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fluvoxamine (Rx)Brand and Other Names:Luvox, Luvox CR

 
 
 

Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

tablets

  • 25mg
  • 50mg
  • 100mg

capsule, extended-release

  • 100mg
  • 150mg
more...

Obsessive-Compulsive Disorder

Conventional tablets

  • 50 mg qHS initially; may increase by 50 mg/day q4-7Days up to 100-300 mg/day
  • Dose >100 mg/day should be divided q12hr

Extended-release capsules

  • 100 mg PO qDay initially; may titrate in 50 mg/day increments every week
  • Not to exceed 300 mg/day

Social Phobia (Off-label)

Immediate release

  • 50 mg PO qDay; may increase by 50 mg at 1 week interval; usual dose range is 100-300 mg/day

Extended-release capsules

  • 100 mg PO qDay initially; may titrate in 50 mg/day increments qWeek
  • Not to exceed 300 mg/day

Panic Disorder (Off-label)

50 mg PO qDay; after several days, gradually increase to 150 mg/day; may increase to 300 mg/day for patients who fail to respond after several weeks of treatment

Dosing considerations

  • Continue therapy for 1-2 years, and consider discontinuation with close supervision; when discontinuing therapy, a slow taper over 2-6 months is recommended

Posttraumatic Stress Disorder (Off-label)

50 mg/day PO initially; may increase dose to 100-250 mg in adults and 100 mg in older adults; not to exceed 300 mg/day

Dosing considerations

  • Patients who respond to therapy may need to continue therapy indefinitely
  • May attempt tapering after 6-12 months in patients with acute PTSD; tapering should occur gradually over 2 weeks to 1 month to avoid withdrawal symptoms; tapering should take place over 4-12 weeks in patients at risk of relapse

Dosing Modifications

Hepatic impairment: Decrease dose

Administration

May be administered with food

Dosage Forms & Strengths

tablet

  • 25mg
  • 50mg
  • 100mg

capsule, extended-release

  • 100mg
  • 150mg
more...

Obsessive-Compulsive Disorder

<8 years: Safety and efficacy not established

Ages 8-17 years (conventional tablets): 25 mg PO qHS initially; may titrate by 25 mg/day increments every 4-7 days to 50-200 mg/day

Not to exceed 200 mg (for ages 8-11 years) or 300 mg for adolescents

Give doses >50 mg/day divided q12hr

The elderly are prone to SSRI/SNRI-induced hyponatremia; monitor closely

Obsessive-Compulsive Disorder

Conventional tablets: 25 mg qHS initially; may increase by 50 mg/day q4-7days up to 100-300 mg/day; dose >100 mg/day should be divided q12hr

Extended-release capsules: 100 mg PO qDay initially; may titrate in 50 mg/day increments every week; not to exceed 300 mg/day

Social Phobia

Extended-release capsules: 100 mg PO qDay initially; may titrate in 50 mg/day increments qWeek; not to exceed 300 mg/day

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Interactions

Interaction Checker

fluvoxamine and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Nausea (40%)

            Headache (22-35%)

            Somnolence (22-27%)

            Weakness (14-26%)

            Insomnia (20-35%)

            Diarrhea (11-18%)

            Dizziness (11-15%)

            Xerostomia (10-14%)

            Anorexia (6-14%)

            Abnormal ejaculation (8-11%)

            1-10%

            Pain (10%)

            Dyspepsia (8-10%)

            Constipation (4-10%)

            Decreased libido (2-10%)

            Upper respiratory infections (9%)

            Anxiety (5-8%)

            Tremor (5-8%)

            Sweating (6-7%)

            Vomiting (4-6%)

            Abdominal pain (5%)

            Myalgia (5%)

            Abnormal taste (2-5%)

            Bruising (4%)

            Abnormal dreams (3%)

            Abnormal thinking (3%)

            Chest pain (3%)

            Palpitation (3%)

            Agitation (2-3%)

            Vasodilation (2-3%)

            Hypertension (1-2%)

            Increased LFTs (1-2%)

            Weight change (1-2%)

            Manic reaction

            <1%

            Activation of mania/hypomania, seizures (discontinue)

            Sinusitis

            Frequency Not Defined

            Edema

            Amnesia

            Apathy

            Asthenia

            Malaise

            Nervousness

            Dry mouth

            Myoclonus

            Cough

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            Warnings

            Black Box Warnings

            In short-term studies, antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults (<24 years) taking antidepressants for major depressive disorders and other psychiatric illnesses

            This increase was not seen in patients aged >24 years; a slight decrease in suicidal thinking was seen in adults >65 years

            In children and young adults, risks must be weighed against the benefits of taking antidepressants

            Patients should be monitored closely for changes in behavior, clinical worsening, and suicidal tendencies; this should be done during initial 1-2 months of therapy and dosage adjustments

            The patient’s family should communicate any abrupt changes in behavior to the healthcare provider

            Worsening behavior and suicidal tendencies that are not part of the presenting symptoms may require discontinuation of therapy

            This drug is not approved for use in pediatric patients

            Contraindications

            Hypersensitivity

            Coadministration with serotonergic drugs

            • Concomitant use or within 14 days of MAOIs increases risk of serotonin syndrome
            • Reactions to concomitant administration with MAOIs include tremor, myoclonus, diaphoresis, nausea, vomiting, flushing, dizziness, hyperthermia with features resembling neuroleptic malignant syndrome, seizures, rigidity, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes (including extreme agitation progressing to delirium and coma)
            • Starting fluvoxamine in a patient who is being treated with linezolid or IV methylene blue is contraindicated because of an increased risk of serotonin syndrome
            • If linezolid or IV methylene blue must be administered, discontinue SSRI immediately and monitor for CNS toxicity; may resume 24 hr after last linezolid or methylene blue dose, or after 2 weeks of monitoring (5 weeks for fluoxetine), whichever comes first

