Coaxil - instructions for use, dose, side effects, contraindications

Active substanceTianeptineTianeptine

Similar drugsTo uncover

Coaxil®

pills inwards

Servier Laboratories France

Dosage form: & nbspcoated tablets

Composition:

One tablet contains:

As active substance - tianeptin sodium - 12.5 mg.

Excipients: starch corn 2.5 mg, mannitol 101.0 mg magnesium stearate 2.5 mg, talc 6.5 mg;

shell: sodium gshshocancarbonate 0.077 mg, carmellose sodium 0.158 mg, wax bee white 0,114 mg, titanium dioxide 6.208 mg, ethyl cellulose 0.247 mg, glyceryl monooleate 0.123 mg, polysorbate 80 0.135 mg, povidone 0.228 mg, sucrose 23.946 mg, silicon dioxide colloidal anhydrous 0.108 mg, talc 13.656 mg.

Description:

Oval tablets are white, coated.

Pharmacotherapeutic group:antidepressant, is on the list of III psychotropic substances

ATX: & nbsp

N.06.A.X Other antidepressants

N.06.A.X.14 Tianeptine

Pharmacodynamics:

Tianeptine is an antidepressant from the group of tricyclic derivatives.

In experiments on laboratory animals tianeptine increases the spontaneous activity of pyramidal cells in the hippocampus and increases the rate of their recovery after functional inhibition; increases the reuptake of serotonin by the neurons of the cerebral cortex and hippocampus. According to the nature of the clinical effect on mood disorders, it takes an intermediate position in the bipolar classification between sedative and stimulating antidepressants. Patients tianeptine helps to reduce somatic symptoms (especially from the gastrointestinal tract) associated with anxiety or mood disorders. Tianeptine not

has an effect on the cholinergic system (does not have anticholinergic action), sleep and the ability to concentrate.

Pharmacokinetics:

The drug is quickly and completely absorbed from the digestive tract and quickly distributed. Has a high degree of binding to proteins (approximately 94%).

Tianeptine is extensively metabolized in the liver by [3-oxidation and N-demethylation. The half-life (T <3) is 2.5 hours. The drug is excreted through the kidneys, unchanged - 8%, the main part - in the form of metabolites.

In elderly patients (over 70 years), Tu2 increases by 1 hour.

Patients with hepatic insufficiency. It is shown that the pharmacokinetic properties of the drug in patients with chronic alcoholism (including, in the presence of cirrhosis) do not change significantly.

Patients with renal insufficiency. In the presence of kidney failure Tu, increases by 1 hour.

Indications:

Depressive states.

Contraindications:

hypersensitivity to tianeptine and other components of the drug.
Simultaneous use of monoamine oxidase inhibitors (MAO). When switching from therapy with MAO inhibitors to tianeptine treatment, a break of at least two weeks is necessary. When switching from tianeptine to MAO inhibitors, it is sufficient to take a break for 24 hours.

a It is not recommended to use the drug in children and adolescents under 18 years due to the lack of data on the safety and efficacy of Coaxil® in this age group. It was shown that the use of other antidepressants in children and adolescents was accompanied by an increase in the frequency of suicidal behavior (suicidal attempts and suicidal thoughts) and manifestations of hostility (predominantly aggression, negative behavior and rage) compared with the placebo group.

□ Coaxil® is not recommended for patients with a deficiency of saccharose - and zomalases, intolerance to fructose, glucose-galactose malabsorption, since the preparation contains sucrose.

Carefully:

Patients with an alcoholic or drug dependence in the anamnesis.

Pregnancy and lactation:

Tianeptine during pregnancy Not recommended.

During pregnancy it is desirable maintain mental balance. If medication is needed for this, then it is possible to start or continue the previously initiated treatment, preferably in the monotherapy regime.

Results of drug studies Coaxil® in laboratory animals is encouraging, but clinical experience is not enough.

Taking into account these data, tianeptine during pregnancy is not recommended.

If for vital reasons it is necessary to start or continue therapy with Coaxil® during pregnancy, pharmacological properties of the drug should be considered when monitoring a newborn.

Due to the fact that tricyclic antidepressants penetrate into breast milk, it is not recommended to breast-feed during the treatment period.

There are no clinical data on the effect on fertility in humans.

Dosing and Administration:

Inside, before eating.

For 12.5 mg (1 tablet) 3 times a day (morning, afternoon and evening).

o For patients with chronic alcoholism with or without cirrhosis, a change in the dosing regimen is not required.

For elderly patients (over 70 years) and in patients with renal failure, the dose should be reduced to 2 tablets per day.

Side effects:

Side effects identified during clinical studies of tianeptine, are expressed slightly. Basically, it's nausea, constipation, abdominal pain, Drowsiness, headache, dryness in mouth and dizziness.

During clinical trials and / or in the post-marketing period the following side effects were Tianeptine with next frequency ', very often (> 1/10), often (> 1/100, <1/10), infrequently (> 1 / 1,000, <1/100), rarely (> 1 / 10,000, <1 / 1,000), very rarely (> 1 / 100,000, <1 / 10.000) and an unknown frequency (the frequency can not be calculated from the available data).

- From the side of cardiovascular system:

Often: tachycardia, extrasystole, pain in the chest, "tides" of blood to the skin of the face.

