Fluvoxamine extended-release capsulesPronunciation
Generic Name: fluvoxamine (floo-VOX-a-meen)
Brand Name: Luvox CR
Antidepressants may increase the risk of suicidal thoughts or actions in children, teenagers, and young adults. However, depression and certain other mental problems may also increase the risk of suicide. Talk with the patient's doctor to be sure that the benefits of using fluvoxamine extended-release capsules outweigh the risks.
Families and caregivers must closely watch patients who take fluvoxamine extended-release capsules. It is important to keep in close contact with the patient's doctor. Tell the doctor right away if the patient has symptoms like worsened depression, suicidal thoughts, or changes in behavior. Discuss any questions with the patient's doctor.
Fluvoxamine extended-release capsules is not approved for use in all children. If fluvoxamine extended-release capsules is prescribed for your child, talk with the doctor to be sure that fluvoxamine extended-release capsules is right for your child.
Fluvoxamine extended-release capsules is used for:
Treating obsessive-compulsive disorder (OCD). It may also be used for other conditions as determined by your doctor.
Fluvoxamine extended-release capsules is a selective serotonin reuptake inhibitor (SSRI). It works by restoring the balance of serotonin, a natural substance in the brain, which helps to decrease anxiety and obsessive or compulsive behavior.
Do NOT use fluvoxamine extended-release capsules if:
- you are allergic to any ingredient in fluvoxamine extended-release capsules
- you have uncontrolled seizure problems
- you are taking or have taken linezolid, a monoamine oxidase inhibitor (MAOI) (eg, phenelzine), or St. John's wort within the last 14 days
- you are taking alosetron, a fenfluramine derivative (eg, dexfenfluramine), nefazodone, pimozide, ramelteon, sibutramine, thioridazine, or tizanidine
- you are taking any other medicine that contains fluvoxamine
Contact your doctor or health care provider right away if any of these apply to you.
Before using fluvoxamine extended-release capsules:
Some medical conditions may interact with fluvoxamine extended-release capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you or a family member has a history of bipolar disorder (manic-depression), other mental or mood problems, suicidal thoughts or attempts, or alcohol or substance abuse
- if you have a history of seizures, stroke, high blood pressure, heart problems, liver or kidney problems, stomach or bowel bleeding, diabetes, blood or bone marrow problems, or metabolism problems
- if you are dehydrated, have low blood sodium levels, or drink alcohol or smoke
- if you will be having electroconvulsive therapy (ECT)
- if you are taking medicine for depression or any other mental or mood problem
- if you are taking a medicine that contains methylene blue
Some MEDICINES MAY INTERACT with fluvoxamine extended-release capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Anorexiants (eg, phentermine), buspirone, fenfluramine derivatives (eg, dexfenfluramine), fentanyl, linezolid, lithium, MAOIs (eg, phenelzine), medicines for mental problems (eg, quetiapine), metoclopramide, nefazodone, quinidine, rasagiline, selegiline, serotonin 5-HT1 receptor agonists (eg, sumatriptan), sibutramine, St. John's wort, trazodone, or tryptophan because severe side effects, such as a reaction that may include fever, rigid muscles, blood pressure changes, mental changes, confusion, irritability, agitation, delirium, and coma, may occur
- Anticoagulants (eg, warfarin), aspirin, or nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen) because the risk of bleeding, including stomach bleeding, may be increased
- Diuretics (eg, furosemide, hydrochlorothiazide) because the risk of low blood sodium levels may be increased
- Tramadol because the risk of seizures may be increased
- Cisapride, phenothiazines (eg, chlorpromazine, thioridazine), or pimozide because severe heart problems, including irregular heartbeat, may occur
- Cyproheptadine because it may decrease fluvoxamine extended-release capsules's effectiveness
- Alosetron, aripiprazole, benzodiazepines (eg, alprazolam, diazepam), beta-blockers (eg, metoprolol, propranolol), carbamazepine, clozapine, diltiazem, methadone, mexiletine, omeprazole, phenytoin, ramelteon, risperidone, other SSRIs (eg, fluoxetine), serotonin-norepinephrine reuptake inhibitors (SNRIs) (eg, venlafaxine), tacrine, theophylline, tizanidine, or tricyclic antidepressants (eg, amitriptyline) because the risk of their side effects may be increased by fluvoxamine extended-release capsules
This may not be a complete list of all interactions that may occur. Ask your health care provider if fluvoxamine extended-release capsules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use fluvoxamine extended-release capsules:
Use fluvoxamine extended-release capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Fluvoxamine extended-release capsules comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get fluvoxamine extended-release capsules refilled.
- Take fluvoxamine extended-release capsules by mouth with or without food.
- Swallow fluvoxamine extended-release capsules whole. Do not break, crush, or chew before swallowing.
- Take fluvoxamine extended-release capsules at bedtime unless your doctor tells you otherwise.
- Continue to take fluvoxamine extended-release capsules even if you feel well. Do not miss any doses.
