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Cymbalta
Overview
What is Cymbalta?
Cymbalta (duloxetine hydrochloride) is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (+)-()--methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is CHNOS•HCl, which corresponds to a molecular weight of 333.88. The structural formula is:
Duloxetine hydrochloride is a white to slightly brownish white solid, which is slightly soluble in water.
Each capsule contains enteric-coated pellets of 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride equivalent to 20, 30, or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include FD&C Blue No. 2, gelatin, hypromellose, hydroxypropyl methylcellulose acetate succinate, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, and triethyl citrate. The 20 and 60 mg capsules also contain iron oxide yellow.
What does Cymbalta look like?
What are the available doses of Cymbalta?
Cymbalta is available as delayed release capsules:
What should I talk to my health care provider before I take Cymbalta?
How should I use Cymbalta?
Cymbalta is indicated for the treatment of major depressive disorder (MDD). The efficacy of Cymbalta was established in four short term and one maintenance trial in adults .
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 ideation.
Cymbalta should be swallowed whole and should not be chewed or crushed, nor should the capsule be opened and its contents sprinkled on food or mixed with liquids. All of these might affect the enteric coating. Cymbalta should be given without regard to meals.
What interacts with Cymbalta?
Sorry No Records found
What are the warnings of Cymbalta?
Sorry No Records found
What are the precautions of Cymbalta?
Sorry No Records found
What are the side effects of Cymbalta?
Sorry No records found
What should I look out for while using Cymbalta?
Use of a monoamine oxidase inhibitor concomitantly or in close temporal proximity ()
Use in patients with uncontrolled narrow-angle glaucoma ()
WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Cymbalta or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. 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 in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Cymbalta is not approved for use in pediatric patients.
[see Warnings and Precautions (), Use in Specific Populations (), and Information for Patients ().]
What might happen if I take too much Cymbalta?
How should I store and handle Cymbalta?
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Cymbalta, duloxetine HCl Delayed Release Capsules, 30 mg Bottles of 15 tablets. NDC 21695-145-15 Bottles of 30 tablets. NDC 21695-145-30 Cymbalta, duloxetine HCl Delayed Release Capsules, 60 mg Bottles of 15 tablets. NDC 21695-146-15 Bottles of 30 tablets. NDC 21695-146-30 Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured by:Eli Lilly and CompanyIndianapolis, IN 46285Repackaged by: Thousand Oaks, CA 91320 Cymbalta, duloxetine HCl Delayed Release Capsules, 30 mg Bottles of 15 tablets. NDC 21695-145-15 Bottles of 30 tablets. NDC 21695-145-30 Cymbalta, duloxetine HCl Delayed Release Capsules, 60 mg Bottles of 15 tablets. NDC 21695-146-15 Bottles of 30 tablets. NDC 21695-146-30 Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured by:Eli Lilly and CompanyIndianapolis, IN 46285Repackaged by: Thousand Oaks, CA 91320 Cymbalta, duloxetine HCl Delayed Release Capsules, 30 mg Bottles of 15 tablets. NDC 21695-145-15 Bottles of 30 tablets. NDC 21695-145-30 Cymbalta, duloxetine HCl Delayed Release Capsules, 60 mg Bottles of 15 tablets. NDC 21695-146-15 Bottles of 30 tablets. NDC 21695-146-30 Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured by:Eli Lilly and CompanyIndianapolis, IN 46285Repackaged by: Thousand Oaks, CA 91320 Cymbalta, duloxetine HCl Delayed Release Capsules, 30 mg Bottles of 15 tablets. NDC 21695-145-15 Bottles of 30 tablets. NDC 21695-145-30 Cymbalta, duloxetine HCl Delayed Release Capsules, 60 mg Bottles of 15 tablets. NDC 21695-146-15 Bottles of 30 tablets. NDC 21695-146-30 Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured by:Eli Lilly and CompanyIndianapolis, IN 46285Repackaged by: Thousand Oaks, CA 91320 Cymbalta, duloxetine HCl Delayed Release Capsules, 30 mg Bottles of 15 tablets. NDC 21695-145-15 Bottles of 30 tablets. NDC 21695-145-30 Cymbalta, duloxetine HCl Delayed Release Capsules, 60 mg Bottles of 15 tablets. NDC 21695-146-15 Bottles of 30 tablets. NDC 21695-146-30 Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured by:Eli Lilly and CompanyIndianapolis, IN 46285Repackaged by: Thousand Oaks, CA 91320 Cymbalta, duloxetine HCl Delayed Release Capsules, 30 mg Bottles of 15 tablets. NDC 21695-145-15 Bottles of 30 tablets. NDC 21695-145-30 Cymbalta, duloxetine HCl Delayed Release Capsules, 60 mg Bottles of 15 tablets. NDC 21695-146-15 Bottles of 30 tablets. NDC 21695-146-30 Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured by:Eli Lilly and