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Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Pain
For use in the management of neuropathic pain associated with diabetic peripheral neuropathy and for the management of chronic musculoskeletal pain in patients with chronic low back pain and chronic pain due to osteoarthritis:
Usual Dose: 60 mg once a day without regard to meals.
For patients in whom tolerability is a concern, a lower starting dose may be considered.
Although a 120 mg per day dose was shown to be safe and effective, there is no evidence that doses higher than 60 mg have any additional benefit. Furthermore, the higher dose has been clearly less well tolerated.
Efficacy beyond 12 weeks has not been systematically studied in placebo-controlled studies, but a one year open label safety study has been conducted.
Usual Adult Dose for Depression
Initial Dose: 40 mg per day (administered as 20 mg twice daily) to 60 mg per day (given either once a day or as 30 mg twice daily) without regard to meals.
Usual Adult Dose for Generalized Anxiety Disorder
Initial dose: 60 mg orally once a day If necessary, dosage may be increased in increments of no more than 30 mg per day Maximum dose: 120 mg per day For patients in whom tolerability is a concern, a lower an initial dose of 30 mg orally once a day may be considered. Following one week of therapy, the dose may be increased to 60 mg orally once a day in this patient population. Although a 120 mg per day dose was shown to be safe and effective, there is no evidence that doses higher than 60 mg have any additional benefit.
It is generally agreed that episodes of generalized anxiety disorder require several months or longer of sustained pharmacological therapy. Maintenance of efficacy in generalized anxiety disorder has been demonstrated with duloxetine as monotherapy. Duloxetine should be administered in a dose range of 60 to 120 mg once daily. Patients should be periodically reassessed to determine the continued need for maintenance treatment and the appropriate dose for such treatment.
Usual Adult Dose for Fibromyalgia
Initial Dose: 30 mg once a day without regard to meals for one week.
Usual Dose: 60 mg once a day without regard to meals.
Treatment should begin at 30 mg once daily for 1 week, to allow patients to adjust to the medication before increasing to 60 mg once daily. Some patients may respond to the starting dose. There is no evidence that doses greater than 60 mg/day confer additional benefit, even in patients who do not respond to a 60 mg dose, and higher doses are associated with a higher rate of adverse reactions.
Fibromyalgia is recognized as a chronic condition. The efficacy of duloxetine in the management of fibromyalgia has been demonstrated in placebo-controlled studies up to three months. The efficacy of duloxetine was not demonstrated in longer studies; however, continued treatment should be based on individual patient response.
Renal Dose Adjustments
Use of duloxetine is not recommended in patients with severe renal impairment or end-stage renal disease (CrCl 30 mL/min or less).
Liver Dose Adjustments
Because duloxetine increases the risk of elevation of serum transaminase levels and may aggravate preexisting liver disease, duloxetine should ordinarily not be prescribed to patients with substantial alcohol use or evidence of chronic liver disease.
No dose adjustment is recommended for elderly patients on the basis of age. However, when individualizing the dosage in elderly patients, extra caution is recommended when increasing the dose.
The effectiveness of duloxetine in hospitalized patients with major depressive disorder has not been studied.
The effectiveness of duloxetine in long-term use for major depressive disorder (more than 9 weeks) has not been systematically evaluated in controlled studies. If duloxetine is to be used for extended periods of time, then the long term usefulness of the drug for the individual patient should be periodically evaluated.
Children, adolescents, and young adults (18 to 24 years of age) with major depressive disorder and other psychiatric disorders may be at an increased risk of suicidal thinking and suicidality with antidepressant use, particularly during the first few months of treatment. Medical evidence has not shown this increased risk to exist in adults older than 24 years of age, but adults 65 years of age and older taking antidepressants appear to have a decreased risk of suicidality. The results of a meta-analysis indicate an overall favorable risk to benefit profile for the use of antidepressants (i.e., selective serotonin and/or norepinephrine reuptake inhibitors) in the treatment of pediatric patients (less than 19 years old) with major depressive disorders (MDD), obsessive-compulsive disorder (OCD), or non OCD anxiety disorders. Although this study also reports an overall increased risk of suicidal ideation/suicide attempt associated with the use of antidepressants in pediatric patients, the risk may be less than originally estimated. Additional prospective studies are warranted in order to confirm these findings.
