Treatment of depressive episodes. Tianeptine can be used in light, moderate and severe depression.
Composition:
1 tabl contains 12.5 mg of tianeptine sodium (and 0.008 mg of cochineal red).
Action:
Antidepressant. Selectively increases the re-uptake of serotonin in neurons of the cerebral cortex and hippocampus. It stimulates the electrical activity of pyramid cells in the hippocampus and accelerates the recovery of activity after functional inhibition. It affects anxiety disorders associated with depression and mood disorders. It occupies an intermediate place between antidepressants acting as stimulants and calming antidepressants. It affects the somatic disorders, especially on the part of the digestive tract, associated with anxiety and mood disorders. Tianeptine is quickly absorbed from the digestive tract. It binds approximately 95% of plasma proteins. It is very much metabolised in the liver. T0,5 It is 2.5 hours. It is excreted in the urine, mainly in the form of metabolites. In patients with renal insufficiency and in elderly T0,5 it extends by about 1 hour.
Contraindications:
Hypersensitivity to the active substance or to any of the excipients. Concomitant use of the drug with non-selective MAO inhibitors (after using MAO inhibitors, wait 2 weeks before initiating therapy with tianeptine, the tianeptine should be discontinued 24 hours before the MAO inhibitor is used).
Precautions:
The safety and efficacy of use in patients <18 years have not been established. In clinical trials, suicide-related behaviors (suicide attempts and suicide attempts) and hostility (mainly aggression, oppositional behavior, anger) have been observed more often in children and adolescents treated with antidepressants than with placebo. If, after all, a decision is made about the implementation of the treatment in connection with clinical need, the patient should be carefully monitored for any symptoms that may indicate an increased risk of suicide. Depression is associated with an increased risk of suicidal thoughts, self harm and suicide. This risk persists until full remission occurs. Patients should be closely monitored until improvement occurs. The risk of suicide may increase at an early stage of recovery. Patients with a history of suicide-related events or patients exhibiting a significant degree of suicidal tendency prior to commencement of treatment are considered to be at increased risk of suicidal thoughts or suicide attempts and should be closely monitored during treatment, particularly those under 25 years of age. During treatment, especially at the beginning of therapy and when the dose is changed, patients should be closely monitored, particularly those at high risk. Tianeptine should be discontinued 24-48 h before general anesthesia. In cases of emergency procedures, the operation may be performed omitting the washout period; Careful observation of the patient in the perioperative period. Patients who are addicted to drugs or alcohol should be closely monitored. Tianeptine should be used with caution in patients with a history of mania. Treatment with tianeptine should be discontinued if the patient enters the mania phase. The tablets contain cochineal red which may cause allergic reactions.
Pregnancy and lactation:
Do not use during pregnancy (no studies) and during breastfeeding (tricyclic antidepressants are excreted in breast milk).
Side effects:
Common: tachycardia, palpitations, additional cramps, chills, pain in the heart area, insomnia, drowsiness, pain and dizziness, chills, syncope, tremors, blurred vision, shortness of breath, dry mouth, constipation, abdominal pain, nausea, vomiting, indigestion, diarrhea, bloating, heartburn, backache, muscle aches, anorexia, hot flushes, weakness, feeling of foreign body presence in the throat, nightmares. Uncommon: follicular or erythematous rash, pruritus, urticaria.Rare: abuse and addiction, especially in people <50 years with an interview indicating addiction to drugs or alcohol. Not known: suicidal thoughts or behaviors (both during treatment with tianeptine and soon after its discontinuation).
Dosage:
Orally. Adults: 1 tabl. 3 times a day (in the morning, in the middle of the day and in the evening). Special groups of patients. In patients with severe renal impairment and in the elderly, the dose should be reduced to 2 tablets. per day. There is no need to modify the dose in patients with alcohol dependence with cirrhosis or without liver cirrhosis. The safety and efficacy of use in patients <18 years has not been established.Way of giving. The drug should be taken before the main meals. The drug should be discontinued gradually over 7-14 days.