Product Information
Prescribing Information for Cymbalta (duloxetine hydrochloride)
Highlights of Prescribing Information
These highlights do not include all the information needed to use Cymbalta safely and effectively. See full Prescribing Information (PDF: 260KB) for Cymbalta.
Cymbalta (duloxetine hydrochloride) Delayed-Release Capsules for Oral use.
Initial U.S. Approval: 2004
WARNING: Suicidality and Antidepressants
See full Prescribing Information for complete Boxed Warning.
Increased risk of suicidal thinking and behavior in children, adolescents and young adults taking antidepressants for major depressive disorder (MDD) and other psychiatric disorders.
Recent Major Changes
- Indications and Usage, Major Depressive Disorder, November 2007
- Indications and Usage, Fibromyalgia, June 2008
- Dosage and Administration, Fibromyalgia, June 2008
- Dosage and Administration, Maintenance/Continuation/Extended Treatment, June 2008
- Warnings and Precautions, Hepatotoxicity, June 2008
- Warnings and Precautions, Abnormal Bleeding, Hyponatremia, Urinary Retention and Hesitation, November 2007
- Warnings and Precautions, Discontinuation of Treatment with Cymbalta, October 2007
Indications and Usage
Cymbalta is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for:
- Major Depressive Disorder (MDD)
- Generalized Anxiety Disorder (GAD)
- Diabetic Peripheral Neuropathic Pain (DPNP)
- Fibromyalgia (FM)
Dosage and Administration
Cymbalta should generally be administered once daily without regard to meals. 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.
| Indication | Recommended Dose |
| MDD | Acute Treatment: 40 mg/day (20 mg twice daily) to 60 mg/day (once daily or as 30 mg twice daily); Maintenance Treatment: 60 mg/day |
| GAD | 60 mg/day (once daily) |
| DPNP | 60 mg/day (once daily) |
| FM | 60 mg/day (once daily) |
- Some patients may benefit from starting at 30 mg once daily.
- There is no evidence that doses greater than 60 mg/day confer additional benefit, while some adverse reactions were observed to be dose-dependent.
- Discontinuing Cymbalta: A gradual dose reduction is recommended.
Dosage Forms and Strengths
- 20, 30 and 60 mg capsules
Contraindications
- Use of a monoamine oxidase inhibitor concomitantly or in close temporal proximity
- Use in patients with uncontrolled narrow-angle glaucoma
Warnings and Precautions
- Suicidality: Monitor for clinical worsening and suicide risk.
- Hepatotoxicity: Hepatic failure, sometimes fatal, has been reported in patients treated with Cymbalta. 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. Cymbalta should ordinarily not be prescribed to patients with substantial alcohol use or evidence of chronic liver disease.
- Orthostatic Hypotension and Syncope: Cases have been reported with duloxetine therapy.
- Serotonin Syndrome: Serotonin syndrome has been reported with SSRIs and SNRIs.
- Abnormal Bleeding: Cymbalta may increase the risk of bleeding events. Patients should be cautioned about the risk of bleeding associated with the concomitant use of duloxetine and NSAIDs, aspirin, or other drugs that affect coagulation.
- Discontinuation: May result in symptoms, including dizziness, nausea, headache, fatigue, paresthesia, vomiting, irritability, nightmares, insomnia, diarrhea, anxiety, hyperhidrosis, and vertigo.
- Activation of mania or hypomania has occurred.
- Seizures: Prescribe with care in patients with a history of seizure disorder.
- Blood Pressure: Monitor blood pressure prior to initiating treatment and periodically throughout treatment.
- Inhibitors of CYP1A2 or Thioridazine: Should not administer with Cymbalta.
- Hyponatremia: Cases of hyponatremia have been reported.
- Hepatic Insufficiency and Severe Renal Impairment: Should ordinarily not be administered to these patients.
- Controlled Narrow-Angle Glaucoma: Use cautiously in these patients.
- Glucose Control in Diabetes: In diabetic peripheral neuropathic pain patients, small increases in fasting blood glucose, HbA1c, and total cholesterol have been observed.
- Conditions that Slow Gastric Emptying: Use cautiously in these patients.
- Urinary Hesitation and Retention.
Adverse Reactions
Most common adverse reactions (≥5% and at least twice the incidence of placebo patients): nausea, dry mouth, constipation, somnolence, hyperhidrosis, and decreased appetite.
To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Drug Interactions
- Potent inhibitors of CYP1A2 should be avoided.
- Potent inhibitors of CYP2D6 may increase duloxetine concentrations.
- Duloxetine is a moderate inhibitor of CYP2D6.
Use in Specific Populations
- Pregnancy and Nursing Mothers: Use only if the potential benefit justifies the potential risk to the fetus or child.
See PATIENT COUNSELING INFORMATION and the FDA approved Medication Guide.
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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.
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