Patients most commonly report a slight stomachache or nausea after taking Cymbalta 1. Dosage modifications are not recommended for smokers. Study FM-1 was three months in duration and enrolled female patients only. Subgroup analyses did not indicate that there were differences in treatment outcomes as a function of NSAIDs use. Pay close attention to any changes in mood, behavior, actions, thoughts, or feelings, especially sudden changes. 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. All patients in both trials fulfilled the ACR clinical and radiographic criteria for classification of idiopathic OA of the knee. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. 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. The safety and effectiveness of Cymbalta have been established for treatment of generalized anxiety disorder (GAD) in patients 7 to 17 years of age and for treatment of juvenile fibromyalgia syndrome in patients 13 to 17 years of age. Signs and symptoms of hyponatremia include headache, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness, which may lead to falls. Subgroup analyses did not indicate that there were any differences in treatment outcomes as a function of age or gender. After 13 weeks of treatment, none of the three Cymbalta dosages showed a statistically significant difference in pain reduction compared to placebo. The empirical formula is C18H19NOS•HCl, which corresponds to a molecular weight of 333.88. It is not known if these adverse maternal and fetal outcomes are a direct result of fibromyalgia or other comorbid factors. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Approximately 12.9% (117/906) of the Cymbalta-treated patients in placebo-controlled adult trials for DPNP discontinued treatment due to an adverse reaction, compared with 5.1% (23/448) for placebo-treated patients. Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with Cymbalta. It should be noted that Cymbalta is not approved for use in treating bipolar depression. Stopping an antidepressant medicine suddenly can cause other symptoms. Keep Cymbalta and all medicines out of the reach of children. This Medication Guide has been approved by the U.S. Food and Drug Administration. Activation of mania or hypomania has been reported in a small proportion of patients with mood disorders who were treated with other marketed drugs effective in the treatment of major depressive disorder. Cymbalta can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. 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. Epidemiological studies of the case-control and cohort design that have demonstrated an association between use of psychotropic drugs that interfere with serotonin reuptake and the occurrence of upper gastrointestinal bleeding have also shown that concurrent use of an NSAID or aspirin may potentiate this risk of bleeding. Consequently, physicians should carefully evaluate patients for a history of drug abuse and follow such patients closely, observing them for signs of misuse or abuse of Cymbalta (e.g., development of tolerance, incrementation of dose, drug-seeking behavior). People who take Cymbalta close in time to an MAOI may have a serious problem called Serotonin Syndrome (see “. High bicarbonate, cholesterol, and abnormal (high or low) potassium, were observed more frequently in Cymbalta-treated patients compared to placebo-treated patients. Cymbalta literally has saved my life and my marriage PRAISE GOD!!!!! While Cymbalta has not been systematically studied in humans for its potential for abuse, there was no indication of drug-seeking behavior in the clinical trials. The potential side effects associated with Cymbalta are relatively minor compared to other types of medication 1. Learn more here. Patients in all trials had no signs of radiculopathy or spinal stenosis. Cymbalta appears to be associated with concentration-dependent but not clinically meaningful QT shortening. Use of Cymbalta concomitantly with heavy alcohol intake may be associated with severe liver injury. Use of duloxetine in the month before delivery may be associated with an increased risk of postpartum hemorrhage [see Warnings and Precautions (5.5)]. Whether any of the symptoms described above represent such a conversion is unknown. For this reason, Cymbalta should not be prescribed for patients with substantial alcohol use [see Warnings and Precautions (5.2) and Drug Interactions (7.15)]. PACKAGE LABEL- Cymbalta 60 mg, bottle of 30. The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric. i Includes feeling jittery, nervousness, restlessness, tension and psychomotor hyperactivity. Figure 2: Cumulative Proportiona of Adult Patients with GAD Relapse (Study GAD-4). The most commonly observed adverse reactions in Cymbalta-treated patients (as defined above) were: The most commonly observed adverse reactions in Cymbalta-treated patients in all the pooled adult populations (i.e., MDD, GAD, DPNP, FM, OA, and CLBP) (incidence of at least 5% and at least twice the incidence in placebo-treated patients) were nausea, dry mouth, somnolence, constipation, decreased appetite, and hyperhidrosis. Elderly people may be at greater risk for this. Most Common Adverse Reactions in Pediatric Trials. 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. are pregnant or plan to become pregnant. