The elimination half-life, however, was similar in both groups. The recommended dosage range is 30 to 60 mg once daily. The no-effect dose was 50 mg/kg/day (1 time the MRHD given to children). The stated frequencies of adverse reactions represent the proportion of patients who experienced, at least once, one treatment-emergent adverse reaction of the type listed. In adult placebo-controlled trials in patients with MDD, activation of mania or hypomania was reported in 0.1% (4/3779) of Cymbalta-treated patients and 0.04% (1/2536) of placebo-treated patients. When Cymbalta and ethanol were administered several hours apart so that peak concentrations of each would coincide, Cymbalta did not increase the impairment of mental and motor skills caused by alcohol. Abruptly stopping a Cymbalta regimen can cause severe withdrawal symptoms that last for several days and can affect a patient’s day-to-day life 1. When switching from another antidepressant to Cymbalta your healthcare provider may want to lower the dose of the initial antidepressant first to potentially avoid side effects. The patients had a baseline BPI of 5.7. Limited data are available on the effects of Cymbalta in patients with end-stage renal disease (ESRD). d Also includes initial insomnia, middle insomnia, and early morning awakening. Some people may have a particularly high risk of having suicidal thoughts or actions. No specific pharmacokinetic study was conducted to investigate the effects of race. Talk to your healthcare provider about the best way to feed your baby while taking Cymbalta. Therefore, an increase in the metabolism of CYP1A2 substrates (e.g., theophylline, caffeine) resulting from induction is not anticipated, although clinical studies of induction have not been performed. If concomitant use of Cymbalta with other serotonergic drugs including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, buspirone, tryptophan, amphetamines, and St. John's Wort is clinically warranted, patients should be made aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases. Caution is advised in using Cymbalta in patients with conditions that may slow gastric emptying (e.g., some diabetics). Subgroup analyses did not indicate that there were differences in treatment outcomes as a function of NSAIDs use. Figure 10: Percentage of Adult Patients with OA Achieving Various Levels of Pain Relief as Measured by 24-Hour Average Pain Severity (Study OA-1). Approximately 13.7% (139/1018) of the Cymbalta-treated patients in placebo-controlled adult trials for GAD discontinued treatment due to an adverse reaction, compared with 5% (38/767) for placebo-treated patients. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. PACKAGE LABEL- Cymbalta 20 mg, bottle of 60. Patients have reported an improvement in as little as a week. Inhibition of the metabolism of CYP2C19 substrates is therefore not anticipated, although clinical studies have not been performed. Anti-depressants like Prozac, Paxil, Zoloft, Lexapro and Effexor are available with a doctor’s prescription. Patients had a mean baseline pain rating of 6 on a numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain). In drug dependence studies, duloxetine did not demonstrate dependence-producing potential in rats. The reporting rate is generally accepted to be an underestimate due to underreporting. Periodically reassess to determine the continued need for maintenance treatment and the appropriate dosage for such treatment. The potential side effects associated with Cymbalta are relatively minor compared to other types of medication 1. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. aspirin, prednisone, trazodone, ibuprofen, tramadol, sertraline, meloxicam, escitalopram, naproxen, alprazolam. Duloxetine is also used to treat pain and tingling caused by diabetic neuropathy (damage to nerves that can develop in people who have diabetes) in adults and fibromyalgia (a long-lasting condition that may cause pain, muscle stiffness and tenderness, tiredness, and difficulty falling asleep or staying asleep) in adults and children 13 years of age and older. Treatment with Cymbalta 60 mg or 120 mg daily statistically significantly improved the endpoint mean pain scores from baseline and increased the proportion of patients with at least a 50% reduction in pain score from baseline. Furthermore, behaviors consistent with increased reactivity, such as increased startle response to noise and decreased habituation of locomotor activity, were observed in pups following maternal exposure to 30 mg/kg/day. Inform patients about the risk of bleeding associated with the concomitant use of Cymbalta and NSAIDs, aspirin, or other drugs that affect coagulation [see Drug Interactions (7.4)]. [See Dosage and Administration (2.9, 2.10), Contraindications (4), and Warnings and Precautions (5.4)]. 