fluvoxamine (Rx)

Brand and Other Names:Luvox, Luvox CR (DSC)
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

tablets

  • 25mg
  • 50mg
  • 100mg

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

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

Panic Disorder (Off-label)

25-50 mg PO qDay; after several days, gradually increase to 100-200 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

Therapy discontinuation

  • To discontinue therapy, gradually taper the dose to minimize the incidence of withdrawal symptoms and allow for detection of re-emerging symptoms

Dosage Forms & Strengths

tablet

  • 25mg
  • 50mg
  • 100mg

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

Social Phobia (Off-label)

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

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Interactions

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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); prescriptions should be written for the smallest quantity consistent with good patient care

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

            May impair platelet aggregation; 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 has been reported with drugs that impair serotonin metabolism (in particular, MAOIs, including nonpsychiatric MAOIs, such as linezolid and IV methylene blue); it has also been reported with reported with SNRIs and SSRIs, including fluvoxamine, alone but particularly with concomitant use of serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John's Wort (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

            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

            Sexual dysfunction

            • Use of may cause symptoms of sexual dysfunction in both male and female patients; inform patients that they should discuss any changes in sexual function and potential management strategies with their healthcare provider
            • Use of SSRIs, may cause symptoms of sexual dysfunction; in male patients, SSRI use may result in ejaculatory delay or failure, decreased libido, and erectile dysfunction
            • In female patients, SSRI/SNRI use may result in decreased libido and delayed or absent orgasm
            • Important for prescribers to inquire about sexual function prior to initiation of therapy and to inquire specifically about changes in sexual function during treatment, because sexual function may not be spontaneously reported
            • When evaluating changes in sexual function, obtaining a detailed history (including timing of symptom onset) is important because sexual symptoms may have other causes, including underlying psychiatric disorder
            • Discuss potential management strategies to support patients in making informed decisions about treatment
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            Pregnancy & Lactation

            Pregnancy

            There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy; healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants

            Prolonged experience with fluvoxamine in pregnant women over decades, based on published observational studies, have not identified a clear drug-associated risk of major birth defects or miscarriage; there are risks associated with untreated depression in pregnancy and risks of persistent pulmonary hypertension of newborn (PPHN) and poor neonatal adaptation with exposure to selective serotonin reuptake inhibitors (SSRIs), including fluvoxamine, during pregnancy

            Women who discontinue antidepressants during pregnancy are more likely to experience a relapse of major depression than women who continue antidepressants; consider risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum

            Neonates exposed to therapy and other SSRIs or SNRIs late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding; such complications can arise immediately upon delivery; reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying; these features are consistent with either a direct toxic effect of SSRIs and SNRIs or, possibly, a drug discontinuation syndrome; it should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome

            Animal findings suggest fertility may be impaired while taking fluvoxamine

            Animal data

            • Pregnant rats treated orally with throughout period of organogenesis, increased embryofetal death and increased incidences of fetal eye abnormalities (folded retinas) was observed at doses ≥3 times maximum recommended human dose (MRHD) of 300 mg/day given to adolescents on a mg/m2 basis; in addition, decreased fetal body weight was seen at a dose 6 times MRHD given to adolescents on a mg/m2 basis
            • There were no adverse developmental effects in rabbits treated with fluvoxamine during period of organogenesis up to a dose 2 times MRHD given to adolescents on a mg/m2 basis; when drug was administered orally to rats during pregnancy and lactation, increased pup mortality at birth was seen at dose 2 times MRHD given to adolescents on a mg/m2 basis; in addition, decreases in pup body weight and survival were observed at doses that are ≥0.13 times MRHD given to adolescents

            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

            Data from published literature report presence of drug in human milk; no adverse effects on breastfed infant have been reported in most cases of maternal use of fluvoxamine during breastfeeding; however, there are reports of diarrhea, vomiting, decreased sleep, and agitation; there are no data on effect of fluvoxamine on milk production

            Developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for fluvoxamine and any potential adverse effects on breastfed child from drug or from the underlying maternal condition

            Monitor infants exposed to fluvoxamine through breast milk for diarrhea, vomiting, decreased sleep, and agitation

            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.

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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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            Administration

            Oral Administration

            May take with or without food

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            Images

            BRAND FORM. UNIT PRICE PILL IMAGE
            fluvoxamine oral
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            50 mg tablet
            fluvoxamine oral
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            100 mg tablet
            fluvoxamine oral
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            25 mg tablet
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            100 mg tablet
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            100 mg tablet
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            50 mg tablet
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            -
            150 mg capsule
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            100 mg capsule
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            100 mg capsule
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            50 mg tablet
            fluvoxamine oral
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            25 mg tablet
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            150 mg capsule
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            100 mg tablet
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            50 mg tablet
            fluvoxamine oral
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            25 mg tablet
            fluvoxamine oral
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            50 mg tablet
            fluvoxamine oral
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            25 mg tablet

            Copyright © 2010 First DataBank, Inc.

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            Patient Handout

            Patient Education
            fluvoxamine oral

            FLUVOXAMINE - ORAL

            (floo-VOX-a-meen)

            COMMON BRAND NAME(S): Luvox

            WARNING: Antidepressant medications are used to treat a variety of conditions, including depression and other mental/mood disorders. These medications can help prevent suicidal thoughts/attempts and provide other important benefits. However, studies have shown that a small number of people (especially people younger than 25) who take antidepressants for any condition may experience worsening depression, other mental/mood symptoms, or suicidal thoughts/attempts. It is very important to talk with the doctor about the risks and benefits of antidepressant medication (especially for people younger than 25), even if treatment is not for a mental/mood condition.Tell the doctor right away if you notice worsening depression/other psychiatric conditions, unusual behavior changes (including possible suicidal thoughts/attempts), or other mental/mood changes (including new/worsening anxiety, panic attacks, trouble sleeping, irritability, hostile/angry feelings, impulsive actions, severe restlessness, very rapid speech). Be especially watchful for these symptoms when a new antidepressant is started or when the dose is changed.

