TRITTIKO
Active material: Trazodone
When ATH: N06AX05
CCF: Antidepressant
ICD-10 codes (testimony): F13, F31, F32, F33, F40, F41.2, F52
Manufacturer: Chemical companies Riunite Angelini Francesco ACRAF. S.p.A. (Italy)
Pharmaceutical form, composition and packaging
Controlled release tablets white or white with a yellowish tint, Oval, with two parallel risk on both sides.
| 1 tab. | |
| trazodone hydrochloride | 75 mg |
Excipients: sucrose, vosk karnaubы, povidone (polyvinylpyrrolidone), magnesium stearate.
15 PC. – blisters (2) – packs cardboard.
30 PC. – blisters (1) – packs cardboard.
Controlled release tablets white or white with a yellowish tint, Oval, with two parallel risk on both sides.
| 1 tab. | |
| trazodone hydrochloride | 150 mg |
Excipients: sucrose, carnauba wax, povidone (polyvinylpyrrolidone), magnesium stearate.
10 PC. – blisters (2) – packs cardboard.
10 PC. – blisters (6) – packs cardboard.
20 PC. – blisters (1) – packs cardboard.
20 PC. – blisters (3) – packs cardboard.
Pharmacological action
Antidepressant. Trazodone, It is derived triazolopyridine, It has mainly antidepressant action, with some sedative and anxiolytic effects. Trazodone has no effect on MAO, which distinguishes it from MAO inhibitors, tricyclic antidepressants.
The mechanism of action of trazodone associated with a high affinity of the drug to certain subtypes of serotonin receptors, trazodone which comes into antagonistic or agonistic interactions, depending on the subtype, as well as with the specific ability to cause inhibition of serotonin reuptake.
Quickly impact on mental (affective tension, irritability, fear, insomnia) and somatic symptoms of anxiety (heartbeat, headache, muscle aches, frequent urination, Sweating, hyperventilation).
Trazodone effective in sleep disorders in patients with depression, increases the depth and duration of sleep, restores its physiological structure and quality.
Trittiko stabilize the emotional state, improves mood, It reduces the craving for alcohol in patients, chronic alcoholism in the period of alcohol withdrawal syndrome, in remission. When withdrawal syndrome patients, addicted to benzodiazepines, Trazodone is effective in treating anxiety, depression and sleep disorders. In remission benzodiazepines can be completely replaced by trazodone.
It helps restore libido and potency in patients with depression, and in individuals, not depressed.
The drug is not addictive. On neutral capture of norepinephrine and dopamine affects few.
No effect on body weight.
Pharmacokinetics
Absorption
The absorption of the drug from the gastrointestinal tract after ingestion of a high. Trazodone during or immediately after a meal slows the rate of absorption, lowers Cmax drug in blood plasma and increases Tmax. Cmax plasma through krovidostigaetsya 0.5-2 hours after ingestion.
Distribution
Binding to plasma proteins - 89-95%. It penetrates the blood-tissue barriers, as well as in tissues and fluids (bile, saliva, breast milk).
Metabolism
Trazodone is metabolized in the liver, active metabolite – 1-Mr. hlorofenilpiperazin.
Deduction
T1/2 h is 3-6, a second phase - 5-9 no. Most of the metabolites excreted by the kidneys – about 75%, and elimination is completed in full 98 h after administration; the bile is injected around 20%.
Testimony
- Anxiety and depression endogenous nature (incl. involutional depression);
- Psychogenic depression (incl. reactive and neurotic depression);
- Anxiety and depression on a background of organic diseases of the CNS (dementia, Alzheimer's disease, cerebral atherosclerosis);
- Depression with prolonged pain syndrome;
- Alcoholic depression;
- Dependence on benzodiazepinovaya;
- Disorders of libido and potency, incl. in depressive states.
Dosage regimen
The drug is taken orally for 30 minutes before meals or 2-4 hours after meals. Prescribed dose pill should be taken as a whole, not chewing and drinking plenty of water.
Adults administered in an initial dose of 100 mg 1 time / day after eating before going to bed. On the 4th day, the dose can be increased to 150 mg. Subsequently, in order to achieve optimum therapeutic effect dose was raised to 50 mg / day every 3-4 day, until you reach the optimal dose. The daily dose more 150 mg should be divided into 2 admission, and take a smaller dose of afternoon, and basic – before bedtime.
