Product Information
Patient Counseling Information
- Information on Medication Guide
- Clinical Worsening and Suicide Risk
- Medication Administration
- Continuing the Therapy Prescribed
- Abnormal Bleeding
- Concomitant Medications
- Serotonin Syndrome
- Pregnancy and Breast Feeding
- Alcohol
- Orthostatic Hypotension and Syncope
- Interference with Psychomotor Performance
Information on Medication Guide
Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with Cymbalta and should counsel them in its appropriate use. A patient Medication Guide About Using Antidepressants in Children and Teenagers is available for Cymbalta. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given 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.
Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking Cymbalta.
Clinical Worsening and Suicide Risk
Patients, their families, and their caregivers should be encouraged 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. Families and caregivers of patients should be advised to observe for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient's prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient's presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication. See Boxed Warning and Warnings and Precautions.
Medication Administration
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.
Continuing the Therapy Prescribed
While patients may notice improvement with Cymbalta therapy in 1 to 4 weeks, they should be advised to continue therapy as directed.
Abnormal Bleeding
Patients should be cautioned about the concomitant use of duloxetine and NSAIDs, aspirin, warfarin, or other drugs that affect coagulation since combined use of psychotropic drugs that interfere with serotonin reuptake and these agents has been associated with an increased risk of bleeding. See Warnings and Precautions.
Concomitant Medications
Patients should be advised to inform their physicians if they are taking, or plan to take, any prescription or over-the-counter medications, since there is a potential for interactions. See Dosage and Administration, Contraindications, Warnings and Precautions, and Drug Interactions.
Serotonin Syndrome
Patients should be cautioned about the risk of serotonin syndrome with the concomitant use of Cymbalta and triptans, tramadol or other serotonergic agents. See Warnings and Precautions and Drug Interactions.
Pregnancy and Breast Feeding
Patients should be advised to notify their physician if they
- become pregnant during therapy
- intend to become pregnant during therapy
- are breast feeding. See Dosage and Administration and Use in Specific Populations
Alcohol
Although Cymbalta does not increase the impairment of mental and motor skills caused by alcohol, use of Cymbalta concomitantly with heavy alcohol intake may be associated with severe liver injury. For this reason, Cymbalta should ordinarily not be prescribed for patients with substantial alcohol use. See Warnings and Precautions and Drug Interactions.
Orthostatic Hypotension and Syncope
Patients should be advised of the risk of orthostatic hypotension and syncope, especially during the period of initial use and subsequent dose escalation, and in association with the use of concomitant drugs that might potentiate the orthostatic effect of duloxetine. See Warnings and Precautions.
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. Therefore, patients should be cautioned about operating hazardous machinery including automobiles, until they are reasonably certain that Cymbalta therapy does not affect their ability to engage in such activities.
Mechanism of Action
Cymbalta is believed to modulate both serotonin and norepinephrine in the brain and spinal cord. Learn more about the MOA of Cymbalta.
Formulary Access Finder
Cymbalta has been added to the Anthem Blue Cross Blue Shield National Preferred Formulary.
Get more information about the formulary access for Cymbalta. Download PDF files of insurance providers covering Cymbalta in your state.