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. For some patients, it may be desirable to start at 30 mg once daily for 1 week, to allow patients to adjust to Cymbalta before increasing to 60 mg once daily. Of the 487 patients in OA trials, 41% (197) were 65 years of age or over. Plasma TCA concentrations may need to be monitored and the dose of the TCA may need to be reduced if a TCA is co-administered with Cymbalta. In rats and rabbits treated with duloxetine during the period of organogenesis, fetal weights were decreased but there was no evidence of developmental effects at doses up to 3 and 6 times, respectively, the maximum recommended human dose (MRHD) of 120 mg/day given to adolescents on a mg/m2 basis. Recommended dosages for Cymbalta are essentially the same, no matter what medical condition it’s treating 1. It’s natural to want the symptoms to immediately disappear, but Cymbalta does take some time to work in the body before patients will see results 1. Depression and other serious mental illnesses are the most important causes of suicidal thoughts or actions. After 7 weeks of treatment, Cymbalta-treated patients with less than 30% reduction in average daily pain and who were able to tolerate 60 mg once daily had their Cymbalta dosage, in a double-blinded fashion, increased to 120 mg once daily for the remainder of the trial. Each capsule contains enteric-coated pellets of 20, 30, or 60 mg of duloxetine (equivalent to 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride, respectively). After a week the dosage is increased to 60 mg once daily. The adverse reaction profile observed in clinical trials in pediatric patients aged 7 to 18 years old with MDD and GAD was consistent with the adverse reaction profile observed in adult clinical trials. High bicarbonate, cholesterol, and abnormal (high or low) potassium, were observed more frequently in Cymbalta-treated patients compared to placebo-treated patients. What is the most important information I should know about Cymbalta? Do not give Cymbalta to other people, even if they have the same symptoms that you have. Patients recorded their pain daily in a diary. The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with Cymbalta is unclear. In the pediatric MDD, GAD, and fibromyalgia trials up to 40 weeks long, there were 988 Cymbalta-treated pediatric patients aged 7 to 17 years of age (most patients received 30-120 mg per day) – 35% were 7 to 11 years of age (65% were 12 to 17 years old) and 56% were female. Copyright © 2004, 2020, Eli Lilly and Company. Read this Medication Guide before you start taking Cymbalta® and each time you get a refill. Both CYP1A2 and CYP2D6 are responsible for duloxetine metabolism. In adult placebo-controlled clinical trials, seizures/convulsions occurred in 0.02% (3/12,722) of patients treated with Cymbalta and 0.01% (1/9513) of patients treated with placebo. In all of these clinical trials, 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. Altered anticoagulant effects, including increased bleeding, have been reported when SSRIs or SNRIs are co-administered with warfarin. Cymbalta is a prescription medicine used to treat a certain type of depression called Major Depressive Disorder (MDD). What is the most important information I should know about antidepressant medicines, depression, other serious mental illnesses, and suicidal thoughts or actions? Monitor all pediatric patients being treated with antidepressants for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of treatment, or at times of dosage changes [see Warnings and Precautions (5.1)]. When duloxetine was administered orally to pregnant rats throughout gestation and lactation, the survival of pups to 1 day postpartum and pup body weights at birth and during the lactation period were decreased at a dose of 30 mg/kg/day (2 times the MRHD given to adolescents on a mg/m2 basis); the no-effect dose was 10 mg/kg/day. To enroll, contact the Cymbalta Pregnancy Registry at 1-866-814-6975 or www.Cymbaltapregnancyregistry.com. 10. low salt (sodium) levels in the blood. **Patients with depression and general anxiety disorder have a variety of medication options. Advise families and caregivers of the need for close observation and communication with the prescriber, Drug-Placebo Difference in Number of Cases of Suicidality per 1000 Patients Treated, Percentage of Patients Reporting Reaction, General Disorders and Administration Site Conditions, Respiratory, Thoracic, and Mediastinal Disorders, Musculoskeletal and Connective Tissue Disorders, Respiratory, Thoracic and Mediastinal