Usual Adult Dose for Depression

TABLETS:
Hospitalized Patients:

• Initial dose: 100 mg orally once a day, increasing to 200 mg/day if necessary
• Titration dose: After increasing the dose to 200 mg/day, if there is no response after 2 weeks, increase the dose to 250 to 300 mg/day.
• Maintenance dose: 100 to 200 mg orally once a day
• Maximum dose: 300 mg/day

• Initial dose: 75 mg orally once a day
• Maintenance dose: 50 to 150 mg orally once a day
• Maximum dose: 200 mg/day

• Initial dose: 100 to 150 mg orally once a day, increasing to 200 mg/day if necessary
• Titration dose: After increasing the dose to 200 mg/day, if there is no response after 2 weeks, increase the dose to 250 to 300 mg/day.
• Maintenance dose: 75 to 150 mg orally once a day
• Maximum dose: 300 mg/day

• Initial dose: 75 mg orally once a day
• Maintenance dose: 75 to 150 mg orally once a day
• Maximum dose: 200 mg/day

• Approximately 1 to 3 weeks of treatment may be needed before effects are observed.
• Treatment may be more effective in patients with endogenous depression compared to patients with other depressive states.
• The daily dosage may be given at bedtime or in divided doses.
• In cases of relapse due to premature withdrawal of the drug, the effective dosage should be reinstituted.

Usual Geriatric Dose for Depression

TABLETS:

• Initial dose: 30 to 40 mg orally once a day
• Maximum dose: 100 mg/day

• Initial dose: 25 to 50 mg orally once a day
• Maximum dose: 100 mg/day

• Approximately 1 to 3 weeks of treatment may be needed before effects are observed.
• Treatment may be more effective in patients with endogenous depression compared to patients with other depressive states.
• Capsules may be used when total daily dosage is established at 75 mg or higher.
• The daily dosage may be given at bedtime or in divided doses.
• In cases of relapse due to premature withdrawal of the drug, the effective dosage should be reinstituted.

Usual Pediatric Dose for Enuresis

TABLETS:
6 years to 12 years:

• Initial dose: 25 mg orally once a day
• Maintenance dose: 50 mg orally once a day
• Maximum dose: 2.5 mg/kg/day

• Initial dose: 25 mg orally once a day
• Maintenance dose: 75 mg orally once a day
• Maximum dose: 2.5 mg/kg/day

• Examination may include voiding cystourethrography and cystoscopy in patients with daytime symptoms of frequency and urgency.
• Effectiveness may decrease with continued treatment.
• This dose should be given one hour before bedtime.
• In early night bedwetters, the drug is more effective when given earlier and in divided amounts, i.e., 25 mg in midafternoon, repeated at bedtime.
• Dosage should be tapered off gradually.

Renal Dose Adjustments

Mild to moderate renal dysfunction: Data not available
Severe renal dysfunction: Use with caution

Liver Dose Adjustments

Mild to moderate liver dysfunction: Data not available
Severe liver dysfunction: Use with caution

Dose Adjustments

Switching TO/FROM this drug FROM/TO a MAOI used to treat psychiatric disorders:

• Allow a medication-free interval of at least 14 days.

• Starting this drug: Use should be avoided; healthcare providers should consider other interventions (e.g., hospitalization) in patients who require urgent treatment.
• Patients already receiving this drug: If alternative treatments are not available AND the potential benefits of treatment outweigh the risks of serotonin syndrome, this drug should be promptly stopped and linezolid or IV methylene blue should be administered.
• Patients should be monitored for serotonin syndrome for 2 weeks OR until 24 hours after the last dose of the MAOI, whichever comes first.
• This drug may be resumed 24 hours after the last dose of the MAOI.

• Discontinue treatment.

Precautions

US BOXED WARNINGS:
Suicidality and Antidepressant Drugs:

• Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders.
• Anyone considering the use of this drug or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older.
• Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior.
• Families and caregivers should be advised of the need for close observation and communication with the prescriber.
• This drug is not approved for use in pediatric patients.

• Safety and effectiveness in the pediatric population other than pediatric patients with nocturnal enuresis have not been established.
• Safety and effectiveness for nocturnal enuresis in pediatric patients less than 6 years of age has not been established.

Dialysis

Data not available

Other Comments

General:

• The risk of serotonin syndrome with the use of non-IV methylene blue formulations or IV doses much lower than 1 mg/kg is unknown.

• Cardiovascular: Blood pressure, cardiac function, especially in elderly patients
• Hematologic: Periodic blood cell counts, signs/symptoms of infection
• Metabolic: Blood glucose levels
• Psychiatric: Patients should be monitored for worsening and emergence of suicidal thoughts.

• Patients should be instructed to inform their other physician(s) and their dentist that they are using this drug.
• Patients should tell their healthcare provider(s) about all the medicines that they take, including prescription and non-prescription medicines.
• This medicine may increase the risk of suicidal thoughts and behavior. Patients should 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. Patients should report any behavior of concern to their healthcare provider(s) 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; patients should avoid driving a car or operating dangerous machinery until the full effects of this drug are seen.