Trumio is indicated for the treatment of depressive disorders with or without anxiety or sleep disturbances.
Prolonged-release film-coated tablets containing:
Active ingredient:
Trazodone hydrochloride 150 mg
Excipients:
Mannitol
Hypromellose
Low-substituted hydroxypropyl cellulose
Hypromellose acetate succinate
Stearic acid
Magnesium stearate
Film coating:
Opadry® Yellow 02F22025 (hypromellose, titanium dioxide, macrogol, yellow iron oxide, talc).
Trumio is indicated for the treatment of depressive disorders with or without anxiety or sleep disturbances.
The medicine is intended for adults (18 years and older).
The dosage and duration of treatment depend on the type of disorder and severity of symptoms. Trumio 150 mg tablets can be divided to allow individualized dosing. The dose should be maintained at the minimum effective level that provides a clinical response. If no response is observed, the available dosage range should be used.
Treatment should be initiated with gradual dose escalation and discontinued with gradual dose reduction.
Although the sedative effect usually appears immediately within the first few days, mood improvement may be expected within 1–3 weeks. The average duration of treatment until remission is generally at least 4–6 weeks.
In cases of endogenous depression, after recovery from the depressive episode, continuation of treatment with a reduced maintenance (outpatient) dose for 4–6 months may be necessary to stabilize remission.
The usual trazodone dose is 150–300 mg/day. Treatment should preferably begin with a low dose (50–100 mg/day) and increased gradually. Once the desired effect is achieved, the dose may be carefully reduced to the required maintenance dose.
Maximum daily dose in outpatient settings: 400 mg
Maximum daily dose in hospitalized patients: 600 mg
The use of trazodone is not recommended in children and adolescents under 18 years of age due to insufficient safety data.
Lower doses are generally required for elderly patients (50–150 mg).
For elderly or debilitated patients, the recommended starting dose is 50–100 mg/day in two divided doses or once in the evening. The dose may then be gradually increased by a physician based on tolerability and effectiveness. Single doses exceeding 100 mg should be avoided in such patients. The total daily dose should not exceed 300 mg.
Trazodone is extensively metabolized by the liver and has hepatotoxic potential. Caution is advised when prescribing trazodone to patients with hepatic impairment, especially severe hepatic insufficiency. Regular monitoring of liver function should be considered.
Dose adjustment is generally not required; however, caution is advised in patients with severe renal insufficiency.
For oral use.
Tablets should be swallowed whole without chewing, independently of meals, with a sufficient amount of non-alcoholic liquid (e.g., a glass of water).
The total daily dose may be taken once daily, preferably in the evening, or divided into two doses, with the larger portion taken in the evening.
The daily dose may be divided in elderly and sensitive patients or when exceeding 200 mg/day. Upon discontinuation, the daily dose should be reduced gradually.
* In such cases, the medicine should be used in the appropriate dosage strength.
Limited experience with trazodone use in pregnant women (<200 cases) indicates no adverse effects on pregnancy or the fetus/newborn. No additional epidemiological data are currently available. Animal studies at therapeutic doses have not shown direct or indirect harmful effects on pregnancy, embryo/fetal development, delivery, or postnatal development.
Epidemiological studies suggest that the use of SSRIs during pregnancy, especially in late pregnancy, may increase the risk of persistent pulmonary hypertension of the newborn (PPHN). The observed risk was approximately 5 cases per 1,000 pregnancies, compared with 1–2 cases per 1,000 pregnancies in the general population.
Caution is advised when prescribing trazodone during pregnancy. When trazodone is used before delivery, newborns should be monitored for possible withdrawal symptoms.
Limited data indicate that trazodone secretion into breast milk is low, while levels of its active metabolite are unknown.
Given the limited available data, the decision to use trazodone during breastfeeding should consider the benefits of breastfeeding for the child and the benefits of trazodone therapy for the mother.
Store at temperatures not exceeding 25°C.
Keep out of reach of children.
