Reduksin

Reduksin – drug of the central action for treatment of obesity.

Form of release and structure

Dosage form – capsules: size No. 2, blue or blue color; contents – powder of white or white-yellowish color (on 10 pieces in blister strip packagings, 3 or 6 packagings in a pack cardboard).

Active ingredients and their contents:

• Capsules of blue color: a sibutramina of a hydrochloride monohydrate – 10 mg, cellulose microcrystallic – 158,5 mg;
• Capsules of blue color: a sibutramina of a hydrochloride monohydrate – 15 mg, cellulose microcrystallic – 153,5 mg.

Auxiliary component: calcium stearate.

Structure of a capsular cover: gelatin, titanium dioxide, dye patent blue, dye an azoruby (in capsules of 10 mg).

Indications to use

Reduksin – the drug used for decrease in body weight:

• Alimentary obesity at patients with the body weight index (BWI) from 30 ^kg/sq.m;
• Alimentary obesity at patients with IMT from 27 ^kg/sq.m with other risk factors caused by the excess body weight (a non-insulin-dependent diabetes mellitus (2 types) or a dislipoproteinemiya).

Contraindications

• Serious violations of a feeding behavior (nervous bulimia and anorexia);
• Obesity of organic genesis (for example, owing to a hypothyroidism);
• Generalized tics (syndrome Gilles de la Turetta);
• Mental diseases;
• Thyrotoxicosis;
• Pheochromocytoma;
• The established alcohol, drug or medicinal addiction;
• Benign hyperplasia of a prostate;
• Closed-angle glaucoma;
• Heavy dysfunctions of livers/kidneys;
• Uncontrollable arterial hypertension (arterial pressure is higher than 145/90 mm hg);
• Arrhythmias, tachycardia, occlusive diseases of peripheral arteries, inborn heart diseases, dekompensirovanny chronic heart failure, coronary heart disease, cerebrovascular diseases (tranzitorny disturbances of cerebral circulation, stroke);
• Period of pregnancy and lactation;
• The age up to 18 years is also more senior than 65 years;
• Simultaneous use of other central acting agents for decrease in body weight;
• The combined use with the drugs containing tryptophane, applied at sleep disorders;
• Simultaneous use of monoamine oxidase inhibitors (for example, ephedrine, a fenfluramin, ethylamphetamine, a deksfenfluramin or phentermine) and within 2 weeks after their cancellation;
• Simultaneous use of other drugs which have effect on the central nervous system (for example, neuroleptics or antidepressants);
• Hypersensitivity to Reduksin's components.

With care:

• Arterial hypertension (controlled and in the anamnesis);
• Arrhythmias in the anamnesis;
• Chronic circulatory unefficiency;
• Neurologic disturbances, including spasms and a delay of intellectual development (in the anamnesis including);
• Motor and verbal tics in the anamnesis;
• Diseases of coronary arteries (in the anamnesis including);
• Renal failures and/or liver easy and moderate severity;
• Cholelithiasis.

Route of administration and dosage

Reduksin it is necessary to accept in 1 times a day, in the morning, swallowing of capsules entirely and washing down them with enough liquid, on an empty stomach or during meal.

The recommended initial dose makes 10 mg. If within 4 weeks it is not possible to reach decrease in body weight at least by 5%, the daily dose is increased to 15 mg.

The general duration of treatment should not exceed 2 years (due to the lack of data on safety and efficiency of more prolonged use of a sibutramin).

If within 3 months decrease in body weight at least for 5% of initial weight is not noted, drug is cancelled. It is not necessary to continue treatment if at further administration of drug the patient puts on the weight of 3 kg and more again.

Side effects

• From the central and peripheral nervous system: often (> 10%) – sleeplessness, dryness in a mouth; sometimes (1-10%) – a headache, concern, dizziness, paresthesias, taste changes; seldom (<1%) – a dorsodynia, spasms, irritability, emotional lability, uneasiness, a depression, nervousness, drowsiness; at one patient with schizoaffective disturbance which presumably already existed prior to administration of drug after treatment acute psychosis developed;
• From the alimentary system: often – a lock, appetite loss; sometimes – an exacerbation of hemorrhoids, nausea; seldom – paradoxical increase in appetite, an abdominal pain, tranzitorny increase in activity of liver enzymes;
• From cardiovascular system: sometimes – tachycardia, a vazodilatation, heartbeat, moderate rise in the arterial pressure (AP) at rest upon 1-3 mm hg, moderate increase in pulse for 3-7 blows/minute; seldom – more expressed increases in the ABP and ChSS (heart rate);
• Dermatological reactions: sometimes – perspiration; seldom – an itch of skin, Shenleyn-Genokh's purple (hemorrhage in skin);
• From an organism in general: seldom – a dysmenorrhea, thrombocytopenia, thirst, a grippopodobny syndrome, rhinitis, bleedings, hypostases, acute intersticial nephrite.

