Trittico 75 mg. 30 tablets

SUMMARY OF PRODUCT CHARACTERISTICS Trittico 75 mg prolonged release
Trittico 150 mg prolonged release


2. Qualitative and quantitative composition:
One tablet contains: Trittico 75 mg prolonged-release active substance is 75 mg trazodone hydrochloride
Trittico 150 mg of prolonged-release tablets Active substance: 150 mg trazodone hydrochloride

3. PHARMACEUTICAL FORM
Split prolonged-release tablets - divisible into 3 parts.

4. Clinical data
4.1 Indications
Depressive disorders with or without anxiety.

4.2 Dosage and method of administration
The drug is taken only by adults. Adults: 75-150 mg / day given as a single dose in the evening before bedtime. The dose may be increased to 300 mg / day in two divided doses. During hospitalization, the dose may be increased Bede to 600 mg / day, in divided doses. Elderly and debilitated patients: starting with an evening dose of 100 mg / day. On prescription dosage can be increased depending on the clinical response. It is uncommon, doses higher than 300 mg / day to be increased. Divisible tablets can be divided into 3 parts, which allows gradually increasing the dose, depending on the severity of the disease, weight, age and general condition of the patient. Treatment should begin with an evening reception and with increasing daily doses prescription. Preferably, the drug is administered after a meal and treatment cycles of at least one month. In elderly patients, the dosage should be carefully specified by the physician to decide how to implement the minimum recommended doses.

4.3 Contraindications
Known hypersensitivity to the drug or its ingredients. The tablets contain zaharoza.Zatova treatment with the drug is contraindicated in hereditary fructose intolerance, glucose-galactose malabsorption and sucrose-isomaltase deficit. Trittico is contraindicated in pregnancy, lactation and children under 18

4.4 Special warnings and precautions for use
Trittico should be administered under medical supervision in patients with clinically significant liver, kidney or heart disease, particularly in patients with known conduction problems or A-V block of varying degrees and after recent myocardial infarction. Although, trazodone does not produce the characteristic effects of tricyclic antidepressants on cardiac activity, its adrenolytic activity, can sometimes cause bradycardia and hypotension, i.e. episodic hypotension accompanied by compensatory tachycardia. Concomitant treatment with antihypertensives and trazodone may require dose reduction of hypotensive medication. With particular attention trazodone should be administered to patients suffering from epilepsy. Rare blood dyscrasias such as agranulocytosis, thrombocytopenia and anemia may occur with the use of trazodone. Report for changes in liver function, sometimes severe, including liver cell damage and jaundice. In these cases requires immediate discontinuation. The use of daily-increasing dose to the maximum recommended dosage according to the medical prescription reduces the risk of symptoms of adverse reactions associated with the drug. Perhaps more common manifestations of adverse reactions observed with co-administration of trazodone with preparations containing Hypericum perforatum (St. John's wort). Tablets contain sucrose, which should be taken into account in patients with diabetes or a low-calorie diet. Keep out of reach of children.

4.5 Interactions
Although no reported side effects, trazodone may enhance the effects of muscle relaxants and volatile anesthetics. Trazodone is well tolerated to the patients with schizophrenia in depression, standard therapy, and patients with Parkinson's disease treated with levodopa. Treatment with trazodone may enhance the effects of alcohol, barbiturates and other central depressant substances. Rarely seen possible interactions with monoamine oxidase inhibitors /MAOIs/.Vapreki that some doctors regularly prescribe these medicines is not recommended the use of trazodone with MAOIs, or discontinuation of therapy with one of these medicines within two weeks. Studies carried out on laboratory animals suggest that trazodone may inhibit the strong action of clonidine. Manifestations of adverse reactions observed with co-administration of trazodone with preparations containing Hypericum perforatum (St. John's wort). Although not reported interactions with other hypotensive agents, the probability of potentiating effects of trazodone should be considered. Trazodone in combination with digoxin or phenytoin may increase serum levels of these substances.

4.6 Pregnancy and lactation
Not proven the safety of trazodone in bremenni.Tryabva also given by nursing mothers and the likelihood of trazodone to be broadcast through breast milk. Not recommended the use of trazodone in the first trimester of pregnancy, while in the remaining months of pregnancy and breastfeeding should be limited to individual cases only after medical risk / benefit assessment.

