Duloxetine is indicated for the-
- Treatment of Major Depressive Disorder (MDD)
- Management of neuropathic pain associated with diabetic peripheral neuropathy.
- Chronic Musculoskeletal Pain
- Urinary stress incontinence.
Dosage & Administration
Major Depressive Disorder (MDD): Starting dose- 20-30 mg b.i.d or 60 mg once daily, Target dose- 60 mg once daily, max. dose- 60 mg once daily
Diabetic peripheral neuropathy: Starting dose- 60 mg/day (once daily), Target dose- 60 mg once daily, max. dose- 60 mg once daily
Chronic Musculoskeletal Pain: Starting dose- 30 mg/day, Target dose- 60 mg once daily, max. dose- 60 mg once daily
Urinary stress incontinence: Starting dose- 40 mg /day, Target dose- 80 mg/day (twice daily, max. dose- 80 mg/day (twice daily).
Monoamine oxidase inhibitors (MAOIs): Due to the risk of serotonin syndrome, Duloxetine should not be used in combination with non selective, irreversible monoamine oxidase inhibitors (MAOIs), or within at least 14 days of discontinuing treatment with an MAOI.
Inhibitors of CYP1A2: Because CYP1A2 is involved in Duloxetine metabolism, concomitant use with potent inhibitors of CYP1A2 is likely to result in higher concentrations of Duloxetine. Therefore, Duloxetine should not be administered in combination with potent inhibitors of CYP1A2 like fluvoxamine.
CNS medicinal products: Caution is advised when Duloxetine is taken in combination with other centrally acting medicinal products or substances, including alcohol and sedative medicinal products (e.g., benzodiazepines, morphinomimetics, antipsychotics, phenobarbital, sedative antihistamines).
Pregnancy & Lactation
Pregnancy: Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women; therefore, Duloxetine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Labor and Delivery: The effect of Duloxetine on labor and delivery in humans is unknown. Duloxetine should be used during labor and delivery only if the potential benefit justifies the potential risk to the fetus.
Lactation: It is unknown whether or not Duloxetine and/or it’s metabolites are excreted into human milk, but nursing while on Duloxetine is not recommended.