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Cymbalta

Generic Cymbalta is an effective medication with highly developed components which is taken in treatment of serious depression and all symptoms connected with depression. Generic Cymbalta is an antidepressant in a group of drugs called selective serotonin and norepinephrine reuptake inhibitors (SSNRIs). Generic Cymbalta affects chemicals in the brain that may become unbalanced and cause depression.

Other names for this medication:

Similar Products:
Lexapro, Elavil, Celexa, Paxil

 

Also known as:  Duloxetine.

Description

Generic Cymbalta is developed by medical scientists to treat major depressive disorder and general anxiety disorder. It is an antidepressant in a group of drugs called selective serotonin and norepinephrine reuptake inhibitors. Generic Cymbalta affects chemicals in the brain that may become unbalanced and cause depression.

Generic Cymbalta is also used to treat a chronic pain disorder called fibromyalgia, treat pain caused by nerve damage in people with diabetes (diabetic neuropathy) and to treat chronic musculoskeletal pain, including discomfort from osteoarthritis and chronic lower back pain.

Dosage

Take Generic Cymbalta with a full glass of water with or without food.

It is recommended to take Generic Cymbalta at the same time each day.

Do not crush, chew, break, or open a delayed-release capsule. Swallow the tablet whole.

If you want to achieve most effective results do not stop using Generic Cymbalta suddenly.

Overdose

If you overdose Generic Cymbalta and you don't feel good you should visit your doctor or health care provider immediately.

Storage

Store at a room temperature between 4 and 30 degrees C (39 and 86 degrees F) away from moisture, light and heat. Throw away the after the expiration date. Keep out of the reach of children.

Side effects

The most common side effects associated with Cymbalta are:

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Side effect occurrence does not only depend on medication you are taking, but also on your overall health and other factors.

Contraindications

Do not take Generic Cymbalta if you are allergic to Generic Cymbalta components.

Do not take Generic Cymbalta if you're pregnant or you plan to have a baby, or you are a nursing mother. This medication can cause birth defects. Tell your doctor right away if you become pregnant during treatment.

Be very careful with Generic Cymbalta if you're pregnant or you plan to have a baby. Do not take Generic Cymbalta if you are breast-feeding.

Do not take Generic Cymbalta together with thioridazine (Mellaril), or an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate). A dangerous drug interaction could occur, leading to serious side effects. You must wait at least 14 days after stopping an MAO inhibitor before you can take Generic Cymbalta. After you stop taking Generic Cymbalta, you must wait at least 5 days before you start taking an MAOI.

Generic Cymbalta can be not safety for children and people younger than 18 years old.

Do not take Generic Cymbalta if you have any of these conditions:liver or kidney disease, seizures or epilepsy, a bleeding or blood clotting disorder, glaucoma, bipolar disorder (manic depression), a history of drug abuse or suicidal thoughts.Be careful if you drive or do anything that requires you to be alert. Generic Cymbalta may impair your thinking or reactions.

Avoid alcohol.

It can be dangerous to stop Generic Cymbalta using suddenly.

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Published evidence on the pathophysiology, diagnosis, and treatment of fibromyalgia is reviewed, with an emphasis on recent clinical trials of various pharmacologic agents.

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Duloxetine and comparator SSRI. Main Outcome Measure Total score on the HAM-D.

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To determine the effect of duloxetine, 60 mg daily, on average pain severity.

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Duloxetine has recently been approved in the USA for chronic musculoskeletal pain, including osteoarthritis and chronic low back pain. The cost effectiveness of duloxetine in osteoarthritis has not previously been assessed. Duloxetine is targeted as post first-line (after acetaminophen) treatment of moderate to severe pain.

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To describe utilization patterns of duloxetine and celecoxib and subsequent opioid use among patients with osteoarthritis.

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Designing medical therapies requires a comprehensive understanding of how the internal and external sphincters are neurologically controlled. In this review recent advances in mapping storage and micturition reflexes, and the association of serotonergic and noradrenergic systems with these reflexes are discussed.

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Serotonin (5-HT) and norepinephrine (NE) are involved in pain modulation via descending inhibitory pathways in the brain and spinal cord.

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The improvement with duloxetine treatment was found in 40 out of 50 patients. Remaining 10 patients did not show any improvement with duloxetine and discontinued the treatment. In 40 patients, the mean baseline IEF was 12.5/week. At the end of three months treatment, IEF was six/week. This shows a statistically significant reduction in the IEF. Also, there was a good improvement in quality of life with 65% of patients in the "very much better" and "much better" categories according to PGI-I scale. In the remaining 10 patients, there was no significant improvement after one month of treatment and patients underwent surgery.