Disorders, Percentage of Pediatric Patients Reporting Reaction, Diabetic Peripheral Neuropathic Pain (DPNP), Figure 7: Percentage of Pediatric Patients Aged 13 to 17 Years Old with Juvenile Fibromyalgia Syndrome Achieving Various Levels of Pain Relief at Week 12 (Study FM-4), Orthostatic Hypotension, Falls and Syncope, Interference with Psychomotor Performance. Study OA-1: Two hundred fifty-six patients (N=128 on Cymbalta, N=128 on placebo) enrolled and 204 (80%) completed the trial. Mellaril together with Cymbalta can cause serious heart rhythm problems or sudden death. Patients in all trials had no signs of radiculopathy or spinal stenosis. Patients take Cymbalta to rid themselves of their depression, anxiety or body pain 1. Talk to your healthcare provider about the side effects of the medicine prescribed for you or your family member. Women who discontinue antidepressants during pregnancy are more likely to experience a relapse of major depression than women who continue antidepressants. SSRIs and SNRIs, including Cymbalta have been associated with clinically significant hyponatremia in geriatric patients, who may be at greater risk for this adverse reaction [see Warnings and Precautions (5.13)]. Falls with serious consequences including bone fractures and hospitalizations have been reported with Cymbalta use [see Warnings and Precautions (5.3) and Adverse Reactions (6.1)]. Other bleeding events related to SSRI and SNRI use have ranged from ecchymoses, hematomas, epistaxis, and petechiae to life-threatening hemorrhages. Generic Name: duloxetine hydrochloride Under steady-state conditions for Cymbalta (60 mg Q 12 hours) and lorazepam (2 mg Q 12 hours), the pharmacokinetics of duloxetine were not affected by co-administration. In an analysis of data from all placebo-controlled-trials, Cymbalta-treated patients reported a higher rate of falls compared to placebo-treated patients. In the extension phase of these studies, which lasted up to 52 weeks, mean fasting blood glucose increased by 12 mg/dL in the Cymbalta group and decreased by 11.5 mg/dL in the routine care group. Cymbalta is in a class of drugs known to affect urethral resistance. Cymbalta literally has saved my life and my marriage PRAISE GOD!!!!! Your healthcare provider may need to change the dose of Cymbalta until it is the right dose for you. Similar effects would be expected with other potent CYP2D6 inhibitors (e.g., fluoxetine, quinidine) [see Warnings and Precautions (5.12)]. Duloxetine's half-life is similar in men and women. Following is a list of adverse reactions reported by patients treated with Cymbalta in clinical adult trials. In this study, Cymbalta (N=135) demonstrated superiority over placebo (N=137) from baseline to endpoint as measured by greater improvement in the Pediatric Anxiety Rating Scale (PARS) for GAD severity score (see Table 9). The proportion of patients who experienced a clinically significant decrease in weight (≥3.5%) was greater in the Cymbalta group than in the placebo group (16% and 6%, respectively). Cymbalta is a medication approved by the Food and Drug Administration to treat several different health conditions 1. Concomitant administration of warfarin (2-9 mg once daily) under steady state conditions with Cymbalta 60 or 120 mg once daily for up to 14 days in healthy subjects (n=15) did not significantly change INR from baseline (mean INR changes ranged from 0.05 to +0.07). Each capsule contains 33.7 mg of duloxetine hydrochloride equivalent to 30 mg duloxetine. There’s no way to tell when a brain zap will occur so it can happen at a bad time and possibly cause a more dangerous situation if a patient is doing things like driving, exercising or holding a child. Common adverse reactions reported as a reason for discontinuation and considered to be drug-related (as defined above) included nausea (Cymbalta 3.5%, placebo 0.7%), dizziness (Cymbalta 1.2%, placebo 0.4%), and somnolence (Cymbalta 1.1%, placebo 0%). If a dose of Cymbalta is missed, take the missed dose as soon as it is remembered. When Cymbalta was administered (at a dose of 60 mg twice daily) in conjunction with a single 50 mg dose of desipramine, a CYP2D6 substrate, the AUC of desipramine increased 3-fold [see Warnings and Precautions (5.12)]. Antidepressants increased the risk of suicidal thoughts and behavior in pediatric patients. The most frequently observed adverse reactions in the MDD pediatric clinical trials included nausea, headache, decreased weight, and abdominal pain. The information contained on this site is for informational purposes only, and should not be used as a substitute for the advice of a professional health care provider. Doctors can treat several different health issues by prescribing Cymbalta to their patients 1. The recommended Cymbalta dosage is 60 mg once daily in adults with chronic musculoskeletal pain. Concomitant administration of Cymbalta 40 mg twice daily with fluvoxamine 100 mg, a potent CYP1A2 inhibitor, to CYP2D6 poor metabolizer subjects (n=14) resulted in a 6-fold increase in duloxetine AUC and Cmax. