Lindaksa

Lindaksa – anorexigenic means, strengthens feeling of saturation.

Form of release and structure

Dosage form – capsules: gelatinous firm with the yellow case and lids of two types, one type of capsules has a lid of brown color and marking of the "10", second – a blue lid and marking "15"; in capsules – almost white or white powder (on 10 pieces in blisters, in a cardboard pack of 3 or 9 blisters).

Active ingredient of Lindaksa – a sibutramin of a hydrochloride monohydrate, in 1 capsule – 10 mg or 15 mg.

Auxiliary components: magnesium stearate, cellulose microcrystallic, lactoses monohydrate, silicon dioxide colloid anhydrous.

Structure of the case of the capsule: gelatin, titanium dioxide, dye the Sunset yellow, dye quinolinic yellow, ink black 1012 (ferrous oxide black, shellac, N butanol, lecithin soy, the ethanol denatured (industrial metilirovanny alcohol), the defoaming agent DC 1510).

Structure of lids of capsules:

• Lid of brown color: gelatin, dye ferrous oxide red, dye ferrous oxide black, titanium dioxide;
• Lid of blue color: gelatin, dye indigo carmine, titanium dioxide.

Indications to use

Lindaksa's use is shown for treatment of alimentary obesity at patients with a body weight index:

• 30 kg on ^sq.m and more;
• 27 kg on ^sq.m and more at patients with a diabetes mellitus of type 2, a dislipoproteinemiya.

Contraindications

• Heavy disturbances of food (bulimia or anorexia);
• Organic reason of obesity;
• Concomitant use with Lindaksa of monoamine oxidase inhibitors (MAO) (including ephedrine, phentermine, дексфенфлурамин, фенфлурамин, ethylamphetamine) or their use in the last 2 weeks before purpose of drug, hypnagogues, inhibitors of the return serotonin reuptake, tryptophane of the containing means, other drugs for weight reduction of a body of the central action;
• Syndrome Gilles de la Turetta (generalized chronic tic);
• Mental pathologies;
• Cerebrovascular diseases (tranzitorny disturbances of cerebral circulation, stroke);
• Heart pathologies (coronary heart disease, inborn heart diseases, chronic heart failure in decompensation stages, occlusal diseases of peripheral arteries, arrhythmia, tachycardia);
• Arterial hypertension with an uncontrollable arterial pressure (AP) over 145/90 mm of a mercury column;
• The expressed renal failures and/or a liver;
• Thyrotoxicosis;
• Hyperplasia (high-quality) prostate;
• Closed-angle glaucoma;
• Pheochromocytoma;
• The diagnosed medicinal, alcohol, drug addiction;
• The age is more senior than 65 years;
• Age up to 18 years;
• Period of pregnancy and breastfeeding;
• Hypersensitivity to drug components.

With care it is necessary to appoint drug sick with chronic heart failure, arrhythmia in the anamnesis, arterial hypertension (controlled or in the anamnesis), cholelithiasis, neurologic disturbances, including spasms and a delay of intellectual development (including the anamnesis), verbal and motor tics in the anamnesis, renal failures and/or a liver of average and easy severity.

Route of administration and dosage

Capsules accept inside, swallowing entirely and washing down with a glass of water, in the morning, 1 time a day, irrespective of meal.

The attending physician establishes a dose individually, considering portability and clinical performance of drug.

The recommended daily dosing: an initial dose – 10 mg. At a speed of weight reduction of a body and good tolerance of drug a dose it is possible to increase less than 2 kg a month to 15 mg. A course of treatment – no more than 2 years.

It is inexpedient to continue treatment in a case:

• If increase in a dose does not give clinical effect and weight reduction of a body within a month does not exceed 2 kg;
• If after three months of therapy the patient did not lose the weight for 5% of initial body weight;
• If after originally reached weight reduction of a body against the background of use of drug for the patient addition of body weight on 3 kg and more is observed.

