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Chemical Name: Duloxetine
Duloxetine (duloxetine hydrochloride) is a selective serotonin and norepinephrine reuptake
inhibitor (SSNRI) for oral administration.
Duloxetine should be administered at a total dose of 40 mg/day (given as 20 mg twcie daily) to
60 mg/day (given either once a day or as 30 mg BID) without regard to meals.
There is no evidence that doses greater than 60 mg/day confer any additional benefits.
Duloxetine has also demonstrated rapid relief of anxiety symptoms associated with depression that was sustained for the length of the study period, according to new data published in the journal Depression and Anxiety. In clinical studies, researchers attribute the Duloxetine effect on a broad spectrum of depression symptoms, which include emotional and painful physical symptoms as well as anxiety, to Duloxetine dual reuptake inhibition of both serotonin and norepinephrine.
Duloxetine is indicated for the treatment of major depressive disorder (MDD).
Patients and their families should be encouraged to be alert to the emergence of anxiety,
agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia, hypomania, mania,
worsening of depression, and suicidal ideation, especially early during antidepressant treatment.
Such symptoms should be reported to the patient's physician, especially if they are severe, abrupt
in onset, or were not part of the patient's presenting symptoms.
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 might affect the enteric coating.
Any psychoactive drug may impair judgment, thinking, or motor skills. Although in controlled
studies duloxetine has not been shown to impair psychomotor performance, cognitive function,
or memory, it may be associated with sedation. Therefore, patients should be cautioned about
operating hazardous machinery including automobiles, until they are reasonably certain that
duloxetine therapy does not affect their ability to engage in such activities.
The efficacy of Duloxetine has been established in 8- and 9-week placebo-controlled trials of
outpatients who met DSM-IV diagnostic criteria for major depressive disorder.
A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly
every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily
functioning, and includes at least 5 of the following 9 symptoms: depressed mood, loss of
interest in usual activities, significant change in weight and/or appetite, insomnia or
hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or
worthlessness, slowed thinking or impaired concentration, or a suicide attempt or suicidal
The effectiveness of Duloxetine in hospitalized patients with major depressive disorder has not
The effectiveness of Duloxetine in long-term use for major depressive disorder, that is, for more
than 9 weeks, has not been systematically evaluated in controlled trials. The physician who elects
to use Duloxetine for extended periods should periodically evaluate the long-term usefulness of
the drug for the individual patient.
Cymbalta Side Effects:
DULOXETINE is associated with the following side effects: Nausea, Dry mouth, Constipation, Diarrhea,
Vomiting, Metabolism and Nutrition Disorders, Appetite decreased, Weight decreased, Fatigue, Dizziness, Somnolence,Tremor, Sweating increased, hot flushes, Vision blurred, Insomnia, Anxiety, Libido decreased, Orgasm abnormal, Erectile dysfunction, delayed ejaculation.
Concomitant use of Duloxetine in patients taking monoamine oxidase inhibitors (MAOIs) is contraindicated. In clinical trials, duloxetine use was associated with an increased risk of mydriasis; therefore, its use should be avoided in patients with uncontrolled narrow-angle glaucoma.
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. Steady-state plasma
concentrations are typically achieved after 3 days of dosing. Elimination of duloxetine is mainly
through hepatic metabolism involving two P450 isozymes, CYP2D6 and CYP1A2.
Patients with major depressive disorder, both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality), whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Although there has been a long-standing concern that antidepressants may have a role in inducing worsening of depression
and the emergence of suicidality in certain patients, a causal role for antidepressants in inducing
such behaviors has not been established. Nevertheless, patients being treated with
antidepressants should be observed closely for clinical worsening and suicidality, especially
at the beginning of a course of drug therapy, or at the time of dose changes, either increases
or decreases. Consideration should be given to changing the therapeutic regimen, including
possibly discontinuing the medication, in patients whose depression is persistently worse or
whose emergent suicidality is severe, abrupt in onset, or was not part of the patient’s presenting
Because of the possibility of co-morbidity between major depressive disorder and other
psychiatric and nonpsychiatric disorders, the same precautions observed when treating patients
with major depressive disorder should be observed when treating patients with other psychiatric
and nonpsychiatric disorders.
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.
Although a causal link between the emergence of such symptoms and either the worsening of
depression and/or the emergence of suicidal impulses has not been established, consideration
should be given to changing the therapeutic regimen, including possibly discontinuing the
medication, in patients for whom such symptoms are severe, abrupt in onset, or were not part of
the patient’s presenting symptoms.
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, and
the other symptoms described above, as well as the emergence of suicidality, and to report
such symptoms immediately to health care providers. Prescriptions for Duloxetine should be
written for the smallest quantity of capsules consistent with good patient management, in order to
reduce the risk of overdose.
If the decision has been made to discontinue treatment, medication should be tapered, as
rapidly as is feasible, but with recognition that abrupt discontinuation can be associated with
A major depressive episode may be the initial presentation of bipolar disorder. 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. Whether any of the symptoms described above represent
such a conversion is unknown. However, prior to initiating treatment with an antidepressant,
patients 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 Duloxetine is not approved for use in
treating bipolar depression.
Monoamine Oxidase Inhibitors (MAOI) — In patients receiving a serotonin reuptake
inhibitor in combination with a monoamine oxidase inhibitor, there have been reports of
serious, sometimes fatal, reactions including hyperthermia, rigidity, myoclonus, autonomic
instability with possible rapid fluctuations of vital signs, and mental status changes that
include extreme agitation progressing to delirium and coma. These reactions have also been
reported in patients who have recently discontinued serotonin reuptake inhibitors and are
then started on an MAOI. Some cases presented with features resembling neuroleptic
malignant syndrome. The effects of combined use of duloxetine and MAOIs have not been
evaluated in humans or animals. Therefore, because duloxetine is an inhibitor of both
serotonin and norepinephrine reuptake, it is recommended that duloxetine not be used in
combination with an MAOI, or within at least 14 days of discontinuing treatment with an
MAOI. Based on the half-life of duloxetine, at least 5 days should be allowed after stopping
duloxetine before starting an MAOI.
The generic alternative is not manufactured by the company that makes the brand product.
All prices are in US dollars.ollars.
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