- Mental disorders:

Often: nightmarish dreams.

Rarely: development of drug dependence and abuse of a medicinal product, especially in patients younger than 50 with a history of drug or alcohol dependence.

Unknown frequency*: reported cases of suicidal thoughts and suicidal behavior at the time of admission or shortly after discontinuation of the medication (see "Special instructions").

Confusion of consciousness, hallucinations.

From the central nervous system '.

Often: insomnia, drowsiness,

dizziness, headache, tremor, syncope (lipotomy). Unidentified frequency *:

Extrapyramidal disorders,

dyskinesia

From the gastrointestinal tract:

Often', abdominal pain, epigastric pain, dry mouth, nausea, vomiting, constipation, flatulence.

- On the part of the skin: Infrequently: maculopapular or

erythematous rash, hives, itching. Unknown frequency *: acne,

bullous dermatitis in extremely rare cases.

From the osteomuscular system and connective tissue:

Often: myalgia, pain in the lumbar region.

From the respiratory system. Often: dyspnea
Metabolic and nutritional disorders:

Often: anorexia.

Unknown frequency *: hyponatremia.

General disorders and symptoms: Often: asthenia, sensation of a "coma" in the throat. From the hepatobiliary system: Unidentified frequency *: increased activity of "hepatic" enzymes, hepatitis, which in extremely rare cases can occur in severe form.

* Post-registration application experience

Overdose:

The experience of tianeptine overdose (the maximum amount was 2,250 mg per dose) revealed the following symptoms andsymptoms: confusion, convulsions, drowsiness, dry mouth and respiratory failure, mainly when tianeptine was combined with alcohol.

In all cases of overdose, stop taking the medication and conduct medical supervision of the patient. If necessary, you should:

- If the drug was taken less

than 2 hours before hospitalization, it is necessary to make

gastric lavage. If for a longer time, it is necessary to take

Activated carbon;

Control the functions of the cardiovascular and respiratory systems, the function of the kidneys, the indices of homeostasis;
if necessary symptomatic treatment (eg, artificial ventilation, correction of metabolic disorders and renal dysfunction). Specific antidotes for tianeptine are unknown.

Interaction:

Unwanted combination of drugs

With simultaneous admission with nonselective MAO inhibitors, it is possible to develop collatts or a sudden increase in blood pressure, hyperthermia, seizures, fatal outcome.

Combined use with mianserin is undesirable, because with this combination of drugs, an antagonistic effect was detected on the experimental model.

Special instructions:Since depressive conditions are characterized by the risk of suicide attempts, patients should be under constant observation, especially in the initial period of treatment.

If it is necessary to perform general anesthesia, the anaesthesiologist must be warned that the patient is taking COAXIL®. The drug should be withdrawn 24 or 48 hours prior to surgery. In the case of emergency surgical care, the operation can be performed without first discontinuing the drug, but under strict control of the patient's condition during the operation.

When discontinuing therapy with COAXIL®, as with any psychotropic drugs, the dose should be reduced gradually, within 7-14 days.

The use of COAXIL® is not recommended for patients with hereditary intolerance to fructose, glucose for o-galactose malabsorption and sucrose isomaltase deficiency

Do not exceed the recommended dose of the drug.

Patients with drug or alcohol dependence should be under close medical supervision to avoid exceeding the recommended dose of the drug.

In some patients, the ability to concentrate and the speed of psychomotor reactions may decrease, and therefore, during the treatment period, care should be taken when driving vehicles and engaging in other potentially dangerous activities requiring increased concentration of attention and speed of psychomotor reactions.

Effect on the ability to drive transp. cf. and fur:In some patients, the ability to concentrate and the speed of psychomotor reactions may decrease, and therefore, during the treatment period, care should be taken when driving vehicles and engaging in other potentially dangerous activities requiring increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:Tcovered laths, 12,5 mg.

Packing for hospitals: By 30 tablets in PVC / Al blister. By 1 blister with instruction on medical application in a pack of cardboard from control of the first autopsy.

When packaging (packaging) at LLC "Serdiks":

Packaging for hospitals: 30 tablets each in PVC / Al blister. 1 blister with instruction on medical application in a pack of cardboard from control of the first autopsy.

Packaging:

Packing for hospitals: 30 tablets in PVC / Al blister. According to 1 table with instructions for medical use in a pack of cardboardfrom control of the first autopsy.

When packaging (packaging) at LLC "Serdiks":

Packing for hospitals: 30 tablets in PVC / Al blister. 1 blister with instructions for medical use in a pack of cardboardfrom control of the first autopsy.

Storage conditions:

At a temperature of no higher than 30 ° C, in inaccessible to children.

Refers to the list of III psychotropic substances, whose turnover in the Russian Federation is limited.

Shelf life:3 years. Do not use after the expiration date indicated on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N011301 / 01

Date of registration:05.06.2009

The owner of the registration certificate:Servier LaboratoriesServier Laboratories France

Manufacturer: & nbsp

Les Laboratoires Servier France

Representation: & nbspServier Laboratories Servier Laboratories France

Information update date: & nbsp27.08.2015

Illustrated instructions

Instructions

Coaxil® (Coaxil®)