Drug Notebook

FDA Alerts

    Suicidality
  • Antidepressants may increase risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (18–24 years of age) with major depressive disorder and other psychiatric disorders; balance this risk with clinical need. Fluvoxamine is not approved for use in pediatric patients except for patients with obsessive-compulsive disorder. (See Pediatric Use under Cautions.)
  • In pooled data analyses, risk of suicidality was not increased in adults >24 years of age and apparently was reduced in adults ≥65 years of age with antidepressant therapy compared with placebo.
  • Depression and certain other psychiatric disorders are themselves associated with an increased risk of suicide.
  • Appropriately monitor and closely observe all patients who are started on fluvoxamine therapy for clinical worsening, suicidality, or unusual changes in behavior; involve family members and/or caregivers in this process. (See Worsening of Depression and Suicidality Risk under Cautions.)

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fluvoxamine
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(floo VOX a meen)

Uses

Obsessive-Compulsive Disorder (OCD)

Management of OCD; reduces but does not eliminate obsessions and compulsions.

Bulimia Nervosa

Has been used in the management of bulimia nervosa†.

Dosage and Administration

General

  • Allow at least 2 weeks to elapse between discontinuance of therapy with an MAO inhibitor and initiation of fluvoxamine therapy and vice versa.
  • Monitor for possible worsening of depression, suicidality, or unusual changes in behavior, especially at the beginning of therapy or during periods of dosage adjustments. (See Worsening of Depression and Suicidality Risk under Cautions.)
  • Sustained therapy may be required; monitor periodically for need for continued therapy.
  • Avoid abrupt discontinuance of therapy. To avoid withdrawal reactions, taper dosage gradually. (See Worsening of Depression and Suicidality Risk and also see Withdrawal of Therapy under Cautions.)
  • Consider cautiously tapering dosage during third trimester of pregnancy prior to delivery. (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

Administration

Oral Administration

Administer orally once or twice daily without regard to meals.

Administer dosages ≤100 mg daily in adults or ≤50 mg in pediatric patients as a single daily dose at bedtime; higher dosages generally are given as 2 divided doses, either as equally divided doses or as unequal doses with the larger dose given at bedtime.

Dosage

Available as fluvoxamine maleate; dosage is expressed in terms of the salt.

Pediatric Patients

OCD

Oral

Children >8 years of age: Initially, 25 mg at bedtime. Increase dosages in 25-mg increments every 4–7 days, as tolerated, until maximum therapeutic benefit is achieved or up to a maximum dosage of 200 mg daily in children ≤11 years of age or 300 mg daily in adolescents ≥12 years of age. Girls ≤11 years of age may require lower dosages.

Optimum duration of therapy not established; may require several months of sustained drug therapy. Use the lowest possible dosage and periodically reassess need for continued therapy.

Adults

OCD

Oral

Initially, 50 mg at bedtime. Increase dosages in 50-mg increments every 4–7 days, as tolerated, until maximum therapeutic benefit is achieved or up to a maximum dosage of 300 mg daily.

Optimum duration of therapy not established; may require several months of sustained drug therapy. Use the lowest possible dosage and periodically reassess need for continued therapy.

Prescribing Limits

Pediatric Patients

OCD

Oral

Children ≤11 years of age: Maximum 200 mg daily.

Adolescents ≥12 years of age: Maximum 300 mg daily.

Adults

OCD

Oral

Maximum 300 mg daily.

Special Populations

Dosage in Hepatic Impairment

OCD

Oral

Use lower initial dosage and titrate dosage slowly.

Dosage in Renal Impairment

OCD

Oral

Limited evidence indicates that dosage modification is not necessary.

Geriatric Patients

Initially, 25 mg daily; titrate dosage slowly.

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