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Uses

Major Depressive Disorder

Management of major depressive disorder.

Efficacy in hospital settings not established.

Generalized Anxiety Disorder

Management of generalized anxiety disorder.

Neuropathic Pain

Management of neuropathic pain associated with diabetic peripheral neuropathy.

Stress Urinary Incontinence

Has been used for the management of moderate to severe stress urinary incontinence (SUI)† in women.

Dosage and Administration

General

• Allow at least 2 weeks to elapse between discontinuance of an MAO inhibitor and initiation of duloxetine, and at least 5 days to elapse between discontinuance of duloxetine and initiation of an MAO inhibitor.
• Monitor for possible worsening of depression, suicidality, or unusual changes in behavior, especially at the beginning of therapy or during periods of dosage adjustments. (See Worsening of Depression and Suicidality Risk under Cautions.)
• Avoid abrupt discontinuance. To avoid withdrawal reactions, taper dosage gradually.(See Worsening of Depression and Suicidality Risk and also see Withdrawal of Therapy under Cautions.)
• Consider cautiously tapering dosage during third trimester of pregnancy prior to delivery. (See Pregnancy under Cautions.)

Administration

Oral Administration

Administer orally without regard to meals.

Swallow delayed-release capsules whole; do not chew or crush.

Do not sprinkle contents of delayed-release capsules on food or mix with liquids.

Dosage

Available as duloxetine hydrochloride; dosage expressed in terms of duloxetine.

Adults

Major Depressive Disorder

Oral

40–60 mg daily (as a single dose or in 2 equally divided doses).

Optimum duration not established; may require several months of therapy or longer.

Periodically reassess need for continued therapy and appropriateness of dosage.

Generalized Anxiety Disorder

Oral

Initially, 60 mg once daily. In some patients, it may be desirable to initiate therapy with a dosage of 30 mg once daily given for 1 week, followed by an increase to 60 mg once daily. Dosage may be increased in increments of 30 mg once daily (up to a maximum dosage of 120 mg once daily). However, no additional benefit demonstrated from dosages >60 mg once daily.

Optimum duration not established; long-term efficacy (>10 weeks) not demonstrated. Generalized anxiety disorder is chronic. Periodically reassess need for continued therapy.

Neuropathic Pain

Diabetic Neuropathy

Oral

60 mg once daily; consider lower initial dosage if suspect tolerability issues in patient.

Assess efficacy individually; progression of diabetic peripheral neuropathy is highly variable, and pain management is empirical.

Long-term efficacy not established in controlled studies.

Stress Urinary Incontinence

Oral

Optimum dosage not established; 80 mg daily (given in 2 divided doses) usually has been given. Dosages have ranged from 20–120 mg daily in clinical studies.†

Prescribing Limits

Adults

Major Depressive Disorder

Oral

Dosages >60 mg daily apparently do not provide additional benefit.

Generalized Anxiety Disorder

Oral

Maximum 120 mg once daily. However, dosages >60 mg daily apparently do not provide additional benefit.

Neuropathic Pain

Diabetic Neuropathy

Oral

Dosages >60 mg daily apparently do not substantially increase benefit and are less well tolerated.

Special Populations

Dosage in Hepatic Impairment

Use not recommended.

Dosage in Renal Impairment

Consider lower initial dosage in patients with mild to moderate renal impairment (Cl_cr 30–80 mL/minute) and increase gradually; do not administer if Cl_cr <30 mL/minute or if end-stage renal disease (requiring dialysis) present.

Geriatric Patients

No dosage adjustment recommended, but use caution when increasing dosage.