Coax

Active material: Tianeptine
When ATH: N06AX14
CCF: Antidepressant
ICD-10 codes (testimony): F31, F32, F33, F41.2
When CSF: 02.02.05
Manufacturer: Servier Laboratories (France)

PHARMACEUTICAL FORM, COMPOSITION AND PACKAGING

Pills, coated white, Oval.

Excipients: mannitol, corn starch, magnesium stearate, talc, Colloidal anhydrous silica, natriya carbonate, carmellose sodium, beeswax white, Titanium dioxide, ethyl cellulose, glyceryl monooleat, polysorbate 80, povidone, sucrose.

30 PC. – blisters (1) – packs cardboard.

Pharmacological action

Antidepressant from a group of tricyclic derivatives.

In experiments on laboratory animals, tianeptine enhances the spontaneous activity of pyramidal cells in the hippocampus and increases the speed of recovery after functional braking; increases the reverse takeover serotonin neurons cortex and hippocampus.

By the nature of the clinical action on mood disorders is intermediate in bipolar classification between sedative and stimulating antidepressants. Patients tianeptine reduces somatic symptoms (especially from the gastrointestinal tract), associated with anxiety or mood disorders.

Tianeptine has no effect on system holinergicescuu (not has antiholinergicakim action), sleep and ability to focus.

Pharmacokinetics

Absorption

After intake of tianeptine is rapidly and completely absorbed from the digestive tract.

Distribution

Tianeptine is rapidly distributed in the body. Highly associated with blood plasma proteins (about 94%).

Metabolism

Tianeptine intensively metabolised in the liver by β-oxidation and N-demethylation.

Deduction

T_1/2 tianeptina is 2.5 no. Tianeptine is excreted by the kidneys: the main part of the – as metabolites, 8% – in unchanged form.

Pharmacokinetics in special clinical situations

In renal insufficiency, as well as in patients over 70 T years_1/2 increases by 1 no.

Pharmacokinetic parameters of the drug did not significantly change in patients with chronic alcoholism (incl. in the presence of cirrhosis).

Testimony

- Depression.

Dosage regimen

The drug is prescribed inside, before meals, by 12.5 mg (1 tab.) 3 times / day (morning, afternoon and evening).

To patients with chronic alcoholism with cirrhosis or without it change the dosing is not required.

Elderly patients (senior 70 years) and in patients with renal insufficiency the dose should be reduced to 2 tab. / day.

Side effect

The following side effects have been noted in the face of the reception tianeptina with the following frequency: Often (≥ 10), often (≥1/100, <1/10), infrequently (≥1/1000, <1/100), rarely (≥1/10 000, <1/1000), rarely (≥1/100 000, <1/10 000) and no established frequency.

Cardio-vascular system: often – tachycardia, arrythmia, pain in prekordial′noj region, tides.

CNS: often – insomnia, drowsiness, dizziness, nightmares, asthenia, headache, tremor, swoon. The development of drug dependence and abuse of medication, especially in patients younger than 50 years with drug or alcohol addiction in history.

From the digestive system: often – stomach ache, epigastric pain, dry mouth, nausea, vomiting, constipation, flatulence.

Musculoskeletal system and connective tissue: often – mialgii, backache.

The respiratory system: often – discomfort when breathing.

Metabolic disorders and diseases, caused by metabolism: often – anorexia.

Common symptoms and disorders in the injection drug: often – feeling “coma” in the throat.

Contraindications

- Simultaneous use of MAO inhibitors; in the transition from therapy MAO inhibitors in the treatment of tianeptinom a break of not less than two weeks. When moving with the MAO ingibiotry tiapentina enough to take a break 24 no;

- Childhood and adolescence up 15 years;

-hypersensitivity to tianeptinu and other components of the drug;

FROM caution shall mean patients with alcohol or drug addiction in history.

Pregnancy and lactation

Reception tianeptina during pregnancy is not recommended.

During pregnancy it is advisable to maintain mental balance. If this requires drug therapy, You can start or continue to earlier treatment, preferably in monotherapies.

The results of studies of the drug Koaksil^® in laboratory animals are encouraging, However, the experience of clinical application of inadequate. Taking into account these data reception tianeptina during pregnancy is not recommended. If for health reasons, you need to start or continue therapy Koaksil^® during pregnancy, should take into account the pharmacological properties of the drug, in monitoring newborn.

Because, that tricyclic antidepressants infiltrating breast milk, to breastfeed during treatment is not recommended.

Cautions

Because depression is characterized by the existence of a risk of suicide attempts, patients should be monitored on a continuous basis, especially in the initial period of treatment.

When it is necessary to carry out general anesthesia must notify anesthesiologist about how, that the patient takes Koaksil^®. Admission drug should be lifted for 24 or 48 hours before surgery. In case emergency surgery operation can be carried out without preliminary preparation, but under the strict supervision of the patient during surgery.

Upon termination of drug therapy Koaksil^®, as with any application of psychotropic drugs, the dose should be reduced gradually, during 7-14 days.

Admission drug Koaksil^® It is not recommended for patients with hereditary fructose intolerance, glucose-galaktoznoj malabsorbziei and saharazo-izomal′taznoj failure.

Do not exceed the recommended daily dose of the drug.

Patients with drug or alcohol addiction should be under close medical supervision, to avoid exceeding the recommended dosage.

Effects on ability to drive vehicles and management mechanisms

Some patients may decrease the ability to focus and speed psychomotor reactions, the period of treatment should be careful when driving vehicles and other potentially hazardous activities, require high concentration and speed of psychomotor reactions.

Overdose

Treatment: in all cases overdose should stop taking the drug and conduct medical monitoring of patient. If necessary, make a gastric lavage, control the function of the cardiovascular and respiratory systems, renal function, indicators of homeostasis and conduct palliative therapy (eg, mechanical ventilation, correction of metabolic disorders and disorders of the kidney).

Drug Interactions

Undesirable combination medicines

Together with the admission of unselective MAO inhibitors may develop sudden collapse or raising HELL, Hyperthermia, seizures, death.

Combined with the appointment of mianserinom undesirable, because of this combination of drugs on an experimental model was identified antagonistic effect.

Conditions of supply of pharmacies

The preparation is available on medical prescription.

Conditions and terms

List B. The drug should be stored at a temperature no higher than 30 ° C, out of reach of children. Shelf life – 3 year. Do not use after the expiry date indicated on the package.