In rare instances after Reduksin's cancellation there are an increased appetite and a headache.

Side effects usually arise in the first 4 weeks of treatment and have reversible moderate character, over time their expressiveness and frequency weaken.

Special instructions

Reduksin appoint only when all non-drug methods of weight reduction were ineffective, i.e. within 3 months body weight was lost less than on 5 kg.

Treatment has to be carried out under control of the doctor having practical experience of treatment of obesity. Reduksin's reception should be combined with dietary food and physical exercises. An important component of successful therapy is creation of premises to permanent change of a way of life and eating habits of the patient that is extremely necessary for preservation of the achieved result, including after the end of drug treatment. Patients have to understand that non-compliance with these requirements will inevitably lead to repeated increase in body weight and need of the address to the attending physician.

Women of childbearing age during treatment need to use well-tried contraceptive remedies.

To the patients inclined to locks, in the first days of treatment it is necessary to control evakuatorny function of intestines. In case of a lock cancel Reduksin and appoint laxatives.

During treatment it is necessary periodic to measure the ABP and ChSS: the first 2 months – each 2 weeks, further - once a month. More careful and frequent control is required to patients with arterial hypertension (the ABP higher than 145/90 mm hg against the background of anti-hypertensive therapy). To patients at whom the ABP at repeated measurements exceeded an indicator of 145/90 mm hg twice treatment by Reduksin is stopped.

Communication between Reduksin's use and development of primary pulmonary hypertensia is authentically not established, however, in connection with well-known risk of medicines of this group, at regular medical examinations special attention should be paid on existence of such symptoms as hypostases standing, thorax pain, the breath disturbance (progressing диспноэ).

Drug can exert impact on ability to concentration of attention and speed of reactions, it should be considered to the drivers of vehicles and patients occupied on potentially dangerous productions.

At a concomitant use of ethanol strengthening of its negative effect was not noted. However alcohol intake is not combined with the dietary actions recommended during treatment by Reduksin at all.

Medicinal interaction

The special attention is required by co-administration of the medicines capable to increase an interval of QT, such as some antiarrhytmic drugs (Amiodaronum, флекаинид, quinidine, пропафенон, мексилетин, соталол), blockers histamine _{H1 receptors} (терфенадин, астемизол) and stimulators of motility of digestive tract (tricyclic antidepressants, Pimozidum, цизаприд, сертиндол). Besides, should be careful patients who accept Reduksin during existence at them of the states which are risk factors concerning increase in an interval of QT (for example, hypomagnesiemia or hypopotassemias).

Between Reduksin's receptions and monoamine oxidase inhibitors it is necessary to observe at least a 2 weeks interval.

Inhibitors of a microsomal oxidation, including inhibitors of an isoenzyme 3A4 _{of P450 cytochrome} (including cyclosporine, erythromycin, кетоконазол) increase concentration of metabolites of a sibutramin in a blood plasma, raise ChSS and clinically insignificantly increase QT interval.

Makrolidny antibiotics, phenobarbital, Phenytoinum, rifampicin, dexamethasone and carbamazepine can accelerate metabolism of a sibutramin.

Simultaneous use of several drugs which increase the content of serotonin in blood can lead to serious effects of such medicinal interaction.

Exceptional cases of development of a serotoninovy syndrome at the combined use of a sibutramin with antibechic drugs are known (for example, dextromethorphan), strong analgetics (pethidine, pentazocine, fentanyl), selective serotonin reuptake inhibitors (antidepressive means), some drugs for treatment of migraine (sumatriptany, dihydroergotamine).

Sibutramin does not exert impact on oral contraceptives.

Terms and storage conditions

To store at a temperature no more than 25 °C in the dry place unavailable to children.

Period of validity – 3 years.