Fluvoxamine is a selective serotonin reuptake inhibitor (SSRI).

Fluvoxamine is used to treat symptoms of obsessive compulsive disorder (OCD) in adults and children at least 8 years old.

Fluvoxamine may also be used for purposes not listed in this medication guide.

People with depression or mental illness may have thoughts about suicide. Some young people may have increased suicidal thoughts when first starting a medicine to treat depression. Tell your doctor right away if you have any sudden changes in mood or behavior, or thoughts about suicide.

Do not stop using fluvoxamine without first asking your doctor.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Take fluvoxamine at bedtime, with or without food.

Swallow the capsule whole and do not crush, chew, break, or open it.

Tell your doctor if you have any changes in sexual function, such as loss of interest in sex, trouble having an orgasm, or (in men) problems with erections or ejaculation. Some sexual problems can be treated.

Do not stop using fluvoxamine suddenly, or you could have unpleasant symptoms (such as agitation, confusion, tingling or electric shock feelings). Ask your doctor before stopping the medicine.

Store tightly closed at room temperature, away from moisture and heat.

Usual Adult Dose for Obsessive Compulsive Disorder:

Initial immediate-release tablet dose: 50 mg orally once a day at bedtime
Initial extended-release capsule dose: 100 mg orally once a day at bedtime
Maintenance dose: 100 to 300 mg orally per day
Maximum dose: 300 mg/day

Comments:
-The dose may be increased in 50 mg increments every 4 to 7 days, as tolerated, until maximum therapeutic benefit is achieved.
-A total daily dose of more than 100 mg should be given in two divided doses. If the doses are not equal, the larger dose should be given at bedtime.

Use: Treatment of obsessions and compulsions in patients with obsessive compulsive disorder (OCD), as defined in DSM-III-R or DSM-IV

Usual Pediatric Dose for Obsessive Compulsive Disorder:

8 to 11 years:
-Initial dose: 25 mg orally once a day at bedtime
-Maintenance dose: 25 to 200 mg orally per day
-Maximum dose: 200 mg/day

11 to 17 years:
-Initial dose: 25 mg orally once a day at bedtime
-Maintenance dose: 25 to 300 mg orally per day
-Maximum dose: 300 mg/day

Comments:
The dose may be increased in 25 mg increments every 4 to 7 days, as tolerated, up to a maximum daily dose.
-Total daily doses of more than 50 mg should be given in two divided doses. If the two divided doses are not equal, the larger dose should be given at bedtime.
-Lower doses may be effective in female versus male patients.

Use: Treatment of obsessions and compulsions in patients with OCD, as defined in DSM-III-R or DSM-IV

You should not take fluvoxamine if you are allergic to it.

Do not use fluvoxamine within 14 days before or 14 days after you have taken an MAO inhibitor. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, tranylcypromine, and others.

Some drugs should not be used with fluvoxamine. Your treatment plan may change if you also use:

• alosetron;

• ramelteon;

• thioridazine; or

• tizanidine.

Tell your doctor if you have ever had:

• bipolar disorder (manic depression);

• a seizure;

• glaucoma;

• sexual problems;

• liver or kidney disease;

• heart disease, high blood pressure, or a stroke;

• bleeding problems; or

• low levels of sodium in your blood (an electrolyte imbalance).

People with depression or mental illness may have thoughts about suicide. Some young people may have increased suicidal thoughts when first starting a medicine to treat depression. Stay alert to changes in your mood or symptoms. Your family or caregivers should also watch for sudden changes in your behavior.

Tell your doctor if you also use stimulant medicine, opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. An interaction with fluvoxamine could cause a serious condition called serotonin syndrome.

Taking fluvoxamine during pregnancy could harm the baby, but stopping the medicine may not be safe for you. Do not start or stop fluvoxamine without asking your doctor.

Do not breastfeed.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose may cause vomiting, diarrhea, breathing problems, slow heartbeats, or seizure.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

Drinking alcohol can increase certain side effects.

Ask your doctor before taking a nonsteroidal anti-inflammatory drug (NSAID) such as aspirin, ibuprofen, naproxen, Advil, Aleve, Motrin, and others. Using an NSAID with fluvoxamine may cause you to bruise or bleed easily.

Avoid driving or hazardous activity until you know how fluvoxamine will affect you. Your reactions could be impaired.

Get emergency medical help if you have signs of an allergic reaction: skin rash, blisters, or hives; fever, joint pain; difficult breathing; swelling of your face, lips, tongue, or throat.

Tell your doctor right away if you have new or sudden changes in mood or behavior, including new or worse depression or anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, more active or talkative, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have;

• anxiety, racing thoughts, risk-taking behavior, sleep problems (insomnia), feelings of extreme happiness or irritability;

• blurred vision, eye pain or redness, seeing halos around lights;

• a seizure;

• changes in weight or appetite;

• easy bruising or unusual bleeding; or

• low blood sodium--headache, confusion, problems with thinking or memory, weakness, feeling unsteady.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea

Fluvoxamine can affect growth in children. Your child's height and weight should be checked often.

Common side effects of fluvoxamine may include:

• drowsiness, dizziness, weakness;

• anxiety, depression, agitation, trouble sleeping;

• shaking, increased muscle movements;

• upset stomach, gas, loss of appetite;

• nausea, vomiting, diarrhea;

• dry mouth, yawning, sore throat;

• muscle pain;

• sweating, rash;

• heavy menstrual periods; or

• sexual problems.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Using fluvoxamine with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Tell your doctor about all your current medicines. Many drugs can affect fluvoxamine, especially:

• methadone, mexiletine, St. John's wort, theophylline, tramadol;

• a benzodiazepine sedative like Valium, Klonopin, or Xanax;

• a blood thinner (warfarin, Coumadin, Jantoven);

• a diuretic or "water pill";

• a "triptan" migraine headache medicine, such as Imitrex or Maxalt; or

• medicine to treat anxiety, mood disorders, thought disorders, or mental illness (such as clozapine, lithium, antidepressants, or antipsychotics).

This list is not complete and many other drugs may affect fluvoxamine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

It is important to keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to fluvoxamine.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.