4.7 Effects on ability to drive and use machines
As with other medikaminti, a going vurhu CNS, patients should be warned that trazodone can change alertness and psychophysical condition while driving, performing hazardous activities or use of complex machinery.

4.8 Undesirable effects
Trittico is an antidepressant with sedative properties may cause drowsiness during the first days, usually disappearing in the process of treatment. Reported rare cases of the following side effects: headache, weakness, dizziness, episodic hypotension, bradycardia and tachycardia, abdominal pain, nausea, vomiting, diarrhea, insomnia and reduced alertness, weight loss, tremors, a state of confusion and rash. Coadministration of Trittico with other psychotropic medications have been rare reports of serotonergic syndrome and convulsions. Rarely reported for cardiac arrhythmias and abnormalities of the blood / agranulocytosis, thrombocytopenia and anemia / severe liver changes and jaundice. In these cases, treatment with trazodone announces cease immediately. As with other drugs with alpha-adrenolytic effect marked Rare cases of priapism associated with treatment with trazodone. If in doubt for the development of this adverse reaction, the patient should discontinue therapy immediately.

4.9 Overdose
The most commonly reported observed effects are dizziness, drowsiness and vomiting. In case of acute overdose, the stomach should as quickly as possible to empty, you need to provoke vomiting and gastric lavage. The patient must be monitored and treated symptomatically and maintain fluid balance.

5. Pharmacological
5.1 Pharmacodynamic properties
Trazodone is triazolopiridinov derivative effective in treating depressive disorders, including depression accompanied by anxiety and sleep disturbances / ATC code: N06AX05 / and characterized by short action / week /. Trazodone is an inhibitor of serotonin reuptake and antagonist 5HT 2A and 2C receptors whose activation is commonly associated with insomnia, anxiety, psychomotor changes and changes in sexual function. Trazodone is not contraindicated in glaucoma and kidney problems, has no extrapyramidal effects and does not potentiate adrenergic transmission because there is no anticholinergic activity and does not cause the typical effects of tricyclic antidepressants on heart function.

5.2 Pharmacokinetic properties
After a single oral dose of trazodone-75 mg prolonged-release tablets of the Cmax of about 0.7 (g / ml are reached with a T max - 4 hours after administration, and an AUC of about 8 (g / ml / h. After a single oral dose of trazodone - 150 mg prolonged release, Cmax of about 1.2 (g / ml are reached with a T max - 4 hours after administration. The half-life of elimination is approximately 12 hours and AUC of about 18 (g / ml / h.

5.3 Preclinical safety data
Acute toxicity: LD50 of trazodone is orally administered 610 mg / kg in mice, 486 mg / kg in rats and 560 mg / kg in rabbits. The observed effects were: sleepiness, salivation, ptosis of the eyelids, and chronic convulsions. Subacute toxicity: subchronic studies were performed on rat, rabbit and dog, and chronic on rat, dog and monkey administered oral dose varies between 15 and 450 mg / kg / day in rats, 15 and 100 mg / kg / day in rabbits, 3 and 100 mg / kg / day in the dog and 20-80 mg / kg / day in the monkey. In studies in rats, the treatment caused hypertrophy of hepatocytes and soft endoplastichen reticulum followed by hepatomegaly. This effect is the result of detoxifying mechanism and could not be interpreted as pathological effect. Moreover lethal dose also produces effects already observed in acute toxicity tests. Dose / levels not observed adverse reactions / NOEL was 30 mg / kg / day. When rabbits were observed only effects of CNS depressants, with a corresponding NOEL 50 mg / kg / day. In the dog, the symptoms already seen in acute intoxication deteriorated in repeat dose and appropriate NOEL was 10 mg / kg / day. The monkey had more resistance from the dog and manifested only pharmacodynamic changes. NOEL was 30 mg / kg / day.

6. Pharmaceutical particulars
6.1 List of ingredients and their quantities
Tablets: saccharoseq polyvinylpyrrolidone, carnauba wax, magnesium stearate

6.2 incompatibilities
Trazodone is not incompatible with other drugs and other commonly-used substances, except those of 4.5

6.3 Shelf life
3 years.
This period is provided for properly stored in unopened packaging product

6.4 Special precautions for storage
The product should be stored under normal conditions

6.5 Nature
Primary packaging tablets are packaged in PVC / aluminum blisters. Secondary packaging Trittico 75 mg prolonged release - a box of 30 tablets, Trittico 150 mg prolonged release - box of 20, 60 or 120 pieces