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Various antidepressants are commonly used for the treatment of depression and several other neuropsychiatric disorders. In addition to their primary effects on serotonergic or noradrenergic neurotransmitter systems, antidepressants have been shown to interact with several receptors and ion channels. However, the molecular mechanisms that underlie the effects of antidepressants have not yet been sufficiently clarified. G protein-activated inwardly rectifying K(+) (GIRK, Kir3) channels play an important role in regulating neuronal excitability and heart rate, and GIRK channel modulation has been suggested to have therapeutic potential for several neuropsychiatric disorders and cardiac arrhythmias. In the present study, we investigated the effects of various classes of antidepressants on GIRK channels using the Xenopus oocyte expression assay. In oocytes injected with mRNA for GIRK1/GIRK2 or GIRK1/GIRK4 subunits, extracellular application of sertraline, duloxetine, and amoxapine effectively reduced GIRK currents, whereas nefazodone, venlafaxine, mianserin, and mirtazapine weakly inhibited GIRK currents even at toxic levels. The inhibitory effects were concentration-dependent, with various degrees of potency and effectiveness. Furthermore, the effects of sertraline were voltage-independent and time-independent during each voltage pulse, whereas the effects of duloxetine were voltage-dependent with weaker inhibition with negative membrane potentials and time-dependent with a gradual decrease in each voltage pulse. However, Kir2.1 channels were insensitive to all of the drugs. Moreover, the GIRK currents induced by ethanol were inhibited by sertraline but not by intracellularly applied sertraline. The present results suggest that GIRK channel inhibition may reveal a novel characteristic of the commonly used antidepressants, particularly sertraline, and contributes to some of the therapeutic effects and adverse effects.

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Higher levels of pain severity and depressive symptoms and a US geographical location were significant predictors of relapse in patients with MDD.

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Twenty-three patients with PD with painful phenomena were treated with duloxetine for 6 weeks in an open-label design. Assessments were performed before and at treatment completion and consisted of a Visual Analogue Scale, the Brief Pain Inventory, Short-Form McGill Pain Questionnaire, Parkinson Disease Quality of Life Questionnaire-39-item version, and motor part of the Unified Parkinson Disease Rating Scale. Pain threshold was assessed by quantitative sensory tests.

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To assess the benefits and harms of duloxetine for treating painful neuropathy and different types of chronic pain.

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This double-blind, concurrent-dose-controlled, parallel-design trial contained a variable expected-duration placebo lead-in period and was conducted in adult outpatients with DSM-IV-TR-defined MDD at psychiatric outpatient sites between October 2004 and January 2006. In actuality, patients received placebo for 1 week and then were randomly assigned to duloxetine 30 mg once daily in the morning (q.a.m.) (N = 219), 30 mg twice daily (b.i.d.) (N = 213), or 60 mg q.a.m. (N = 215) for 1 week along with 1 of 2 instructions about food: take study drug with food or do not take within 1 hour of eating. For the remaining 5 weeks of acute treatment, all patients received 60 mg once daily. The primary objective was to compare incidence of treatment-emergent nausea at 30 mg q.a.m. versus 60 mg q.a.m. using item 112 (nausea) of the Association for Methodology and Documentation in Psychiatry adverse event scale (AMDP-5). Secondary outcome measures included mean change on AMDP-5 item 112, discontinuations due to adverse events, mean changes in AMDP-5 items and subscales, spontaneously reported treatment-emergent adverse events, and vital signs. Efficacy was evaluated by the 17-item Hamilton Rating Scale for Depression (HAM-D-17).

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Cost-effectiveness results are sensitive to changes in efficacy parameters and resource use data were collected from physician panel.

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The a priori primary outcome was improvement in the Hamilton Depression Rating Scale (HAMD) item 7 (work/activities). Secondary outcomes included improvement in depressive symptoms assessed by the HAMD Maier subscale, and improvement in functioning assessed by the Sheehan Disability Scale (SDS), and the Social Adaptation Self-evaluation Scale (SASS). Patients were randomly assigned to duloxetine 60 mg/day (Trial I, n = 257; Trial II, n = 261) or placebo (Trial I, n = 127; Trial II, n = 131). Changes from baseline were analyzed using a mixed-effects model repeated measures approach.

