Medically reviewed on December 1, Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. 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.
In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [see Warnings and Precautions 5. Do not chew or crush. Do not open the capsule and sprinkle its contents on food or mix with liquids.
All of these might affect the enteric coating. Cymbalta can be given without regard to meals. If a dose of Cymbalta is missed, take the missed dose as soon as it is remembered. If it is almost time for the next dose, skip the missed dose and take the next dose at the regular time. Do not take two doses of Cymbalta at the same time.
Periodically reassess to determine the need for maintenance treatment and the appropriate dose for such treatment [see Clinical Studies Periodically reassess to determine the continued need for maintenance treatment and the appropriate dose for such treatment [see Clinical Studies Cymbalta and body temperature maximum dose studied was mg per day.
Safety of doses above mg once daily has not been adequately evaluated [see Clinical Studies For patients for whom tolerability is a concern, cymbalta and body temperature lower starting dose may be considered. Since diabetes is frequently complicated by renal disease, consider a lower starting dose and gradual increase in dose for patients with renal impairment [see Dosage and Administration 2. Some patients may respond to the starting dose.
Hepatic Impairment — Avoid use in patients with chronic liver disease or cirrhosis [see Warnings and Precautions 5. Adverse reactions after discontinuation of Cymbalta, after abrupt or tapered discontinuation, include: A gradual reduction in dosage rather than abrupt cessation is recommended whenever possible [see Warnings and Precautions 5.
At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with Cymbalta. Conversely, at least 5 days should be allowed after stopping Cymbalta before starting an MAOI intended to treat psychiatric disorders [see Contraindications 4 ]. Do not start Cymbalta in a patient who is being treated with linezolid or intravenous methylene blue because there is an increased risk of serotonin syndrome.
In a patient who requires more urgent treatment of a psychiatric condition, cymbalta and body temperature, other interventions, including hospitalization, should be considered [see Contraindications 4 ]. In some cases, a patient already receiving Cymbalta therapy may require urgent treatment with linezolid or intravenous methylene blue, cymbalta and body temperature.
If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, Cymbalta should be stopped promptly, and linezolid or intravenous methylene blue can be administered.
The patient should be monitored for symptoms of serotonin syndrome for 5 days or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with Cymbalta may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue [see Warnings and Precautions 5. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use [see Warnings and Precautions 5.
The use of Cymbalta within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated [see Dosage and Administration 2. Starting Cymbalta in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome [see Dosage and Administration 2.
Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. 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.
Pooled analyses of short-term placebo-controlled trials of antidepressant drugs SSRIs and others showed that these drugs increase the risk of suicidal thinking and behavior suicidality in children, adolescents, and young adults ages with major depressive disorder MDD and other psychiatric disorders. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction with antidepressants compared to placebo in adults aged 65 and older.
The pooled analyses of placebo-controlled trials in children and adolescents with MDD, obsessive compulsive disorder OCDor other psychiatric disorders included a total of 24 short-term trials of 9 antidepressant drugs in over patients.
The pooled analyses of placebo-controlled trials in adults with MDD or other psychiatric disorders included a total of short-term trials median duration of 2 months of 11 antidepressant drugs in over 77, patients. There was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the younger patients for almost all drugs studied.
There were differences in absolute risk of suicidality across the different indications, with the highest incidence in MDD. The risk of differences drug vs placebohowever, were relatively stable within age strata and across indications.
These risk differences drug-placebo difference in the number of cases of suicidality per patients treated are provided in Table 1. No suicides occurred cymbalta and body temperature any of the pediatric trials.
There were suicides in the adult trials, but the number was not sufficient to reach any conclusion about drug effect on suicide. It is unknown whether the suicidality risk extends to longer-term use, cymbalta and body temperature, i. However, cymbalta and body temperature, there is substantial evidence from placebo-controlled maintenance trials in adults with depression that the use of antidepressants can delay cymbalta and body temperature recurrence of depression.
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. The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia psychomotor restlessnesshypomania, 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.
If the decision has been made to discontinue treatment, medication should be tapered, cymbalta and body temperature, as rapidly as is feasible, but with recognition that discontinuation can be associated with certain symptoms [see Dosage and Administration 2.
Families and caregivers of patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior, and the other symptoms described above, cymbalta and body temperature, as well as the emergence of suicidality, and to report such symptoms immediately to health cymbalta and body temperature providers.
Such monitoring should include daily observation by families and caregivers. Prescriptions for Cymbalta should be written for the smallest quantity clonidine and menopause symptoms capsules consistent with good patient management, in order to reduce the risk of overdose.
