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Pharmacological properties

Trazodone is a triazolpyridine derivative. Trittico is effective for the treatment of depressive conditions, including depression associated with anxiety and sleep disturbance, and is characterized by a rapid onset of action (about 1 week).

Trazodone is a serotonin reuptake inhibitor and 5-HT antagonist2 receptors, the activation of which is usually associated with the appearance of insomnia, anxiety, psychomotor agitation and changes in sexual function.

Unlike other psychotropic drugs, Trazodone is not contraindicated in glaucoma and disorders of the urinary system, it does not have extrapyramidal effects and does not potentiate adrenergic transmission. Trazodone is deprived of anticholinergic activity; therefore, it does not exert effects typical of tricyclic antidepressants on heart function.

Pharmacokinetics After a single oral administration of Trazodone with prolonged release at a dose of 75 mg of its Cmax in plasma is about 0.7 μg / ml and is achieved per Tmax 4 hours AUC is about 8 μg / ml / h. After a single oral administration of Trazodone with prolonged release at a dose of 150 mg Cmax is about 1.2 mcg / ml and is achieved per Tmax 4 h. T½ - about 12 hours, and AUC - about 18 μg / ml / h.

In vitro studies on human liver microsomes found that Trazodone is metabolized mainly by cytochrome P450 3A4 (CYP 3A4).

Trazodone is excreted mainly in the urine in the form of metabolites.

Indications

Depressive disorders with or without anxiety.

Application

The drug is used only in adults.

Therapy should begin with evening receptions with a daily dose increase as recommended by the doctor. Treatment should last at least 1 month.

To minimize side effects (increased resorption and decreased Cmax in blood plasma), the drug is best taken after meals. A tablet with two parallel incisions on the surface can be divided into three parts for the possibility of a gradual increase in dose depending on the severity of the disease, body weight, age and general condition of the patient.

Adults: 75–150 mg / day taken once in the evening before bedtime. The dose can be increased to 300 mg / day, which should be divided into 2 doses. For inpatients, the dose can be increased to 600 mg / day, which should be divided into several doses.

Elderly patients: take an initial dose of 100 mg / day in the evening. The dose may be increased depending on the clinical effect. In general, single doses of more than 100 mg should be avoided in these patients. Rarely there is a need to take a dose of more than 300 mg / day.

Children. The drug is not used in children.

Contraindications

Known hypersensitivity to the drug or its components. alcohol intoxication and intoxication with sleeping pills. acute myocardial infarction.

Side effects

Cases of a suicidal orientation of thinking and suicidal behavior were reported during the period of therapy with Trazodone or shortly after its termination. the following symptoms are also registered in patients receiving Trazodone therapy, some of which are often noted in cases of untreated depression.

System / Organ / MedDRA Class Frequency unknown (cannot be estimated from available data)
On the part of the blood and lymphatic system Blood dysrasia (including agranulocytosis, thrombocytopenia, eosinophilia, leukopenia and anemia)
From the immune system Allergic reactions
Endocrine system Inadequate Secretion Antidiuretic Hormone Syndrome
Metabolic and nutritional disorders Hyponatremia1, weight loss, lack of appetite, increased appetite
From the psyche Suicidal mindset or suicidal behavior2, confusion, insomnia, disorientation, mania, anxiety, nervousness, agitation (which very rarely develops into delirium), delirium, aggressive reaction, hallucinations, nightmares, decreased libido, drug withdrawal syndrome
From the nervous system Serotonin syndrome, convulsions, malignant antipsychotic syndrome, dizziness, vertigo, headache, drowsiness3, anxiety, decreased attention span, tremor, blurred vision, memory impairment, myoclonus, expressive aphasia, paresthesia, dystonia, impaired taste
From the heart Cardiac arrhythmias4 (including polymorphic ventricular tachycardia (torsade de pointes), increased heart rate, ventricular extrasystoles, paired ventricular extrasystoles, ventricular tachycardia), bradycardia, tachycardia, abnormalities on the part of ECG data (prolongation of the Q – T interval)2
From the vessels Orthostatic arterial hypotension, hypertension, syncope
From the respiratory system, chest and mediastinum Nasal congestion, shortness of breath
From the gastrointestinal tract Nausea, vomiting, dry mouth, constipation, diarrhea, dyspepsia, stomach pain, gastroenteritis, increased salivation, paralytic bowel obstruction
Hepatobiliary disorders Impaired liver function (including jaundice and hepatocellular lesions)5intrahepatic cholestasis
On the part of the skin and subcutaneous tissue Skin rashes, itching, hyperhidrosis
From the musculoskeletal system and connective tissue Pain in the limbs, back pain, myalgia, arthralgia
From the kidneys and urinary tract Urination disorders
From the reproductive system and mammary glands Priapism6
General disorders and reactions at the injection site Weakness, swelling, flu-like symptoms, fatigue, chest pain, fever
Survey results Increased liver enzymes

1In patients with appropriate symptoms, fluid levels and electrolyte balance in the body should be monitored.

2See also the SPECIAL INSTRUCTIONS section.

3 Trazodone is a sedative antidepressant, and the drowsiness that patients sometimes experience during the first days of therapy usually disappears as it continues.

4Animal studies have shown that Trazodone has less pronounced cardiotoxicity than tricyclic antidepressants, and clinical studies indicate that Trazodone is less likely to cause cardiac arrhythmias in humans. Clinical studies with patients with heart disease indicate that Trazodone may exhibit arrhythmogenic effects in some patients in this population.

5Rare cases of side effects, sometimes severe, on liver function have been reported.

6See also the SPECIAL INSTRUCTIONS section.

special instructions

Use in children and adolescents. do not use Trazodone in children and adolescents. in a clinical study involving children and adolescents, suicidal behavior (attempted suicide and its planning of suicide) and hostility (mainly aggressiveness, protest behavior and anger) were more often observed in the antidepressant group than in the placebo group. in addition, there is no data on the long-term safety of the drug in children and adolescents, taking into account its effect on growth, puberty, and cognitive and behavioral development.

Suicide / suicidal thoughts or clinical impairment. Depression is associated with an increased risk of suicidal thoughts, the patient causing harm to himself and suicide (manifestations of suicidal behavior). This risk persists until significant remission occurs. There may be no improvement in the first few weeks of therapy or longer.Patients should be carefully monitored until such an improvement occurs. General clinical experience indicates a possible increased risk of suicide in the early stages of recovery.

It is known that patients with a history of suicidal behavior or patients who have identified a significant degree of suicidal thinking before starting therapy have a higher risk of developing suicidal thoughts or attempted suicide, so careful monitoring is necessary during treatment. In a meta-analysis of placebo-controlled clinical trials of antidepressants for mental disorders, it was found that among patients under the age of 25 years, a higher risk of suicidal behavior is characteristic of individuals of the antidepressant group compared to the placebo group.

Therapy with this drug should be accompanied by careful observation of patients, in particular people from high-risk groups, especially at the beginning of treatment and after changing the dose of the drug. Patients (and those who care for them) should be warned that they are required to monitor any clinical recognition.