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A simple, rapid, and robust liquid chromatography method was developed and validated for the enantiomeric separation of duloxetine in bulk drug substance. The enantiomers of duloxetine were resolved on a Chiralpak AD-H (amylose based stationary phase) column using a mobile phase consisting of n-hexane-ethanol-diethyl amine (80:20:0.2, v/v/v) at a flow rate of 1.0 mL/min. The resolution between the enantiomers was found to be not less than 2.8 in optimized method. The presence of diethyl amine in the mobile phase played an important role in enhancing chromatographic efficiency and resolution between the enantiomers. The developed method was extensively validated and proved to be robust. The calibration curve for (R)-enantiomer showed excellent linearity over the concentration range of 750 ng/mL (LOQ) to 7500 ng/mL. The limit of detection and quantitation for (R)-enantiomer were 250 and 750 ng/mL, respectively. The percentage recovery of the (R)-enantiomer ranged between 98.3% to 101.05% in bulk drug samples of duloxetine. The proposed method was found to be suitable and accurate for quantitative determination of (R)-enantiomer in bulk drug substance.

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A screen-printed disposable electrode system for the determination of duloxetine hydrochloride (DL) was developed using screen-printing technology. Homemade printing has been characterized and optimized on the basis of effects of the modifier and plasticizers. The fabricated bi-electrode potentiometric strip containing both working and reference electrodes was used as duloxetine hydrochloride sensor. The proposed sensors worked satisfactorily in the concentration range from 1.0 × 10-6-1.0 × 10-2 mol L-1 with detection limit reaching 5.0 × 10-7 mol L-1 and adequate shelf life of 6 months. The method is accurate, precise and economical. The proposed method has been applied successfully for the analysis of the drug in pure and in its dosage forms. In this method, there is no interference from any common pharmaceutical additives and diluents. Results of the analysis were validated statistically by recovery studies.

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Calculation of change from baseline to maximum in ECG parameters showed significant differences between treatment groups for all parameters, with decreases from baseline in RR, QRS and QT intervals for patients receiving duloxetine and increases from baseline for patients treated with placebo. These shifts were related to small heart rate changes, but the mean differences were not considered clinically relevant. Categorical analyses of shifts from normal to abnormal (or abnormal to normal) for heart rate and QT corrected for heart rate using Fridericia's formula (QTcF) values showed that most patients did not shift from their baseline category. Patients with MDD who were treated for up to 1 year with duloxetine had blood pressure changes early in treatment that then stabilised. Even in patients with elevated blood pressure at baseline in these clinical trials, no increased risk of sustained blood pressure elevation with duloxetine treatment was found.

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National Basic Research Program of China (973 Program).

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Recent clinical studies show convergence of symptoms (i.e. comorbidity) for incontinence, depression and pain, suggesting common biochemical imbalances. Duloxetine, a dual serotonin and noradrenaline reuptake inhibitor, has a central mechanism of action at different locations in the central nervous system and has proven to be a sound treatment of all these different diseases. Data obtained from animal model studies, randomised placebo-controlled clinical trials, as well as open label trials have provided evidence of the efficacy and safety of duloxetine as a suitable compound for the treatment of stress urinary incontinence in women as well as major depressive disorder and diabetic neuropathic pain in both men and women.

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Chemotherapy-induced peripheral neuropathy (CIPN) is common among cancer patients who undergo chemotherapy with platinum analogues, taxanes, vinca alkaloids, epothilone, bortezomib, and thalidomide. The purpose of this study was to investigate the evidence of using drugs affecting the central nervous system (CNS) to alleviate CIPN in cancer patients.

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Ipsilateral SC injections (2 mg/0.4 mL) of R-duloxetine and N-methyl duloxetine reduced both postoperative allodynia and hyperalgesia by approximately 89% to 99% in the area under the curve of skin responses next to incision over 5 days. Systemic intraperitoneal injections at a higher dosage (10 mg) had smaller analgesic effects (reduced by approximately 53%-69%), whereas contralateral SC injections (10 mg) were ineffective. Both R-duloxetine and N-methyl duloxetine blocked neuronal Na⁺ currents, with a higher affinity for the inactivated than the resting states. In addition, both drugs elicited significant use-dependent block of Na currents when stimulated at 5 Hz.

