Pharmacological action - antidepressant.
Dosage and administration
Inside. Capsules should be swallowed whole without chewing or crushing. Do not add the drug to food or mix it with liquids, as it can damage the enteric coating of pellets.Depression. The initial and recommended maintenance dose is 60 mg 1 time per day, regardless of food intake.In clinical studies, safety assessments of doses from 60 to a maximum dose of 120 mg / day were performed.
However, no clinical evidence that patients who did not respond to the initial recommended dose showed any improvement with increasing dose was not obtained. The response to therapy is usually observed 2–4 weeks after the start of treatment. In order to avoid relapse after reaching a response to antidepressant therapy, it is recommended to continue treatment for several months. In patients who respond positively to duloxetine therapy with recurring cases of depression in history, further long-term therapy is possible at a dose of 60 to 120 mg / day. Generalized Anxiety Disorder.
The recommended starting dose for patients with generalized anxiety disorder is 30 mg / day, regardless of the meal. In patients with an insufficient response to therapy, it is possible to increase the dose to 60 mg / day, the usual maintenance dose in most patients. In patients with concomitant depression, the initial and maintenance dose is 60 mg / day (see also recommendations above). During clinical trials, the effectiveness of doses up to 120 mg / day was shown, in addition, such dosages were evaluated from a safety point of view. Therefore, in patients with an insufficient response to a dose of 60 mg, it may be appropriate to increase the dose to 90 or 120 mg / day.
Dose increases should be based on clinical response and tolerance.In order to avoid relapse after reaching a response to therapy, it is recommended to continue treatment for several months.A painful form of peripheral diabetic neuropathy. The initial and recommended maintenance dose is 60 mg 1 time per day, regardless of the meal. During clinical trials, safety assessments of doses from 60 to a maximum dose of 120 mg / day, divided into equal doses, were also performed.The concentration of duloxetine in plasma is characterized by significant individual variability.
Therefore, some patients with an insufficient response to a dose of 60 mg / day may experience improvements when using a higher dose. Assessment of response to therapy should be carried out after 2 months. In patients with insufficient initial response, an improvement in response after this period of time is unlikely. The therapeutic effect should be regularly evaluated (at least 1 time in 3 months). Chronic pain of the musculoskeletal system (including due to fibromyalgia, chronic pain in the lower back and with osteoarthritis of the knee joint).
Initial treatment. The recommended dose of the drug Simbalta® is 60 mg once a day. Therapy can be started with a dose of 30 mg for 1 week to allow patients to adapt to the drug before increasing the dose to 60 mg once a day. Evidence that higher doses provide an added benefit is not even in patients who do not respond to 60 mg / day. Higher doses are associated with a high incidence of adverse reactions.
Continuation of treatment. The effectiveness of the drug Simbalta in the treatment of fibromyalgia has been demonstrated in placebo-controlled studies lasting up to 3 months. The effectiveness of the drug Symbalta® has not been established in longer studies, however, the decision to continue treatment should be based on the individual response of the patient.In patients with renal failure: with Cl creatinine 30–80 ml / min dose adjustment is not required, with Cl creatinine <30 ml / min, the use of the drug is contraindicated. In patients with impaired liver function: the drug can not be prescribed to patients with liver diseases that led to liver failure.
Age. For elderly patients, for the treatment of generalized anxiety disorder, an initial dose of 30 mg is recommended for 2 weeks before starting the use of duloxetine in a target dose of 60 mg / day. In the future, it is possible to use the drug in a dose of over 60 mg / day to achieve a good result. A systematic assessment of taking the drug in a dose of over 120 mg / day was not carried out. When using duloxetine for other indications, dose adjustment depending on age is not required.The use of the drug in patients ≥18 years of age is recommended. Duloxetine is not recommended for children under 18 years of age due to insufficient data on its safety and efficacy in this age group of patients.
Abrupt withdrawal of therapy should be avoided. Upon termination of treatment with duloxetine, the dose should be gradually reduced over 1–2 weeks in order to reduce the risk of “withdrawal” syndrome. If, after a dose reduction or after discontinuation of treatment, pronounced symptoms of “withdrawal” syndrome occur, then continued administration of the previously prescribed dose may be considered. Subsequently, the doctor may continue to reduce the dose, but even more gradually.