TRAZODONE

Patients with a history of suicide-related events, or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment are known to be at greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment.

A meta-analysis of placebo- controlled clinical trials of antidepressant drugs in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old.

Close supervision of patients and in particular those at high risk should accompany drug therapy especially in early treatment and following dose changes. Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms are present.

To minimize the potential risk of suicide attempts, particularly at therapy initiation, only restricted quantities of Trazodone hydrochloride should be prescribed at each occasion. It is recommended that careful dosing and regular monitoring is adopted in patients with the following conditions: - Epilepsy, specifically abrupt increases or decreases of dosage should be avoided - Patients with hepatic or renal impairment, particularly if severe - Patients with cardiac disease, such as angina pectoris, conduction disorders or atrioventricular (AV) blocks of different degree, recent myocardial infarction - Hyperthyroidism - Micturition disorders, such as prostate hypertrophy, although problems would not be anticipated as the anticholinergic effect of Trazodone hydrochloride is only minor - Acute narrow angle glaucoma, raised intra-ocular pressure, although major changes would not be anticipated due to the minor anticholinergic effect of Trazodone hydrochloride Should jaundice occur in a patient, Trazodone hydrochloride therapy must be withdrawn.

Severe hepatic disorders with potential fatal outcome have been reported with trazodone use (see adverse reaction section). Patients should be instructed to report immediately signs such as asthenia, anorexia, nausea, vomiting, abdominal pain or icterus to a physician.

Investigations including clinical examination and biological assessment of liver function should be undertaken immediately, and withdrawal of trazodone therapy be considered. Administration of antidepressants in patients with schizophrenia or other psychotic disorders may result in a possible worsening of psychotic symptoms.

Paranoid thoughts may be intensified. During therapy with Trazodone hydrochloride a depressive phase can change from a manic – depressive psychosis into a manic phase. In that case Trazodone hydrochloride must be stopped. g. tricyclic antidepressants, SSRI's, SNRI's and MAO-inhibitors) and neuroleptics.

Malignant neuroleptic syndromes with fatal outcome have been reported in cases of co- administration with neuroleptics, for which this syndrome is a known possible adverse drug reaction. 8 for further information. Since agranulocytosis may clinically reveal itself with influenza-like […]

Close supervision of patients and in particular those at high risk should accompany drug therapy especially in early treatment and following dose changes. Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms are present.

To minimize the potential risk of suicide attempts, particularly at therapy initiation, only restricted quantities of Trazodone hydrochloride should be prescribed at each occasion. It is recommended that careful dosing and regular monitoring is adopted in patients with the following conditions: - Epilepsy, specifically abrupt increases or decreases of dosage should be avoided - Patients with hepatic or renal impairment, particularly if severe - Patients with cardiac disease, such as angina pectoris, conduction disorders or atrioventricular (AV) blocks of different degree, recent myocardial infarction - Hyperthyroidism - Micturition disorders, such as prostate hypertrophy, although problems would not be anticipated as the anticholinergic effect of Trazodone hydrochloride is only minor - Acute narrow angle glaucoma, raised intra-ocular pressure, although major changes would not be anticipated due to the minor anticholinergic effect of Trazodone hydrochloride Should jaundice occur in a patient, Trazodone hydrochloride therapy must be withdrawn.

Severe hepatic disorders with potential fatal outcome have been reported with trazodone use (see adverse reaction section). Patients should be instructed to report immediately signs such as asthenia, anorexia, nausea, vomiting, abdominal pain or icterus to a physician.

Investigations including clinical examination and biological assessment of liver function should be undertaken immediately, and withdrawal of trazodone therapy be considered. Administration of antidepressants in patients with schizophrenia or other psychotic disorders may result in a possible worsening of psychotic symptoms.

Paranoid thoughts may be intensified. During therapy with Trazodone hydrochloride a depressive phase can change from a manic – depressive psychosis into a manic phase. In that case Trazodone hydrochloride must be stopped. g. tricyclic antidepressants, SSRI's, SNRI's and MAO-inhibitors) and neuroleptics.

Malignant neuroleptic syndromes with fatal outcome have been reported in cases of co- administration with neuroleptics, for which this syndrome is a known possible adverse drug reaction. 8 for further information. Since agranulocytosis may clinically reveal itself with influenza-like symptoms, sore throat, and fever, in these cases it is recommended to check haematology.

Hypotension, including orthostatic hypotension and syncope, has been reported to occur in patients receiving Trazodone hydrochloride. Concomitant administration of antihypertensive therapy with Trazodone hydrochloride may require a reduction in the dose of the antihypertensive drug.

Elderly patients may more often experience orthostatic hypotension, somnolence and other anticholinergic effects of trazodone. Careful consideration should be given to the potential for additive effects with concomitant medication use such as with other psychotropics or anti- hypertensives or in the presence of risk factors such as comorbid disease, which may exacerbate these reactions.

It is recommended that the patient/carer is informed of the potential for these reactions and monitored closely for such effects following initiation of therapy, prior to and following upward dose titration. Following therapy with Trazodone hydrochloride, particularly for a prolonged period, an incremental dosage reduction to withdrawal is recommended, to minimise the occurrence of withdrawal symptoms, characterised by nausea, […]