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Rats were treated with either 4 or 8 mg/kg/d of duloxetine, paroxetine, desipramine, or vehicle via subcutaneous osmotic minipumps for 21 days. Binding sites for serotonin and norepinephrine transporters were measured in amygdala and hippocampus using quantitative autoradiography.

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Normal and abnormal pregnancy outcomes. Abnormal outcomes comprised spontaneous abortion, premature/post-term birth, congenital anomaly, perinatal/post-perinatal complication, still birth, and ectopic pregnancy. Descriptive statistics are provided for LSS data. A disproportionality analysis was performed using the Empirical Bayes Geometric Mean (EBGM) for the AERS data. The lower bound of the 90% confidence interval of EBGM (EB05) ≥1 was used as the threshold to determine disproportionality.

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We report a case of severe hyponatremia related to duloxetine and ziprasidone. A 50-year-old woman on duloxetine and ziprasidone treatment for major depressive disorder developed polydipsia, polyuria, and two episodes of seizures, followed by admission to the emergency department on the 10th day of treatment. Laboratory investigations revealed elevated creatine kinase (CK) as well as hyponatremia, hypo-osmolality, and increased urine sodium. Syndrome of Inappropriate Antidiuretic Hormone (SIADH) was considered, although urine osmolality was not measured. Duloxetine and ziprasidone were discontinued and the CK gradually normalized after correction of hyponatremia. Clinicians should be aware of the possibility of antipsychotic-induced hyponatremia, particularly in patients with symptoms of polydipsia.

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To assess the efficacy and safety of SGAs for the treatment of SAD in adults in comparison with placebo, light therapy, other SGAs or psychotherapy.

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This model found pregabalin 300 mg and 450 mg to be cost effective compared with placebo and, within the limits of available evidence, against duloxetine using standard UK criteria in patients with fibromyalgia experiencing severe pain.

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Using NNT can help predict treatment response in terms of both efficacy and tolerability.

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Efficacy was primarily assessed using the HAMD(17). Safety/tolerability assessments included spontaneously reported adverse events (AEs), overall rates and reasons for discontinuation, laboratory analyses, and vital signs.

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Participants were medication-free MDD patients (n = 32; mean age 40.2 years) in an acute depressive episode and healthy controls matched for age, gender, and IQ (n = 25; mean age 38.8 years). MDD patients received treatment with duloxetine 60 mg daily for 12 weeks with an optional dose increase to 120 mg daily after 8 weeks. All participants had serial imaging at weeks 0, 1, 8, and 12 on a 3 Tesla magnetic resonance imaging (MRI) scanner. Neuroimaging tasks included emotional facial processing, negative attentional bias (emotional Stroop), resting state functional MRI and structural MRI.

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The results of therapy were assessed with a Patient Global Impression of Improvement (PGI-I) questionnaire. One hundred and forty-eight (67%) women were initially treated with 40 mg twice a day, 67 (30%) women were treated with an escalating dose initially at 20 mg twice a day increasing to 40 mg twice a day after 2 weeks and seven (3%) women were started on a dose of 20 mg twice a day which they continued.

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Sixty-eight patients completed the study. They received one of three types of elective spine surgery.

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Among commercially insured patients with DPNP, continuous treatment with duloxetine was associated with a reduction in opioid use between the 12-month pre- and post-index periods compared with treatment with SOC or non-continuous treatment with duloxetine. Duloxetine continuous patients also incurred lower subsequent healthcare costs than non-continuous duloxetine patients.

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Inhibitors of serotonin (5-HT) and/or noradrenaline (NA) reuptake have been developed for pharmacological treatment of major depressive disorder. Insights in the role of 5-HT and NA in the neurological control of the lower urinary tract have also led to their application in common urological conditions such as stress urinary incontinence (SUI), nocturnal enuresis and ejaculatory disorders. The European approval of the 5-HT and NA reuptake inhibitor (SNRI) duloxetine for treatment of SUI underlines the importance of a new approach in SUI, but has also given rise to questions about the safety of antidepressants in urology. This paper reviews the safety of 5-HT and NA reuptake inhibitors in their on- and off-label use in urology. A systematic Medline search was performed for randomised controlled trials, meta-analyses and practice guidelines dealing with antidepressants in urology. The safety profiles of the drugs in the urological population were compared with data from psychiatric populations. Tricyclic antidepressants are associated with serious cardiovascular side effects. In addition, anticholinergic and antihistaminic side effects are common. Although recently questions have been raised regarding the cardiovascular safety profile of venlafaxine, most selective 5-HT reuptake inhibitors and SNRI have not been associated with serious cardiovascular effects. Their most common side effect is nausea. However, nausea tends to be mild and, importantly, transient. Patient counselling about side effects and up-titrating doses may be useful strategies for minimising discomfort and withdrawals.

