Fluvoxamine (Oral Route)

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ARTICLE SECTIONS

US Brand Names

Luvox
Luvox CR

Description

Fluvoxamine is used to treat obsessive compulsive disorder (OCD) and social anxiety disorder (social phobia).

Fluvoxamine 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:

Tablet
Capsule, Extended Release

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

Obsessive compulsive disorder—Appropriate studies performed to date have not demonstrated pediatrics-specific problems that would limit the usefulness of fluvoxamine tablets in children. 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.

Obsessive compulsive disorder—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 geriatrics-specific problems that would limit the usefulness of fluvoxamine in the elderly. However, fluvoxamine may be removed from the body more slowly in elderly patients, which may require an adjustment in the dose for patients receiving fluvoxamine.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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

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
Dihydroergotamine
Ergoloid Mesylates
Ergonovine
Ergotamine
Furazolidone
Isocarboxazid
Levomethadyl
Methylergonovine
Phenelzine
Rasagiline
Terfenadine
Thioridazine
Tizanidine

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

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, history of or
Seizures (convulsions), history of—May make these conditions worse.

Heart attack, recent or
Heart disease—Use with caution. May cause an increase in heart rate.

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

Proper Use

Take this medicine only 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.

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.

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.

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 oral dosage form (tablets):
- For treatment of obsessive-compulsive disorder:
  - 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 a 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 a 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.
For oral dosage form (extended-release capsules):
- For treatment of obsessive-compulsive disorder or social phobia:
  - 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 a day.
  - Children—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 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®), diazepam (Valium®), 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 a serious condition called serotonin syndrome when taken with certain medicines such as linezolid [e.g., Zyvox®], lithium, tryptophan, St. John's Wort, 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.

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. If you, your child, or your caregiver notice any of these side effects, tell your doctor or your child's doctor right away.

Stop taking this medicine and check with your doctor right away if you have any of the following symptoms while using this medicine: convulsions (seizures); difficulty with breathing; a fast heartbeat; a high fever; high or low blood pressure; increased sweating; loss of bladder control; severe muscle stiffness; unusually pale skin; or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).

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 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.

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:

Less common

Behavior, mood, or mental changes
Trouble in breathing
Trouble in urinating
Twitching

Rare

Absence of or decrease in body movements
Agitation
Blurred vision
Clumsiness or unsteadiness
Confusion
Convulsions (seizures)
Diarrhea
Fever
Inability to move eyes
Increase in body movements
Menstrual changes
Nose bleeds
Overactive reflexes
Poor coordination
Red or irritated eyes
Redness, tenderness, itching, burning or peeling of 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:

Symptoms of overdose

Coma
Dizziness
Drowsiness
Dryness of 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:

More common