No

Antidepressant, Selective Serotonin Reuptake Inhibitor

Treatment of obsessive-compulsive disorder (OCD)

C

Hypersensitivity to fluvoxamine; concurrent use with terfenadine, astemizole or cisapride; use of MAO inhibitors within 14 days

Potential for severe reaction when used with MAO inhibitors - serotonin syndrome (hyperthermia, muscular rigidity, mental status changes/agitation, autonomic instability) may occur. May precipitate a shift to mania or hypomania in patients with bipolar disease. Has a low potential to impair cognitive or motor performance - caution operating hazardous machinery or driving. Use caution in patients with depression, particularly if suicidal risk may be present. Use caution in patients with a previous seizure disorder or condition predisposing to seizures such as brain damage, alcoholism, or concurrent therapy with other drugs which lower the seizure threshold. Use with caution in patients with hepatic or dysfunction and in elderly patients. May cause hyponatremia/SIADH. Use with caution in patients with renal insufficiency or other concurrent illness (cardiovascular disease). Use with caution in patients at risk of bleeding or receiving concurrent anticoagulant therapy, although not consistently noted, fluvoxamine may cause impairment in platelet function. May cause or exacerbate sexual dysfunction.

>10%:

Central nervous system: Headache, somnolence, insomnia, nervousness, dizziness

Gastrointestinal: Nausea, diarrhea, xerostomia

Neuromuscular & skeletal: Weakness

1% to 10%:

Cardiovascular: Palpitations

Central nervous system: Somnolence, headache, insomnia, dizziness, nervousness, mania, hypomania, vertigo, abnormal thinking, agitation, anxiety, malaise, amnesia, yawning, hypertonia, CNS stimulation, depression

Endocrine & metabolic: Decreased libido

Gastrointestinal: Abdominal pain, vomiting, dyspepsia, constipation, abnormal taste, anorexia, flatulence

Genitourinary: Delayed ejaculation, impotence, anorgasmia, urinary frequency, urinary retention

Neuromuscular & skeletal: Tremors

Ocular: Blurred vision

Respiratory: Dyspnea

Miscellaneous: Diaphoresis

<1%: Angina, bradycardia, seizures, ataxia, acne, alopecia, dry skin, dermatitis, urticaria, delayed menstruation, dysuria, lactation, nocturia, thrombocytopenia, elevated liver transaminases, anemia, leukocytosis, extrapyramidal reactions

Symptoms of overdose include drowsiness, nausea, vomiting, abdominal pain, tremors, sinus bradycardia, and seizures

Specific antidote does not exist; treatment is supportive. Although vomiting has not been extensive in overdose to date, patients should be monitored for fluid and electrolyte loss, and appropriate replacement therapy instituted when necessary.

CYP1A2 enzyme substrate; CYP1A2, 2C9, 2C19, 2D6, and 3A3/4 enzyme inhibitor

Fluvoxamine may cause hyponatremia; additive hyponatremic effects may be seen with combined use of a loop diuretic (bumetanide, furosemide, torsemide); monitor for hyponatremia

Fluvoxamine inhibits the reuptake of serotonin; combined use with a serotonin agonist (buspirone) may cause serotonin syndrome

Fluvoxamine may inhibit the metabolism of carbamazepine resulting in increased carbamazepine levels and toxicity; monitor for altered CBZ response

Cyproheptadine, a serotonin antagonist may inhibit the effects of serotonin reuptake inhibitors (fluvoxamine); monitor for altered antidepressant response

Fluvoxamine should not be used with nonselective MAOIs (isocarboxazid, phenelzine). Fatal reactions have been reported. Wait two weeks after stopping fluvoxamine before starting an MAOI and two weeks after stopping an MAOI before starting fluvoxamine.

Patients receiving fluvoxamine and lithium may develop neurotoxicity; if combination is used; monitor for neurotoxicity

Fluvoxamine inhibits the reuptake of serotonin; combined use with other drugs which inhibit the reuptake (nefazodone, sibutramine) may cause serotonin syndrome. Monitor patient for altered response with nefazodone; avoid sibutramine combination.