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Initial responders to duloxetine treatment demonstrated further significant improvement (within-group) in pain, physical function, and quality of life. Significant within-group improvements were also observed in the extension phase for placebo-treated patients who were switched to duloxetine. Duloxetine was well tolerated with no new safety findings reported.

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MDMA produced mydriasis, prolonged the latency, reduced the response to light, and shortened the recovery time. The impaired reflex cymbalta buy response was associated with subjective, cardiostimulant, and hyperthermic drug effects and returned to normal within 6 h after MDMA administration when plasma MDMA levels were still high. Mydriasis was associated with changes in plasma MDMA concentration over time and longer-lasting. Both reboxetine and duloxetine interacted with the effects of MDMA on pupillary function. Clonidine did not significantly reduce the mydriatic effects of MDMA, although it produced miosis when administered alone. Carvedilol and doxazosin did not alter the effects of MDMA on pupillary function.

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To compare opioid utilization and healthcare costs over a 1-year period following cymbalta buy the initiation with duloxetine versus other standard of care (SOC) treatments among patients with diabetic peripheral neuropathic pain (DPNP).

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Painful physical symptoms are common in patients with major depressive disorder (MDD) and may predict poorer treatment outcomes. Duloxetine has demonstrated efficacy in treating both MDD and certain other painful conditions. This randomized, double-blind clinical trial Glucovance Tablet Technology assessed the effects of duloxetine in patients with both MDD and MDD-associated physical pain.

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To provide duloxetine for the treatment of major depressive disorder (MDD), generalized anxiety disorder (GAD), fibromyalgia (FM) and diabetic peripheral neuropathic pain (DPNP) to patients who had previously completed a duloxetine clinical study and for whom, in Ventolin Dose the opinion of the investigator, no effective alternative therapy was available.

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Of the 4 Flagyl Feline Dosage ,517 patients enrolled (mean age: 52.2 years, 71.8% female), 3,320 patients (73.5%) completed the study. 80% of the patients had moderate to severe overall pain (VAS > 30 mm) at baseline. A 50% VAS overall pain reduction after 4 weeks was associated with a 13.32 points higher mean KUSTA score after 6 months, and a 50% pain reduction after 2 weeks with a 6.33 points improvement. No unexpected safety signals were detected in this naturalistic study.

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Patients with MDD treated with duloxetine tended to have a more complex and costly antecedent clinical presentation compared with venlafaxine Diamox Dose Pediatrica XR patients, suggesting that physicians do not use the medications interchangeably.

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Although statistically superior to placebo in efficacy trials, the clinical effects of duloxetine therapy on incontinence are small, suggesting that any benefits to the patient would be modest and must Sporanox With Alcohol be weighed against the drug's adverse event profile. No comparative efficacy/tolerability data with alpha-receptor agonists (eg, pseudoephedrine) are available. On the basis of available data, duloxetine is a modest, but welcome, advance in the pharmacotherapeutic management of stress urinary incontinence.

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Data were combined from two similarly designed, multicenter, randomized, double-blind, parallel group studies in which patients with major depressive disorder were randomized to either duloxetine 60 mg/day or venlafaxine extended release (XR) 150 mg/day (75 mg/day for the first 2 weeks) for a 6-week fixed dosing period followed by an additional 6 weeks of treatment in which the dose could be increased up to 120 mg/day for duloxetine and 225 mg/day for venlafaxine. Patients completing the study (or receiving study drug for 2 weeks or more) were eligible to enter a taper period where the dose of study drug was gradually reduced over 1-2 weeks prior to drug discontinuation. The primary outcome measure (defined a priori) was the GBR comparison of duloxetine 60 mg/day and venlafaxine XR 150 mg/day after 6 weeks of treatment. In the GBR analysis, benefit was defined as remission at endpoint [17-item Hamilton Depression Rating Scale (HAMD17) 7]. Risk was defined by four categories: patients having either no Cytoxan Generic Name adverse events (AEs), AEs with no severity rating greater than moderate, AEs with at least one severity rating of severe, or having discontinued with a reason of self-reported adverse event (regardless of any AE severity). Additional efficacy measures included HAMD17 total score and subscales, HAMA, CGI-S, and PGI-I. Safety and tolerability were assessed via analysis of reasons for discontinuation, treatment-emergent adverse events (TEAEs), discontinuation-emergent adverse events, and changes in vital signs, weight, and laboratory analytes.

