Generic Name: vortioxetine (VOR-tye-OX-e-teen)
Brand Name: Brintellix
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 vortioxetine outweigh the risks.
Family and caregivers must closely watch patients who take vortioxetine. 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.
Vortioxetine is not approved for use in children. Talk with the doctor.
Vortioxetine is used for:
Treating depression. It may also be used for other conditions as determined by your doctor.
Vortioxetine is an antidepressant. Exactly how it works to treat depression is not known. It is thought to work by restoring the balance of serotonin, a natural substance in the brain, which helps to improve certain mood problems.
Do NOT use vortioxetine if:
- you are allergic to any ingredient in vortioxetine
- you have severe liver problems
- you are taking or have taken a monoamine oxidase inhibitor (MAOI) (eg, phenelzine, selegiline) within the last 14 days
- you are taking or have taken linezolid within the last 24 hours
Contact your doctor or health care provider right away if any of these apply to you.
Before using vortioxetine:
Some medical conditions may interact with vortioxetine. 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, high or low blood pressure, liver problems, or bleeding problems
- if you are dehydrated, have low blood sodium levels, or drink alcohol
- if you are taking a medicine that contains methylene blue
Some MEDICINES MAY INTERACT with vortioxetine. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Fentanyl; linezolid; medicines used to treat mood, anxiety, or thought problems, such as buspirone, lithium, MAOIs (eg, phenelzine, rasagiline, selegiline), serotonin 5-HT1 receptor agonists (eg, sumatriptan), serotonin-norepinephrine reuptake inhibitors (SNRIs) (eg, venlafaxine), selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine, paroxetine), tricyclic antidepressants (eg, amitriptyline), or tryptophan; methylene blue; quinidine; St. John's wort; or tramadol because severe side effects, such as a reaction that may include fever, rigid muscles, blood pressure changes, mental changes, confusion, irritability, agitation, delirium, or coma, may occur
- Anticoagulants (eg, warfarin), aspirin, or nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen, intranasal ketorolac) 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
- Carbamazepine, phenytoin, or rifampicin because they may decrease vortioxetine's effectiveness
This may not be a complete list of all interactions that may occur. Ask your health care provider if vortioxetine 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 vortioxetine:
Use vortioxetine as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Vortioxetine comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get vortioxetine refilled.
- Take vortioxetine by mouth with or without food.
- Taking vortioxetine at the same time each day will help you remember to take it.
- Continue to take vortioxetine even if you feel well. Do not miss any doses.
- Do not suddenly stop taking vortioxetine without checking with your doctor. You may have an increased risk of side effects (eg, mood swings, dizziness, headache, light-headedness, runny nose, stiff muscles, sudden outburst of anger). If you need to stop vortioxetine, your doctor may need to gradually lower your dose.
- If you miss a dose of vortioxetine, 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 vortioxetine.
Important safety information:
- Vortioxetine may cause dizziness. It may also cause you to not be able to make decisions, think clearly, or react quickly. Do not drive or perform other possibly unsafe tasks until you know how you react to vortioxetine.
- Do not drink alcohol while you are taking vortioxetine.
- Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are taking vortioxetine; 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 take vortioxetine for longer than prescribed without checking with your doctor.
- Children and teenagers who take vortioxetine may be at increased risk for suicidal thoughts or actions. Adults may also be affected. The risk may be greater in patients who have had suicidal thoughts or actions in the past. The risk may also be greater in patients who have had bipolar (manic-depressive) illness, or if their family members have had it. Watch patients who take vortioxetine 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.
- Serotonin syndrome is a possibly fatal syndrome that can be caused by vortioxetine. Your risk may be greater if you take vortioxetine with certain other medicines (eg, "triptans," MAOIs). 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.
- If your doctor tells you to stop taking vortioxetine, you will need to wait at least 21 days before beginning to take certain other medicines (eg, MAOIs). Ask your doctor when you should start to take your new medicines after you have stopped taking vortioxetine.
- Low blood sodium levels may occur from treatment with vortioxetine. In severe cases, this can be deadly. Call your doctor right away if you have confusion, decreased coordination, fainting, hallucinations, headache, memory problems, mental or mood changes, seizures, sluggishness, trouble concentrating, or weakness.
- Use vortioxetine with caution in the ELDERLY; they may be more sensitive to its effects, especially low blood sodium levels.
- PREGNANCY and BREAST-FEEDING: Vortioxetine may cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using vortioxetine while you are pregnant. It is not known if vortioxetine is found in breast milk. Do not breast-feed while you are taking vortioxetine.
Possible side effects of vortioxetine:
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; dry mouth; nausea; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); black, bloody, or tarry stools; new or worsening mental, mood, or behavior changes (eg, depression, anxiety, agitation, panic attacks, aggressiveness, impulsiveness, irritability, hostility, exaggerated feeling of well-being, restlessness, or inability to sit still); severe or persistent nausea, vomiting, diarrhea, or stomach pain; suicidal thoughts or attempts; symptoms of low blood sodium levels (eg, confusion, decreased coordination, fainting, hallucinations, headache, memory problems, mental or mood changes, seizures, sluggishness, trouble concentrating, unusual weakness); unusual bruising or bleeding; vomit that looks like coffee grounds.
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.Proper storage of vortioxetine:
Store vortioxetine at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep vortioxetine out of the reach of children and away from pets.
- If you have any questions about vortioxetine, please talk with your doctor, pharmacist, or other health care provider.
- Vortioxetine 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 vortioxetine 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 vortioxetine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to vortioxetine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using vortioxetine.
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.