Instruction for use: Coaxil

Dosage form: coated tablets

Active substance: Tianeptine*

ATX

N06AX14 Tianeptin

Pharmacological groups:

Antidepressant

The nosological classification (ICD-10)

F32 Depressive episode: Adynamic subdepression; Astheno-adynamic subdepressive states; Asthenoadressive disorder; Astheno-depressive disorder; Asthenodepressive state; Astheno-depressive state; Major Depressive Disorder; Vyaloapatichesky depression with retardation; Double Depression; Depressive pseudodement; Depressive illness; Depressive mood disorder; Depressive disorder; Depressive mood disorder; Depressive state; Depressive disorders; Depressive syndrome; Depressive syndrome larviated; Depressive syndrome in psychoses; Depressed masks; Depression; Depression Depletion; Depression with the phenomena of inhibition within the framework of cyclothymia; Depression is smiling; Involutional depression; Involutionary melancholy; Involutional depression; Manic-depressive disorder; Masked Depression; Melancholic Attack; Neurotic depression; Neurotic depression; Shallow Depression; Organic depression; Organic depressive syndrome; Simple depression; Simple melancholic syndrome; Psychogenic depression; Reactive depression; Reactive depression with moderate psychopathological symptoms; Reactive depressive states; Reactive depression; Recurrent depression; Seasonal depressive syndrome; Severostatic depression; Senile Depression; Symptomatic Depression; Somatogenic depression; Cyclotymic depression; Exogenous depression; Endogenous depression; Endogenous Depressive Conditions; Endogenous Depression; Endogenous depressive syndrome

Composition and release form

1 tablet, coated, contains tianeptine 12.5 mg; in a blister pack of 30 pcs., in a box of 1 blister.

Pharmachologic effect

Pharmacological action - antidepressant.

Increases the reuptake of serotonin in the synapses of the cerebral cortex and hippocampus.

Pharmacodynamics

Occupies an intermediate position between antidepressants with stimulating properties and sedatives. Has an effect with somatic complaints from the digestive tract related to anxiety or mood disorders.

In animal experiments, it has been shown that Coaxil increases the spontaneous activity of pyramidal cells in the hippocampus and increases the rate of their recovery after functional suppression.

Pharmacokinetics

Well and completely absorbed from the digestive tract, quickly distributed in the body, characterized by a high degree of binding to blood proteins (94%). Metabolised in the liver by beta-oxidation and N-demethylation. T1 / 2 - 2.5 h or higher (3.5) - in the elderly (over 70 years) and patients with renal insufficiency. It is excreted by the kidneys (mainly in the form of metabolites).

Clinical Pharmacology

Promotes the disappearance of somatic complaints caused by anxiety and mood changes. Little affects the cardiovascular system, sleep, reaction speed, parasympathetic nervous system, does not cause addiction. Relatively rare causes side effects.

Indications for the Coaxil

Depression and anxiety-depressive conditions.

Contraindications

Children and adolescence (up to 15 years).

Application in pregnancy and lactation

Not recommended.

Side effects

Gastrointestinal pain, abdominal pain, dry mouth, anorexia, nausea, vomiting, constipation, flatulence, dizziness, headache, tremor, lipotymia, hot flashes, insomnia, drowsiness, heavy dreams, asthenia, tachycardia, extrasystole, cardiac pain, discomfort with breathing, spasm of the larynx, myalgia, back pain.

Interaction

The combination with nonselective MAO inhibitors increases the risk of collapse or sudden increase in blood pressure, hyperthermia, seizures (until death).

Dosing and Administration

Inside, before meals, 12.5 mg 3 times a day (patients older than 70 years and with kidney failure - 2 times a day).

Overdose

Treatment: the gastric lavage is performed and appropriate symptomatic agents are prescribed, supporting the work of the heart, lungs, kidneys and normalizing metabolism.

Precautionary measures

At the beginning of treatment requires constant monitoring of the patient (suicidal attempts are possible). In case of planned operations under general anesthesia, it is recommended to cancel the drug 24-48 hours before the beginning of surgery. In the case of an operation on the background of Coaxil, strict medical control over the patient's condition is necessary. When discontinuing treatment, the dose should be reduced gradually (within 7-10 days). In some patients there is a decrease in the ability to concentrate, which is restored after the drug is discontinued.

When switching from MAO inhibitors to Coaxil, a break of at least 2 weeks is necessary; when switching from Coaxil to MAO inhibitors, a break of 24 hours is sufficient.

Storage conditions for Coaxil

At a temperature not exceeding 30 ° C.

Keep out of the reach of children.

Shelf life of Coaxil

3 years.

Do not use after the expiry date printed on the package.