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Dosage adjustment based on gender is not necessary. CYP2D6 Inhibitors — Because CYP2D6 is involved in Cymbalta metabolism, concomitant use of Cymbalta with potent inhibitors of CYP2D6 would be expected to, and does, result in higher concentrations (on average of 60%) of Cymbalta [see Drug Interactions (7.2)]. a n=Number of patients with non-missing change score for ASEX total. The major biotransformation pathways for duloxetine involve oxidation of the naphthyl ring followed by conjugation and further oxidation. GAD Trial in Pediatric Patients 7 to 17 Years Old. l Includes increased diastolic blood pressure, increased systolic blood pressure, diastolic hypertension, essential hypertension, hypertension, hypertensive crisis, labile hypertension, orthostatic hypertension, secondary hypertension, and systolic hypertension. In Study GAD-4, 887 patients meeting DSM-IV-TR criteria for GAD received Cymbalta 60 mg to 120 mg once daily during an initial 26-week open-label treatment phase. There is no evidence that doses higher than 60 mg once daily confer additional significant benefit and the higher dosage is clearly less well tolerated. In three clinical trials of Cymbalta for the management of neuropathic pain associated with diabetic peripheral neuropathy [see Clinical Studies (14.4)], the mean duration of diabetes was approximately 12 years, the mean baseline fasting blood glucose was 176 mg/dL, and the mean baseline hemoglobin A1c (HbA1c) was 7.8%. As geriatric patients tend to have a higher prevalence of risk factors for falls such as medications, medical comorbidities and gait disturbances, the impact of increasing age by itself on falls during Cymbalta treatment is unclear. Stopping Cymbalta too quickly or changing from another antidepressant too quickly may result in serious symptoms including: Only some people are at risk for these problems. Store Cymbalta at room temperature between 68°F to 77°F (20°C to 25°C). Duloxetine administered orally to either male or female rats prior to and throughout mating at doses up to 45 mg/kg/day (3 times the MRHD given to adolescents on a mg/m2 basis) did not alter mating or fertility. The peak concentration measured in breast milk occurred at a median of 3 hours after the dose. Recommended Dosage in Adults Less than 65 Years of Age. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Cymbalta and any potential adverse effects on the breastfed child from Cymbalta or from the underlying maternal condition. Fifteen percent of patients were down titrated. All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases. Study OA-2: Two hundred thirty-one patients (N=111 on Cymbalta, N=120 on placebo) enrolled and 173 (75%) completed the trial. Concomitant use of Cymbalta (40 mg once daily) with paroxetine (20 mg once daily) increased the concentration of duloxetine AUC by about 60%, and greater degrees of inhibition are expected with higher doses of paroxetine. SD: standard deviation; SE: standard error; LS Mean: least-squares mean; CI: confidence interval, not adjusted for multiplicity in trials where multiple dose groups were included. The figure is cumulative, so that patients whose change from baseline is, for example, 50%, are also included at every level of improvement below 50%. Only trace (<1% of the dose) amounts of unchanged duloxetine are present in the urine. Table 7 provides the incidence of adverse reactions in a fibromyalgia pediatric placebo-controlled trial (Study FM-4) that occurred in greater than 5% of patients treated with Cymbalta and with an incidence greater than patients treated with placebo [see Clinical Studies (14.5)]. Use of duloxetine in the month before delivery may be associated with an increased risk of postpartum hemorrhage [see Warnings and Precautions (5.5)]. Adverse Reactions in Pooled MDD and GAD Trials in Adults. Duloxetine has no significant affinity for dopaminergic, adrenergic, cholinergic, histaminergic, opioid, glutamate, and GABA receptors in vitro. i Includes feeling jittery, nervousness, restlessness, tension and psychomotor hyperactivity. Both CYP1A2 and CYP2D6 catalyze the oxidation of the naphthyl ring in vitro. d Includes abdominal pain upper, abdominal pain lower, abdominal tenderness, abdominal discomfort, and gastrointestinal pain. Cymbalta belongs to a class of medicines known as SNRIs (or serotonin-norepinephrine reuptake inhibitors). Patients were permitted up to 4 grams of acetaminophen per day as needed for pain, in addition to Cymbalta. It is generally believed (though not established in controlled trials) that treating such an episode with an antidepressant alone may increase the likelihood of precipitation of a mixed/manic episode in patients at risk for bipolar disorder. In adult placebo-controlled clinical trials across the approved adult populations from baseline to endpoint, Cymbalta treatment was associated with mean increases of 0.5 mm Hg in systolic blood pressure and 0.8 mm Hg in diastolic blood pressure compared to mean decreases of 0.6 mm Hg systolic and 0.3 mm Hg diastolic in placebo-treated patients. For more information, ask your healthcare provider or pharmacist. The AUCs of the major circulating metabolites, 4-hydroxy duloxetine glucuronide and 5-hydroxy, 6-methoxy duloxetine sulfate, largely excreted in urine, were approximately 7- to 9-fold higher and would be expected to increase further with multiple dosing. If you miss a dose of Cymbalta, take the missed dose as soon as you remember. In adult placebo-controlled trials, for patients with normal and abnormal baseline ALT values, elevation of ALT >3 times the ULN occurred in 1.25% (144/11,496) of Cymbalta-treated patients compared to 0.45% (39/8716) of placebo-treated patients. While a 120 mg once daily dosage was shown to be effective, there is no evidence that doses greater than 60 mg/day confer additional benefit. Treatment with Cymbalta and any concomitant serotonergic agents, should be discontinued immediately if the above events occur and supportive symptomatic treatment should be initiated. The purpose of this registry is to monitor the pregnancy outcomes in women who have been treated with Cymbalta at any time during pregnancy. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Chronic Low Back Pain: nausea, dry mouth, insomnia, somnolence, constipation, dizziness, and fatigue. As geriatric patients tend to have a higher underlying risk for falls due to a higher prevalence of risk factors such as use of multiple medications, medical comorbidities and gait disturbances, the impact of increasing age by itself is unclear. There is no evidence that higher dosages confer additional benefit, even in patients who do not respond to a 60 mg once daily dosage, and higher dosages are associated with a higher rate of adverse reactions [see Clinical Studies (14.6)]. The safety and effectiveness of Cymbalta for the treatment of GAD in pediatric patients less than 7 years of age have not been established. The total warfarin (protein bound plus free drug) pharmacokinetics (AUCτ,ss, Cmax,ss or tmax,ss) for both R- and S-warfarin were not altered by duloxetine. Cymbalta should be discontinued before initiating treatment with the MAOI [see Dosage and Administration (2.9, 2.10) and Contraindications (4)]. No more extreme lows with suicidal thoughts, sleeping all day long, just wanting life to end. In extremely acidic conditions, Cymbalta, unprotected by the enteric coating, may undergo hydrolysis to form naphthol. The recommended starting dosage in adults with MDD is 40 mg/day (given as 20 mg twice daily) to 60 mg/day (given either once daily or as 30 mg twice daily). In Study MDD-5, 533 adult patients meeting DSM-IV criteria for MDD received Cymbalta 60 mg once daily during an initial 12-week open-label treatment phase. However, fetal weights were decreased at this dose, with a no-effect dose of 10 mg/kg/day (approximately equal to the MRHD in rats and 2 times the MRHD in rabbits). Cymbalta is one of the medications classified as serotonin and norepinephrine reuptake inhibitors (SNRIs. Of the 1,761 patients in FM trials, 8% (140) were 65 years of age or over. There was no significant difference in the frequency of sustained (3 consecutive visits) elevated blood pressure [see Warnings and Precautions (5.3, 5.11)]. If you would like more information, talk with your healthcare provider. Metabolites found in plasma include 4-hydroxy duloxetine glucuronide and 5-hydroxy, 6-methoxy duloxetine sulfate. Cymbalta has not been systematically evaluated in patients with a recent history of myocardial infarction or unstable coronary artery disease. Cymbalta increased the risk of elevation of serum transaminase levels in development program clinical trials. Fibromyalgia: nausea, dry mouth, constipation, somnolence, decreased appetite, hyperhidrosis, and agitation. Underlying risk appears to increase steadily with age. Subsequently, the healthcare provider may continue decreasing the dose but at a more gradual rate [see Dosage and Administration (2.8)]. Adverse reactions reported as a