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Fluvoxamine (Oral Route)

US Brand Names

Description

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.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, fluvoxamine is used in certain patients with the following medical condition:

• Mental depression.

This product is available in the following dosage forms:

• Capsule, Extended Release
• Tablet

Before Using

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.

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. 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.

Geriatric

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 liver problems, which may require an adjustment in the dose for patients receiving fluvoxamine.

Pregnancy

Breastfeeding

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.

Drug Interactions

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.

• Alosetron
• Astemizole
• Cisapride
• Furazolidone
• Isocarboxazid
• Levomethadyl
• Methylene Blue
• Metoclopramide
• Phenelzine
• Ramelteon
• Rasagiline
• Terfenadine
• Thioridazine
• Tizanidine

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
• Aceclofenac
• Acemetacin
• Acenocoumarol
• Alclofenac
• Almotriptan
• Ancrod
• Anisindione
• Antithrombin III Human
• Apazone
• Ardeparin
• Aspirin
• Bendamustine
• Benoxaprofen
• Bivalirudin
• Bromfenac
• Bufexamac
• Carprofen
• Certoparin
• Cilostazol
• Citalopram
• Clometacin
• Clonixin
• Clopidogrel
• Clorgyline
• Dalteparin
• Danaparoid
• Defibrotide
• Dermatan Sulfate
• Desirudin
• Desvenlafaxine
• Dexfenfluramine
• Dexketoprofen
• Dextromethorphan
• Diclofenac
• Dicumarol
• Diflunisal
• Dihydroergotamine
• Dipyridamole
• Dipyrone
• Domperidone
• Droperidol
• Droxicam
• Duloxetine
• Eletriptan
• Eltrombopag
• Enoxaparin
• Eptifibatide
• Ergoloid Mesylates
• Ergonovine
• Ergotamine
• Escitalopram
• Etodolac
• Etofenamate
• Felbinac
• Fenbufen
• Fenfluramine
• Fenoprofen
• Fentiazac
• Floctafenine
• Flufenamic Acid
• Fluoxetine
• Flurbiprofen
• Fluvoxamine
• Fondaparinux
• Frovatriptan
• Heparin
• Ibuprofen
• Indomethacin
• Indoprofen
• Iproniazid
• Isoxicam
• Ketoprofen
• Ketorolac
• Linezolid
• Lorcaserin
• Lornoxicam
• Magnesium Salicylate
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Methylergonovine
• Milnacipran
• Mirtazapine
• Moclobemide
• Nabumetone
• Nadroparin
• Naproxen
• Naratriptan
• Nepafenac
• Nialamide
• Niflumic Acid
• Nimesulide
• Oxaprozin
• Oxycodone
• Oxyphenbutazone
• Pargyline
• Parnaparin
• Paroxetine
• Pentosan Polysulfate Sodium
• Phenindione
• Phenprocoumon
• Phenylbutazone
• Pirazolac
• Piroxicam
• Pirprofen
• Prasugrel
• Procarbazine
• Propyphenazone
• Proquazone
• Reviparin
• Rizatriptan
• Salicylic Acid
• Salsalate
• Selegiline
• Sertraline
• Sibutramine
• St John's Wort
• Sulindac
• Sumatriptan
• Suprofen
• Tapentadol
• Tenidap
• Tenoxicam
• Theophylline
• Tiaprofenic Acid
• Ticlopidine
• Tinzaparin
• Tirofiban
• Tolmetin
• Toloxatone
• Tramadol
• Tranylcypromine
• Trazodone
• Vilazodone
• Warfarin
• Zolmitriptan
• Zomepirac

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.

• Amitriptyline
• Asenapine
• Clomipramine
• Clozapine
• Cyclosporine
• Diazepam
• Fosphenytoin
• Galantamine
• Ginkgo
• Haloperidol
• Imipramine
• Lithium
• Methadone
• Mexiletine
• Midazolam
• Olanzapine
• Phenytoin
• Propranolol
• Roflumilast
• Ropivacaine
• Tacrine
• Triazolam
• Tryptophan
• Zolpidem

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.

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 cycles of elation and depression), history of or
• Bleeding problems or
• Hypomania (mild form of mania), or history of or
• Hyponatremia (low sodium in the blood) or
• Mania (feeling elated), or history of or
• Neuroleptic malignant syndrome (NMS), history of or
• Seizures (convulsions), history of—Use with caution. May make these conditions worse.