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Both the duloxetine (n = 794) and pregabalin (n = 1779) cohorts had a mean age of 56 years, and 58% of female. Common co-morbid conditions among duloxetine and pregabalin patients were cardiovascular disease (82.5 vs. 82.2%), neuropathic pain other than DPNP (71.1 vs. 72.7%), osteoarthritis (39.0 vs. 41.3%), and low back pain (29.4 vs. 30.5%). More than 73% of the patients had opioid use prior to the initiation of duloxetine or pregabalin. Among patients with similar demographic, clinical and economic characteristics, and prior treatment patterns, duloxetine-treated patients had significantly higher Hyzaar 30 Mg MPR (0.34 vs. 0.13), higher proportion of patients with MPR ≥ 0.8 (15.5 vs. 0.7%), and significantly lower total healthcare costs ($34,146 vs. 34,897) over the 12-month post-index period than pregabalin-treated patients (all p < 0.05).

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Patients with MDD treated with duloxetine (n = 9,641) versus venlafaxine XR (n Desyrel 30 Mg = 8,514) tended to be older, slightly more likely to be female, and treated by a psychiatrist (P < 0.0001). In the prior year, more duloxetine patients (vs. venlafaxine XR) received ≥ 3 unique antidepressants (20.8% vs. 16.6%), ≥ 3 unique pain medications (25.5% vs. 15.6%), and had ≥ 8 unique diagnosed comorbid medical and psychiatric conditions (38.6% vs. 29.1%). The prior 6-month total health care costs were $1,731 higher for duloxetine than for venlafaxine XR and declined for both medications in the 6 months after treatment began. Logistic regression analysis revealed that 61% of duloxetine patients and 61% of venlafaxine XR patients were predictable from prior patient and treatment factors.

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Duloxetine is an antidepressant effective for major depressive disorder and also the alleviation of pain for patients with Zyrtec 45 Tablets diabetic peripheral neuropathy, chronic musculoskeletal pain, and fibromyalgia. How duloxetine works in pain relief remains unknown. In this study, we address whether duloxetine could act as an analgesic via systemic and local applications.

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Two chiral methodologies were developed by capillary electrophoresis (CE) with UV and mass spectrometry (MS) detection to ensure the quality control of the drug duloxetine, commercialized as a pure enantiomer. Both methods were optimized to achieve a high baseline enantioresolution (Rs>2) and an acceptable precision (RSD values <5% for instrumental repeatability and <10% for intermediate precision). In addition to allow the unequivocal identification of duloxetine enantiomers, the CE-MS method improved the sensitivity with respect to the use of CE-UV (LOD 200 ng/mL by CE-UV and 20 ng/mL by CE-MS) enabling to detect 0.02% of duloxetine enantiomeric impurity. This is the lowest LOD value ever reported for this drug, being this work the first one enabling to accomplish with the ICH guidelines requirements. The developed methods were validated and applied for the first time to the analysis of four pharmaceutical formulations. The content of R-duloxetine in all these samples was below the detection limit and the Combivir Generic Price amount of S-duloxetine was in good agreement with the labeled content, obtaining results by the two methods that did not differ significantly (p-values >0.05).

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The frequency of TESD at 6 months with duloxetine was comparable to that with SSRI monotherapy (23.4 and 28.7%, respectively; P = 0.087). Improvements in Clinical Global Impressions of Severity (CGI-S), 16-item Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR(16)), Integral Inventory for Depression (IID) total Aciphex Reviews scores, remission and sustained remission rates were statistically significantly greater with duloxetine than SSRI monotherapy at 6 months (P < 0.001 for each), but TESD attenuated improvements in quality of life measures. Four factors were consistently significantly (P ≤ 0.05) associated with TESD at week 8 and 6 months.

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The safety data from this long-term compassionate use study of duloxetine Tofranil Y Alcohol were consistent with previous experience and revealed no new safety signals.

