Luvox CR Extended-Release CapsulesGeneric Name: Fluvoxamine
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 Luvox CR Extended-Release Capsules outweigh the risks.
Family and caregivers must closely watch patients who take Luvox CR 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.
Luvox CR Extended-Release Capsules are used for:
Treating social anxiety disorder or obsessive-compulsive disorder (OCD). It may also be used for other conditions as determined by your doctor.
Luvox CR Extended-Release Capsules are 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 Luvox CR Extended-Release Capsules if:
- you are allergic to any ingredient in Luvox CR Extended-Release Capsules
- you are taking or have taken a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) or St. John's wort within the last 14 days
- you are taking alosetron, astemizole, a fenfluramine derivative (eg, dexfenfluramine), nefazodone, pimozide, ramelteon, sibutramine, terfenadine, thioridazine, or tizanidine
Contact your doctor or health care provider right away if any of these apply to you.
Before using Luvox CR Extended-Release Capsules:
Some medical conditions may interact with Luvox CR 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, heart problems, liver 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)
Some MEDICINES MAY INTERACT with Luvox CR Extended-Release Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Anorexiants (eg, phentermine), fenfluramine derivatives (eg, dexfenfluramine), 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
- Astemizole, cisapride, phenothiazines (eg, chlorpromazine, thioridazine), pimozide, or terfenadine because severe heart problems, including irregular heartbeat, may occur
- Cyproheptadine because it may decrease Luvox CR Extended-Release Capsules's effectiveness
- Alosetron, aripiprazole, benzodiazepines (eg, alprazolam, diazepam), beta-blockers (eg, metoprolol, propranolol), carbamazepine, clozapine, diltiazem, methadone, mexiletine, phenytoin, ramelteon, risperidone, 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 Luvox CR Extended-Release Capsules
This may not be a complete list of all interactions that may occur. Ask your health care provider if Luvox CR 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 Luvox CR Extended-Release Capsules:
Use Luvox CR Extended-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Luvox CR Extended-Release Capsules comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Luvox CR Extended-Release Capsules refilled.
- Take Luvox CR Extended-Release Capsules by mouth with or without food.
- Swallow Luvox CR Extended-Release Capsules whole. Do not break, crush, or chew before swallowing.
- Take Luvox CR Extended-Release Capsules at bedtime unless your doctor tells you otherwise.
- Continue to take Luvox CR Extended-Release Capsules even if you feel well. Do not miss any doses.
- Do not suddenly stop taking Luvox CR 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 Luvox CR Extended-Release Capsules and whenever a change in dose is made.
- If you miss a dose of Luvox CR 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 Luvox CR Extended-Release Capsules.
Important safety information:
- Luvox CR Extended-Release Capsules may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Luvox CR 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 Luvox CR Extended-Release Capsules.
- Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Luvox CR 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 Luvox CR Extended-Release Capsules for longer than prescribed without checking with your doctor.
- Children, teenagers, and young adults who take Luvox CR Extended-Release Capsules may be at increased risk for suicidal thoughts or actions. Watch patients who take Luvox CR 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 Luvox CR 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 Luvox CR Extended-Release Capsules.
- Serotonin syndrome is a possibly fatal syndrome that can be caused by Luvox CR Extended-Release Capsules. Your risk may be greater if you take Luvox CR 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 Luvox CR 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.
- Luvox CR 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 Luvox CR Extended-Release Capsules in the ELDERLY; they may be more sensitive to its effects, especially low blood sodium levels.
- Luvox CR 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.
- Luvox CR Extended-Release Capsules may cause weight changes. CHILDREN and teenagers may need regular weight and growth checks while they take Luvox CR Extended-Release Capsules.
- PREGNANCY and BREAST-FEEDING: Luvox CR Extended-Release Capsules may cause harm to the fetus if it is used during the last 3 months of pregnancy. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Luvox CR Extended-Release Capsules while you are pregnant. Luvox CR Extended-Release Capsules are found in breast milk. Do not breast-feed while taking Luvox CR Extended-Release Capsules.
Possible side effects of Luvox CR 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:
Constipation; decreased sexual ability; diarrhea; dizziness; drowsiness; dry mouth; gas; headache; increased sweating; loss of appetite; nausea; nervousness; sore throat; stomach upset; trouble sleeping; vomiting; weakness.Seek medical attention right away if any of these SEVERE side effects occur:
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 loss; new or worsening agitation, anxiety, depression, panic attacks, aggressiveness, impulsiveness, irritability, hostility, exaggerated feeling of well-being, restlessness, or inability to sit still; painful 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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), 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 Luvox CR Extended-Release Capsules:
Store Luvox CR Extended-Release Capsules at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Avoid temperatures above 86 degrees F (30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Luvox CR Extended-Release Capsules out of the reach of children and away from pets.
- If you have any questions about Luvox CR Extended-Release Capsules, please talk with your doctor, pharmacist, or other health care provider.
- Luvox CR Extended-Release Capsules are 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.
This information is summary only. It does not contain all information about Luvox CR Extended-Release Capsules. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.