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. 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, as well as the emergence of suicidality, and to report such symptoms immediately to health care providers.
Such monitoring should include daily observation by families and caregivers. Prescriptions for CYMBALTA should be written for the smallest quantity of 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. 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.
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 a 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. 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. 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 related 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. 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.
Serotonin Syndrome 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, tryptophan , buspirone, amphetamines, and St.
Serotonin syndrome symptoms may include mental status changes e. Patients should be monitored for the emergence of serotonin syndrome. No reports involved the administration of methylene blue by other routes such as oral tablets or local tissue injection or at lower doses. 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, 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.
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.
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: Although these events are generally self-limiting, some have been reported to be severe. 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. No activation 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.
Angle-Closure Glaucoma The pupillary dilation that occurs following use of many antidepressant drugs including CYMBALTA may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy. There was no significant difference in the frequency of sustained 3 consecutive visits elevated blood pressure.
In a clinical pharmacology study designed to evaluate the effects of CYMBALTA on various parameters, including blood pressure at supratherapeutic doses with an accelerated dose titration, there was evidence of increases in supine blood pressure at doses up to mg twice daily.
At the highest mg twice daily dose, the increase in mean pulse rate was 5. In many cases, this hyponatremia appears to be the result of the syndrome of inappropriate antidiuretic hormone secretion SIADH. Also, patients taking diuretics or who are otherwise volume depleted may be at greater risk [see Use In Specific Populations]. Signs and symptoms of hyponatremia include headache, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness , which may lead to falls.
CYMBALTA has not been systematically evaluated in patients with a recent history of myocardial infarction or unstable coronary artery disease. In the week acute treatment phase of these studies, CYMBALTA was associated with a small increase in mean fasting blood glucose as compared to placebo. HbA1c increased by 0. If symptoms of urinary hesitation develop during treatment with CYMBALTA, consideration should be given to the possibility that they might be drug-related.
In post marketing experience, cases of urinary retention have been observed. Laboratory Tests No specific laboratory tests are recommended. Instruct patients, their families, and their caregivers to read the Medication Guide before starting CYMBALTA and each time their prescription is renewed, and assist them in understanding its contents.
Give patients the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document. Suicidal Thoughts and Behaviors - Encourage patients, their families, and their caregivers to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia psychomotor restlessness , hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down.
Advise families and caregivers of patients to observe for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. CYMBALTA should be swallowed whole and should not be chewed or crushed, nor should the capsule be opened and its contents be sprinkled on food or mixed with liquids. All of these might affect the enteric coating. Instruct patients to talk to their healthcare provider about their alcohol consumption.
Serotonin Syndrome —Caution patients about the risk of serotonin syndrome with the concomitant use of CYMBALTA and other serotonergic agents including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, buspirone, tryptophan, amphetamines, and St.
Advise patients of the signs and symptoms associated with serotonin syndrome that may include mental status changes e. Caution patients to seek medical care immediately if they experience these symptoms. This may need to be treated in a hospital and may be life-threatening. Activation of Mania or Hypomania - Adequately screen patients with depressive symptoms for risk of bipolar disorder e.
Pre-existing glaucoma is almost always open-angle glaucoma because angle-closure glaucoma, when diagnosed, can be treated definitively with iridectomy. Open-angle glaucoma is not a risk factor for angle-closure glaucoma. Patients may wish to be examined to determine whether they are susceptible to angle-closure, and have a prophylactic procedure e.
Pregnancy and Nursing Mothers Advise patients to notify their physician if they: Interference with Psychomotor Performance - Any psychoactive drug may impair judgment, thinking, or motor skills. Although in controlled studies CYMBALTA has not been shown to impair psychomotor performance, cognitive function, or memory, it may be associated with sedation and dizziness.
Duloxetine is used to treat depression and anxiety. In addition, duloxetine is used to help relieve nerve pain peripheral neuropathy in people with diabetes or ongoing pain due to medical conditions such as arthritis , chronic back pain , or fibromyalgia a condition that causes widespread pain.
Duloxetine may improve your mood, sleep , appetite, and energy level, and decrease nervousness. It can also decrease pain due to certain medical conditions. Duloxetine is known as a serotonin -norepinephrine reuptake inhibitor SNRI.
This medication works by helping to restore the balance of certain natural substances serotonin and norepinephrine in the brain. Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start using duloxetine and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Take this medication by mouth as directed by your doctor, usually 1 or 2 times a day with or without food. If you have nausea , it may help to take this drug with food. Swallow the capsule whole. Do not crush or chew the capsule or mix the contents with food or liquid. Doing so can release all of the drug at once, increasing the risk of side effects. The dosage is based on your medical condition and response to treatment. To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose.
Follow your doctor's instructions carefully. Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time s each day.
It is important to continue taking this medication as prescribed even if you feel well. Do not stop taking this medication without consulting your doctor. Some conditions may become worse when this drug is suddenly stopped. Also, you may experience symptoms such as dizziness , confusion , mood swings , headache , tiredness , diarrhea , sleep changes, and brief feelings similar to electric shock. Your dose may need to be gradually decreased to reduce side effects.
Children And Adolescents Ages 7 To 17 Years Duloxetine steady-state plasma concentration was comparable in children 7 to 12 years of ageadolescents 13 to 17 years of age and adults. The risk of similar appears to be related to the degree of orthostatic decrease in blood pressure as well as other factors that may increase the underlying risk of falls. The complete text of the Medication Guide is reprinted at the end of this document. At the highest mg twice daily dose, the increase in mean pulse rate was 5. To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. Do not stop taking this medication without consulting your doctor. HbA1c increased by 0. The dosage is based on your medical condition and response to treatment. The apparent volume of distribution averages about L. In a clinical pharmacology study designed to evaluate the effects of CYMBALTA on various parameters, including blood pressure at supratherapeutic doses with an accelerated cymbalta titration, there was evidence of increases in supine blood pressure at doses up to mg twice daily. Take this medication regularly to get the most benefit from it. Take this medication by mouth as directed by your doctor, usually 1 or 2 times a day with or generic food. Duloxetine has no drug affinity for dopaminergic, adrenergic, cholinergic, histaminergic, opioidglutamateand GABA receptors in vitro, generic drugs similar to cymbalta.
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