Fluvoxamine combined with tramadol (serotonergic effects) may cause serotonin syndrome; monitor

Fluvoxamine may inhibit the metabolism of trazodone resulting in increased toxicity; monitor

Fluvoxamine inhibits the reuptake of serotonin; combination with tryptophan, a serotonin precursor, may cause agitation and restlessness; this combination is best avoided

Fluvoxamine may alter the hypoprothombinemic response to warfarin; monitor

Fluvoxamine inhibits the metabolism of clozapine; adjust clozapine dosage downward or use an alternative SSRI

Fluvoxamine inhibits the metabolism of tacrine; use alternative SSRI

Fluvoxamine inhibits the metabolism of theophylline; monitor for theophylline toxicity or use alternative SSRI

Fluvoxamine inhibits the metabolism of triazolam; monitor for altered response; consider lowering dose of triazolam by 50%

Fluvoxamine may increase serum concentrations of buspirone

Fluvoxamine may inhibit the metabolism of tacrolimus; monitor for adverse effects; consider an alternative SSRI

Protect from high humidity and store at controlled room temperature 15°C to 30°C (59°F to 86°F); dispense in tight containers

Inhibits CNS neuron serotonin uptake; minimal or no effect on reuptake of norepinephrine or dopamine; does not significantly bind to alpha-adrenergic, histamine or cholinergic receptors

Onset of effect: >2 weeks for therapeutic effect

Half-life: ~15 hours

Time to peak plasma concentration: 3-8 hours

Oral:

Elderly or hepatic impairment: Reduce dose, titrate slowly

Alcohol: Additive CNS effect, avoid use

Signs and symptoms of depression, anxiety, weight gain or loss, nutritional intake, sleep

Although caution should be used in patients taking tricyclic antidepressants, no interactions have been reported with vasoconstrictors and fluvoxamine, a nontricyclic antidepressant which acts to increase serotonin

No effects or complications reported

Take exactly as directed (do not increase dose or frequency); may take 2-3 weeks to achieve desired results; may cause physical and/or psychological dependence. Take once-a-day dose at bedtime. Avoid excessive alcohol, caffeine, and other prescription or OTC medications not approved by prescriber. Maintain adequate hydration (2-3 L/day of fluids unless instructed to restrict fluid intake). You may experience drowsiness, lightheadedness, impaired coordination, dizziness, or blurred vision (use caution when driving or engaging in tasks requiring alertness until response to drug is known); nausea, vomiting, or anorexia (small frequent meals, frequent mouth care, chewing gum, or sucking lozenges may help); constipation (increased exercise, fluids, or dietary fruit and fiber may help); diarrhea (buttermilk, yogurt, or boiled milk may help); postural hypotension (use caution when climbing stairs or changing position from lying or sitting to standing); or decreased sexual function or libido (reversible). Report persistent CNS effects (nervousness, restlessness, insomnia, anxiety, excitation, headache, sedation, seizures, mania, abnormal thinking); rash or skin irritation; muscle cramping, tremors, or change in gait; chest pain or palpitations; change in urinary pattern; or worsening of condition. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to be pregnant. Breast-feeding is not recommended.

Tablet: 50 mg, 100 mg

de Vries MH, Raghoebar M, Mathlener IS, et al, "Single and Multiple Oral Dose Fluvoxamine Kinetics in Young and Elderly Subjects," Ther Drug Monit, 1992, 14(6):493-8.

Grimsley SR and Jann MW, "Paroxetine, Sertraline, and Fluvoxamine: New Selective Serotonin Reuptake Inhibitors," Clin Pharm, 1992, 11(11):930-57.

Roose SP, Glassman AH, Attia E, et al, "Comparative Efficacy of Selective Serotonin Reuptake Inhibitors and Tricyclics in the Treatment of Melancholia," Am J Psychiatry, 1994, 151(12):1735-9.

Wynn RL, "New Antidepressant Medications," Gen Dent, 1997, 45(1):24-8.