Usual Adult Dose for Obsessive Compulsive Disorder

Initial immediate-release tablet dose: 50 mg orally once a day at bedtime
Initial extended-release capsule dose: 100 mg orally once a day at bedtime
Maintenance dose: 100 to 300 mg orally per day
Maximum dose: 300 mg/day

Comments:

• The dose may be increased in 50 mg increments every 4 to 7 days, as tolerated, until maximum therapeutic benefit is achieved.
• A total daily dose of more than 100 mg should be given in two divided doses. If the doses are not equal, the larger dose should be given at bedtime.

Use: Treatment of obsessions and compulsions in patients with obsessive compulsive disorder (OCD), as defined in DSM-III-R or DSM-IV

Usual Pediatric Dose for Obsessive Compulsive Disorder

8 to 11 years:

• Initial dose: 25 mg orally once a day at bedtime
• Maintenance dose: 25 to 200 mg orally per day
• Maximum dose: 200 mg/day

11 to 17 years:

• Initial dose: 25 mg orally once a day at bedtime
• Maintenance dose: 25 to 300 mg orally per day
• Maximum dose: 300 mg/day

Comments:
The dose may be increased in 25 mg increments every 4 to 7 days, as tolerated, up to a maximum daily dose.

• Total daily doses of more than 50 mg should be given in two divided doses. If the two divided doses are not equal, the larger dose should be given at bedtime.
• Lower doses may be effective in female versus male patients.

Use: Treatment of obsessions and compulsions in patients with OCD, as defined in DSM-III-R or DSM-IV

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Liver dysfunction:

• Immediate-release tablets: Patients should begin on a low dose, and the dose should be increased slowly with close monitoring.
• Extended-release capsules: It may be appropriate to titrate slowly following the initial dose of 100 mg.

Dose Adjustments

Elderly patients:

• Immediate-release tablets: Patients should begin on a low dose, and the dose should be increased slowly with close monitoring.
• Extended-release capsules: It may be appropriate to titrate slowly following the initial dose of 100 mg.

Patients taking concomitant medications with the potential for interactions: A lower or less frequent dosage may be appropriate.

• Alprazolam: Initial alprazolam doses should be reduced by at least 50%, and treatment should be titrated to the lowest effective dose.
• Diazepam: Coadministration should be avoided.

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 14 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 14 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.

Treatment discontinuation:

• A gradual dose reduction is recommended instead of abrupt cessation where possible.
• If intolerable symptoms occur, it is recommended to consider resuming the previously prescribed dose; discontinuation/dose reduction may continue, but at a more gradual rate.

Precautions

US BOXED WARNINGS:
SUICIDALITY AND ANTIDEPRESSANTS:

• 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 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 except for patients with obsessive compulsive disorder (OCD).

Safety and efficacy in patients younger than 8 years have not been established.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• This drug should be swallowed whole and not chewed.
• Patients should be maintained on the lowest effective dose.
• Treatment of depression should be maintained for at least 6 months to ensure that patients are free from symptoms.
• In patients with obsessive compulsive disorder, continuation of treatment beyond 10 weeks may be considered in responsive patients and periodically the need for treatment should be reassessed.

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.

Monitoring:

• Psychiatric: Patients should be monitored for discontinuation symptoms, and for worsening and emergence of suicidal thoughts.
• Neurologic: Patients should be monitored for symptoms of serotonin syndrome.
• Cardiovascular: Patients should have regular monitoring of blood pressure.

Patient advice:

• Patients should tell healthcare provider about all of 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 as soon as possible.
• Somnolence has been reported. Caution in driving and operating machinery is recommended until the individual response to the drug has been determined.
• 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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