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

Comments:

• 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/day.
Severe renal dysfunction (CrCl 15 to 29 mL/min): Maintenance dose should not exceed 40 mg/day.
End stage renal disease: Not recommended.

Liver Dose Adjustments

Data not available

Dose Adjustments

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).

Treatment Discontinuation:

• 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.

Switching from this drug to a MAO inhibitor (MAOI) MAOI intended to treat psychiatric disorders: At least 7 days should elapse after stopping this drug and starting a MAOI

Switching from a MAOI intended to treat of psychiatric disorders to this drug: At least 14 days should elapse after stopping a MAOI and starting this drug

Patients who require urgent treatment with linezolid/IV methylene blue during treatment:

• The potential benefits must outweigh the risks of serotonin syndrome.
• Hospitalization and other psychiatric interventions should be considered in patients requiring urgent treatment for a psychiatric condition.
• This drug should be stopped promptly before administering linezolid/IV methylene blue.
• Patients should be monitored for serotonin syndrome for 2 weeks 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

CONTRAINDICATIONS:

• Hypersensitivity to the active component or to any of the ingredients

US BOXED WARNINGS:
SUICIDAL THOUGHTS AND BEHAVIORS:

• Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies.

Recommendations:

• Patients treated with antidepressants should be closely monitored for clinical worsening and for the emergence of suicidal thoughts and behaviors.
• 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.

Dialysis

Data not available

Other Comments

Administration advice:

• This drug may be administered without regard to meals, but it 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.

General:

• 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.

Monitoring:

• CARDIOVASCULAR: Regular blood pressure monitoring
• NERVOUS SYSTEM: Signs/symptoms of serotonin syndrome
• PSYCHIATRIC: Discontinuation symptoms; worsening and emergence of suicidal thoughts

Patient advice:

• This drug may impair judgment, thinking, and motor skills. Driving or operating machinery should be avoided if these side effects occur.
• Patients should be instructed to avoid abrupt discontinuation of treatment.
• Patients, families, and caregivers should report worsening of depression, suicidal ideation, or any unusual changes in behavior, especially during early antidepressant treatment and when doses are adjusted up or down.
• Advise patients to speak to their healthcare provider if they become pregnant, intend to become pregnant, or are breastfeeding.

Frequently asked questions

• Does Fetzima cause weight loss or weight gain?
• Does Fetzima cause hair loss?