TRIMIPRAMINE

Posology Adults:

For depression 50-75 mg/day initially increasing to 150-300 mg/day in divided doses or one dose at night. The maintenance dose is 75-150 mg/day. Elderly: 10-25 mg three times a day initially. The initial dose should be increased with caution under close supervision.

Half the normal maintenance dose may be sufficient to produce a satisfactory clinical response.

Paediatric population:

Not recommended. Method of administration Oral

The following adverse reactions are classified by system organ class and ranked under heading of frequency using the following convention: Common (≥1/100 to <1/10) Rare (≥1/10,000 to <1/1,000) Not known (cannot be estimated from the available data) The following adverse effects, although not necessarily all reported with trimipramine, have occurred with other tricyclic antidepressants:- Atropine-like side effects including dry mouth, disturbance of accommodation, tachycardia, constipation and hesitancy of micturition are common early in treatment but usually lessen.

Other common adverse effects include drowsiness, sweating, postural hypotension, tremor and skin rashes. Interference with sexual function may occur. 4). 4). Nervous system disorders Rare Seizure, Neuropathy peripheral Cardiac disorders Not known Cardiac arrhythmias and severe hypotension are likely to occur with high dosage or in deliberate overdosage.

They may also occur in patients with pre-existing heart disease taking normal dosage. 4). Hepatobiliary disorders Rare Cholestatic jaundice General disorders and administration site conditions Not known Withdrawal syndrome: symptoms may occur on abrupt cessation of therapy and include insomnia, irritability and excessive perspiration.

Adverse effects such as withdrawal symptoms, respiratory depression and agitation have been reported in neonates whose mothers had taken trimipramine during the last trimester of pregnancy. 4). Class effects Epidemiological studies, mainly conducted in patients 50 years of age and older, show an increased risk of bone fractures in patients receiving SSRIs and TCAs.

The mechanism leading to this risk is unknown. Reporting of suspected adverse reaction Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

Suicide/suicidal thoughts or clinical worsening Depression is associated with an increased risk of suicidal thoughts, self-harm and suicide (suicide-related events). This risk persists until significant remission occurs. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs.

It is general clinical experience that the risk of suicide may increase in the early stages of recovery. Other psychiatric conditions for which Trimipramine is prescribed can also be associated with an increased risk of suicide-related events.

In addition, these conditions may be co-morbid with major depressive disorder. The same precautions observed when treating patients with major depressive disorder should therefore be observed when treating patients with other psychiatric disorders.

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 present.

Hyperglycaemia/Diabetes:

Epidemiologic studies have identified an increased risk of diabetes mellitus in depressed patients receiving tricyclic antidepressants. 8). 5). 5). If concomitant treatment with other serotonergic agents is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases.

1. Recent myocardial infarction. Any degree of heart block or other cardiac arrhythmias. Mania. Severe liver disease During breast feeding.