Applies to the following strengths: 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/day
-The dose may be increased in increments of 40 mg at intervals of 2 or more days based on tolerability and efficacy.
-Efficacy was established in trials lasting 5 weeks.
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
Data not available
-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.
CYP450 3A4 Strong Inhibitors:
-The dose should not exceed 80 mg once a day when used with strong CYP450 3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir).
US BOXED WARNINGS:
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, and should not be opened, chewed, or crushed.
-This drug should not be taken with alcohol.
-Limitation of use: This drug is not approved for the management of fibromyalgia.
-Patients should be reassessed periodically to determine the need for maintenance treatment and the appropriate dose for treatment.
-Cardiovascular: Regular blood pressure monitoring
-Neurologic: Signs/symptoms of serotonin syndrome
-Psychiatric: Discontinuation symptoms; worsening and emergence of suicidal thoughts
-This drug may impair judgment, thinking, and motor skills. Driving or operating machinery should be avoided if patient is affected.
-Patients should be instructed to avoid abrupt discontinuation of treatment.
-Patients and caregivers should be told to report any new or worsening depression.
-Patients should be advised to speak to a healthcare provider if they are pregnant, intend to become pregnant, or are breastfeeding.
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- Drug class: serotonin-norepinephrine reuptake inhibitors
Other brands: Fetzima