Luvox CR (Oral)

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

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

It is very important for your doctor to check your progress at regular visits. This will help adjust the dose and 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. Using these medicines together could lead to more side effects than usual.

Do not take fluvoxamine with a monoamine oxidase (MAO) inhibitor (for example, isocarboxazid [Marplan®], linezolid [Zyvox®], methylene blue injection, phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]). Do not start fluvoxamine within 2 weeks after stopping a MAO inhibitor and wait 2 weeks after stopping fluvoxamine before starting a MAO inhibitor. Taking them together or not waiting 2 weeks may cause confusion, agitation, restlessness, stomach or intestinal symptoms, a sudden high body temperature, extremely high blood pressure, or severe seizures.

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

Fluvoxamine may cause some people to feel agitated, irritable, or show other unusual behaviors. It may also lead some children, teenagers, and young adults to have suicidal thoughts or to feel more depressed. Some people may have trouble sleeping, become easily upset, experience a large increase in energy, or act recklessly. If you or your caregiver notice any of these side effects, tell your doctor right away. Inform your doctor if you or anyone in your family has bipolar disorder (manic-depressive) or has attempted suicide.

Avoid drinking alcohol while taking fluvoxamine.

This medicine may cause some people to feel drowsy, think less clearly, or experience blurred vision or poor muscle control. Make sure you understand how you react to this medicine before driving, using machines, or doing anything else that could be dangerous if you are not alert or able to see clearly.

Do not suddenly stop taking this medicine without consulting your doctor first. Your doctor may want you to gradually lower your dose before stopping it completely. This helps reduce the chance of withdrawal symptoms like agitation, confusion, headache, irritability, numbness or tingling, restlessness, trouble sleeping, or unusual drowsiness or weakness.

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

Hyponatremia (low sodium in the blood) may occur with this medicine. Contact your doctor immediately if you experience confusion, difficulty concentrating, headaches, memory issues, weakness, or 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 immediately if you experience decreased interest in sexual intercourse, delayed or inability to have an orgasm in women, inability to have or maintain an erection in men, or loss in sexual ability, desire, drive, or performance. These may be signs of sexual dysfunction.

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

Do not take other medicines unless your doctor has discussed them with you. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (like St. John's wort) or vitamin supplements.

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

Allergies

Inform your clinician 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.

Pediatric

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. Since fluvoxamine may cause weight loss or a lower in appetite, children who will be using 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.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of fluvoxamine in the elderly. Nevertheless, elderly patients are more likely to have hyponatremia (low sodium in the blood) and age-related liver issues, 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 prior to using this drug while breastfeeding.

Interactions with Medicines

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

Using this medication with any of the following medications 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 drug with any of the following medicines is typically not advised, but may be required in some cases. If both medicines are prescribed together, your clinician 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
• Everolimus
• 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
• Methylphenidate
• 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 drugs are prescribed together, your clinician 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

Interactions with Food/Tobacco/Alcohol

Certain drugs 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 drugs may additionally 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 normally not recommended, but may be unavoidable in some cases. If used together, your physician may change the dose or how frequently 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 issues may affect the use of this medicine. Make sure you inform your clinician if you have any other medical issues, especially:

• Bipolar disorder (mental disease with mania and depression), history of or
• Bleeding issues or
• Depression, or history of or
• Glaucoma, angle-closure or
• Heart attack, recent or
• Heart disease or
• Heart rhythm issues (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 drug from the body.

Along with its necessary effects, this medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, 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.

In the U.S.

• Luvox
• Luvox CR

Available Dosage Forms:

• Capsule, Extended Release
• Tablet

Therapeutic Class: Antidepressant

Pharmacologic Class: Serotonin Reuptake Inhibitor

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.

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