• Diseases affecting metabolism or diseases involving blood circulation—Caution should be used in patients with these medical problems.

• Heart attack, recent or
• Heart disease, unstable—The effects of fluvoxamine in patients with these conditions are not known.

• Liver disease—Higher blood levels for fluvoxamine may occur, increasing the chance of side effects.

Proper Use

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. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

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

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

If you are taking this medicine, do not take other medicines containing fluvoxamine.

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 increase your dose if needed. However, the dose usually is 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 increase your dose if needed. However, the dose usually is 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 two divided doses.
    • Children 8 to 17 years of age—At first, 25 mg once a day at bedtime. Your doctor may increase your dose if needed. However, the dose usually is not more than 200 mg per day. If your daily dose is higher than 50 mg, your doctor may want you to take it in two 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.

For twice-a-day dosing: 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

It is very important that your doctor check your progress at regular visits, to allow for changes in your dose and to help reduce any side effects. You might have to take this medicine for up to 10 or 12 weeks before you begin to feel better.

Do not take alosetron (Lotronex®), pimozide (Orap®), ramelteon (Rozerem™), thioridazine (Mellaril®), or tizanidine (Zanaflex®) while you are taking fluvoxamine. If you do, it could increase the amounts of these medicines in your body which may cause serious unwanted effects.

Do not take fluvoxamine if you have taken a monoamine oxidase (MAO) inhibitor such as isocarboxazid, phenelzine, selegiline, tranylcypromine, Eldepryl®, Marplan®, Nardil®, or Parnate® within the past 14 days. Do not start taking an MAO inhibitor within 14 days of stopping fluvoxamine. If you do, you may develop agitation, coma, extreme muscle stiffness, sudden high body temperature, or other severe unwanted effects.

Make sure your doctor knows about all the other medicines you are using. Fluvoxamine may cause serious conditions called serotonin syndrome or neuroleptic malignant syndrome (NMS)-like reactions when taken with certain medicines such as linezolid (Zyvox®), lithium, tryptophan, or some pain or migraine medicines (e.g., tramadol [Ultram®], sumatriptan [Imitrex®], zolmitriptan [Zomig®], or rizatriptan [Maxalt®]). Check with your doctor first before taking any other medicines.

Avoid drinking alcohol while taking fluvoxamine.

Since smoking may decrease the treatment effects of this medicine, it is best to avoid smoking while you are using it. If you have any questions about this, check with your doctor.

Check with your doctor as soon as possible if you develop a skin rash, hives, or itching while you are taking 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, your child, or your caregiver notice any of these side effects, tell your doctor or your child's 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.

Fluvoxamine may cause some people to become drowsy or 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, able to see clearly, or able to control your movements well.

Do not suddenly stop taking this medicine without first checking with your doctor. Your doctor may want you to reduce gradually the amount you are taking before stopping completely. This is to decrease the chance of having discontinuation symptoms such as agitation, confusion, headache, irritability, numbness or tingling feeling, restlessness, trouble in 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, such as aspirin, nonsteroidal anti-inflammatory agents also called NSAIDs (e.g., ibuprofen, naproxen, Advil®, Aleve®, Celebrex®, or Motrin®), or warfarin (Coumadin®, Jantoven®).

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

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 (e.g., St. John's wort) or vitamin supplements.

Side Effects

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:

• Behavior, mood, or mental changes
• Trouble with breathing
• Trouble with urinating
• Twitching

• Absence of or decrease in body movements
• Agitation
• Blurred vision
• Clumsiness or unsteadiness
• Confusion
• Convulsions (seizures)
• 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
• Shivering
• Skin rash
• Sore throat, fever, and chills
• 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

Get emergency help immediately if any of the following symptoms of overdose occur:

• Coma
• Dizziness
• Drowsiness
• Dryness of the mouth
• Fast, slow, or irregular heartbeat
• Large pupils
• Low blood pressure
• Nausea
• Vomiting

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:

• Change in sexual performance or desire
• Constipation
• Headache
• Trouble with sleeping
• Unusual tiredness

• Abdominal or stomach pain
• Change in sense of taste
• Decreased appetite
• Feeling of constant movement of self or surroundings
• Frequent urination
• Heartburn
• Increased sweating
• Unusual weight gain or loss

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.

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