Pronunciation:

floo-VOX-a-meen

Brand Names:

• Luvox
• Luvox CR

Dosage Forms:

• Capsule, Extended Release
• Tablet

Warnings:

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 fluvoxamine maleate 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 . . Fluvoxamine maleate tablets are not approved for use in pediatric patients except for patients with obsessive compulsive disorder .

Classifications:

Therapeutic—

Antidepressant

Pharmacologic—

Serotonin Reuptake Inhibitor

Uses of This Medicine:

Fluvoxamine is used to treat obsessive compulsive disorder (OCD). It belongs to a group of medicines known as selective serotonin reuptake inhibitors (SSRIs). These medicines are thought to work by increasing the activity of a chemical called serotonin in the brain. .

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of fluvoxamine tablets in children 8 to 17 years of age. Because fluvoxamine may cause weight loss or a decrease in appetite, children who will be taking fluvoxamine for a long time should have their weight and growth measured by the doctor regularly.

Appropriate studies have not been performed on the relationship of age to the effects of fluvoxamine extended-release capsules in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of fluvoxamine in the elderly. However, elderly patients are more likely to have hyponatremia (low sodium in the blood) and age-related liver problems, which may require an adjustment in the dose for patients receiving fluvoxamine.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Agomelatine
• Alosetron
• Astemizole
• Bromopride
• Cisapride
• Eliglustat
• Fezolinetant
• Isocarboxazid
• Levomethadyl
• Linezolid
• Mavacamten
• Methylene Blue
• Metoclopramide
• Ozanimod
• Phenelzine
• Pimozide
• Procarbazine
• Ramelteon
• Rasagiline
• Safinamide
• Selegiline
• Terfenadine
• Thioridazine
• Tizanidine
• Tranylcypromine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abciximab
• Abrocitinib
• Acalabrutinib
• Aceclofenac
• Acemetacin
• Acenocoumarol
• Alfentanil
• Almotriptan
• Alprazolam
• Amineptine
• Amiodarone
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Amphetamine
• Amtolmetin Guacil
• Anagrelide
• Anileridine
• Apixaban
• Aprepitant
• Ardeparin
• Argatroban
• Asenapine
• Aspirin
• Atazanavir
• Avapritinib
• Belzutifan
• Bemiparin
• Bendamustine
• Benzhydrocodone
• Benzphetamine
• Betrixaban
• Bivalirudin
• Bosutinib
• Brigatinib
• Bromfenac
• Brompheniramine
• Bufexamac
• Buprenorphine
• Bupropion
• Buspirone
• Butorphanol
• Cangrelor
• Carbamazepine
• Carvedilol
• Celecoxib
• Certoparin
• Chlorpheniramine
• Choline Salicylate
• Cilostazol
• Citalopram
• Clomipramine
• Clonixin
• Clopidogrel
• Clorgyline
• Clozapine
• Cobicistat
• Cocaine
• Codeine
• Colchicine
• Cyclobenzaprine
• Dabigatran Etexilate
• Dalteparin
• Danaparoid
• Daridorexant
• Darunavir
• Deflazacort
• Desipramine
• Desirudin
• Desmopressin
• Desvenlafaxine
• Dexfenfluramine
• Dexibuprofen
• Dexketoprofen
• Dextroamphetamine
• Dextromethorphan
• Diazepam
• Dibenzepin
• Diclofenac
• Difenoxin
• Diflunisal
• Dihydrocodeine
• Dihydroergotamine
• Diphenoxylate
• Dipyridamole
• Dipyrone
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Droperidol
• Droxicam
• Duloxetine
• Edoxaban
• Elacestrant
• Eletriptan
• Elexacaftor
• Encorafenib
• Enoxaparin
• Entrectinib
• Epoprostenol
• Eptifibatide
• Ergoloid Mesylates
• Ergonovine
• Ergotamine
• Escitalopram
• Ethylmorphine
• Etodolac
• Etofenamate
• Etoricoxib
• Fedratinib
• Felbinac
• Fenfluramine
• Fenoprofen
• Fentanyl
• Fepradinol
• Feprazone
• Fexinidazole
• Finerenone
• Floctafenine
• Flufenamic Acid
• Fluoxetine
• Flurbiprofen
• Fondaparinux
• Fosaprepitant
• Frovatriptan
• Gepirone
• Granisetron
• Heparin
• Hydrocodone
• Hydromorphone
• Hydroxytryptophan
• Ibrutinib
• Ibuprofen
• Iloprost
• Imipramine
• Indomethacin
• Infigratinib
• Iobenguane I 123
• Iobenguane I 131
• Ivacaftor
• Ivosidenib
• Ketobemidone
• Ketoprofen
• Ketorolac
• Lasmiditan
• Lemborexant
• Lepirudin
• Levomilnacipran
• Levorphanol
• Lisdexamfetamine
• Lithium
• Lofepramine
• Lorcaserin
• Lornoxicam
• Loxoprofen
• Lumateperone
• Lumiracoxib
• Lurbinectedin
• Meclofenamate
• Mefenamic Acid
• Melatonin
• Melitracen
• Meloxicam
• Meperidine
• Metaxalone
• Methadone
• Methamphetamine
• Methylergonovine
• Milnacipran
• Mirtazapine
• Mitapivat
• Mobocertinib
• Morniflumate
• Morphine
• Morphine Sulfate Liposome
• Nabumetone
• Nadroparin
• Nalbuphine
• Naproxen
• Naratriptan
• Nefazodone
• Nepafenac
• Nialamide
• Nicomorphine
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Nortriptyline
• Olanzapine
• Olaparib
• Omaveloxolone
• Ondansetron
• Opipramol
• Opium
• Opium Alkaloids
• Ospemifene
• Oxaprozin
• Oxycodone
• Oxymorphone
• Oxyphenbutazone
• Pacritinib
• Palonosetron
• Palovarotene
• Papaveretum
• Parecoxib
• Paregoric
• Parnaparin
• Paroxetine
• Pemigatinib
• Pentazocine
• Pexidartinib
• Phenindione
• Phenobarbital
• Phenprocoumon
• Phenylbutazone
• Piketoprofen
• Piperaquine
• Pirfenidone
• Piritramide
• Piroxicam
• Pixantrone
• Pomalidomide
• Pralsetinib
• Pranoprofen
• Prasugrel
• Primidone
• Proglumetacin
• Propyphenazone
• Proquazone
• Protein C
• Protriptyline
• Remifentanil
• Reviparin
• Rimegepant
• Rivaroxaban
• Rizatriptan
• Rofecoxib
• Salicylic Acid
• Salsalate
• Selexipag
• Selumetinib
• Sertraline
• Sibutramine
• Sirolimus Protein-Bound
• Sodium Salicylate
• Sonidegib
• Sparsentan
• St John's Wort
• Sufentanil
• Sulfinpyrazone
• Sulindac
• Sulodexide
• Sumatriptan
• Tacrolimus
• Tamoxifen
• Tapentadol
• Tasimelteon
• Tazemetostat
• Tenoxicam
• Tezacaftor
• Theophylline
• Tianeptine
• Tiaprofenic Acid
• Ticagrelor
• Ticlopidine
• Tilidine
• Tinzaparin
• Tirofiban
• Tolfenamic Acid
• Tolmetin
• Toloxatone
• Tolvaptan
• Tramadol
• Trazodone
• Treprostinil
• Triclabendazole
• Trimipramine
• Tryptophan
• Ubrogepant
• Valdecoxib
• Venetoclax
• Venlafaxine
• Vilazodone
• Voclosporin
• Vorapaxar
• Vortioxetine
• Warfarin
• Zanubrutinib
• Ziprasidone
• Zolmitriptan
• Zolpidem