Side effects

Lindaksa's use can cause side effects which are noted more often within the first 4 weeks of treatment and have reversible and easy character:

• Nervous system: often – sleeplessness; sometimes – taste change, dizziness, a headache, paresthesias, concern;
• Cardiovascular system: sometimes – tachycardia (pulse increases by 3-7 beats per minute), a heart consciousness, increase in the ABP by 1-3 mm of a mercury column at rest, a vazodilatation (inflows, a dermahemia); in some cases – more expressed increase in pulse and the ABP;
• Alimentary system: often – a lock, appetite loss, dryness in a mouth; sometimes – nausea;
• Others: sometimes – an exacerbation of hemorrhoids, increase in sweating; in isolated cases – a skin itch, hypostases, a dysmenorrhea, a grippopodobny syndrome, thirst, a dorsodynia and/or in a stomach, rhinitis, paradoxical increase in appetite, drowsiness, a depression, emotional lability, irritability, uneasiness, nervousness, bleedings, acute intersticial nephrite, Shenleyna-Genokh's purpura, thrombocytopenia, spasms, tranzitorny increase in activity of liver enzymes in a blood plasma.

The case of development of acute psychosis in the patient with schizoaffective disturbance is described.

Special instructions

Only those patients for whom the attempt of weight reduction of a body exercise stresses and a rigid diet was ineffective should appoint Lindaksa's use, and after 3 months of efforts decrease in weight made less than 5 kg.

Treatment has to take place under control of the experienced specialist in the field of treatment of obesity.

Clinical performance of drug is reached as a part of the complex therapy including not only culture of healthy nutrition and exercise stresses, but also change of a former way of life and the patient's habits. Non-compliance with strict requirements of the doctor does not give a weight reduction guarantee during treatment and leads to increase in weight of the patient after drug withdrawal.

At use of a sibutramin it is necessary within the first two months regularly (1 time in 2 weeks) to control pulse and the patient's ABP, then – once a month. At the accompanying arterial hypertension control needs to be carried out more often and more carefully. Patients at whom the ABP twice at control measurement exceeds the level of 145/90 mm of a mercury column should suspend treatment.

With care patients are recommended to appoint drug with a hypomagnesiemia and other conditions or a concomitant use of the drugs extending QT interval. Antiarrhytmic means (quinidine, Amiodaronum, соталол, флекаинид, пропафенон, мексилетин), blockers histamine _{H1 receptors} (терфенадин, астемизол), цизаприд, сертиндол, Pimozidum, tricyclic antidepressants belong to such drugs.

The interval between purpose of a sibutramin and reception of furasolidone, Procarbazinum, selegilin and other MAO inhibitors has to be more than 2 weeks.

Influence of drug on development of primary pulmonary hypertensia is definitely therefore the patient needs to watch closely possible standing, the progressing and thorax not established.

At the accidental admission of the next dose it is not necessary to accept a double dose of drug at the following reception, and to continue reception according to the scheme.

Reactions of an organism to Lindaksa's cancellation in the form of a headache and the increased appetite are observed seldom. There are no data on disturbance of mood or development of an abstinence syndrome and a withdrawal after the therapy termination.

Alcohol intake during administration of drug is contraindicated.

The medicines influencing a nervous system can limit the speed of reactions, intellectual activity and memory. Therefore during administration of drug patients are recommended to be careful when performing potentially dangerous types of activity requiring special attention and high speed of psychomotor reactions including control of motor transport.

Medicinal interaction

CYP3A4 isoenzyme inhibitors (cyclosporine, erythromycin, кетоконазол, тролеандомицин) against the background of Lindaksa's reception increase concentration of metabolites of a sibutramin and lead to increase in pulse and insignificant lengthening of an interval of QT.

Acceleration of metabolism of drug can exponentiate a concomitant use of antibiotics of group of macroleads, rifampicin, Phenytoinum, phenobarbital, carbamazepine and dexamethasone.

Exceptional cases of development of a serotoninovy syndrome can be observed at a combination of a sibutramin with sumatriptany, dihydroergotamine and other drugs against migraine, antidepressants, antibechics (dextromethorphan), strong analgetics (pethidine, pentazocine, fentanyl).

Drug does not exert impact on efficiency of oral contraceptives and on effect of ethanol.

Terms and storage conditions

To store at a temperature up to 30 °C. To protect from children.

Period of validity – 2 years.