Trittico (Trittico)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceTrazodoneTrazodone
Dosage form: & nbspLong-acting tablets.
Composition:

One long-acting tablet contains:

Active substance: trazodone hydrochloride 150.0 mg.

Excipients: sucrose 84.0 mg; carnauba wax 24.0 mg; povidone 24.0 mg; magnesium stearate 6.0 mg.

Description:Biconvex tablets are white or white with a yellowish hue of oval color with two parallel risks on both sides.
Pharmacotherapeutic group:Antidepressant.
ATX: & nbsp

N.06.A.X   Other antidepressants

N.06.A.X.05   Trazodone

Pharmacodynamics:

Pharmacodynamics: trazodone inhibits reverse neuronal seizure of serotonin, is a 5-HT antagonist2A/ 2c-serotonin receptor and α-blocker1-adrenoceptors and has an antidepressant effect.

Pharmacokinetics:

Athe absorption of trazodone from the gastrointestinal tract after ingestion is high. Taking trazodone during or immediately after a meal slows the rate of absorption, reduces the maximum concentration of trazodone in the blood plasma and increases the time to reach the maximum concentration (TCmax).

TCmax is achieved through 1 / 2-2 hours after ingestion.

Trazodone penetrates through gistogematicheskie barriers in tissue and fluid (bile, saliva, breast milk).

The connection with plasma proteins is 89 - 95%.

Trazodone is metabolized in the liver, the active metabolite is 1-m-chlorophenylpiperazine. The half-life is 3-6 hours, in the second phase 5-9 hours. Most of the metabolized trazodone is excreted by the kidneys with urine - about 75%, and completely completed 98 hours after admission; with bile is about 20%. Research in vitro on human microsomes showed that trazodone is mainly metabolized by the isoenzyme of cytochrome P450 (isoenzyme CYP3A4).

Indications:Depression with anxiety or without it.
Contraindications:
- hypersensitivity to the active substance or any auxiliary substance;
- period of pregnancy;
- lactation period;
- alcohol intoxication and intoxication with hypnotics;
- safety trazodone for children under the age of 18 years is not established, so the use of the drug by children and adolescents is not recommended;
- deficiency of sugar / isomaltase, intolerance to fructose, glucose-galactose malabsorption, since the drug contains sucrose.
Carefully:The drug should be administered with caution to patients with AV blockade,myocardial infarction (early recovery period), with arterial hypertension (correction of doses of antihypertensive drugs may be necessary), ventricular arrhythmia, history of priapism, renal and / or hepatic insufficiency.
Pregnancy and lactation:The drug is not recommended for pregnant women. The drug is not recommended for use during breastfeeding.
Dosing and Administration:

Tablets should be taken orally 30 minutes before meals or 2 to 4 hours after meals. Tablets should be taken whole, not liquid, and with enough water.

Initial dose of the drug: 100 mg, taken once before bedtime after a meal. On the 4th day, you can increase the dose to 150 mg. Further increase in the dose in order to achieve the optimal therapeutic effect should be performed at 50 mg / day every 3-4 day until the optimal dose is reached. A daily dose of more than 150 mg should be divided into 2 divided doses, with a smaller dose taken after lunch, and the main dose at bedtime.

The maximum daily dose for outpatients 450 mg.

The maximum daily dose for inpatients. 600 mg.

For elderly and debilitated patients the initial dose to 100 mg / day in divided doses or once before bedtime. It can be increased under the supervision of a doctor, depending on the effectiveness and tolerability of the drug. Usually, a dose exceeding 300 mg / day is not required.

Side effects:

Trittico can cause side effects, although they do not occur in all patients.

FROMabout the side of the blood and lymphatic system: agranulocytosis, thrombocytopenia, eosinophilia, leukopenia and anemia;

From the immune system: allergic reactions;

From the endocrine system: syndrome of inadequate secretion of antidiuretic hormone (SNA ADH);

Disorders of the psyche: suicidal thoughts or suicidal behavior, confused state, mania, phobias, emotional instability, delirium, hallucinations;

From the nervous system: epileptic seizures, dizziness, headache, insomnia or drowsiness, amnesia, tremor, cramps, paresthesia, a violation of taste sensations;

From the cardiovascular system: palpitation, tachycardia, bradycardia, ventricular extrasystoles, ventricular paroxysmal tachycardia, lengthening of the interval QT, increased blood pressure (BP), lowering blood pressure, fainting;

From the digestive tract: nausea, vomiting, dry mouth, indigestion; abdominal pain, diarrhea, increased salivation, paralytic intestinal obstruction;

From the skin and subcutaneous tissues: itching, erythematous rash, sweating;

From the side of the musculoskeletal and connective tissue: myalgia, arthralgia;

From the side of the kidneys and urinary tract: violation of urination;

From the genitals and the breast: priapism (patients who have this side effect should immediately stop taking the drug and consult a doctor);

Other: increased fatigue, weakness, fever, flu-like syndrome.

Overdose:

Symptoms: drowsiness, dizziness, nausea, vomiting. In more severe cases, coma, tachycardia, hypotension, hyponatremia, convulsions and respiratory failure. Violation of the function of the cardiovascular system (lengthening of the interval QT, bradycardia). After an overdose, symptoms may occur within 24 hours or more.