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This randomized, double-blind, placebo-controlled study assessed efficacy and safety of duloxetine in patients with chronic low back pain (CLBP). Adults (n = 401) with a nonneuropathic CLBP and average pain intensity of ≥ 4 on an 11-point numerical scale (Brief Pain Inventory [BPI]) were treated with either duloxetine 60 mg once daily or placebo for 12 weeks. The primary measure was BPI average pain. Secondary endpoints included Patient's Global Impressions of Improvement (PGI-I), Roland Morris Disability Questionnaire (RMDQ-24), BPI-Severity (BPI-S), BPI-Interference (BPI-I), and response rates (either ≥ 30% or ≥ 50% BPI average pain reduction at endpoint). Health outcomes included Short Form-36, European Quality of Life-5 Dimensions, and the Work Productivity and Activity Impairment questionnaire. Safety and tolerability were assessed. Compared with placebo-treated patients, duloxetine-treated patients reported a significantly greater reduction in BPI average pain (P ≤ .001). Similarly, duloxetine-treated patients reported significantly greater improvements in PGI-I, BPI-S, BPI-I, 50% response rates, and some health outcomes. The RMDQ and 30% response rate showed numerical improvements with duloxetine treatment. Significantly more patients in the duloxetine group (15.2%) than patients in the placebo group (5.4%) discontinued because of adverse events (P = .002). Nausea and dry mouth were the most common treatment-emergent adverse events with rates significantly higher in duloxetine-treated patients.

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In data from all 8 studies, duloxetine's advantage over placebo did not differ significantly between melancholic and non-melancholic patients (treatment-by-melancholic status interactions were not statistically significant). Duloxetine demonstrated significantly greater improvement in depressive symptom severity, compared with placebo, within both melancholic and non-melancholic cohorts (p

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The DLX (N=485) and DLX+TI (N=477) groups did not differ significantly at baseline. At study endpoint, remission rates (42.8% vs. 43.5%, P=0.87), response rates (56.6% vs. 58.4%, P=0.58) and other secondary outcomes were similar between the groups. A similar proportion of patients in each group completed the study, and adverse event discontinuation rates were not significantly different (10.7% vs. 13.0%, P=0.318). More AEs were reported by patients in the DLX+TI group, however, and constipation (3.5% vs. 10.1%, P<0.001) and hot flush (0.2% vs. 1.7%, P=0.020) were reported by more DLX+TI patients. Adherence to medication was high (>90% at every visit) in both groups.

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This study investigated hypothesized early symptom changes as differential predictors of long-term remission for duloxetine and escitalopram.

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To assess the benefits and harms of duloxetine for treating painful neuropathy and different types of chronic pain.

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This study aimed to compare the effectiveness of duloxetine (DLX) and the anticonvulsants pregabalin (PGB) and gabapentin (GBP) for the treatment of diabetic peripheral neuropathic pain (DPNP) in routine clinical care.

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Patients age 65 and over with recurrent MDD were stratified by arthritis status and randomized to duloxetine (a dual reuptake-inhibitor of serotonin and norepinephrine) or placebo treatment for 8 weeks (duloxetine, N=117; placebo, N=55).

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Compared with the patients receiving placebo, duloxetine-treated female patients demonstrated a significantly greater improvement in the Brief Pain Inventory (BPI) average pain severity score and in the Fibromyalgia Impact Questionnaire (FIQ) total score, beginning at week 1 and continuing through week 12 (p < 0.001). Duloxetine was superior to placebo on all efficacy measures, including mean tender point threshold, Clinical Global Impression of Severity, Patient Global Impression of Improvement, and average interference from pain scores. The duloxetine-treated group was superior to placebo on all quality of life and functional measures, including each domain of the Medical Outcomes Study Short Form-36 (SF-36). A direct treatment effect of duloxetine on pain reduction was demonstrated and shown to be independent of secondary improvement in mood (based on BPI average pain score). Significantly more duloxetine-treated patients reported treatment-emergent adverse events (296 [90.8%] duloxetine-treated and 165 [77.8%] placebo-treated, p < 0.001). Rates of serious adverse events were similar between duloxetine-treated and placebo-treated patients.

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The safety profile for the molecule from the overall duloxetine exposures integrated safety database suggests that benign and common pharmacologic side effects occur with duloxetine treatment. Because these pooled analyses do not allow for statistical comparison to placebo or active comparator, and include data from five different studied indications, these data do not suggest causality for AEs, nor are they necessarily generalizable to each disease stated studied.

