Coaxil is an antidepressant medication.
Release form and composition
Coaxil is available in the form of coated tablets of white color (30 pieces in blisters, 1 blister in a carton box with the control of the first opening).
The active ingredient of the drug is tianeptine sodium (12.5 mg in 1 tablet).
Auxiliary components: magnesium stearate, corn starch, carmellose sodium.
Shell composition: white beeswax, glyceryl monooleate, anhydrous colloidal silicon dioxide, sodium bicarbonate, ethyl cellulose, sucrose, titanium dioxide, polysorbate 80, povidone, talc.
Indications for use
- Depressive states, including those in old age;
- Anxiety-depressive conditions, accompanied by somatic symptoms;
- Anxiety-depressive states in patients with chronic alcoholism in the period of abstinence.
Coaxil should not be used in the following cases:
- Lack of sucrase-isomaltase, fructose intolerance, glucose-galactose malabsorption;
- The need to use monoamine oxidase inhibitors (MAO);
- Age up to 18 years;
- Hypersensitivity to tianeptine or auxiliary components of the drug.
Patients with a history of suicide attempts, alcohol or drug dependence should be under special observation during the treatment period.
Dosing and Administration
Coaxil should be ingested before eating.
The average therapeutic dose is 12.5 mg tianeptine sodium (1 tablet) 3 times a day - in the morning, in the afternoon and in the evening.
The maximum permissible daily dose for the elderly and patients with renal insufficiency is 25 mg (2 tablets).
The side effects revealed during clinical trials are insignificant. It is mainly nausea, abdominal pain, constipation, dry mouth, drowsiness, dizziness and headache.
During clinical studies and the post-registration period, the following adverse reactions from various body systems were identified:
- Mental disorders: often - nightmares; rarely, drug dependence, abuse (especially in patients under 50 years of age with alcohol or drug dependence in history); frequency is unknown - suicidal thoughts and suicidal behavior during treatment or soon after its termination, hallucinations, confusion;
- Digestive system: often - epigastric pain, nausea, vomiting, dry mouth, constipation, abdominal pain, flatulence;
- Cardiovascular system: often - chest pain, extrasystole, tachycardia, flushing of the skin of the face;
- Musculoskeletal system and connective tissue: often - pain in the lumbar region, myalgia;
- Central nervous system: often - fainting (lipotymia), drowsiness, headache, insomnia, dizziness, tremor; frequency is unknown - dyskinesia, extrapyramidal disorders;
- Respiratory system: often - shortness of breath;
- Hepatobiliary system: unknown frequency - increased activity of liver enzymes, hepatitis (very rarely in severe form);
- Skin: infrequently - urticaria, pruritus, erythematous or maculopapular rash; frequency unknown - acne; extremely rare - bullous dermatitis;
- Metabolic disorders and diseases caused by metabolic disorders: often - anorexia; frequency is unknown - hyponatremia;
- Other: often - a feeling of a coma in the throat, asthenia.
The experience of an overdose of Coaxil (a case of taking 2250 mg of tianeptine at a time is known) indicates the development of drowsiness, confusion, seizures, respiratory failure. Basically, these symptoms were observed with the combination of the drug with alcohol. If no more than 2 hours have passed from the moment of taking the medication, you need to do a gastric lavage, if it is longer, take activated charcoal. In all cases of overdose, Coaxil should be canceled and patient monitoring should be established: monitor kidney, respiratory and cardiovascular systems, measure homeostasis, and if necessary conduct symptomatic therapy, such as correction of renal dysfunction and metabolic disorders, artificial respiration.
Patients receiving MAO inhibitors can take Coaxil no earlier than 2 weeks after their cancellation.
Drug treatment is stopped gradually, reducing the dose within 7-14 days.
It should be borne in mind that in depressive states there is a high probability of self-harm, suicidal thoughts and behavior. The risk persists until a distinct remission occurs, so patients should be closely monitored by medical personnel until they improve (it may take several weeks). Clinical experience confirms that the risk of suicide may increase in the early stages of remission.
Patients who had suicidal intentions before using Coaxil, as well as people with a history of suicidal events, are at risk of suicide, so during treatment with the drug and when changing the dose should be under special medical supervision. Both the patients themselves and their caregivers should be warned of the need to immediately consult a doctor if their condition worsens, unusual behavior, or suicidal thoughts appear.
Reception of tianeptine should be stopped 24-48 hours before the scheduled operation, if it is performed with general anesthesia. In the case of emergency surgical care, the operation is performed under the strict supervision of a physician.
Patients with alcohol or drug dependence should be under special medical supervision to prevent the dose prescribed by the doctor from being exceeded.
In connection with the possibility of reducing the speed of psychomotor reactions and the ability to concentrate, during treatment it is recommended to use caution when driving motor vehicles and performing potentially hazardous types of work.
During the period of treatment is not recommended to drink alcohol and take drugs containing ethanol.
The simultaneous use of mianserin is undesirable, since during the experiments with this combination an antagonistic effect was revealed.
With the simultaneous use of non-selective MAO inhibitors there is a possibility of hyperthermia, a sudden increase in blood pressure or the development of collapse, seizures and death. Such a combination is contraindicated.
Terms and conditions of storage
Store at temperatures up to 30 ºC. Keep out of the reach of children!
Shelf life - 3 years.