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older [see Warnings and Precautions (5.1)]. f Also includes initial insomnia, insomnia, middle insomnia, and terminal insomnia. The data described below reflect exposure to Cymbalta (N=567) in pediatric patients aged 7 to 18 years of age from two 10-week, placebo-controlled trials in patients with MDD (N=341) (Studies MDD-6 and MDD-7), one 10-week placebo-controlled trial in GAD (N=135) (Study GAD-6), and a 13-week trial in fibromyalgia (N=91). The major biotransformation pathways for duloxetine involve oxidation of the naphthyl ring followed by conjugation and further oxidation. Cymbalta has not been systematically evaluated in patients with a recent history of myocardial infarction or unstable coronary artery disease. 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. Patients enrolled had Type I or II diabetes mellitus with a diagnosis of painful distal symmetrical sensorimotor polyneuropathy for at least 6 months. Discontinuation of Cymbalta should be considered in patients with symptomatic hyponatremia and appropriate medical intervention should be instituted. b Incidence of 120 mg/day is significantly greater than the incidence for 60 mg/day. Antidepressants are medicines used to treat depression and other illnesses. A major depressive episode may be the initial presentation of bipolar disorder. There were suicides in the adult Cymbalta trials, but the number was not sufficient to reach any conclusion about Cymbalta effect on suicide. Neither trial demonstrated a benefit of 120 mg compared to 60 mg, and a higher dosage was associated with more adverse reactions and premature discontinuations of treatment. Drugs that interfere with serotonin reuptake inhibition, including Cymbalta, may increase the risk of bleeding events. If you are experiencing serious medical symptoms, seek emergency treatment immediately. Eventually the dosage reaches 60 mg once per day. All medications pose a risk for side effects and Cymbalta is no exception 1. Most patients received Cymbalta dosages of a total of 60 to 120 mg per day [see Clinical Studies (14)]. If symptoms of urinary hesitation develop during treatment with Cymbalta, consideration should be given to the possibility that they might be drug-related. Disease-associated Maternal and/or Embryo/Fetal Risk. In Study GAD-5, the starting dose was 30 mg once daily for 2 weeks before further dose increases in 30 mg increments at treatment weeks 2, 4, and 7 up to 120 mg once daily were allowed based on investigator judgment of clinical response and tolerability. 2, gelatin, hypromellose, hydroxypropyl methylcellulose acetate succinate, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, and triethyl citrate. 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). In an emergency, call 911. Some patients experienced a decrease in pain as early as week 1, which persisted throughout the trial. There is no evidence that dosages greater than 60 mg/day confer additional benefit, even in patients who do not respond to a 60 mg/day dosage, and higher dosages were associated with a higher rate of adverse reactions. 5. severe skin reactions: Cymbalta may cause serious skin reactions that may require stopping its use. Cymbalta should be discontinued in patients who develop jaundice or other evidence of clinically significant liver dysfunction and should not be resumed unless another cause can be established. It should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome [see Warnings and Precautions (5.4)]. In adult placebo-controlled studies using a fixed dose design, there was evidence of a Cymbalta dose response relationship for ALT and AST elevation of >3 times the ULN and >5 times the ULN, respectively. Copyright © 2009, 2019, Eli Lilly and Company. // Leaf Group Lifestyle. The women were given 40 mg of Cymbalta twice daily for 3.5 days. Find everything you need to know about Cymbalta (duloxetine), including what it is used for, warnings, reviews, side effects, and interactions. Read this Medication Guide before you start taking Cymbalta® and each time you get a refill. Pain reduction was observed in patients both with and without comorbid MDD. All medications pose a risk for side effects and Cymbalta is no exception 1. These effects were observed at the high dose of 45 mg/kg/day (2 times the MRHD, for a child); the no-effect-level was 20 mg/kg/day (≈1 times the MRHD, for a child). Common adverse reactions reported as a reason for discontinuation and considered to be drug-related (as defined above) included nausea (Cymbalta 3.3%, placebo 0.4%), and dizziness (Cymbalta 1.3%, placebo 0.4%). Adult patients were initially treated with Cymbalta 60 mg once daily for eight weeks in open-label fashion. Cymbalta is indicated for the treatment of chronic musculoskeletal pain in adults. There has been a long-standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. 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. Subsequently, completers of this phase were randomized to double-blind treatment with Cymbalta at either 60 mg once daily or 120 mg once daily. Only trace (<1% of the dose) amounts of unchanged duloxetine are present in the urine. For various degrees of improvement in pain from baseline to study endpoint, Figure 7 shows the fraction of patients achieving that degree of improvement in Study FM-4. Patients considering Cymbalta should first understand these pros and cons before starting the medication 1. Each capsule contains 33.7 mg of duloxetine hydrochloride equivalent to 30 mg duloxetine. If a decision is made to increase the dose beyond 60 mg once daily, increase dosage in increments of 30 mg once daily. Cymbalta withdrawal symptoms can range from minor headaches to nausea to nightmares and irritability 1. Take Cymbalta exactly as your healthcare provider tells you to take it. Limited data are available on the effects of Cymbalta in patients with end-stage renal disease (ESRD). PACKAGE LABEL- Cymbalta 30 mg, bottle of 30. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older, In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. In the 12-week acute treatment phase of these studies, Cymbalta was associated with a small increase in mean fasting blood glucose as compared to placebo. The age range in this pooled population was 17 to 89 years of age. Cymbalta (N=91) was initiated at a dosage of 30 mg once daily for one week and titrated to 60 mg once daily for 12 weeks, as tolerated. In an analysis of patients from all placebo-controlled trials, patients treated with Cymbalta reported a higher rate of falls compared to patients treated with placebo. 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. After 13 weeks of treatment, patients taking Cymbalta had significantly greater pain reduction than patients taking placebo. Patients had a mean baseline pain rating of 6 on a numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain). Studies GAD-2 and GAD-3 involved dose titration with Cymbalta doses ranging from 60 mg once daily to 120 mg once daily (N=168 and N=162) compared to placebo (N=159 and N=161) over a 10-week treatment period. The efficacy of Cymbalta in chronic low back pain (CLBP) in adults was assessed in two double-blind, placebo-controlled, randomized clinical trials of 13-weeks duration (Studies CLBP-1 and CLBP-2), and one of 12-weeks duration (CLBP-3). Cymbalta and other antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment or when the dose is changed. 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. Cymbalta must be consumed daily to avoid withdrawal symptoms 1. A total of 457 patients (342 Cymbalta, 115 placebo) were enrolled in Study DPNP-1 and a total of 334 patients (226 Cymbalta, 108 placebo) were enrolled in Study DPNP-2. Cymbalta is in a class of drugs known to affect urethral resistance [see Warnings and Precautions (5.15)]. There may be circumstances when it is necessary to initiate treatment with an MAOI such as linezolid or intravenous methylene blue in a patient taking Cymbalta. Because of the risk of serious ventricular arrhythmias and sudden death potentially associated with elevated plasma levels of thioridazine, Cymbalta and thioridazine should not be co-administered [see Drug Interactions (7.9)]. Common possible side effects in people who take Cymbalta include: 2. changes in blood pressure and falls. 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. Data from published literature report the presence of duloxetine in human milk (see Data). 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. No suicides occurred in any of the pediatric Cymbalta trials. Effect of Food: Food does not affect the Cmax of duloxetine, but delays the time to reach peak concentration from 6 to 10 hours and it marginally decreases the extent of absorption (AUC) by about 10%. Last updated on Nov 1, 2020. There is a median 2 hour lag until absorption begins (Tlag), with maximal plasma concentrations (Cmax) of duloxetine occurring 6 hours post dose. Some patients may benefit from dosages above 60 mg once daily. 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)a. a Pain relief Measured by Brief Pain Inventory – Modified Short Form: Adolescent Version Average Pain Score. Cymbalta is a registered trademark of Eli Lilly and Company. Study OA-2: Two hundred thirty-one patients (N=111 on Cymbalta, N=120 on placebo) enrolled and 173 (75%) completed the trial. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use [see Warnings and Precautions (5.4)]. Patients with clinically evident hepatic impairment have decreased duloxetine metabolism and elimination. Adverse reactions after discontinuation of Cymbalta, after abrupt or tapered discontinuation, include: dizziness, headache, nausea, diarrhea, paresthesia, irritability, vomiting, insomnia, anxiety, hyperhidrosis, and fatigue. Never stop an antidepressant medicine without first talking to a healthcare provider. 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. Patients have reported an improvement in as little as a week. Discontinuation symptoms have been systematically evaluated in patients taking Cymbalta. In extremely acidic conditions, Cymbalta, unprotected by the enteric coating, may undergo hydrolysis to form naphthol. Adverse Reactions in Pediatric Patients Aged 13 to 17 Years Old with Fibromyalgia. Patients treated with Cymbalta (N=151) demonstrated significantly greater improvement compared with placebo (N=140) on mean change from baseline to endpoint as measured by the HAM-A total score (see Table 8). Study DPNP-1 additionally compared Cymbalta 20 mg with placebo. How long does it take for guanfacine to work? Long-Term Treatment . 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. The sources cited below consist of evidence from peer-reviewed journals, prominent medical organizations, academic associations, and government data. Cymbalta must be consumed daily to avoid withdrawal symptoms 1. Provided by (August 2019) It may take four to eight weeks to get the maximum benefit once the right dose is determined. Your healthcare provider may need to change the dose of Cymbalta until it is the right dose for you. 