            Cautions

            Conflicting evidence regarding use of SSRIs during pregnancy and increased risk of persistent pulmonary hypertension of the newborn (see Pregnancy)

            In neonates exposed to SNRIs/SSRIs late in third trimester: Risk of complications such as feeding difficulties, irritability, and respiratory problems

            Risk of mydriasis; may trigger angle closure attack in patients with angle closure glaucoma with anatomically narrow angles without a patent iridectomy

            May need to modify dose for hepatic impairment; titrate at smaller increments and longer intervals

            Clinical worsening and suicide ideation may occur despite medication in adolescents and young adults (18-24 years)

            May worsen mania symptoms or precipitate mania in patients with bipolar disorder

            Increases risk of bleeding in patients taking anticoagulants/antiplatelets concomitantly

            Do not use concurrently with alosetron, astemizole, cisapride, pimozide, terfenadine, or tizanidine due to QT prolongation risk

            Potentially life-threatening serotonin syndrome reported when coadministered with drugs that impair serotonin metabolism (in particular, MAOIs, including nonpsychiatric MAOIs, such as linezolid and IV methylene blue) (see Contraindications)

            May impair ability to operate heavy machinery and other tasks requiring mental alertness

            Bone fractures have been associated with antidepressant treatment; consider possibility of fragility fracture if patient presents with pain, joint tenderness, or swelling

            Impaired glucose control (hyperglycemia or hypoglycemia) reported; monitor for signs/symptoms of loss of glucose control, especially in patients with diabetes

            May cause or exacerbate sexual dysfunction

            Syndrome of inapropriate antidiuretic hormone and hyponatremia reported with SSRI and SNRI use; volume deplretion and/or concurrent use of diuretics may increase risk; consider discontinuing therapy if symptomatic hyponatremia occurs

            Use caution in patients with cardiovascular disease or history of seizure disorder

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            Pregnancy & Lactation

            Pregnancy

            Category: C

            Use late in the third trimester associated with complications in newborns and may require prolonged hospitalization, respiratory support, and tube feeding

            Persistent pulmonary hypertension of the newborn

            • Potential risk of persistent pulmonary hypertension of the newborn when used during pregnancy
            • Initial Public Health Advisory in 2006 was based on a single published study; since then, there have been conflicting findings from new studies, making it unclear whether use of SSRIs during pregnancy can cause PPHN
            • FDA has reviewed the additional new study results and has concluded that, given the conflicting results from different studies, it is premature to reach any conclusion about a possible link between SSRI use in pregnancy and PPHN
            • FDA recommendation: FDA advises healthcare professionals not to alter their current clinical practice of treating depression during pregnancy and to report any adverse events to the FDA MedWatch program
            • A meta-analysis of 7 observational studies, found exposure to SSRIs in late pregnancy (ie, >20 weeks' gestation) more than doubled the risk of PPHN that could not be explained by other etiologies (eg, congenital malformations, meconium aspiration) (BMJ 2014;348:f6932)

            Lactation

            Present in breast milk; avoid

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

            more...
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            Pharmacology

            Mechanism of Action

            Selective serotonin reuptake inhibitor; little or no affinity for dopamine, alpha-adrenergic histamine, or cholinergic receptor

            Absorption

            Bioavailability: 53%

            Peak plasma time: 3-8 hr

            Peak plasma concentration: 88-546 ng/mL (nonlinear)

            Distribution

            Protein bound: 80%

            Vd: 25 L/kg

            Metabolism

            Metabolism: Hepatic oxidative demethylation, deamination

            Metabolites: Inactive

            Enzymes inhibited: Hepatic CYP1A2, CYP2C9, CYP3A4

            Elimination

            Half-life: 15.6 hr; 17.4-25.9 hr (elderly)

            Dialyzable: No

            Excretion: Urine (85%)

            Pharmacogenomics

            Several SSRIs (eg, fluoxetine, fluvoxamine, paroxetine, sertraline) are metabolized by CYP2D6

            CYP2D6 is involved in the metabolism of approximately 20% of drugs in clinical use and displays large individual-to-individual variability in activity due to genetic polymorphisms

            More than 80 CYP2D6 variant alleles have been identified; however, 4 of the most prevalent alleles, CYP2D6*3, *4, *5, and *6, account for 93-97% of CYP2D6 poor metabolizers (PMs)

            CYP2D6*4, the most common variant (~25% frequency in whites), causes a splicing defect; CYP2D6*3 (2.7% frequency) causes a frameshift mutation; and CYP3D6*5 (2.6%) is an entire deletion of the CYP2D6 gene; individuals homozygous for these alleles have no CYP2D6 activity

            The impact of CYP2D6 activity is further complicated in some SSRIs (eg, fluoxetine, fluvoxamine, paroxetine, sertraline) that, in addition to being substrates for CYP2D6, are also known to moderately inhibit CYP2D6 activity

            Genetic testing laboratories

            • Genotyping tests for CYP2D6 variants are commercially available through Applied Biosystems (http://www.appliedbiosystems.com/) and GenPath Diagnostics (http://www.genpathdiagnostics.com/)
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            Images

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            Formulary

            FormularyPatient Discounts

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
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            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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