Treatment: There is no specific antidote to trazodone. In cases of overdosage, gastric lavage and the appointment of activated charcoal within 1 hour after taking a superdose are necessary.Conduct symptomatic and supportive treatment.

Interaction:
Trazodone can enhance the effect of certain antihypertensive drugs and usually requires a reduction in their doses.
Simultaneous use with drugs that depress the central nervous system (incl. clonidine, methyldopa), enhances the effect of the latter.
H1-histamine receptor blockers and drugs with m-cholinoblocking activity enhance the m-cholinoblocking effect of trazodone.
Trazodone enhances and prolongs the sedative and m-cholinoblocking effects of tricyclic antidepressants, haloperidol, loxapine, maprotiline, phenothiazine, pimozidane and thioxanthin.
With the simultaneous use of tricyclic antidepressants and trazodone, cardiovascular side effects may occur.
MAO inhibitors increase the risk of side effects.
When combined, increases the concentration of digoxin and phenytoin in the blood plasma.
In vitro studies of drug metabolism indicate the possibility of pharmacological interaction of trazodone with cytochrome P450 isoenzyme inhibitors (isoenzyme CYP3A4), such as ketoconazole, ritonavir, indinavir and fluoxetine. Inhibitors of the isoenzyme CYP3A4 can lead to a significant increase in the concentration of trazodone in the plasma, thereby increasing the likelihood of adverse events. Therefore, in case of administration in combination with potent inhibitors of the isoenzyme CYP3A4, the dose of trazodone should be reduced. When taking trazodone in combination with carbamazepine, trazodone concentration in plasma decreases. Therefore, patients in parallel receiving trazodone and carbamazepine, must be carefully monitored.
Special instructions:

Suicide / suicidal thoughts or worsening of clinical symptoms: In depressive states, the risk of suicidal thoughts, self-harm or suicide is increased. The risk may last until a marked remission occurs. Because improvement may not occur during the first few weeks of treatment or more, patients should be closely monitored until such an improvement occurs. According to general clinical experience, the risk of suicide may increase in the early stages of recovery. It is known that patients with a history of suicidal events, or patients,who exhibit a significant degree of suicidal thinking even before starting treatment, have a higher risk of suicidal thoughts or suicide attempts, and should be closely monitored in course of treatment. The results of a meta-analysis of placebo-controlled clinical trials of antidepressants that are used in adults with mental disorders have shown an increased risk of suicidal behavior in patients younger than 24 years with antidepressant medications compared with placebo. Careful monitoring of patients, especially those at high risk, should accompany the drug therapy, especially in its early stages and after dose changes. It is necessary to warn patients (and caregivers) about the need to monitor any clinical deterioration, suicidal behavior or suicidal thoughts, unusual behavioral changes, and immediately seek professional advice if such symptoms appear.

Since the drug has some adrenoblocking activity, it is possible to develop bradycardia and reduce blood pressure.Therefore, care should be taken when prescribing the drug to patients with a tendency to lengthen the interval QT, atrio-ventricular blockage of varying severity, patients with recent myocardial infarction. When trazodone therapy in patients with bipolar disorder, depressive attacks can range from manic-depressive to manic psychosis. In these cases it is necessary to interrupt treatment.

When epilepsy should be taken trazodone with caution, in particular avoiding dramatic increases or decreases in dose. With the simultaneous use of trazodone with drugs that have serotonergic activity (tricyclic antideoperants, selective serotonin reuptake inhibitors, norepinephrine and serotonin reuptake inhibitors and monoamine oxidase inhibitors) and neuroleptics, a serotonin syndrome may occur. With the simultaneous use of trazodone with preparations containing St. John's wort, side effects may be more frequent.

When using trazodone, it is possible to develop agranulocytosis, therefore, it is recommended that peripheral blood, especially if there are pains in the throat when swallowing and the appearance of fever.

Trazodone is effective in sleep disorders in patients with depression, increases the depth and duration of sleep, restores its physiological structure and quality. The use of the drug does not affect the body weight.

The drug is not addictive.

Effect on the ability to drive transp. cf. and fur:During the period of Tritgico's use, care must be taken when driving vehicles and engaging in other potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:
Long-acting tablets 150 mg.
Packaging:
For 10 tablets in a blister of PVC / aluminum foil.
For 2 or 6 blisters together with instructions for use in a cardboard box.
In the case of packaging and packaging, PHARMACOR PRODUCTION LLC, Russia:
10 tablets per blister of polyvinylchloride film and aluminum foil
printed lacquered. For 2 or 6 blisters together with instructions for use in a pack of cardboard.
Storage conditions:
At a temperature of no higher than 25 ° C. Keep out of the reach of children!
Shelf life:
3 years.Do not use after the expiration date.
Terms of leave from pharmacies:On prescription
Registration number:П N015703 / 01
Date of registration:15.07.2009
The owner of the registration certificate:Aziande Kimike Riounite Angelini Francesco AKR.A.A. SpAAziande Kimike Riounite Angelini Francesco AKR.A.A. SpA Italy
Manufacturer: & nbsp
Representation: & nbspCBS CJSC LTDCBS CJSC LTDItaly
Information update date: & nbsp15.09.2015
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