sibutramine hydrochloride monohydrate - 10 mg, microcrystalline cellulose - 158.5 mg;
    Capsules of blue color: sibutramine hydrochloride monohydrate - 15 mg, microcrystalline cellulose - 153.5 mg.
Auxiliary component: calcium stearate.
The composition of the capsule shell: gelatin, titanium dioxide, patent blue dye, azorubine dye (10 mg in capsules).

Pharmacodynamics

Sibutramine is a prodrug, its effect is due to metabolites (primary and secondary amines). The latter are monoamine reuptake inhibitors (dopamine, norepinephrine and serotonin). An increase in the level of neurotransmitters in synapses contributes to an increase in the activity of central adrenergic and 5HT-serotonin receptors, which enhances the feeling of satiety and reduces the need for food, as well as the intensification of thermal production.
Sibutramine indirectly activates beta3-adrenergic receptors, affecting brown adipose tissue. A decrease in body weight is accompanied by an increase in plasma concentrations of high density lipoproteins and a decrease in the content of uric acid, triglycerides, low density lipoproteins and total cholesterol. Sibutramine and its metabolites do not affect the release of monoamines and do not belong to monoamine oxidase inhibitors, and are also characterized by low affinity for a large number of neurotransmitter receptors, including glutamate (NMDA), serotonin (5-HT2C, 5-HT1, 5-Н1В, 5НТ1А) benzodiazepine, adrenergic (alpha1, alpha2, beta1, beta2, beta3), histamine (H1), dopamine (D1, D2) and muscarinic receptors.
Microcrystalline cellulose is an enterosorbent, has sorption properties and has a non-selective detoxification effect. It binds and removes from the body a variety of microorganisms, waste products, xenobiotics, allergens, toxins of endogenous and exogenous origin, as well as an excess of certain metabolites and metabolic products that provoke the development of endogenous toxicosis.

Pharmacokinetics

After oral administration, Reduxin is rapidly absorbed from the gastrointestinal tract by at least 77%. Sibutramine is characterized by the effect of “primary passage” through the liver, where it is involved in biotransformation processes involving CYP3A4 isoenzyme. In this case, two active metabolites are formed: monodesmethylsibutramine (M1) and didesmethylsibutramine (M2). After a single dose of 15 mg, the maximum plasma level M1 is 4 ng / ml (range 3.2–4.8 ng / ml), and M2 6.4 ng / ml (range 5.6–7, 2 ng / ml). The maximum concentration of sibutramine in plasma is achieved after 1.2 hours, and its metabolites M1 and M2 - after 3-4 hours.
When taking Reduxin with food, the maximum concentration of metabolites decreases by 30%, and the time to reach it increases by 3 hours, and the area under the concentration-time curve does not change. The active components of the drug are rapidly distributed throughout the tissues. Sibutramine binds to plasma proteins by 97%, and its metabolites M1 and M2 - by 94%. The equilibrium concentration of metabolites with pharmacological activity is achieved within 4 days after the start of treatment and is approximately 2 times higher than the concentration in blood plasma after a single dose of a therapeutic dose. The half-life of sibutramine is 1.1 hours, metabolite M1 - 14 hours, metabolite M2 - 16 hours. Active metabolites participate in the processes of hydroxylation and conjugation, forming inactive metabolites that are excreted mainly in the urine.
Limited research results at the moment do not confirm the existence of clinically significant differences in the pharmacokinetics of the drug in male and female patients.
Pharmacokinetics in healthy elderly people (average age 70 years) is identical to that in young volunteers.
Renal failure does not affect the AUC of the active metabolites M1 and M2, with the exception of the metabolite M2 in patients with end-stage renal failure undergoing dialysis.
In patients with moderate hepatic insufficiency after a single dose of Reduxin, the AUC of active metabolites M1 and M2 is 24% higher than in healthy volunteers.

Indications for use

According to the instructions, Reduxin is a drug used to reduce body weight:
    Alimentary obesity in patients with a body mass index (BMI) of 30 kg / m2;
    Alimentary obesity in patients with a BMI of 27 kg / m2 in the presence of other risk factors due to overweight (non-insulin-dependent diabetes mellitus (type 2) or dyslipoproteinemia).

