Expiration date: 07/2025
Action: antidepressant.
has a central mechanism to overcome the pain, which is primarily manifested by increased pain threshold when the etiology of neuropathic pain syndrome.
Composition: duloxetine hydrochloride equivalent to 30 or 60 mg of duloxetine
Testimony: Depression, diabetic neuropathy (painful form).
Synonyms: Intriv.
Dosing and Administration
Inside. The capsules should be swallowed whole without chewing or crushing. You can not add drug to food or mix it with liquids because This can damage the shell enteric pellets.
Depression. Starting and recommended maintenance dose is 60 mg 1 time a day, regardless of the meal.
In clinical studies, the application dose safety assessment was carried out from 60 to a maximum dose of 120 mg / day. However, no clinical evidence that patients do not respond to the recommended initial dose of any marked improvement with increasing dose was received. Response to therapy is usually observed 2-4 weeks after starting treatment. To prevent relapse after the response to antidepressant therapy recommended to continue the treatment for several months. In patients positively responding to treatment duloxetine, depression with repeated incidents may further history holding term therapy at a dose of 60 to 120 mg / day.
Generalized anxiety disorder. The recommended starting dose in patients with generalized anxiety disorder is 30 mg / day, regardless of the meal. Patients with inadequate response to therapy may increase the dose to 60 mg / day, usual maintenance dose in most patients. In patients with comorbid depression and initial maintenance dose is 60 mg / day (see. Also above recommendations). In clinical studies have demonstrated the efficacy of doses up to 120 mg / day, in addition, such doses were evaluated in terms of safety. Therefore, in patients with insufficient response at a dose of 60 mg may be appropriate to increase the doses of 90 or 120 mg / day. Increasing doses should be carried out based on clinical response and tolerability.
To prevent relapse after the response to therapy is recommended to continue the treatment for several months.
Pain form of peripheral diabetic neuropathy. Starting and recommended maintenance dose is 60 mg once a day 1, regardless of the meal. In clinical studies carried out also safety assessment application doses of 60 to a maximum dose of 120 mg / day, divided into equal doses.
The concentration of duloxetine in plasma is characterized by a large individual variability. Therefore, some patients with insufficient response to the dose of 60 mg / day may be marked improvement in the application of the higher dose. Assessment of response to treatment should be carried out after two months. In patients with insufficient response to the initial response improved after this period of time is unlikely. assessment should be conducted regularly therapeutic effect (at least 1 time in 3 months).
Chronic pain of the musculoskeletal system (including those caused by fibromyalgia, chronic pain in the lower back and in osteoarthritis of the knee joint)
Initial treatment. The recommended dose Simbalta® drug is 60 mg 1 time per day. Therapy can begin with a dose of 30 mg for one week, to allow patients to adapt to the drug before increasing the dose to 60 mg 1 time per day. Evidence that higher doses provide an additional advantage, even absent in patients who do not respond to drug therapy at a dose of 60 mg / day. Higher doses are associated with a high incidence of adverse reactions.
Continued treatment. Efficacy Simbalta® in the treatment of fibromyalgia has been demonstrated in placebo-controlled studies for up to 3 months. Efficiency Simbalta® the drug has not been established in a more long-term studies, but the decision on the continuation of treatment should be based on individual patient response.
In patients with renal failure: the creatinine Cl 30-80 ml / min dose adjustment is required, with creatinine Cl <30 ml / min is contraindicated drug.
Patients with impaired hepatic function: the drug should not be prescribed to patients with liver disease, which led to liver failure.
Age. Older patients for the treatment of generalized anxiety disorder recommended initial dose of 30 mg for 2 weeks before the start of the use of duloxetine in the target dose of 60 mg / day. Further possible application of the drug in doses exceeding 60 mg / day to achieve a good result. Systematic evaluation of the drug at a dose of more than 120 mg / day has not been evaluated. In the application of duloxetine for other indications dose adjustment depending on age is required.
It is recommended to use the drug in patients ?18 years. Duloxetine is not recommended for children under 18 years of age due to insufficient data on its safety and efficacy in this age category of patients.
Abrupt withdrawal of therapy should be avoided. Upon termination of duloxetine treatment the dose should be gradually reduced over 1-2 weeks in order to reduce the risk of "cancellation" syndrome. If after a dose reduction or discontinuation of treatment after having severe symptoms "cancellation" syndrome, it can be considered a continuation of the previously prescribed dose reception. Subsequently, the physician may continue to dose reduction, but more gradually.
Release Form
Enteric capsules 30 mg or 60 mg. On 14 caps. in a blister pack. 1, 2 or 6 plaques. In the paper cartons.
Manufacturer
Produced by:
Eli Lilly and Company, USA. Eli Lilly and Company, Lilly Technology Tsenter, Indianapolis, IN 46285 and 46 US
Lilly del Caribe Inc.., Puerto Rico. Lilly del Caribe Inc.., 12.6 km 65th Infantri Road, Carolina, 00985 Puerto Rico.
Packed: Lilly SA, Spain. Lilly C.A., Avda de la Industry, 30, 28108, Alcobendas, Madrid, Spain.
Storage conditions
At a temperature of 15-30 ° C.
Keep out of the reach of children.
The shelf life: 3 years.
Do not use beyond the expiration date printed on the package.
