Usual Adult Dose for Obsessive Compulsive Disorder

Initial dose: 25 mg orally once a day at bedtime
Maintenance dose: 100 mg orally per day
Maximum dose: 250 mg/day

Comments:

• The dose should be increased gradually, as tolerated, to 100 mg during the first 2 weeks. After the initial titration, the dose may be increased gradually over the next several weeks to a maximum of 250 mg/day.
• During initial titration, this drug should be given in divided doses with meals to reduce gastrointestinal side effects.
• During maintenance, the total daily dose may be given once a day at bedtime to minimize daytime sedation.
• Dosage adjustments should be made to maintain the patient on the lowest effective dosage.

Use: Treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD) who have obsessions/compulsions that must cause marked distress, be time consuming, or significantly interfere with social/occupational functioning

Usual Pediatric Dose for Obsessive Compulsive Disorder

10 to 17 years:

• Initial dose: 25 mg orally once a day at bedtime
• Maintenance dose: May increase to 3 mg/kg or 100 mg orally per day, whichever is the smaller dose
• Maximum dose: 3 mg/kg/day or 200 mg/day, whichever is the smaller dose

Comments:

• During initial titration, this drug should be given in divided doses with meals to reduce gastrointestinal side effects.
• After titration, the total daily dose may be given once a day at bedtime to minimize daytime sedation.
• Dosage adjustments should be made to maintain the patient on the lowest effective dosage.

Use: Treatment of obsessions and compulsions in patients with OCD who have obsessions/compulsions that must cause marked distress, be time consuming, or significantly interfere with social/occupational functioning

Renal Dose Adjustments

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

Liver Dose Adjustments

Patients with known liver disease: Use with caution; frequent monitoring recommended.

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.

Use with other MAOIs (e.g., IV methylene blue, linezolid):

• 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.

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 except for patients with obsessive compulsive disorder (OCD).

Safety and efficacy have not been established in patients with OCD younger than 10 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Storage requirements:

• Protect from moisture

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.
• Obsessions are ego-dystonic recurrent, persistent ideas, thoughts, images, or impulses.
• Compulsions are recognized by the patient as excessive or unreasonable, and are characterized by repetitive, purposeful, and intentional behaviors performed in response to an obsession/in a stereotyped fashion.

Monitoring:

• Cardiovascular: Blood pressure, cardiac function, especially in elderly patients
• Hematologic: Periodic blood cell counts and signs/symptoms of agranulocytosis, especially early in therapy and during prolonged treatment
• Metabolic: Blood glucose levels
• Psychiatric: Patients should be monitored for worsening and emergence of suicidal thoughts.
• Renal: Renal function, especially in patients with liver and renal disease or a history of liver disease

Patient advice:

• 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 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.
• Somnolence has been reported. Caution in driving and operating machinery is recommended until the individual response to the drug has been determined.

Frequently asked questions

• What are some common side effects of antidepressants?