Usual Adult Dose for Depression

50 mg orally once a day, with or without food

• Maximum dose: 400 mg/day

• Doses of 10 to 400 mg/day were studied in clinical trials.
• There is no evidence that doses greater than 50 mg per day provide additional benefit.
• Side effects and discontinuations were more common at higher doses.
• Efficacy in patients with major depressive disorder was established in 4 short-term and 2 maintenance studies.

Renal Dose Adjustments

Mild renal dysfunction (CrCl greater than 50 mL/min): No adjustment recommended.
Moderate renal dysfunction (CrCl 30 to 50 mL/min): 50 mg orally once a day
Severe renal dysfunction (CrCl less than 30 mL/min) OR end-stage renal disease (CrCl less than 15 mL/min): 25 mg orally once a day OR 50 mg orally every other day

Liver Dose Adjustments

Mild liver dysfunction (Child-Pugh Class A): No adjustment recommended.

Moderate to severe liver dysfunction (Child-Pugh Class B to C): 50 mg per day

• Doses above 100 mg per day are not recommended.

Dose Adjustments

• A reduction in dose OR discontinuation should be considered in patients who develop a sustained increase in blood pressure.
• Prior to discontinuing treatment, gradual dose reduction to 25 mg/day is recommended to minimize discontinuation symptoms.

• Starting treatment with this drug: At least 14 days should elapse between discontinuing MAOI therapy and starting treatment.
• Stopping treatment with this drug: At least 7 days should elapse between stopping treatment and starting an MAOI.

• The potential benefits must outweigh the risks of serotonin syndrome.
• This drug should be stopped promptly before administering linezolid/IV methylene blue.
• Patients should be monitored for serotonin syndrome for 7 days OR 24 hours after the last dose of linezolid/IV methylene blue, whichever comes first.
• Treatment may resume 24 hours after the last dose of linezolid/IV methylene blue.

Precautions

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.

Dialysis

Supplemental doses should not be administered after dialysis.

Other Comments

Administration advice:

• Tablets should be taken at approximately the same time each day.
• Tablets should be swallowed whole with fluid and not divided, crushed, chewed, or dissolved.

• Acute episodes usually require at least several months of sustained treatment.
• Patients should be periodically reassessed to determine the need for continued treatment.
• A gradual dose reduction is recommended whenever possible.
• If intolerable symptoms develop following a decrease in the dose or upon discontinuation, resumption of the previously prescribed dose should be considered.
• Discontinuation symptoms have been reported when switching from other antidepressants, including venlafaxine, to this drug.

• Cardiovascular: Regular blood pressure monitoring
• Neurologic: Signs/symptoms of serotonin syndrome
• Psychiatric: Discontinuation symptoms, worsening and emergence of suicidal thoughts

• Patients should be advised to avoid alcohol.
• Patients may notice an inert matrix tablet passing in the stool or via colostomy.
• Inform patients that this drug may impair judgement, motor skills, and/or thinking, and they should avoid driving or operating machinery if these side effects occur.
• Advise patients to speak to their healthcare provider if they become pregnant, intend to become pregnant, or are breastfeeding.

Frequently asked questions

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