Generic Name: fluvoxamine (Oral route)
Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies with major depressive disorder (MDD) and other psychiatric disorders. Short term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24, and there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. This risk must be balanced with the clinical need. Monitor patients closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber . Fluvoxamine maleate extended-release capsules are not approved for use in pediatric patients . Fluvoxamine maleate tablets are not approved for use in pediatric patients except for patients with obsessive compulsive disorder (OCD) .
Commonly used brand name(s):
In the U.S.
Available Dosage Forms:
Therapeutic Class: Antidepressant
Pharmacologic Class: Serotonin Reuptake Inhibitor
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:
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:
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.
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.
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.
|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.|
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.
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.
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.
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.
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.
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:
This section provides information on the proper use of a number of products that contain fluvoxamine. It may not be specific to Luvox CR. Please read with care.
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.
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.
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.
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.
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.
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
Get emergency help immediately if any of the following symptoms of overdose occur:Symptoms of overdose
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
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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