Duloxetine

Source: UK SPC (eMC) for Cymbalta 30mg hard gastro-resistant capsules, §4.2 (https://www.medicines.org.uk/emc/product/3880/smpc). MAJOR DEPRESSIVE DISORDER: starting and recommended maintenance dose 60 mg once daily with or without food; dosages above 60 mg once daily up to a maximum of 120 mg/day have been evaluated from a safety perspective, but there is no clinical evidence that patients not responding to the initial recommended dose benefit from dose up-titration; therapeutic response is usually seen after 2-4 weeks; after consolidation of the antidepressive response continue treatment for several months to avoid relapse; in responders with a history of repeated episodes of major depression, further long-term treatment at 60 to 120 mg/day could be considered. GENERALISED ANXIETY DISORDER: recommended starting dose 30 mg once daily; if response is insufficient increase to 60 mg, the usual maintenance dose in most patients; in patients with co-morbid major depressive disorder the starting and maintenance dose is 60 mg once daily; doses up to 120 mg/day have been shown to be efficacious, so in patients with insufficient response to 60 mg, escalation to 90 mg or 120 mg may be considered based on clinical response and tolerability. DIABETIC PERIPHERAL NEUROPATHIC PAIN: starting and recommended maintenance dose 60 mg daily with or without food; dosages above 60 mg once daily up to a maximum of 120 mg/day administered in evenly divided doses have been evaluated from a safety perspective; response to treatment should be evaluated after 2 months and additional response after this time is unlikely in patients with inadequate initial response; reassess therapeutic benefit at least every three months. ELDERLY: no dosage adjustment recommended solely on the basis of age, but caution is required, especially with 120 mg per day for major depressive disorder or generalised anxiety disorder, for which data are limited. HEPATIC IMPAIRMENT: must not be used in patients with liver disease resulting in hepatic impairment. PAEDIATRIC (not expressed as a per-kg dose in the SPC): duloxetine should NOT be used in children and adolescents under 18 years for major depressive disorder because of safety and efficacy concerns; safety and efficacy for generalised anxiety disorder in paediatric patients aged 7-17 years have not been established; safety and efficacy for diabetic peripheral neuropathic pain has not been studied and no data are available. Verify any under-18 use against a children's formulary. DISCONTINUATION: abrupt discontinuation should be avoided — reduce the dose gradually over at least one to two weeks to reduce the risk of withdrawal reactions; if intolerable symptoms occur, resuming the previously prescribed dose may be considered, then decreasing more gradually. METHOD OF ADMINISTRATION: for oral use. §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.