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The PReDICT study's evaluation of biological, psychological, and clinical factors that may differentially impact treatment outcomes represents a sizeable step toward developing personalized treatments for MDD. Identified predictors should help guide the selection of initial treatments, and identify those patients most vulnerable to recurrence, who thus warrant maintenance or combination treatments to achieve and maintain wellness.

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The efficacy and tolerability of Lu AA21004 at 5 mg/day, a novel multimodal antidepressant, were assessed in elderly patients with recurrent major depressive disorder. Patients were randomly assigned (1:1:1) to Lu AA21004 5 mg/day, duloxetine 60 mg/day (reference) or to placebo in an 8-week double-blind study. The primary efficacy measure was the 24-item Hamilton Depression Scale (HAM-D(24)) total score (analysis of covariance, last observation carried forward). Patients (mean age 70.6 years) had a mean baseline HAM-D(24) score of 29.0. Lu AA21004 showed significantly (P = 0.0011) greater improvement on the primary efficacy endpoint compared with placebo at week 8 (3.3 points). Duloxetine also showed superiority to placebo at week 8, thereby validating the study. HAM-D(24) response (53.2 vs. 35.2%) and HAM-D(17) remission (29.2 vs. 19.3%) rates at endpoint were higher for Lu AA21004 than for placebo. Lu AA21004 showed superiority to placebo in cognition tests of speed of processing, verbal learning and memory. The withdrawal rate due to adverse events was 5.8% (Lu AA21004), 9.9% (duloxetine) and 2.8% (placebo). Whereas nausea was the only adverse event with a significantly higher incidence on treatment with Lu AA21004 (21.8%) compared with placebo (8.3%), the incidence of nausea, constipation, dry mouth, hyperhidrosis and somnolence was higher for duloxetine. In conclusion, Lu AA21004 was efficacious and well tolerated in the treatment of elderly patients with recurrent major depressive disorder.

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Serotonin syndrome is gaining attention in perioperative and chronic pain settings due to the growing prevalence of multimodal therapies that increase serotonin levels and thereby heighten patient risk. A patient's genetic make-up may further increase the risk of serotonin syndrome. A case of serotonin syndrome on emergence after general anesthesia is presented. A subsequent cytochrome P4502D6 genetic test result suggested a potential alteration in metabolism. For this patient, who was taking combination antidepressant medications and receiving common perioperative medicines, additive pharmacodynamic effects converged with a pharmacogenetic predisposition, resulting in serotonin syndrome.

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We searched the Cochrane Depression, Anxiety and Neuorosis Review Group's specialised register (CCDANCTR) on the 26 August 2011. The CCDANCTR contains reports of relevant randomised controlled trials from The Cochrane Library (all years), EMBASE (1974 to date), MEDLINE (1950 to date) and PsycINFO (1967 to date). In addition, we searched pharmaceutical industry trials registers via the Internet to identify unpublished trial data. Furthermore, we searched OVID MEDLINE, MEDLINE In-process, EMBASE and PsycINFO to 27July 2011 for publications on adverse effects (including non-randomised studies).

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A total of 683 North American women 22 to 84 years old were enrolled in this double-blind, placebo controlled study. The case definition included a predominant symptom of SUI with a weekly incontinence episode frequency (IEF) of 7 or greater, the absence of predominant symptoms of urge incontinence, normal diurnal and nocturnal frequency, a bladder capacity of 400 ml or greater, and a positive cough stress test and stress pad test. After a 2-week placebo lead-in period subjects were randomly assigned to receive placebo (339) or 80 mg duloxetine daily (344) as 40 mg twice daily for 12 weeks. Primary outcome variables included IEF and an incontinence quality of life questionnaire. Van Elteren's test was used to analyze percent changes in IEF with a stratification variable of weekly baseline IEF (less than 14 and 14 or greater). ANCOVA was used to analyze incontinence quality of life scores.

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Retrospective cohort study.

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Outcomes from a 6-month, observational study with 2575 patients initiating/switching DPNP treatment were analyzed post-hoc. Propensity scoring was used to adjust for baseline factors influencing treatment choice in 1523 patients receiving duloxetine or anticonvulsants. Analysis of covariance models with fixed effects for baseline pain, treatment, propensity score, baseline characteristics or comorbidities, and their interaction with treatment were used to estimate LSmean effects on Brief Pain Inventory (BPI) average pain and interference scores.

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The primary focus was pain and second on adjustment factors and psychiatric symptoms: depression and anxiety. The amount of opioid use presurgery and postsurgery was also evaluated.