Applies to the following strength(s): 20 mg-40 mg ; 120 mg ; 20 mg ; 40 mg ; 80 mg
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Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Depression
Initial dose: 20 mg orally once a day for 2 days then increase to 40 mg orally once a day
Maintenance dose: 40 to 120 mg orally once a day
Maximum dose: 120 mg orally once a day
-The dose may be increased in increments of 40 mg at intervals of 2 or more days based on tolerability and efficacy.
Use: Treatment of Major Depressive Disorder (MDD)
Renal Dose Adjustments
Mild renal dysfunction (CrCl 60 to 89 mL/min): No adjustment recommended
Moderate renal dysfunction (CrCl 30 to 59 mL/min): Maintenance dose should not exceed 80 mg once a day
Severe renal dysfunction (CrCl 15 to 29 mL/min): Maintenance dose should not exceed 40 mg once a day
End stage renal disease: Not recommended
Liver Dose Adjustments
Mild hepatic dysfunction (Child-Pugh 1 to 6): No adjustment recommended
Moderate hepatic dysfunction (Child-Pugh 7 to 9): No adjustment recommended
Severe hepatic dysfunction (Child-Pugh 10 to 13): No adjustment recommended
-Gradual dose reduction is recommended whenever possible. If intolerable symptoms occur following a dose decrease or discontinuation of treatment, resuming the previous dose and decreasing the dose at a more gradual rate should be considered.
-The dose should not exceed 80 mg once a day when used with strong CYP450 3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir).
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
-Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24. There was a reduction in risk with antidepressant use in patients aged 65 and older.
-In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber.
-This drug is not approved for use in pediatric patients.
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Data not available
-This drug may be administered without regard to meals.
-This drug should be taken at approximately the same time each day.
-This drug should be swallowed whole.
-The capsule should not be opened, chewed, or crushed.
-This drug should not be taken with alcohol.
-Patients should be reassessed periodically to determine the need for maintenance treatment and the appropriate dose for treatment.
-Psychiatric: Patients should be monitored for discontinuation symptoms, and for worsening and emergence of suicidal thoughts.
-Neurologic: Patients should be monitored for symptoms of serotonin syndrome.
-Cardiovascular: Patients should have regular monitoring of blood pressure.
-This drug may impair judgment, thinking, and motor skills. Driving or operating machinery should be avoided if patient is affected.
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- Drug class: serotonin-norepinephrine reuptake inhibitors
Other brands: Fetzima