Dosulepin hydrochloride

Source: UK SPC (eMC) for Dosulepin capsules 25 mg, §4.2 (https://www.medicines.org.uk/emc/product/101603/smpc). NIGHT-TIME REGIMEN: 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 to 75 mg daily initially; as with any antidepressant the initial dose should be increased with caution under close supervision, and half the normal adult dose may be sufficient to produce a satisfactory clinical response. The elderly are particularly liable to experience adverse effects with antidepressants, especially agitation, confusion and postural hypotension (§4.4). PAEDIATRIC: §4.2 states 'Children: Not recommended' — no paediatric dose is given. Verify any under-18 use against a children's formulary. OVERDOSE SAFETY (§4.4, quoted): '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 those at risk of suicide; a maximum prescription equivalent to two weeks supply of 75 mg/day should be considered in patients with increased risk factors for suicide at initiation of treatment, during any dosage adjustment and until improvement occurs. Patients should be advised to store tablets securely, out of sight and reach of children. ONSET: it may be two to four weeks from the start of treatment before there is an improvement in depression, though the anxiolytic effect may be observed within a few days. CAUTIONS (§4.4): avoid in patients with a history of epilepsy, thyroid disease, mania or urinary retention, and in those with narrow-angle glaucoma or symptoms suggestive of prostatic hypertrophy. The eMC §4.4 was truncated at the source-fetch limit and §4.5 was not retrieved.