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amlodipine
• Cyclosporine
• Fosphenytoin
• Galantamine
• Ginkgo
• Haloperidol
• Mexiletine
• Midazolam
• Phenytoin
• Propranolol
• Roflumilast
• Ropivacaine
• Suvorexant
• Tacrine
• Triazolam

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol
• Tobacco

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bipolar disorder (mental disease with mania and depression), history of or
• Bleeding problems or
• Depression, or history of or
• Glaucoma, angle-closure or
• Heart attack, recent or
• Heart disease or
• Heart rhythm problems (eg, arrhythmia, QT prolongation) or
• Hyponatremia (low sodium in the blood) or
• Mania (feeling elated), history of or
• Mental health problems, or history of or
• Seizures, or history of—Use with caution. May make these conditions worse.

• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Fluvoxamine may be taken with or without food. Take this medicine at bedtime, unless your doctor tells you otherwise.

Swallow the extended-release capsule whole. Do not crush, break, or chew it.

You might have to take this medicine for several months before you begin to feel better.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For treatment of obsessive-compulsive disorder:
  • For oral dosage form (extended-release capsules):
    • Adults—At first, 100 milligrams (mg) once a day at bedtime. Your doctor may adjust your dose as needed. However, the dose is usually not more than 300 mg per day.
    • Children—Use and dose must be determined by your doctor.
  • For oral dosage form (tablets):
    • Adults—At first, 50 milligrams (mg) once a day at bedtime. Your doctor may adjust your dose as needed. However, the dose is usually not more than 300 mg per day. If your daily dose is higher than 100 mg, your doctor may want you to take it in 2 divided doses.
    • Children 8 to 17 years of age—At first, 25 mg once a day at bedtime. Your doctor may adjust your dose as needed. However, the dose is usually not more than 200 mg or 300 mg per day based on age. If your daily dose is higher than 50 mg, your doctor may want you to take it in 2 divided doses.
    • Children younger than 8 years of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits. This will allow for changes in the dose and to help reduce any side effects. Blood tests may be needed to check for unwanted effects.