reason for discontinuation and considered to be drug-related (as defined above) included nausea (Cymbalta 2.2%, placebo 1%). Research suggests that taking Cymbalta can cause modest changes in body weight. Recommended Dosage in Pediatric Patients 13 to 17 Years of Age. It’s also important to note that patients must continue their daily use of Cymbalta in order to keep their symptoms at bay 1. Subgroup analyses did not indicate that there were any differences in treatment outcomes as a function of age or gender. After a single 60 mg dose of Cymbalta, Cmax and AUC values were approximately 100% greater in patients with ESRD receiving chronic intermittent hemodialysis than in subjects with normal renal function. The pharmacokinetics of duloxetine after a single dose of 40 mg were compared in healthy elderly females (65 to 77 years) and healthy middle-age females (32 to 50 years). Like all medications, Cymbalta has its advantages and disadvantages 1. Administer 60 mg once daily in adults with diabetic peripheral neuropathic pain. Some people may have a particularly high risk of having suicidal thoughts or actions. Cymbalta is also used to treat or manage: People who take Cymbalta close in time to an MAOI may have a serious problem called Serotonin Syndrome (see “What are the possible side effects of Cymbalta?”). There may be new information. The data below do not include results of the trial that evaluated the efficacy of Cymbalta for the treatment of GAD in patients ≥65 years old (Study GAD-5) [see Clinical Studies (14.3)]; however, the adverse reactions observed in this geriatric population were generally similar to adverse reactions in the overall adult population. Cymbalta-treated female patients did not experience more sexual dysfunction than placebo-treated female patients as measured by ASEX total score. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness). Learn more here. Keep a list of all medicines to show your healthcare provider. Results of in vitro studies demonstrate that duloxetine does not inhibit or induce CYP3A activity. The ASEX scale includes five questions that pertain to the following aspects of sexual function: 1) sex drive, 2) ease of arousal, 3) ability to achieve erection (men) or lubrication (women), 4) ease of reaching orgasm, and 5) orgasm satisfaction. These are not all the possible side effects of Cymbalta. Post-weaning growth was not adversely affected. Subsequently, over the 4- to 6-month uncontrolled extension periods, Cymbalta-treated patients on average trended toward recovery to their expected baseline weight percentile based on population data from age- and sex-matched peers. After 7 weeks of treatment with Cymbalta 60 mg once daily, in Study OA-1 patients with sub-optimal response to treatment (<30% pain reduction) and tolerated Cymbalta 60 mg once daily had their dose increased to 120 mg. Do not open the capsule and sprinkle on food or mix with liquids. Table 4 displays the incidence of adverse reactions that occurred in 2% or more of Cymbalta-treated patients (determined prior to rounding) in the premarketing acute phase of DPNP, FM, OA, and CLBP placebo-controlled adult trials and with an incidence greater than placebo-treated patients. Caution is advised in using Cymbalta in patients with conditions that may slow gastric emptying (e.g., some diabetics). Long-Term Treatment . b Doses statistically significantly superior to placebo. Drug class: serotonin-norepinephrine reuptake inhibitors, Serotonin-norepinephrine reuptake inhibitors, Item 3 — Ability to achieve erection (men); Lubrication (women), blue (opaque blue) , white (opaque white), green (opaque green) , blue (opaque blue), 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE, Generalized anxiety disorder in adults and pediatric patients 7 years of age and older, Diabetic peripheral neuropathic pain in adults, Fibromyalgia in adults and pediatric patients 13 years of age and older, 20 mg opaque green capsules imprinted with “Lilly 3235 20mg”, 30 mg opaque white and blue capsules imprinted with “Lilly 3240 30mg”, 60 mg opaque green and blue capsules imprinted with “Lilly 3270 60mg”, Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults. For various degrees of improvement in pain from baseline to study endpoint, Figures 5 and 6 show the fraction of patients achieving that degree of improvement in Studies FM-1 and FM-2, respectively. Cymbalta has an enteric coating that resists dissolution until reaching a segment of the gastrointestinal tract where the pH exceeds 5.5. Data sources include IBM Watson Micromedex (updated 1 Apr 2021), Cerner Multum™ (updated 5 Apr 2021), ASHP (updated 6 Apr 2021) and others.
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