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Indications
Dosage
How Supplied

INDICATIONS

CYMBALTA® is indicated for the treatment of:

DOSAGE AND ADMINISTRATION

Swallow CYMBALTA whole. Do not chew or crush. Do not open the capsule and sprinkle its contents on food or mix with liquids. All of these might affect the enteric coating. CYMBALTA can be given without regard to meals. If a dose of CYMBALTA is missed, take the missed dose as soon as it is remembered. If it is almost time for the next dose, skip the missed dose and take the next dose at the regular time. Do not take two doses of CYMBALTA at the same time.

Dosage For Treatment Of Major Depressive Disorder

Administer CYMBALTA at a total dose of 40 mg/day (given as 20 mg twice daily) to 60 mg/day (given either once daily or as 30 mg twice daily). For some patients, it may be desirable to start at 30 mg once daily for 1 week, to allow patients to adjust to the medication before increasing to 60 mg once daily. While a 120 mg/day dose was shown to be effective, there is no evidence that doses greater than 60 mg/day confer any additional benefits. The safety of doses above 120 mg/day has not been adequately evaluated. Periodically reassess to determine the need for maintenance treatment and the appropriate dose for such treatment [see Clinical Studies].

Dosage For Treatment Of Generalized Anxiety Disorder

Adults

For most patients, initiate CYMBALTA 60 mg once daily. For some patients, it may be desirable to start at 30 mg once daily for 1 week, to allow patients to adjust to the medication before increasing to 60 mg once daily. While a 120 mg once daily dose was shown to be effective, there is no evidence that doses greater than 60 mg/day confer additional benefit. Nevertheless, if a decision is made to increase the dose beyond 60 mg once daily, increase dose in increments of 30 mg once daily. The safety of doses above 120 mg once daily has not been adequately evaluated. Periodically reassess to determine the continued need for maintenance treatment and the appropriate dose for such treatment [see Clinical Studies].

Elderly

Initiate CYMBALTA at a dose of 30 mg once daily for 2 weeks before considering an increase to the target dose of 60 mg. Thereafter, patients may benefit from doses above 60 mg once daily. If a decision is made to increase the dose beyond 60 mg once daily, increase dose in increments of 30 mg once daily. The maximum dose studied was 120 mg per day. Safety of doses above 120 mg once daily has not been adequately evaluated [see Clinical Studies].

Children and Adolescents (7 to 17 years of age)

Initiate CYMBALTA at a dose of 30 mg once daily for 2 weeks before considering an increase to 60 mg. The recommended dose range is 30 to 60 mg once daily. Some patients may benefit from doses above 60 mg once daily. If a decision is made to increase the dose beyond 60 mg once daily, increase dose in increments of 30 mg once daily. The maximum dose studied was 120 mg per day. The safety of doses above 120 mg once daily has not been evaluated [see Clinical Studies].

Dosage For Treatment Of Diabetic Peripheral Neuropathic Pain

Administer CYMBALTA 60 mg once daily. There is no evidence that doses higher than 60 mg confer additional significant benefit and the higher dose is clearly less well tolerated [see Clinical Studies]. For patients for whom tolerability is a concern, a lower starting dose may be considered.

Since diabetes is Frequently complicated by renal disease, consider a lower starting dose and gradual increase in dose for patients with renal impairment [see DOSAGE AND ADMINISTRATION, Use in Specific Populations, and CLINICAL PHARMACOLOGY].

Dosage For Treatment Of Fibromyalgia

Administer CYMBALTA 60 mg once daily. Begin treatment 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 [see Clinical Studies].

Dosage For Treatment Of Chronic Musculoskeletal Pain

Administer CYMBALTA 60 mg once daily. Begin treatment at 30 mg for one week, to allow patients to adjust to the medication before increasing to 60 mg once daily. There is no evidence that higher doses 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 [see Clinical Studies].

Dosing In Special Populations

Hepatic Impairment

Avoid use in patients with chronic liver disease or cirrhosis [see WARNINGS AND PRECAUTIONS and Use in Specific Populations].

Severe Renal Impairment

Avoid use in patients with severe renal impairment, GFR < 30 mL/min [see WARNINGS AND PRECAUTIONS and Use in Specific Populations].

Discontinuing CYMBALTA

Adverse reactions after discontinuation of CYMBALTA, after abrupt or tapered discontinuation, include: dizziness, headache, nausea, diarrhea, paresthesia, irritability, vomiting, insomnia, anxiety, hyperhidrosis, and fatigue. A gradual reduction in dosage rather than abrupt cessation is recommended whenever possible [see WARNINGS AND PRECAUTIONS].

Switching A Patient To Or From A Monoamine Oxidase Inhibitor (MAOI) Intended To Treat Psychiatric Disorders

At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with CYMBALTA. Conversely, at least 5 days should be allowed after stopping CYMBALTA before starting an MAOI intended to treat psychiatric disorders [see CONTRAINDICATIONS].

Use Of CYMBALTA With Other MAOIs Such As Linezolid Or Methylene Blue

Do not start CYMBALTA in a patient who is being treated with linezolid or intravenous methylene blue because there is an increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered [see CONTRAINDICATIONS].

In some cases, a patient already receiving CYMBALTA therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, CYMBALTA should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 5 days or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with CYMBALTA may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue [see WARNINGS AND PRECAUTIONS].

The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with CYMBALTA is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use [see WARNINGS AND PRECAUTIONS].

HOW SUPPLIED

Dosage Forms And Strengths

CYMBALTA is available as delayed release capsules:

20 mg opaque green capsules imprinted with “Lilly 3235 20mg”

30 mg opaque white and blue capsules imprinted with “Lilly 3240 30mg”

60 mg opaque green and blue capsules imprinted with “Lilly 3270 60mg”

CYMBALTA is available as delayed release capsules in the following strengths, colors, imprints, and presentations:

Features Strengths
20 mga 30 mga 60 mga
Body color Opaque green Opaque white Opaque green
Cap color Opaque green Opaque blue Opaque blue
Cap imprint Lilly 3235 Lilly 3240 Lilly 3270
Body imprint 20mg 30mg 60mg
Capsule number PU3235 PU3240 PU3270
Presentations and NDC Codes
Bottles of 30 NA 0002-3240-30 0002-3270-30
Bottles of 60 0002-3235-60 NA NA
Bottles of 90 NA 0002-3240-90 NA
Bottles of 1000 NA 0002-3240-04 0002-3270-04
Blisters ID†100 NA 0002-3240-33 0002-3270-33
aequivalent to duloxetine base
† Identi-Dose® (unit dose medication, Lilly)

Storage And Handling

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, USA. Literature revised October 2014

Last reviewed on RxList: 10/31/2014
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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