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For both trials, efficacy analyses were conducted using 13-week data from the combined Cymbalta 60 mg and 120 mg once daily treatment groups compared to the placebo group.In Study OA-1, for various degrees of improvement in pain from baseline to study endpoint, Cymbalta (duloxetine delayed-release capsules) is available in the following strengths, colors, imprints, and presentations:Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Advise the patient to read the FDA-approved patient labeling (Medication Guide).Copyright © 2004, 2020, Eli Lilly and Company. Patients in the placebo treatment groups in both trials received a matching placebo for the entire duration of trials. Cymbalta demonstrated superiority over placebo as measured by greater improvement in the Pediatric Anxiety Rating Scale (PARS) for GAD severity score The safety and effectiveness of Cymbalta for the treatment of GAD in pediatric patients less than 7 years of age have not been established.Use of Cymbalta for treatment of fibromyalgia in patients 13 to 17 years of age is supported by a 13-week placebo-controlled trial in 184 patients with juvenile fibromyalgia syndrome (Study FM-4). 6X�A�!�����}�A����0�s&?������wd\�p��:�=Fn����@'md��lΐ�0���� �|�Y�l�`i.��c@� �� фͺ Study FM-2 was six months in duration and enrolled male and female patients. The 20 and 60 mg capsules also contain iron oxide yellow.Although the exact mechanisms of the antidepressant, central pain inhibitory and anxiolytic actions of duloxetine in humans are unknown, these actions are believed to be related to its potentiation of serotonergic and noradrenergic activity in the CNS.Preclinical studies have shown that duloxetine is a potent inhibitor of neuronal serotonin and norepinephrine reuptake and a less potent inhibitor of dopamine reuptake. Steady-state plasma concentrations are typically achieved after 3 days of dosing. All rights reserved.Each capsule contains 22.4 mg of duloxetine hydrochloride equivalent to 20 mg duloxetine.Each capsule contains 33.7 mg of duloxetine hydrochloride equivalent to 30 mg duloxetine.Each capsule contains 67.3 mg of duloxetine hydrochloride equivalent to 60 mg duloxetine.The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. <<3b6c1c6c4af24947b97826452b103485>]>> Dosage adjustment based on gender is not necessary.Duloxetine bioavailability (AUC) appears to be reduced by about one-third in smokers.
Neither Cymbalta nor an active control (approved for treatment of pediatric MDD) was superior to placebo.The most frequently observed adverse reactions in the MDD pediatric clinical trials included nausea, headache, decreased weight, and abdominal pain. Following abrupt or tapered discontinuation in adult placebo-controlled clinical trials, the following symptoms occurred at 1% or greater and at a significantly higher rate in Cymbalta-treated patients compared to those discontinuing from placebo: dizziness, headache, nausea, diarrhea, paresthesia, irritability, vomiting, insomnia, anxiety, hyperhidrosis, and fatigue.During marketing of other SSRIs and SNRIs (serotonin and norepinephrine reuptake inhibitors), there have been spontaneous reports of adverse events occurring upon discontinuation of these drugs, particularly when abrupt, including the following: dysphoric mood, irritability, agitation, dizziness, sensory disturbances (e.g., paresthesias such as electric shock sensations), anxiety, confusion, headache, lethargy, emotional lability, insomnia, hypomania, tinnitus, and seizures. In all of these clinical studies, analyses of the relationship between treatment outcome and age, gender, and race did not suggest any differential responsiveness on the basis of these patient characteristics.
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