FLUVOXAMINE [ LUVOX ]

What is fluvoxamine?

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.

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

Warnings

Some young people have thoughts about suicide when first taking fluvoxamine. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Before taking this medicine

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;
• 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).

Some young people have thoughts about suicide when first taking fluvoxamine. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Tell your doctor if you also take 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 this medicine 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.

How should I take fluvoxamine?

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.

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.

What happens if I miss a dose?

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.

What happens if I overdose?

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.

What should I avoid while taking fluvoxamine?

Drinking alcohol can increase certain side effects of fluvoxamine.

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.

Fluvoxamine side effects

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.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, 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;
• seizure (convulsions);
• 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 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.

Fluvoxamine dosing information

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