Do not take alosetron (Lotronex®), pimozide (Orap®), ramelteon (Rozerem®), thioridazine (Mellaril®), or tizanidine (Zanaflex®) while you are taking fluvoxamine. You could have more side effects than usual if you use these medicines together.

Do not take fluvoxamine with a monoamine oxidase (MAO) inhibitor (eg, isocarboxazid [Marplan®], linezolid [Zyvox®], methylene blue injection, phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]). Do not start taking fluvoxamine during the 2 weeks after you stop a MAO inhibitor and wait 2 weeks after stopping fluvoxamine before you start taking a MAO inhibitor. If you take them together or do not wait 2 weeks, you may develop confusion, agitation, restlessness, stomach or intestinal symptoms, a sudden high body temperature, an extremely high blood pressure, or severe seizures.

Fluvoxamine may cause a serious condition called serotonin syndrome if taken together with some medicines. Do not use fluvoxamine with buspirone (Buspar®), fentanyl (Abstral®, Duragesic®), lithium (Eskalith®, Lithobid®), tryptophan, St. John's wort, amphetamines, or some pain or migraine medicines (eg, meperidine, methadone, rizatriptan, sumatriptan, tramadol, Demerol®, Methadose®, Frova®, Imitrex®, Maxalt®, Relpax®, Ultram®, Zomig®). Check with your doctor first before taking any other medicines with fluvoxamine.

Fluvoxamine may cause some people to be agitated, irritable or display other abnormal behaviors. It may also cause some children, teenagers, and young adults to have suicidal thoughts and tendencies or to become more depressed. Some people may have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. If you, or your caregiver notice any of these side effects, tell your doctor right away. Let the doctor know if you or anyone in your family has bipolar disorder (manic-depressive) or has tried to commit suicide.

Avoid drinking alcohol with fluvoxamine.

This medicine may cause some people to become drowsy, less able to think clearly, or to have blurred vision or poor muscle control. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert or able to see clearly.

Do not suddenly stop taking this medicine without checking with your doctor first. Your doctor may want you to gradually reduce the amount you are taking before stopping it completely. This is to decrease the chance of having withdrawal symptoms such as agitation, confusion, headache, irritability, numbness or tingling, restlessness, trouble sleeping, or unusual drowsiness or weakness.

This medicine may increase your risk for bleeding problems. Make sure your doctor knows if you are also taking other medicines that thin the blood, including aspirin, NSAIDs (eg, diclofenac, ibuprofen, naproxen, Advil®, Aleve®, Celebrex®, Voltaren®), or warfarin (Coumadin®, Jantoven®).

Hyponatremia (low sodium in the blood) may occur with this medicine. Check with your doctor right away if you have confusion, difficulty concentrating, headaches, memory problems, weakness, and unsteadiness.

Tell your doctor right away if you develop a rash or hives, swelling of the face, eyes, or mouth, or trouble breathing after taking this medicine.

Check with your doctor right away if you have decreased interest in sexual intercourse, delayed or inability to have an orgasm in women, inability to have or keep an erection in men, or loss in sexual ability, desire, drive, or performance. These could be symptoms of sexual dysfunction.

Some men and women who use this medicine have become infertile (unable to have children). Talk with your doctor before using this medicine if you plan to have children.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Decreased interest in sexual intercourse

inability to have or keep an erection

loss in sexual ability, desire, drive, or performance

Less common

Behavior, mood, or mental changes

delayed or inability to have an orgasm

trouble with breathing

trouble with urinating

twitching

Rare

Absence of or decrease in body movements

agitation

blurred vision

chills

clumsiness or unsteadiness

confusion

diarrhea

fever

inability to move the eyes

increase in body movements

menstrual changes

nosebleeds

overactive reflexes

poor coordination

red or irritated eyes

redness, tenderness, itching, burning, or peeling of the skin

restlessness

seizures

shivering

skin rash

sore throat

sweating

talking or acting with excitement you cannot control

trembling or shaking

unusual bruising

unusual, incomplete, or sudden body or facial movements

unusual secretion of milk (in females)

weakness

Incidence not known

Agitation

anger

bloating

chest tightness

constipation

cough

difficulty swallowing

darkened urine

fast heartbeat

headache

hostility

indigestion

irritability

loss of appetite

nausea

pains in the stomach, side, or abdomen, possibly radiating to the back

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

swelling of the breasts or unusual milk production

vomiting

yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Change in sexual performance or desire

trouble sleeping

unusual tiredness

Less common

Change in sense of taste

decreased appetite

feeling of constant movement of self or surroundings

frequent urination

heartburn

increased sweating

stomach pain

unusual weight gain or loss

Incidence not known

Decrease in smell

loss of sense of smell

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.