Paroxetine

Source: UK SPC (eMC) for Paroxetine 10 mg Tablets, §4.2 (https://www.medicines.org.uk/emc/product/9582/smpc). MAJOR DEPRESSIVE EPISODE: recommended dose 20 mg daily; improvement generally starts after one week but may only become evident from the second week; dosage should be reviewed and adjusted if necessary within 3 to 4 weeks of initiation and thereafter as judged clinically appropriate; in some patients with insufficient response to 20 mg the dose may be increased gradually up to a maximum of 50 mg a day in 10 mg steps according to response; treat for a sufficient period of at least 6 months to ensure freedom from symptoms. OBSESSIVE COMPULSIVE DISORDER: recommended dose 40 mg daily; start on 20 mg/day and increase gradually in 10 mg increments to the recommended dose; if insufficient response after some weeks, some patients may benefit from gradual increase up to a maximum of 60 mg/day; treatment period may be several months or longer. PANIC DISORDER: recommended dose 40 mg daily; start at 10 mg/day and increase gradually in 10 mg steps according to response (a low initial starting dose is recommended to minimise potential worsening of panic symptomatology early in treatment); maximum 60 mg/day if insufficient response; treatment period may be several months or longer. SOCIAL ANXIETY DISORDER/SOCIAL PHOBIA: recommended dose 20 mg daily; may be increased gradually in 10 mg steps up to a maximum of 50 mg/day; long-term use should be regularly evaluated. GENERALISED ANXIETY DISORDER: recommended dose 20 mg daily; may be increased gradually in 10 mg steps up to a maximum of 50 mg/day. POST-TRAUMATIC STRESS DISORDER: recommended dose 20 mg daily; may be increased gradually in 10 mg steps up to a maximum of 50 mg/day. DISCONTINUATION: abrupt discontinuation should be avoided; the taper regimen used in clinical trials decreased the daily dose by 10 mg at weekly intervals; if intolerable symptoms occur after a dose decrease or on discontinuation, resuming the previously prescribed dose may be considered, then decreasing more gradually. ELDERLY: increased plasma concentrations occur; dosing should commence at the adult starting dose; increasing the dose might be useful in some patients but the maximum should not exceed 40 mg daily. PAEDIATRIC (not expressed as a per-kg dose in the SPC): paroxetine should NOT be used for the treatment of children and adolescents (7-17 years) as controlled clinical trials found it to be associated with increased risk for suicidal behaviour and hostility and efficacy was not adequately demonstrated; use has not been studied in children under 7 years and it should not be used in that age group as safety and efficacy have not been established. Verify any under-18 use against a children's formulary. HEPATIC IMPAIRMENT: increased plasma concentrations occur — dosage should be restricted to the lower end of the dosage range. METHOD OF ADMINISTRATION: once daily in the morning with food; the tablet should not be sucked, chewed or kept in the mouth but swallowed whole immediately with plenty of water (at least 1 glass of 150 ml). §4.5 Interactions was not retrieved in this bundle — the interactions listed below are taken from the §4.3 Contraindications text; verify the full §4.5.