Medically reviewed by Drugs.com. Last updated on Nov 21, 2018.
Applies to the following strengths: 5 mg; 10 mg; 20 mg
Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Depression
Initial dose: 10 mg orally once a day
Maintenance dose: 5 to 20 mg orally once a day
Maximum dose: 20 mg/day
-Efficacy was established in trials lasting 6 to 8 weeks.
-Treatment of acute episodes should be followed by maintenance therapy lasting at least several months to decrease the risk of recurrence.
Use: Treatment of major depressive disorder (MDD)
Renal Dose Adjustments
Mild renal dysfunction to end stage renal disease: No adjustment recommended.
Liver Dose Adjustments
Mild to moderate hepatic dysfunction: No adjustment recommended.
Severe hepatic dysfunction: Not recommended.
-Patients who do not tolerate higher doses may be maintained on 5 mg orally once a day.
Switching to/from an MAOI:
-From an MAOI used to treat psychiatric disorders: Allow at least 14 days before beginning this drug.
-To an MAOI used to treat psychiatric disorders: Allow at least 21 days after stopping this drug before beginning treatment with the MAOI.
-Use with linezolid or IV methylene blue: If treatment is absolutely necessary, promptly discontinue treatment with this drug, and monitor the patient for symptoms of serotonin syndrome for 21 days or until 24 hours after the last dose of linezolid/IV methylene blue, whichever comes first. Treatment may be resumed 24 hours after the last dose of linezolid/IV methylene blue.
---Serotonin syndrome associated with oral/local injection of methylene blue or IV doses of this drug lower than 1 mg/kg is unknown.
CYP450 2D6 Poor Metabolizers: The maximum dose is 10 mg/day
Patients taking Strong Inhibitors of CYP450 2D6:
-Reduce the dose by 50% with concomitant treatment.
-CYP450 2D6 discontinuation: Increase the dose to the original level.
Patients taking Strong Inducers of CYP450 2D6:
-Coadministration for greater than 14 days: Increased doses should be considered; doses should not exceed 3 times the original dose.
-CYP450 2D6 discontinuation: Reduce the dose to the original level within 14 days.
-This drug may be abruptly discontinued; however, headache and muscle tension occurred at doses of 15 to 20 mg/day.
-Adverse reactions may be avoided by decreasing the dose to 10 mg/day for 1 week, then completely discontinuing treatment.
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 trend toward reduced risk with antidepressant use in patients aged 65 and older.
-This drug has not been evaluated for use in pediatric patients.
-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.
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 taken without regard to meals.
-If a dose is missed, the next dose should be taken at the usual time; patients should not take a double dose to make up for a missed dose.
-Patients should be periodically assessed for usefulness of the drug.
-Efficacy was usually observed by week 2.
-Hematologic: Bleeding events
-Nervous system: Signs/symptoms of serotonin syndrome
-Psychiatric: Changes in mood/behavior, including depression and suicide
-Tell your healthcare provider about all of the medicines that you take, including prescription and non-prescription medicines.
-This medicine may increase the risk of suicidal thoughts and behavior. Be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Report any behavior of concern to your healthcare provider as soon as possible.
-Patients should be advised to speak to a healthcare provider if they are pregnant, intend to become pregnant, or are breastfeeding.
-This medicine may cause impaired judgment, thinking, or motor skills; do not drive a car or operate dangerous machinery until you know how this drug affects you.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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