CompanyIndianapolis, IN 46285Repackaged by: Thousand Oaks, CA 91320 Cymbalta, duloxetine HCl Delayed Release Capsules, 30 mg Bottles of 15 tablets. NDC 21695-145-15 Bottles of 30 tablets. NDC 21695-145-30 Cymbalta, duloxetine HCl Delayed Release Capsules, 60 mg Bottles of 15 tablets. NDC 21695-146-15 Bottles of 30 tablets. NDC 21695-146-30 Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured by:Eli Lilly and CompanyIndianapolis, IN 46285Repackaged by: Thousand Oaks, CA 91320 Cymbalta, duloxetine HCl Delayed Release Capsules, 30 mg Bottles of 15 tablets. NDC 21695-145-15 Bottles of 30 tablets. NDC 21695-145-30 Cymbalta, duloxetine HCl Delayed Release Capsules, 60 mg Bottles of 15 tablets. NDC 21695-146-15 Bottles of 30 tablets. NDC 21695-146-30 Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured by:Eli Lilly and CompanyIndianapolis, IN 46285Repackaged by: Thousand Oaks, CA 91320 Cymbalta, duloxetine HCl Delayed Release Capsules, 30 mg Bottles of 15 tablets. NDC 21695-145-15 Bottles of 30 tablets. NDC 21695-145-30 Cymbalta, duloxetine HCl Delayed Release Capsules, 60 mg Bottles of 15 tablets. NDC 21695-146-15 Bottles of 30 tablets. NDC 21695-146-30 Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured by:Eli Lilly and CompanyIndianapolis, IN 46285Repackaged by: Thousand Oaks, CA 91320 Cymbalta, duloxetine HCl Delayed Release Capsules, 30 mg Bottles of 15 tablets. NDC 21695-145-15 Bottles of 30 tablets. NDC 21695-145-30 Cymbalta, duloxetine HCl Delayed Release Capsules, 60 mg Bottles of 15 tablets. NDC 21695-146-15 Bottles of 30 tablets. NDC 21695-146-30 Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured by:Eli Lilly and CompanyIndianapolis, IN 46285Repackaged by: Thousand Oaks, CA 91320
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
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.
Non-Clinical Toxicology
Use of a monoamine oxidase inhibitor concomitantly or in close temporal proximity ()Use in patients with uncontrolled narrow-angle glaucoma ()
WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Cymbalta or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. 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 in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Cymbalta is not approved for use in pediatric patients.
[see Warnings and Precautions (), Use in Specific Populations (), and Information for Patients ().]
Because diethylpropion hydrochloride is a monoamine, hypertension may result when this agent is used with monoamine oxidase (MAO) inhibitors (see ).
Efficacy of diethylpropion with other anorectic agents has not been studied and the combined use may have the potential for serious cardiac problems; therefore, the concomitant use with other anorectic agents is contraindicated.
Antidiabetic drug requirements (i.e., insulin) may be altered. Concurrent use with general anesthetics may result in arrhythmias. The pressor effects of diethylpropion and those of other drugs may be additive when the drugs are used concomitantly; conversely, diethylpropion may interfere with antihypertensive drugs (i.e., guanethidine, α-methyldopa). Concurrent use of phenothiazines may antagonize the anorectic effect of diethylpropion.
Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. 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 18-24) 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 (OCD), or other psychiatric disorders included a total of 24 short-term trials of 9 antidepressant drugs in over 4400 patients. The pooled analyses of placebo-controlled trials in adults with MDD or other psychiatric disorders included a total of 295 short-term trials (median duration of 2 months) of 11 antidepressant drugs in over 77,000 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 placebo), however, were relatively stable within age strata and across indications. These risk differences (drug-placebo difference in the number of cases of suicidality per 1000 patients treated) are provided in .
No suicides occurred in 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, i.e., beyond several months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with depression that the use of antidepressants can delay the 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 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, there is concern that such symptoms may represent precursors to emerging suicidality.
Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if these symptoms are severe, abrupt in onset, or were not part of the patient's presenting symptoms.
If the decision has been made to discontinue treatment, medication should be tapered, as rapidly as is feasible, but with recognition that discontinuation can be associated with certain symptoms for descriptions of the risks of discontinuation of Cymbalta.
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.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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