Fluvoxamine (By mouth)

Introduction

Fluvoxamine Maleate (floo-VOX-a-meen MAL-ee-ate)

Treats symptoms of obsessive compulsive disorder (OCD).

Brand Name(s)

Luvox CR

There may be other brand names for this medicine.

When This Medicine Should Not Be Used

You should not use this medicine if you have had an allergic reaction to fluvoxamine. You should not use fluvoxamine if you are also using the following medicines: alosetron (Lotronex®), pimozide (Orap®), ramelteon (Rozerem®), thioridazine (Mellaril®), or tizanidine (Zanaflex®). Make sure your doctor knows if you have taken an MAO inhibitor (such as isocarboxazid, phenelzine, selegiline, tranylcypromine, Eldepryl®, Nardil®, Marplan®, or Parnate®) within the past 14 days. Do not start taking an MAO inhibitor within 14 days of stopping fluvoxamine.

How to Use This Medicine

Long Acting Capsule, Tablet

• Your doctor will tell you how much of this medicine to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.
• You may take this medicine with or without food.
• Take this medicine at bedtime, unless your doctor tells you otherwise.
• Do not use this medicine for longer than 10 weeks 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.
• This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• There are many other drugs that can interact with fluvoxamine. Make sure your doctor knows about ALL other medicines you are using, especially medicines to treat depression or mental illness. These includes amitriptyline, clomipramine, imipramine, Anafranil®, Elavil®, or Tofranil®.
• Tell your doctor if you are using blood thinners (warfarin, Coumadin®, or Jantoven®), diuretics or "water pills" (such as furosemide, torsemide, Demadex®, or Lasix®), or pain or arthritis medicine called "NSAIDs" (such as aspirin, celecoxib, ibuprofen, naproxen, Aleve®, Celebrex®, or Motrin®). Tell your doctor if you use a tranquilizer or sedative such as alprazolam (Xanax®), diazepam (Valium®), midazolam (Versed®), or triazolam (Halcion®).
• Your doctor should know if you use blood pressure medicine (such as atenolol, metoprolol, propranolol, Corgard®, Inderal®, Lopressor®, Toprol®, or Tenormin®) or medicine to treat headaches (such as eletriptan, sumatriptan, Imitrex®, or Relpax®).
• Tell your doctor if you also use carbamazepine (Tegretol®), clozapine (Clozaril®), diltiazem (Cardizem®), linezolid (Zyvox®), lithium (Eskalith®), methadone (Dolophine®), mexiletine (Mexitil®), omeprazole (Prilosec®), phenytoin (Dilantin®), quinidine, St. John's wort, tacrine (Cognex®), theophylline (Theo-Dur®), tramadol (Ultram®), or tryptophan supplements.
• Do not drink alcohol while you are using this medicine.
• Since smoking may decrease the treatment effects of this medicine, it is best to avoid smoking while you are using it.

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have a recent heart attack or heart disease, liver disease, bleeding problems, diabetes, epilepsy or seizures, low sodium in the blood, or a history of mania or drug abuse. Tell your doctor if you smoke.
• For some children, teenagers, and young adults, this medicine can increase thoughts of suicide. Tell your or your child's doctor right away if you or your child start to feel more depressed and have thoughts about hurting yourselves. Report any unusual thoughts or behaviors that trouble you or your child, especially if they are new or are getting worse quickly. Make sure the doctor knows if you or your child have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell the doctor if you or your child have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. Let the doctor know if you, your child, or anyone in your family has bipolar disorder (manic-depressive) or has tried to commit suicide.
• Fluvoxamine should not be used to treat depression. It should not be given to a child unless that child has been diagnosed with OCD.
• This medicine may cause serious conditions called serotonin syndrome or neuroleptic malignant syndrome (NMS)-like reactions when it is taken with certain medicines. Check with your doctor first before taking any other medicines.
• 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.
• This medicine may make you dizzy or drowsy. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert.
• Check with your doctor as soon as possible if you develop a skin rash, hives, or itching while you are taking fluvoxamine.
• Do not stop using this medicine suddenly without asking your doctor. You may need to slowly decrease your dose before stopping it completely.
• While you are using this medicine, be sure to keep all appointments with your caregiver or mental health counselor. It is very important that your caregivers observe you for changes in your mental status or behavior.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Anxiety, agitation, aggression, trouble sleeping, or panic attack.
• Blurred vision, shallow breathing, or trouble standing or walking.
• Change in how much or how often you urinate.
• Chest pain.
• Confusion, extreme weakness, or muscle twitching.
• Fast, slow, or uneven heartbeat.
• Feeling irritable, nervous, or shaky.
• Fever, chills, cough, sore throat, and body aches.
• Lightheadedness or fainting.
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet.
• Seizures or tremors.
• Sudden and severe stomach pain, nausea, or vomiting.
• Swelling in your hands, feet, or ankles.
• Unusual behavior, thoughts of hurting yourself or others.
• Unusual bleeding or bruising.
• Yellowing of your skin or the whites of your eyes.

If you notice these less serious side effects, talk with your doctor:

• Diarrhea, constipation, stomach upset, or loss of appetite.
• Dry mouth.
• Headache or dizziness.
• Mood or behavior changes after you stop using the medicine.
• Muscle pain.
• Pain during monthly periods.
• Problems having sex.
• Prolonged erection of the penis.
• Skin rash.
• Sleepiness.
• Sweating more than usual.
• Weakness.

If you notice other side effects that you think are caused by this medicine, tell your doctor

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