- Do not suddenly stop taking fluvoxamine extended-release capsules without checking with your doctor. Side effects may occur. They may include mental or mood changes, numbness or tingling of the skin, dizziness, confusion, headache, trouble sleeping, or unusual tiredness. You will be closely monitored when you start fluvoxamine extended-release capsules and whenever a change in dose is made.
- If you miss a dose of fluvoxamine extended-release capsules, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use fluvoxamine extended-release capsules.
Important safety information:
- Fluvoxamine extended-release capsules may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use fluvoxamine extended-release capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Do not drink alcohol while you are using fluvoxamine extended-release capsules.
- Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using fluvoxamine extended-release capsules; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
- Several weeks may pass before your symptoms improve. Do NOT take more than the recommended dose, change your dose, or use fluvoxamine extended-release capsules for longer than prescribed without checking with your doctor.
- Children, teenagers, and young adults who take fluvoxamine extended-release capsules may be at increased risk of suicidal thoughts or actions. Watch patients who take fluvoxamine extended-release capsules closely. Contact the doctor at once if new, worsened, or sudden symptoms, such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior, occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
- If your doctor tells you to stop taking fluvoxamine extended-release capsules, you will need to wait for several weeks before beginning to take certain other medicines (eg, MAOIs, nefazodone). Ask your doctor when you should start to take your new medicines after you have stopped taking fluvoxamine extended-release capsules.
- Serotonin syndrome is a possibly fatal syndrome that can be caused by fluvoxamine extended-release capsules. Your risk may be greater if you take fluvoxamine extended-release capsules with certain other medicines (eg, MAOIs, "triptans"). Symptoms may include agitation; confusion; hallucinations; coma; fever; fast or irregular heartbeat; tremor; excessive sweating; and nausea, vomiting, or diarrhea. Contact your doctor at once if you have any of these symptoms.
- Neuroleptic malignant syndrome (NMS) is a possibly fatal syndrome that can rarely be caused by fluvoxamine extended-release capsules. Symptoms may include fever; stiff muscles; confusion; abnormal thinking; fast or irregular heartbeat; and sweating. Contact your doctor at once if you have any of these symptoms.
- Fluvoxamine extended-release capsules may rarely cause a prolonged, painful erection. This could happen even when you are not having sex. If this is not treated right away, it could lead to permanent sexual problems such as impotence. Contact your doctor right away if this happens.
- Caution is advised when using fluvoxamine extended-release capsules in the ELDERLY; they may be more sensitive to its effects, especially low blood sodium levels.
- Fluvoxamine extended-release capsules should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed. They may be more sensitive to its effects, especially increased risk of suicidal thoughts or actions.
- Fluvoxamine extended-release capsules may cause weight changes. CHILDREN and teenagers may need regular weight and growth checks while they take fluvoxamine extended-release capsules.
- PREGNANCY and BREAST-FEEDING: Fluvoxamine extended-release capsules may cause harm to the fetus if it is taken during the last 3 months of pregnancy. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking fluvoxamine extended-release capsules while you are pregnant. Fluvoxamine extended-release capsules is found in breast milk. Do not breast-feed while taking fluvoxamine extended-release capsules.
Possible side effects of fluvoxamine extended-release capsules:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Constipation; decreased sexual desire or ability; diarrhea; dizziness; drowsiness; dry mouth; gas; headache; increased sweating; loss of appetite; nausea; nervousness; sore throat; stomach upset; trouble sleeping; vomiting; weakness; yawning.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bizarre behavior; black or bloody stools; chest pain; confusion; decreased concentration; decreased coordination; exaggerated reflexes; fainting; fast or irregular heartbeat; fever; hallucinations; memory problems; new or worsening agitation, anxiety, depression, panic attacks, aggressiveness, impulsiveness, irritability, hostility, exaggerated feeling of well-being, restlessness, or inability to sit still; painful or unusually heavy menstrual periods; persistent, painful erection; red, swollen, blistered, or peeling skin; seizures; severe or persistent headache or trouble sleeping; stiff muscles; stomach pain; suicidal thoughts or attempts; tremor; unusual bruising or bleeding; unusual or severe mental or mood changes; unusual swelling; unusual weakness; vision changes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include chest pain; coma; fast, slow, or irregular heartbeat; seizures; severe or persistent dizziness, drowsiness, diarrhea, nausea, or vomiting; tremor; trouble breathing.Proper storage of fluvoxamine extended-release capsules:
Store fluvoxamine extended-release capsules at room temperature between 59 and 86 degrees F (15 and 30 degrees C) in a tightly closed container. Avoid temperatures above 86 degrees F (30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep fluvoxamine extended-release capsules out of the reach of children and away from pets.
- If you have any questions about fluvoxamine extended-release capsules, please talk with your doctor, pharmacist, or other health care provider.
- Fluvoxamine extended-release capsules is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take fluvoxamine extended-release capsules or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about fluvoxamine extended-release capsules. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to fluvoxamine extended-release capsules. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using fluvoxamine extended-release capsules.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.