Worsening of depression and/or increased suicidal thinking or behavior may always be a possibility in patients treated with antidepressant medications, particularly those being treated for depression. Anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia (severe restlessness), hypomania, and mania have been reported in patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric. It is unknown if these symptoms are a precursor to either worsening of depression or the emergence of suicidal impulses; however, there is concern that patients who experience one or more of these symptoms may be at increased risk for worsening depression or suicidality. Although the FDA has not concluded that antidepressant drugs cause worsening depression or suicidality, health care providers should be aware that worsening of symptoms could be due to the underlying disease or might be a result of drug therapy.
Health care providers should carefully monitor patients receiving antidepressants for possible and/or persistent worsening of depression or emergent suicidality, especially at the beginning of therapy or when the dose either increases or decreases. If symptoms are severe, abrupt in onset, or were not part of the patient's presenting symptoms, the health care provider will need to determine what intervention, including discontinuing or modifying the current drug therapy, is indicated. Prescriptions should be written for small quantities of drug to reduce the risk of an attempt to overdose. Health care providers should instruct patients, their families and their caregivers to be alert for the emergence of agitation, irritability, and the other symptoms described above, as well as the emergence of suicidality and worsening depression, and to report such symptoms immediately to their health care provider.
Because antidepressants are believed to have the potential for inducing manic episodes in patients with bipolar disorder, there is a concern about using antidepressants alone in this population. Therefore, patients should be adequately screened to determine if they are at risk for bipolar disorder before initiating antidepressant treatment so that they can be appropriately monitored during treatment. Such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression.
The concomitant administration of duloxetine and monoamine oxidase inhibitors is contraindicated.
The development of a potentially life-threatening serotonin syndrome may occur with use of duloxetine, especially with concomitant use of serotonergic drugs (e.g., triptans, tramadol) and drugs which impair metabolism of serotonin (including monoamine oxidase inhibitors). Caution and close monitoring is recommended in any patient in whom the concomitant use of duloxetine with a 5 hydroxytryptamine receptor agonist (triptan) is clinically necessary, especially during initiation of treatment and dose increases. The concomitant use of duloxetine and serotonin precursors (such as tryptophan) is not advised.
Duloxetine should be used cautiously in patients with a history of mania, seizure disorder, or narrow-angle glaucoma.
Duloxetine may alter glycemic control in some patients with diabetes mellitus. Use of duloxetine has been associated with increases in fasting blood glucose and hemoglobin A1c in diabetic patients.
Elevations in blood pressure, orthostatic hypotension, and syncope have been reported following therapeutic doses of duloxetine. Although these events tend to occur within the first week of therapy or after a dose increase, they may occur at any time during treatment. Discontinuation of therapy may be considered in symptomatic patients.
Hyponatremia has been reported in patients receiving duloxetine and it appears to be reversible upon discontinuation. It has occurred most frequently in the elderly and in patients taking diuretics or were otherwise volume depleted.
Concomitant use of duloxetine with potent inhibitors of CYP450 1A2 and CYP450 2D6 may result in increased concentrations of duloxetine. In contrast, duloxetine is known to be a moderate inhibitor CYP450 2D6 activity. Duloxetine should be used with caution when concomitant administration with other drugs that are metabolized by CYP450 2D6 is unavoidable, particularly drugs with a narrow therapeutic index. Plasma levels may need to be monitored and dosing adjustments may be required when these drugs are used concurrently. Use of thioridazine is considered contraindicated with duloxetine. Duloxetine does not appear to significantly affect drugs that are metabolized by CYP450 1A2 or CYP450 3A.
Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).
Hemodialysis: not recommended
Peritoneal dialysis: not recommended
Duloxetine should be swallowed whole and should not be chewed or crushed, nor should the contents be sprinkled on food or mixed with liquids. All of these may affect the enteric coating.
Since duloxetine is rapidly hydrolyzed under acidic conditions, caution is advised in patients with conditions that may slow gastric emptying. There are no data regarding the effect that alterations in gastric motility may have on the stability of duloxetine's enteric coating.
Blood pressure should be measured prior to initiating therapy and periodically throughout treatment.
There are reports of withdrawal symptoms associated with discontinuation of duloxetine and other related agents. It is recommended to gradually taper the dose and to monitor patients for these symptoms when discontinuing treatment. If intolerable symptoms occur, it is recommended to consider resuming the previously prescribed dose and to decrease the dose at a more gradual rate.
Duloxetine may affect urethral resistance. Patients should be monitored for symptoms of urinary hesitation.
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