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. Alcohol — Use of Cymbalta concomitantly with heavy alcohol intake may be associated with severe liver injury. In Study MDD-4, patients were randomized to Cymbalta 40 or 60 mg twice daily (N=95 and N=93, respectively) or placebo (N=93) for 8 weeks. Duloxetine has an elimination half-life of about 12 hours (range 8 to 17 hours) and its pharmacokinetics are dose proportional over the therapeutic range. Most (about 70%) of the duloxetine dose appears in the urine as metabolites of duloxetine; about 20% is excreted in the feces. Adverse Reactions Leading to Treatment Discontinuation in Adult Placebo-Controlled Trials. Approximately 17.5% (227/1294) of the Cymbalta-treated patients in 3- to 6-month placebo-controlled adult trials for FM discontinued treatment due to an adverse reaction, compared with 10.1% (96/955) for placebo-treated patients. For most adults less than 65 years of age with GAD, initiate Cymbalta 60 mg once daily. a The inclusion of an event in the table is determined based on the percentages before rounding; however, the percentages displayed in the table are rounded to the nearest integer. Liver transaminase elevations resulted in the discontinuation of 0.3% (92/34,756) of Cymbalta-treated patients. After a single 20 mg dose of Cymbalta, 6 cirrhotic patients with moderate liver impairment (Child-Pugh Class B) had a mean plasma duloxetine clearance about 15% that of age- and gender-matched healthy subjects, with a 5-fold increase in mean exposure (AUC). Some people may have a particularly high risk of having suicidal thoughts or actions. Improvement was also demonstrated on measures of function (Fibromyalgia Impact Questionnaires) and patient global impression of change (PGI). The peak concentration measured in breast milk occurred at a median of 3 hours after the dose. The same study did not find a clinically meaningful increase in the risk for major birth defects in the comparison of 2532 women exposed to duloxetine in the first trimester of pregnancy to 1,284,827 unexposed women after adjusting for several confounders. 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)]. In animal studies, duloxetine did not demonstrate barbiturate-like (depressant) abuse potential. Duloxetine comprises about 3% of the total radiolabeled material in the plasma, indicating that it undergoes extensive metabolism to numerous metabolites. In vitro drug interaction studies demonstrate that duloxetine does not induce CYP1A2 activity. Cymbalta should be prescribed with care in patients with a history of a seizure disorder. In clinical trials of all approved adult populations, 34,756 patients were treated with Cymbalta. Patients should discuss all treatment choices with your healthcare provider, not just the use of antidepressants. If you would like more information, talk with your healthcare provider. Doctors prescribe Cymbalta to treat depression, anxiety, and some chronic pain disorders. If a patient wishes to stop using Cymbalta, then it’s essential that he work with his doctor to taper off the medication 1. Do not use Cymbalta for a condition for which it was not prescribed. Generalized Anxiety Disorder The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. 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. No QT interval prolongation was detected. The risk of falling appears to be related to the degree of orthostatic decrease in blood pressure (BP) as well as other factors that may increase the underlying risk of falls. Most Common Adverse Reactions in Adult Trials. Coumadin, Jantoven, and Mellaril are trademarks of their respective owners and not trademarks of Eli Lilly and Company. After 13 weeks of treatment, patients taking Cymbalta 60-120 mg daily had a significantly greater pain reduction compared to patients taking placebo. In Study GAD-6, the starting dosage was 30 mg once daily for 2 weeks. For depression and general anxiety disorder, the first recommended dosage is 20 mg twice a day. Cymbalta (duloxetine) is a prescription drug for anxiety, pain from diabetic neuropathy, and other conditions. If a decision is made to increase the dose beyond 60 mg once daily, increase dose in increments of 30 mg once daily. The purpose of this registry is to monitor the pregnancy outcomes in women who have been treated with Cymbalta at any time during pregnancy. Negative numbers signify an improvement from a baseline level of dysfunction, which is commonly seen in depressed patients. 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. Cymbalta may: 3. ** Each has its own set of benefits and side effects, just like Cymbalta 1. Some patients experienced a decrease in pain as early as week 1, which persisted throughout the trial. 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. Lea Winters has written professionally since 2003. Use of Cymbalta for the treatment of GAD in patients 7 to 17 years of age is supported by one 10-week, placebo-controlled trial (GAD-6). Symptoms may include: 11. problems with urination. Patients who did not complete the trial were assigned 0% improvement. Call your healthcare provider right away or get emergency help if you have skin blisters, peeling rash, sores in the mouth, hives or any other allergic reactions. The patients had a baseline BPI of 5.7. The efficacy of Cymbalta in the treatment of pediatric patients 7 to 17 years of age with GAD was established in 1 flexible-dose randomized, double-blind, placebo-controlled trial in pediatric outpatients with GAD (based on DSM-IV criteria) (Study GAD-6).
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