Depressive Disorder: The starting and recommended maintenance
dose is 60 mg once daily with or without food. Dosages above 60 mg
once daily, up to a maximum dose of 120 mg per day have been
evaluated from a safety perspective in clinical trials. However,
there is no clinical evidence suggesting that patients not responding
to the initial recommended dose may benefit from dose up- titrations.
response is usually seen after 2-4 weeks of treatment.
consolidation of the antidepressive response, it is recommended to
continue treatment for several months, in order to avoid relapse. In
patients responding to duloxetine, and with a history of repeated
episodes of major depression, further long-term treatment at a dose
of 60 to 120 mg/day could be considered.
Anxiety Disorder: The recommended starting dose in patients with
generalised anxiety disorder is 30 mg once daily with or without
food. In patients with insufficient response, the dose should be
increased to 60 mg, which is the usual maintenance dose in most
patients with co-morbid major depressive disorder, the starting and
maintenance dose is 60 mg once daily.
up to 120 mg per day have been shown to be efficacious and have been
evaluated from a safety perspective in clinical trials. In patients
with insufficient response to 60 mg, escalation up to 90 mg or 120 mg
may therefore be considered. Dose escalation should be based upon
clinical response and tolerability.
consolidation of the response, it is recommended to continue
treatment for several months, in order to avoid relapse.
Peripheral Neuropathic Pain: The starting and recommended
maintenance dose is 60 mg daily with or without food. Dosages above
60 mg once daily, up to a maximum dose of 120 mg per day administered
in evenly divided doses, have been evaluated from a safety
perspective in clinical trials. The plasma concentration of
duloxetine displays large inter-individual variability. Hence, some
patients that respond insufficiently to 60 mg may benefit from a
to treatment should be evaluated after 2 months. In patients with
inadequate initial response, additional response after this time is
therapeutic benefit should be reassessed regularly (at least every
dosage adjustment is recommended for elderly patients solely on the
basis of age. However, as with any medicine, caution should be
exercised when treating the elderly, especially with Cymbalta 120 mg
per day for major depressive disorder or generalised anxiety
disorder, for which data are limited.
must not be used in patients with liver disease resulting in hepatic
dosage adjustment is necessary for patients with mild or moderate
renal dysfunction (creatinine clearance 30 to 80 ml/min). Cymbalta
must not be used in patients with severe renal impairment (creatinine
clearance <30 ml/min).
should not be used in children and adolescents under the age of 18
years for the treatment of major depressive disorder because of
safety and efficacy concerns.
safety and efficacy of duloxetine for the treatment of generalised
anxiety disorder in paediatric patients aged 7-17 years have not been
established. Current available data are described in sections 4.8,
5.1 and 5.2.
safety and efficacy of duloxetine for the treatment of diabetic
peripheral neuropathic pain has not been studied. No data are
discontinuation should be avoided. When stopping treatment with
Cymbalta the dose should be gradually reduced over a period of at
least one to two weeks in order to reduce the risk of withdrawal
reactions. If intolerable symptoms occur following a decrease in the
dose or upon discontinuation of treatment, then resuming the
previously prescribed dose may be considered. Subsequently, the
physician may continue decreasing the dose, but at a more gradual
[Summary of Product Characteristics]. Utrecht, The Netherlands: Eli
Lilly Nederland B.V.