DOSULEPIN

Dosulepin Tablets 75mg are for oral administration. ADULTS Initially 75 mg/day in divided doses or as a single dose at night, increasing to 150 mg/day. g. in hospital use, dosages up to 225 mg daily have been used. Suggested regimens: 25 to 50 mg three times daily or, alternatively, 75 to 150 mg as a single dose at night.

Should the regimen of 150 mg as a single night-time dose be adopted, it is better to give a smaller dose for the first few days. ELDERLY 50 - 75 mg daily initially. As with any antidepressant, the initial dose should be increased with caution under close supervision.

Half the normal adult dose may be sufficient to produce a satisfactory clinical response. CHILDREN Not recommended.

The following adverse effects, although not necessarily all reported with Dosulepin have occurred with other tricyclic antidepressants. Atropine-like side-effects including dry mouth, disturbances of accommodation, tachycardia, constipation and hesitancy of micturition are common in early treatment, but usually lessen.

Other adverse effects include drowsiness, sweating, postural hypotension, tremor and skin rashes. Interference with sexual function may occur. Serious adverse effects are rare. These include depression of the bone marrow, agranulocytosis, cholestatic jaundice, hypomania and convulsions.

Psychotic manifestations, including mania and paranoid delusions may be exacerbated during treatment with tricyclic antidepressants. Withdrawal symptoms may occur on abrupt cessation of tricyclic therapy and include insomnia, irritability and excessive perspiration.

Similar symptoms in neonates whose mothers received tricyclic antidepressants during the third trimester have also been reported, although this has not been observed following treatment with Dosulepin. 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). 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.

Toxicity in overdose Dosulepin is associated with high mortality in overdose. There is a low margin of safety between the (maximum) therapeutic dose and potentially fatal doses. Onset of toxicity occurs within 4-6 hours. - A limited number of tablets should be prescribed to reduce the risk from overdose for all patients and especially for patients at risk of suicide.

- A maximum prescription equivalent to two weeks supply of 75mg/day should be considered in patients with increased risk factors for suicide at initiation of treatment, during any dosage adjustment and until improvement occurs. 5) - Patients should be advised to store the tablets securely, out of sight and reach of children.

9) The elderly are particularly liable to experience adverse reactions to antidepressants, especially agitation, confusion and postural hypotension. 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.

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.

Recent Myocardial Infarction. Any degree of heart block of other cardiac arrhythmias. Mania. Severe Liver Disease.