Contraindications

    Serious eating disorders (bulimia nervosa and anorexia);
    Obesity of organic origin (for example, due to hypothyroidism);
    Generalized tics (Gilles de la Tourette syndrome);
    Mental illness
    Thyrotoxicosis;
    Pheochromocytoma;
    Established alcohol, drug or drug dependence;
    Benign prostatic hyperplasia;
    Angle-closure glaucoma;
    Severe impairment of liver / kidney function;
    Uncontrolled arterial hypertension (blood pressure above 145/90 mm Hg);
    Arrhythmias, tachycardia, peripheral arterial occlusive diseases, congenital heart defects, decompensated chronic heart failure, coronary heart disease, cerebrovascular disease (transient cerebrovascular accident, stroke);
    The period of pregnancy and lactation;
    Age up to 18 years and over 65;
    The simultaneous use of other central means to reduce body weight;
    The combined use with drugs containing tryptophan, used for sleep disorders;
    The simultaneous use of monoamine oxidase inhibitors (for example, ephedrine, fenfluramine, ethylamfetamine, dexfenfluramine or phentermine) and within 2 weeks after their withdrawal;
    The simultaneous use of other drugs that have an effect on the central nervous system (for example, antipsychotics or antidepressants);
    Hypersensitivity to the components of Sibutramine.

Carefully

    Arterial hypertension (controlled and history);
    A history of arrhythmias;
    Chronic circulatory failure;
    Neurological disorders, including seizures and mental retardation (including medical history);
    A history of motor and verbal tics;
    Coronary artery disease (including medical history);
    Impaired renal and / or liver function of mild to moderate severity;
    Cholelithiasis.

Instructions for use of Reduxin: method and dosage

The drug should be taken orally 1 time a day, in the morning, swallowing the capsules whole and drinking them with a sufficient amount of liquid, on an empty stomach or during meals.
The recommended starting dose is 10 mg. If within 4 weeks it is not possible to achieve a decrease in body weight of at least 5%, the daily dose is increased to 15 mg.
The total duration of treatment should not exceed 2 years (due to the lack of data on the safety and effectiveness of longer use of sibutramine).
If within 3 months there is no decrease in body weight by at least 5% of the initial weight, Reduxin is canceled. Treatment should not be continued if, with further administration of the drug, the patient again adds 3 kg or more in weight.

Side effects

    From the central and peripheral nervous system: often (> 10%) - insomnia, dry mouth; sometimes (1-10%) - headache, anxiety, dizziness, paresthesia, taste changes; rarely (<1%) - back pain, cramps, irritability, emotional lability, anxiety, depression, nervousness, drowsiness; in one patient with a schizoaffective disorder, which supposedly already existed before taking Reduxin, acute psychosis developed after treatment;
    From the digestive system: often - constipation, loss of appetite; sometimes - exacerbation of hemorrhoids, nausea; rarely - a paradoxical increase in appetite, abdominal pain, a transient increase in the activity of liver enzymes;
    From the cardiovascular system: sometimes - tachycardia, vasodilation, palpitations, a moderate rise in blood pressure (BP) at rest by 1-3 mm Hg, a moderate increase in heart rate by 3-7 beats / minute; rarely - more pronounced increase in blood pressure and heart rate (heart rate);
    Dermatological reactions: sometimes - sweating; rarely - itching of the skin, Shenlein-Genoch purple (hemorrhage in the skin);
    From the body as a whole: rarely - dysmenorrhea, thrombocytopenia, thirst, flu-like syndrome, rhinitis, bleeding, edema, acute interstitial nephritis.
In rare cases, after the withdrawal of Reduxin, increased appetite and headache appear.
Side effects usually occur in the first 4 weeks of treatment and are reversible moderate in nature, over time, their severity and frequency weaken.

Overdose

At the moment, there is extremely limited information regarding an overdose of sibutramine. It is most often manifested by the following undesirable symptoms: dizziness, headache, increased blood pressure, tachycardia. If you suspect an overdose, you should immediately contact your doctor.
Special treatment for an overdose of Reduxin is not carried out, and there is no specific antidote. It is recommended to resort to general measures, which include monitoring of the cardiovascular system, ensuring free breathing, and also, if necessary, the appointment of supportive symptomatic therapy. Timely intake of activated carbon, as well as gastric lavage, can reduce the intake of sibutramine in the body. Patients with high blood pressure and tachycardia are allowed to appoint beta-blockers. The effectiveness of hemodialysis or forced diuresis has not been proven.

