Trittico XR tablets are used for the following indications: depressive disorders with / without anxiety.
The active ingredient is trazodone hydrochloride (one tablet contains 300 mg of trazodone hydrochloride).
Excipients: hypromellose, anhydrous colloidal silicon dioxide, sodium stearyl fumarate, modified pregelatinized starch (E 1442).
Shell composition: mixture for coating "Opadry® II, Pink 85F94306" (polyvinyl alcohol, talc, macrogol, titanium dioxide (E 171), iron oxide yellow (E 172), iron oxide red (E172)).
This medicinal product is intended for use by adults only.
The tablets can be divided, which allows for a gradual dose increase depending on the severity of the disease, body weight, age and general condition of the patient.
Tablets should be taken before meals with a glass of water when applied once a day, it is advisable to take the preparation in the evening or just before bedtime.
To ensure the prolonged action of the tablets, they should not be crushed or chewed; if necessary, divide the tablets by pressing the halves of the tablet on either side of the center line of fracture on both sides
Adult patients: the initial dose of the preparation is 75-150 mg per day and may be increased by 75 mg per day every three days (for example, up to 225 mg per day on the fourth day of treatment) to a maximum dose of 300 mg per day in one dose.
The long-term efficacy of extended-release trazodone in maintaining antidepressant effects has not been studied.
Pregnant
Pregnant women should use this preparation with caution. If trazodone is used by a pregnant woman, the baby's condition should be monitored after childbirth to identify a possible withdrawal syndrome, taking into account the benefit to the mother / risk to the fetus ratio.
Limited data indicate that trazodone passes into breast milk in small quantities, but the content of the active metabolite is unknown. Due to insufficient data, the decision to prolong / discontinue breastfeeding or to continue / discontinue trazodone therapy should be made taking into account the benefits of breastfeeding for the baby and the benefits of trazodone therapy for the mother.
Children
Do not use for children.
Drivers
Slight to moderate trazodone affects the ability to drive and operate other machinery. Patients should be warned that, before driving and operating other mechanisms, it is necessary to make sure that there is no drowsiness, sedation, dizziness, confusion or blurred vision while taking trazodone.
Most often, with an overdose, drowsiness, dizziness, nausea and vomiting are observed. In complex cases, coma, tachycardia, arterial hypotension, hyponatremia, convulsions and respiratory failure occurred.
Cardiac symptoms may include bradycardia, prolongation of the QT interval, and polymorphic ventricular tachycardia (torsade de pointes).
Symptoms may appear within 24 hours of an overdose or later.
Simultaneous overdose of trazodone and other antidepressants can cause serotonin syndrome.
There is no specific antidote. Adults who have taken more than 1 g of trazodone, or children who have taken more than 150 mg of trazodone, should be given activated charcoal within 1 hour after an overdose is detected. In other cases, in adults, gastric lavage may be appropriate for 1 hour after taking potentially life-threatening doses.
It is necessary to monitor the patient's condition for at least 6 hours after taking the preparation (or 12 hours when taking a sustained-release preparation). Blood pressure, pulse, and the Glasgow Coma Scale (GCS) should be monitored. In case of a decrease in the number of points on the GCS, the oxygen saturation of the blood should be monitored.
In symptomatic patients, cardiac monitoring is necessary.
When some short-term seizures appear, treatment is not required. For frequent or prolonged seizures, intravenous diazepam (0.1-0.3 mg / kg body weight) or lorazepam (4 mg for adults and 0.05 mg / kg for children) is prescribed.
If these measures do not control seizures, intravenous infusion of phenytoin may be appropriate. If necessary, oxygen is used and the acid-base balance and metabolic disorders are corrected.
In the case of arterial hypotension and excessive sedation, symptomatic and supportive therapy is used. If severe arterial hypotension persists, the advisability of using inotropic preparations, for example, dopamine or dobutamine, should be weighed.
Cases of suicidal ideation and suicidal behavior have been reported during or shortly after trazodone therapy.
The introductory part of the instructions is given, read the full instructions inside the package.
This medicinal product does not require any special storage conditions. Half a tablet can be stored for 24 hours in its primary container to protect it from light.
Shelf life is 4 years.
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