Koaksil

Koaksil – antidepressant.

Form of release and structure

Dosage form – tablets: oval, coated white color (in blisters on 30 pieces, on 1 blister in a pack cardboard with control of the first opening).

Active ingredient of Koaksil – тианептин sodium: in 1 tablet – 12,5 mg.

Auxiliary components: Mannitolum, talc, magnesium stearate, starch corn.

Structure of a cover: white beeswax, karmelloz of sodium, glyceryl monooleate, titanium dioxide, Natrii hydrocarbonas, polysorbate 80, ethyl cellulose, silicon dioxide colloid anhydrous, talc, sucrose, povidone.

Indications to use

Koaksil is applied to treatment of depressions.

Contraindications

Absolute:

• Glyukozo-galaktozny malabsorption, deficit of invertase-isomaltase and intolerance of fructose;
• Age up to 18 years;
• Simultaneous use of non-selective monoamine oxidase inhibitors (MAO), and also the period 2 weeks after their cancellation;
• Hypersensitivity to drug components.

With care Koaksil it is necessary to apply at treatment of patients with medicinal and alcohol addiction in the anamnesis.

Route of administration and dosage

It is necessary to take a pill inside on 1 piece before meal 3 times a day (in the morning, in the afternoon and in the evening).

To people of advanced age frequency rate of use of drug is reduced to 2 times.

Side effects

Frequency of development of side effects:

• Often – ≥1/100, but <1/10;
• Infrequently – ≥1/1000, but <1/100;
• Seldom – ≥1/10 000, but <1/1000;
• Frequency is unknown – data of post-registration experience of use.

The possible undesirable reactions caused by Koaksil's reception:

• Gepatobiliarny system: frequency is unknown – increase in activity of liver enzymes, hepatitis (in extremely exceptional cases – in a severe form);
• Alimentary system: often – pains in epigastriums and a stomach, dryness in a mouth, a lock, nausea, vomiting, a meteorism;
• Cardiovascular system: often – rushes of blood to face skin, a stethalgia, premature ventricular contraction, tachycardia;
• Respiratory system: often – an asthma;
• Mental disorders: often – "dreadful" dreams; seldom at abuse of drug – medicinal dependence (especially at patients aged up to 50 years with alcohol/medicinal addiction in the anamnesis); frequency is unknown – suicide thoughts and behavior (including soon after Koaksil's cancellation), hallucinations, confusion of consciousness;
• Central nervous system: often – a headache, dizziness, a tremor, drowsiness or sleeplessness, faints (lipotimiya); frequency is unknown – dyskinesia, extrapyramidal frustration;
• Connecting fabric and musculoskeletal system: often – pain in lumbar area, a mialgiya;
• The disturbances of metabolism and disease which arose on this background: often – anorexia; frequency is unknown – a hyponatremia;
• Integuments: infrequently – erythematic or makulopapulezny rash, an itch, a small tortoiseshell; frequency is unknown – an acne; extremely seldom – violent dermatitis;
• Others: often – feeling of a lump in a throat, an adynamy.

Special instructions

At depressions the probability of emergence of suicide thoughts and behavior, self-damage attempts is high. This risk remains before obvious remission. For this reason all patients who are receiving medical treatment have to be under careful observation of the doctor before considerable improvement of a state (several weeks for this purpose can be necessary). According to data of clinical experience, the risk of a suicide can increase at early stages of approach of remission.

Under especially fixed medical observation the entire period of therapy there have to be patients in whose anamnesis there are instructions on the events connected with a suicide and also patients who prior to treatment had suicide intentions.

Results of meta-analysis of clinical trials of use of antidepressive drugs by patients with mental disorders demonstrate that the risk of suicide behavior is increased at young people aged up to 25 years.

All patients to whom appoint Koaksil have to be informed on need of the immediate address to the doctor in case of an aggravation of symptoms, unusual behavior or emergence of suicide thoughts.

In need of performing surgery using the general anesthesia drug needs to be cancelled in 24-48 hours. In case of the acute surgical management operation should be performed under strict control of a condition of the patient.

As well as any other psychotropic drugs, Koaksil it is impossible to cancel sharply, the dose should be reduced gradually, within 7-14 days.

It is forbidden to exceed the dose appointed by the doctor independently. Under special observation, in order to avoid increase in a dose, there have to be patients with alcohol/medicinal addiction in the anamnesis.

In certain cases Koaksil influences the speed of reactions and ability to concentration of attention therefore it is necessary to be careful at control of vehicles and performance of potentially dangerous types of activity.

Medicinal interaction

At simultaneous use of MAO inhibitors sharp increase in arterial pressure, a spasm, a collapse, a hyperthermia and a lethal outcome are possible. Therefore Koaksil it is possible to accept not earlier than in 2 weeks after their cancellation.

Co-administration of a mianserin since during the experiments the antagonistic effect was established is undesirable.

During treatment it is recommended to refrain from the ethanol use.

Terms and storage conditions

To store at a temperature not above 30 °C in the place unavailable to children.

Period of validity – 3 years.