            USES: Fluvoxamine is used to treat obsessive-compulsive disorder (OCD). It helps decrease thoughts that are unwanted or that don't go away (obsessions), and it helps to reduce the urge to perform repeated tasks (compulsions such as hand-washing, counting, checking) that interfere with daily living. Fluvoxamine is known as a selective serotonin reuptake inhibitor (SSRI). This medication works by helping to restore the balance of a certain natural substance (serotonin) in the brain.

            HOW TO USE: Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start taking fluvoxamine and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth with or without food as directed by your doctor, usually once daily at bedtime, or twice daily (once in the morning and once at bedtime). If you are taking this medication twice daily and the doses are not equal, then the larger of the 2 doses should be taken at bedtime.The dosage is based on your medical condition, response to treatment, age, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). In children, the dosage may also be based on their age and gender. To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully.Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase. Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day.Keep taking this medication even if you feel well. Do not stop taking this medication without consulting your doctor. Some conditions may become worse when this drug is suddenly stopped. Also, you may experience symptoms such as mood swings, headache, tiredness, sleep changes, and brief feelings similar to electric shock. To prevent these symptoms while you are stopping treatment with this drug, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details. Report any new or worsening symptoms right away.It may take up to several weeks before you get the full benefit of this drug.Tell your doctor if your condition does not improve or if it worsens.

            SIDE EFFECTS: See also Warning section.Nausea, vomiting, drowsiness, dizziness, loss of appetite, trouble sleeping, weakness, and sweating may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: easy bleeding/bruising, shaking (tremor), decreased interest in sex, changes in sexual ability.Get medical help right away if you have any very serious side effects, including: fainting, irregular heartbeat, black stools, vomit that looks like coffee grounds, seizures, eye pain/swelling/redness, widened pupils, vision changes (such as seeing rainbows around lights at night, blurred vision).This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take (see Drug Interactions section). Get medical help right away if you develop some of the following symptoms: fast heartbeat, hallucinations, loss of coordination, severe dizziness, severe nausea/vomiting/diarrhea, twitching muscles, unexplained fever, unusual restlessness.Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, stop using this drug and get medical help right away, or permanent problems could occur.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

            PRECAUTIONS: Before taking fluvoxamine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: personal or family history of bipolar/manic-depressive disorder, personal or family history of suicide attempts, liver problems, seizures, low sodium in the blood, bleeding problems, personal or family history of glaucoma (angle-closure type).This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Fluvoxamine may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using fluvoxamine, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics "water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using fluvoxamine safely.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Older adults may be more sensitive to the side effects of this drug, especially bleeding, or loss of coordination, QT prolongation. Older adults may also be more likely to develop a type of salt imbalance (hyponatremia), especially if they are taking "water pills" (diuretics). Loss of coordination can increase the risk of falling.Children may be more sensitive to the side effects of this drug, especially loss of appetite and weight loss. Monitor weight and height in children who are taking this drug.During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Also, babies born to mothers who have used this drug during the last 3 months of pregnancy may rarely develop withdrawal symptoms such as feeding/breathing difficulties, seizures, muscle stiffness, or constant crying. If you notice any of these symptoms in your newborn, tell the doctor promptly.Since untreated mental/mood problems (such as depression, obsessive compulsive disorder, post-traumatic stress disorder) can be a serious condition, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately discuss with your doctor the benefits and risks of using this medication during pregnancy.This drug passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

            DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug are: other drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, NSAIDs such as ibuprofen/naproxen, "blood thinners" such as dabigatran/warfarin).Aspirin can increase the risk of bleeding when used with this medication. However, if your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually 81-162 milligrams a day), you should continue taking it unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.Many drugs besides fluvoxamine may affect the heart rhythm (QT prolongation), including pimozide, thioridazine, among others.This medication can slow down the removal of other medications from your body, which may affect how they work. Examples of affected drugs include alosetron, clozapine, methadone, melatonin, ramelteon, tacrine, tizanidine, certain benzodiazepines such as alprazolam/diazepam/triazolam, certain beta-blockers such as metoprolol/propranolol, tricyclic antidepressants such as imipramine, among others.Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, metaxalone, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before and after treatment with this medication. Ask your doctor when to start or stop taking this medication.The risk of serotonin syndrome/toxicity increases if you are also taking other drugs that increase serotonin. Examples include street drugs such as MDMA/"ecstasy," St. John's wort, certain antidepressants (including other SSRIs such as fluoxetine/paroxetine, SNRIs such as duloxetine/venlafaxine), tryptophan, among others. The risk of serotonin syndrome/toxicity may be more likely when you start or increase the dose of these drugs.This medication can increase the effects of caffeine. Avoid drinking large amounts of beverages containing caffeine (coffee, tea, colas) or eating large amounts of chocolate or taking nonprescription products that contain caffeine.Tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, marijuana (cannabis), antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, and opioid pain relievers (such as codeine).Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.Cigarette smoking decreases blood levels of this medication. Tell your doctor if you smoke or if you have recently stopped smoking.This medication may interfere with certain medical/laboratory tests (including brain scan for Parkinson's disease), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

            OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: fast/slow/irregular heartbeat, trouble breathing, seizures.

            NOTES: Do not share this medication with others.Keep all regular medical and psychiatric appointments.

            MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

            STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

            Information last revised May 2022. Copyright(c) 2022 First Databank, Inc.

            IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            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.
            • Manage and view all your plans together – even plans in different states.
            • 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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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.