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Cymbalta Indications, Dosage, Storage, Stability - Duloxetine Hcl

INDICATIONS AND USAGE

Major Depressive Disorder

Cymbalta is indicated for the treatment of major depressive disorder (MDD).

The efficacy of Cymbalta has been established in 8- and 9-week placebo-controlled trials of outpatients who met DSM-IV diagnostic criteria for major depressive disorder (see CLINICAL STUDIES).

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.

The effectiveness of Cymbalta in hospitalized patients with major depressive disorder has not been studied.

The effectiveness of Cymbalta 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 Cymbalta for extended periods should periodically evaluate the long-term usefulness of the drug for the individual patient.

Diabetic Peripheral Neuropathic Pain

Cymbalta is indicated for the management of neuropathic pain associated with diabetic peripheral neuropathy (see CLINICAL STUDIES).

DOSAGE AND ADMINISTRATION

Initial Treatment

Major Depressive Disorder

Cymbalta should be administered at a total dose of 40 mg/day (given as 20 mg BID) 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.

Diabetic Peripheral Neuropathic Pain

Cymbalta should be administered at a total dose of 60 mg/day given once a day, without regard to meals.

While a 120 mg/day dose was shown to be safe and effective, there is no evidence that doses higher than 60 mg confer additional significant benefit, and the higher dose is clearly less well tolerated. For patients for whom tolerability is a concern, a lower starting dose may be considered. Since diabetes is frequently complicated by renal disease, a lower starting dose and gradual increase in dose should be considered for patients with renal impairment (see CLINICAL PHARMACOLOGY, Special Populations and below).

Maintenance/Continuation/Extended Treatment

Major Depressive Disorder

It is generally agreed that acute episodes of major depression require several months or longer of sustained pharmacologic therapy. There is insufficient evidence available to answer the question of how long a patient should continue to be treated with Cymbalta. Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment.

Diabetic Peripheral Neuropathic Pain

As the progression of diabetic peripheral neuropathy is highly variable and management of pain is empirical, the effectiveness of Cymbalta must be assessed individually. Efficacy beyond 12 weeks has not been systematically studied in placebo-controlled trials, but a one-year open-label safety study was conducted.

Special Populations

Dosage for Renally Impaired Patients � Cymbalta is not recommended for patients with end-stage renal disease (requiring dialysis) or in severe renal impairment (estimated creatinine clearance <30 mL/min) (see CLINICAL PHARMACOLOGY).

Dosage for Hepatically Impaired Patients � It is recommended that Cymbalta not be administered to patients with any hepatic insufficiency (see CLINICAL PHARMACOLOGY and PRECAUTIONS).

Dosage for Elderly Patients � No dose adjustment is recommended for elderly patients on the basis of age. As with any drug, caution should be exercised in treating the elderly. When individualizing the dosage in elderly patients, extra care should be taken when increasing the dose.

Treatment of Pregnant Women During the Third Trimester � Neonates exposed to SSRIs or SNRIs, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding (see PRECAUTIONS). When treating pregnant women with Cymbalta during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. The physician may consider tapering Cymbalta in the third trimester.

Discontinuing Cymbalta

Symptoms associated with discontinuation of Cymbalta and other SSRIs and SNRIs have been reported (see PRECAUTIONS). Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.

Switching Patients to or from a Monoamine Oxidase Inhibitor

At least 14 days should elapse between discontinuation of an MAOI and initiation of therapy with Cymbalta. In addition, at least 5 days should be allowed after stopping Cymbalta before starting an MAOI (see CONTRAINDICATIONS and WARNINGS).

HOW SUPPLIED

Cymbalta^® (duloxetine hydrochloride) Delayed-release Capsules are available in 20, 30, and 60 mg strengths.

The 20 mg* capsule has an opaque green body and cap, and is imprinted with "20 mg" on the body and "LILLY 3235" on the cap:

NDC 0002-3235-60 (PU3235) � Bottles of 60

NDC 0002-3235-33 (PU3235) � (ID�100) Blisters

The 30 mg* capsule has an opaque white body and opaque blue cap, and is imprinted with "30 mg" on the body and "LILLY 3240" on the cap:

NDC 0002-3240-30 (PU3240) � Bottles of 30

NDC 0002-3240-90 (PU3240) � Bottles of 90

NDC 0002-3240-04 (PU3240) � Bottles of 1000

NDC 0002-3240-33 (PU3240) � (ID�100) Blisters

The 60 mg* capsule has an opaque green body and opaque blue cap, and is imprinted with "60 mg" on the body and "LILLY 3237" on the cap:

NDC 0002-3237-30 (PU3237) � Bottles of 30

NDC 0002-3237-90 (PU3237) � Bottles of 90

NDC 0002-3237-04 (PU3237) � Bottles of 1000

NDC 0002-3237-33 (PU3237) � (ID�100) Blisters

REFERENCE

*equivalent to duloxetine base.

�Identi-Dose^® (unit dose medication, Lilly).

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

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