Screening Patients for Bipolar Disorder — A major depressive episode may be the initial presentation of bipolar disorder. Whether any of the symptoms described above represent such a conversion is unknown, cymbalta and body temperature.
However, prior to initiating treatment with an antidepressant, patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression. It should be noted that Cymbalta is not approved for use in treating bipolar depression, cymbalta and body temperature.
There have been reports of hepatic failure, sometimes fatal, in patients treated with Cymbalta. These cases have presented as hepatitis with abdominal pain, hepatomegaly, and elevation of transaminase levels to more than twenty times the upper limit of normal with or without jaundice, reflecting cymbalta and body temperature mixed or hepatocellular pattern of liver injury. 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.
Cases of cholestatic jaundice with minimal elevation of transaminase levels have also been reported. Other postmarketing reports indicate that elevated transaminases, bilirubin, and alkaline phosphatase have occurred in patients with chronic liver disease or cirrhosis.
Cymbalta increased the risk of elevation of serum transaminase levels in development program clinical trials. Liver transaminase elevations resulted in the discontinuation of 0.
In most patients, the median time to detection of the transaminase elevation was about two months. Because it is possible that Cymbalta and alcohol may interact to cause liver injury or that Cymbalta may aggravate pre-existing liver disease, Cymbalta should not be prescribed to patients with substantial alcohol use or evidence of chronic liver disease.
Orthostatic hypotension, falls and syncope have been reported with therapeutic doses of Cymbalta. Syncope and orthostatic hypotension tend to occur within the first week of therapy but can occur at any time during Cymbalta treatment, particularly after dose increases. The risk of falling appears to be cymbalta and body temperature to the degree of orthostatic decrease in blood pressure as well as other factors that may increase the underlying risk of falls. 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.
Risk appears to be related to the presence of orthostatic decrease in blood pressure. The risk of blood pressure decreases may be greater in patients taking concomitant medications that induce orthostatic hypotension such as antihypertensives or are potent CYP1A2 inhibitors [see Warnings and Precautions 5.
As elderly 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.
Falls with serious consequences including bone fractures and hospitalizations have been reported [see Adverse Reactions 6. The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs and SSRIs, including Cymbalta, alone but particularly with concomitant use of other serotonergic drugs including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, cymbalta and body temperature, tryptophan, buspirone, amphetamines, and St.
Serotonin syndrome symptoms may include mental status changes e. Patients should be monitored for the emergence of serotonin syndrome, cymbalta and body temperature. The concomitant use of Cymbalta with MAOIs intended cymbalta and body temperature treat psychiatric disorders is contraindicated.
Cymbalta should also not be started in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue. No reports involved the administration of methylene blue by other routes such as oral tablets or local tissue injection or at lower doses.
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.
If concomitant use of Cymbalta with other serotonergic drugs including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, buspirone, tryptophan, amphetamines, and St. Treatment with Cymbalta and any concomitant serotonergic agents, should be discontinued immediately if the above events occur and supportive symptomatic treatment should be initiated. Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs, cymbalta and body temperature, warfarin, and other anti-coagulants may add to this risk.
Case reports and epidemiological studies case-control and cohort design have demonstrated an association between use of drugs that interfere with serotonin reuptake and the occurrence of gastrointestinal bleeding.
Patients should be cautioned about the risk of bleeding associated with the concomitant use of Cymbalta and NSAIDs, aspirin, or other drugs that affect coagulation. The reporting rate of SJS associated with Cymbalta use exceeds the general population background incidence rate for this serious skin reaction 1 to 2 cases per million person years, cymbalta and body temperature. The reporting rate is generally accepted to be an underestimate due to underreporting. Cymbalta should be discontinued at the first appearance of blisters, peeling rash, mucosal erosions, or any other sign of hypersensitivity if no other etiology can be identified.
Discontinuation symptoms have been systematically evaluated in patients taking Cymbalta. During marketing of other SSRIs and SNRIs serotonin and norepinephrine reuptake inhibitorsthere have cymbalta and body temperature spontaneous reports of adverse events occurring upon discontinuation of these drugs, particularly when abrupt, including the following: Although these events are generally self-limiting, some have cymbalta and body temperature reported to be severe.
Patients should be monitored for these symptoms when discontinuing treatment with Cymbalta. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but cymbalta and body temperature a more gradual rate [see Dosage and Administration 2.
In adult placebo-controlled trials in patients with major depressive disorder, activation of mania or hypomania was reported in 0. No cymbalta and body temperature of mania or hypomania was reported in DPNP, GAD, fibromyalgia, or chronic musculoskeletal pain placebo-controlled trials.
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.