Special instructions

The drug is prescribed only in cases where all non-drug methods of weight loss have been ineffective, i.e. within 3 months, body weight decreased by less than 5 kg.
Treatment should be under the supervision of a physician with practical experience in treating obesity. Taking Reduxin should be combined with diet and exercise. An important component of successful therapy is the creation of prerequisites for a persistent change in the patient’s lifestyle and eating habits, which is extremely necessary to maintain the achieved result, including after the end of drug treatment. Patients should understand that failure to comply with these requirements will inevitably lead to a repeated increase in body weight and the need to consult a doctor.
Women of childbearing age must use reliable contraceptives during treatment.
Patients prone to constipation, in the first days of treatment, it is necessary to control the evacuation function of the intestine. In case of constipation, Reduxin is canceled and laxatives are prescribed.
During treatment, it is necessary to periodically measure blood pressure and heart rate: the first 2 months - every 2 weeks, then - 1 time per month. More thorough and frequent monitoring is required for patients with arterial hypertension (blood pressure above 145/90 mm Hg with antihypertensive therapy). Patients in whom blood pressure during repeated measurements twice exceeded the rate of 145/90 mm Hg, treatment with Reduxin is stopped.
The relationship between the use of Reduxin and the development of primary pulmonary hypertension has not been reliably established, however, due to the well-known risk of drugs of this group, regular medical examinations should pay special attention to the presence of symptoms such as swelling in the legs, chest pain, respiratory failure (progressive dyspnea).
Reduxin can affect the ability to concentrate and the speed of reactions, this should be taken into account for vehicle drivers and patients working in potentially hazardous industries.
With the simultaneous intake of ethanol, an increase in its negative effect was not noted. However, the use of alcohol is absolutely not combined with the recommended dietary measures during the period of Reduxin treatment.

Drug interaction

Particular attention requires the simultaneous administration of drugs that can increase the QT interval, such as some antiarrhythmic drugs (amiodarone, flecainide, quinidine, propafenone, mexiletine, sotalol), histamine H1 receptor blockers (terfenadine, astemizole) and gastrointestinal motility stimulants ( tricyclic antidepressants, pimozide, cisapride, sertindole). In addition, caution should be exercised in patients who take Reduxin while they have conditions that are risk factors for increasing the QT interval (for example, hypomagnesemia or hypokalemia).
A minimum 2-week interval should be observed between doses of Reduxin and monoamine oxidase inhibitors.
Inhibitors of microsomal oxidation, including inhibitors of the 3A4 isoenzyme of cytochrome P450 (including cyclosporine, erythromycin, ketoconazole) increase the concentration of sibutramine metabolites in blood plasma, increase heart rate and clinically insignificantly increase the QT interval.
Macrolide antibiotics, phenobarbital, phenytoin, rifampicin, dexamethasone and carbamazepine can accelerate the metabolism of sibutramine.
The simultaneous use of several drugs that increase the content of serotonin in the blood can lead to serious consequences of such a drug interaction.
Rare cases of the development of serotonin syndrome are known with the combined use of sibutramine with antitussive drugs (for example, dextromethorphan), potent analgesics (petidine, pentazocine, fentanyl), selective serotonin reuptake inhibitors (antidepressant drugs), and some drugs for the treatment of migraine migraine.
Sibutramine has no effect on oral contraceptives.

Terms and conditions of storage

Store at a temperature not exceeding 25 ° C in a dry place out of the reach of children.
Shelf life is 3 years.

Reviews

According to reviews, Reduxin 15 mg is effective when used for weight loss in combination with an active lifestyle. Sometimes patients who write on thematic forums even leave reviews with photos proving the effectiveness of the drug. Often there are positive opinions about Reduxin with a dosage of 10 mg. Those who lost weight on the drug reported that their appetite was significantly reduced. This, in the end, led to a decrease in body weight.
Some women report that in the first weeks after starting treatment, they suffered from increased thirst. Some of them combined Reduxin with the use of other drugs for weight loss, while they emphasize that this should be done only under the supervision of a doctor. There are few reviews of doctors about adverse reactions, which mention the weak severity and rapid disappearance of such effects. In this case, the drug must be taken strictly according to the instructions and not exceed the recommended dose. Sometimes even a daily dose of 20 mg can provoke an increase in blood pressure. Doctors also do not recommend drinking alcohol during therapy.
Some reviews mention the program of Elena Malysheva, in the framework of which the group “Losing Weight with Reduxin” was organized. The presenter claims that her participants got rid of the extra 15-20 kg, and many spoke positively about the drug.

Terms of sell

You can buy Reduxin without a prescription.