The maximum daily dose for outpatients – 450 mg.
The maximum daily dose for inpatients – 600 mg.
At the treatment of disorders of libido the recommended daily dose 50 mg.
At the treatment of impotence, in the case of monotherapy, more than the recommended daily dose 200 mg, with combined therapy – 50 mg.
At treatment of benzodiazepine dependence The recommended regimen is based on the gradual, sometimes within a few months, reduction of the dose of benzodiazepine. Everytime, reducing the dose of benzodiazepine at 1/4 or 1/2 tablets, simultaneously added 50 mg of trazodone. This ratio is left unchanged during 3 weeks, then proceed to a further gradual reduction of the dose of benzodiazepines until their complete cancellation. Then reduce the daily dose to trazodone 50 mg every 3 of the week.
To the elderly and debilitated patients the initial dose – to 100 mg / day in divided doses, or 1 time / day before bedtime. The dose may be increased by a physician, depending on the efficacy and tolerability. Not normally required dose, exceeding 300 mg / day.
Children 6-18 years: the initial daily dose of 1.5-2 mg / kg / day, divided into several times. If necessary, the dose is gradually increased to 6 mg / kg / day intervals 3-4 day.
Side effect
From the central and peripheral nervous system: fatigue, drowsiness, excitation, headache, dizziness, weakness, myalgia, incoordination, paresthesia, disorientation, tremor.
Cardio-vascular system: decrease in blood pressure, orthostatic hypotension (especially in patients with vasomotor lability) due to the action of the drug adrenolytic, arrhythmia, asequence, bradycardia, leukopenia and neutropenia (usually minor).
From the digestive system: dryness and bitterness in the mouth, nausea, vomiting, diarrhea, decreased appetite.
Other: allergic reactions, eye irritation, priapism (Patients, who says the side effect, should immediately stop taking the drug and seek medical advice).
Contraindications
- Pregnancy;
- Lactation;
- Children up to age 6 years;
- Hypersensitivity to the drug.
FROM caution should be prescribed to patients with AV-block, myocardial infarction (early recovery period), with hypertension (It may require adjustment of doses of antihypertensive drugs), ventricular arrhythmia, priapism history, with kidney and / or liver failure, patients aged 18 years.
Pregnancy and lactation
The drug is contraindicated during pregnancy and lactation (breast-feeding).
Cautions
Because the drug has some activity adrenoliticheskoy, may develop bradycardia and decrease in blood pressure. Therefore, caution should be prescribed to patients with cardiac conduction, AV-block of varying severity, patients with recent myocardial infarction.
When using trazodone may be some reduction in the number of white blood cells, which does not require a specific treatment, except as expressed leukopenia. Therefore, the period of treatment to conduct studies of peripheral blood, especially if there is pain in the throat when swallowing, and the appearance of fever.
The drug does not possess anticholinergic action, therefore, can be administered in elderly patients, suffering from prostatic hypertrophy, angle-closure glaucoma, impaired cognitive function.
When prolonged erections inadequate and the patient should see a doctor.
During treatment, the patient must abstain from alcohol.
Effects on ability to drive vehicles and management mechanisms
Since the drug has anxiolytic and sedative activity, may reduce the ability to concentrate attention and speed of psychomotor reactions. During treatment, the patient should avoid activities potentially hazardous activities, incl. drive vehicles and management mechanisms.
Overdose
Symptoms: nausea, drowsiness, hypotension, increase in the frequency and severity of side effects.
Treatment: No specific antidote drug. In cases of overdose symptomatic treatment (incl. gastric lavage, diurez).
Drug Interactions
Trazodone may enhance the effect of certain antihypertensive drugs and is usually required to reduce their doses.
Co-administration with drugs, CNS depressants (incl. klonidin, methyldopa), enhances the effect of the past.
Antihistamines and drugs, having holinoliticheskoy activity, enhance the anticholinergic effect of trazodone.
Trazodone intensifies and prolongs the sedative and anticholinergic effects of tricyclic antidepressants, haloperidol, loxapine, Maprotiline, phenothiazines, pimozide and thioxanthene.
MAO inhibitors increase the risk of side effects of trazodone.
In a joint application increases the concentration of digoxin and phenytoin plasma.
Conditions of supply of pharmacies
The drug is released under the prescription.
Conditions and terms
List B. The drug should be stored out of reach of children at or above 25 ° C. Shelf life – 3 year.
