Trittico. 75 mg. 30 tablets
Trittico. 75 mg. 30 tablets
QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains : Trittico 75 mg prolonged-release tablets Active ingredient : 75 mg trazodone hydrochloride
Trittico 150 mg prolonged-release tablets Active substance : 150 mg trazodone hydrochloride
3 . PHARMACEUTICAL FORM
Divisible prolonged-release tablets - split into 3 parts.
4 . clinical data
Depressive disorders with or without anxiety.
4.2 Posology and method of administration
Administer only by adults. Adults : 75-150 mg / day given as a single dose in the evening before bedtime. The dosage may be increased to 300 mg / day in two divided doses . During patient treatment dose can Bede increased to 600 mg / day in divided doses. Elderly and debilitated patients : starting with evening administration of 100 mg / day. Prescription dose may be increased depending on clinical response. It is not common , a higher dosage of 300 mg / day can be increased . Divisible tablet can be divided into 3 parts , which allows a gradual increase of the dosage , depending on the severity of the disease , the weight , age and general condition of the patient. Treatment should begin with an evening reception and increasing daily doses prescription. Preferably, the drug is administered after a meal and a therapeutic cycles of at least one month. In elderly patients , dosage should be carefully adjusted by your doctor to decide how to implement the minimum recommended doses.
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 deficiency. 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 hepatic , renal or cardiac disease , particularly in patients with known conduction problems or A -V block of varying degrees or after myocardial infarction . Although trazodone does not produce characteristic effects of tricyclic antidepressants on cardiac adrenolitichna its activity can sometimes cause bradycardia and hypotension , particularly episodic hypotension accompanied by compensatory tachycardia. Concomitant treatment with antihypertensives and trazodone may require a dose reduction of hypotensive medication. Particular attention must trazodone is administered to patients suffering from epilepsy . Rare blood dyscrasia such granulotsitoza , thrombocytopenia and anemia can occur with the use of trazodone . Reported for changes in liver function , sometimes severe, including liver cell damage and jaundice. In these cases, immediate withdrawal of treatment. Using daily - increasing doses up to the maximum recommended dose , according to the doctor 's prescription , reduces the risk of developing side effects associated with the drug. Perhaps more common manifestations of adverse reactions observed with concomitant 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 .
Although no reported side effects Trazodone may enhance the effects of muscle relaxants and volatile anesthetics . Trazodone is well tolerated by patients with schizophrenia, depression , standard therapy , and patients with Parkinson's disease treated with levodopa. Trazodone may increase the effects of alcohol, barbiturates and other substances CNS depressants . Rarely observed possible interactions with monoamine oxidase inhibitors / MAOIs / .Vapreki that some doctors regularly prescribe these medicines are not recommended for use of trazodone with MAOIs, or discontinuation of therapy with one of these medications within 2 weeks. Tests carried out on laboratory animals suggest that trazodone may inhibit the strong action of clonidine. Manifestations of adverse reactions observed with concomitant 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 the 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 trazodone be transmitted via 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 , deystvashi vurhu CNS , patients should be warned that trazodone can change alertness and psychophysical condition while driving , performing hazardous activities or the use of sophisticated machinery .
4.8 Undesirable effects
Trittico is an antidepressant with sedative properties may cause drowsiness during the first days , usually disappear in the course of treatment. Have rarely been reported on the following side effects: headache , weakness , dizziness, episodic hypotension, bradycardia and tachycardia , abdominal pain, nausea , vomiting , diarrhea, insomnia and decreased attention , weight loss , tremors , confusion and rash. With concomitant Trittico with other psychotropic medications have been rare reports of serotonergic syndrome and convulsions. Rarely reported and cardiac arrhythmias and changes in the blood picture / granulotsitoza , thrombocytopenia and anemia / severe liver changes and jaundice. In these cases, treatment with trazodone announces to cease immediately. As with other drugs with alpha- adrenolitichen effects noted are rare cases of priapism associated with treatment with trazodone . If in doubt about the development of this adverse reaction , the patient should discontinue therapy immediately .
The most frequently reported observed effects are dizziness, drowsiness and vomiting. In case of acute overdose , the stomach should as quickly as possible to empty , should provoke vomiting and gastric lavage . The patient must be monitored and managed symptomatically and to maintain fluid balance .
5 . pharmacological
5.1 Pharmacodynamic properties
Trazodone is triazolopyridine derivative effective in the treatment of depressive disorders, including depression accompanied by anxiety and sleep disorders / ATC code : N06AX05 / and is 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 potentiate adrenergic transmission because no anticholinergic activity and does not cause the typical effects of tricyclic antidepressants on cardiac function.
5.2 Pharmacokinetic properties
After a single oral dose of trazodone , 75 mg prolonged- release , the Cmax of about 0.7 (g / ml are reached with a T max - 4 hours after application and an AUC of about one 8 (g / ml / h. After single oral dose of trazodone - 150 mg prolonged release , the Cmax of about 1.2 (g / ml are reached with a T max - 4 hours postdose . half-life of elimination is approximately 12 hours and an AUC of about 18 (g / ml / h.
5.3 Preclinical safety data
Acute toxicity: LD50 of trazodone is administered orally 610 mg / kg in mice, 486 mg / kg in rats and 560 mg / kg in rabbits . Observed effects : drowsiness, salivation, ptosis of the eyelids, and chronic convulsions. Subacute toxicity : subchronic studies were performed on rat , rabbit and dog , and on chronic rat , dog and monkey administered oral dose ranges between 15 and 450 mg / kg / day in rats , 15 and 100 mg / kg / day in rabbits , 3 and 100 mg / kg / day in dogs and 20-80 mg / kg / day in monkeys. In studies in rats , treatment caused hypertrophy of hepatocytes and mild endoplastichen reticulum with subsequent hepatomegaly . This effect is the result of detoxifying mechanism and can not be interpreted as pathological effect . Moreover lethal dose also produced effects already observed in acute toxicity tests . Dose / levels not seen side effects / NOEL was 30 mg / kg / day. When rabbits were observed only on the effects on the central nervous system depressant , a corresponding NOEL 50 mg / kg / day. In dogs , the symptoms already observed in acute intoxication worsened in repeat dose and the corresponding NOEL was 10 mg / kg / day. The monkey had greater resistance by the dog and developed only pharmacodynamic changes . NOEL was 30 mg / kg / day.
6 . pharmaceutical particulars
6.1 List of excipients and their amounts
Tablets : saccharoseq polyvinylpyrrolidone, carnauba wax, magnesium stearate
Trazodone is not compatible with other drugs and other commonly - used materials , with the exception of those from the 4.5
6.3 Shelf life
Three years .
This is scheduled for properly stored in unopened packaging product
6.4 Special precautions for storage
The product should be stored under normal conditions
6.5 Nature and contents of container
Primary packaging tablets are packed in PVC / aluminum blisters . Secondary packaging Trittico 75 mg prolonged-release tablets - box of 30 tablets , Trittico 150 mg prolonged-release tablets - box of 20, 60 or 120 pieces
6.6 Recommendations for use
Double- concave scored allows adjustment of an ascending dose prescription.