vortioxetine

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Pronunciation: VOR tye OX e teen

Brand: Trintellix

What is the most important information I should know about vortioxetine?

Do not use this medicine if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine. After you stop taking vortioxetine you must wait at least 21 days before you start taking an MAO inhibitor.

Some young people have thoughts about suicide when first taking an antidepressant. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

What is vortioxetine?

Vortioxetine is an antidepressant that affects chemicals in the brain that may be unbalanced.

Vortioxetine is used to treat major depressive disorder in adults.

Vortioxetine may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking vortioxetine?

You should not use this medicine if you are allergic to vortioxetine, or if you are being treated with linezolid or methylene blue injection.

Do not use an MAO inhibitor within 14 days before you take vortioxetine. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, phenelzine, rasagiline, selegiline, tranylcypromine, and others. After you stop taking vortioxetine you must wait at least 21 days before you start taking an MAO inhibitor.

Vortioxetine is not approved for use by anyone younger than 18 years old.

To make sure vortioxetine is safe for you, tell your doctor if you have:

  • bipolar disorder (manic depression), or a history of drug abuse or suicidal thoughts;
  • liver disease;
  • narrow-angle glaucoma;
  • seizures or epilepsy;
  • bleeding or blood clotting disorder; or
  • low levels of sodium in your blood.

Some young people have thoughts about suicide when first taking an antidepressant. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Taking vortioxetine in the last 3 months of pregnancy may cause problems in the newborn, such as life-threatening withdrawal symptoms, serious lung problems or other complications in the baby. Tell your doctor if you are pregnant.

Follow your doctor's instructions about taking vortioxetine if you are pregnant. Do not start or stop taking this medicine without your doctor's advice, and tell your doctor right away if you become pregnant. Vortioxetine may cause harm to an newborn baby, but you may have a relapse of major depressive disorder or other problems if you stop taking your medicine during pregnancy. The benefit of continuing treatment with vortioxetine may outweigh any risks to the baby.

It is not known whether vortioxetine passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

How should I take vortioxetine?

Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not use this medicine in larger or smaller amounts or for longer than recommended.

You may take vortioxetine with or without food.

Do not stop using vortioxetine suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using vortioxetine.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking vortioxetine?

Vortioxetine may impair your thinking or reactions. Avoid driving or operating machinery until you know how this medicine will affect you.

Ask your doctor before taking a nonsteroidal anti-inflammatory drug (NSAID) for pain, arthritis, fever, or swelling. This includes aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib (Celebrex), diclofenac, indomethacin, meloxicam, and others. Using an NSAID with vortioxetine may cause you to bruise or bleed easily.

Avoid drinking alcohol while taking vortioxetine.

What are the possible side effects of vortioxetine?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Stop using vortioxetine and call your doctor at once if you have:

  • blurred vision, tunnel vision, eye pain, eye redness or swelling, seeing halos around lights;
  • racing thoughts, decreased need for sleep, unusual risk-taking behavior, feelings of extreme happiness or sadness, being more talkative than usual;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), coughing up blood;
  • high levels of serotonin in the body --agitation, hallucinations, fever, fast heart rate, muscle stiffness, overactive reflexes, vomiting, diarrhea, loss of coordination, fainting; or
  • low levels of sodium in the body (may be more likely in older adults) --headache, confusion, slurred speech, severe weakness, memory problems, hallucinations, loss of coordination, feeling unsteady.

Common side effects may include:

  • nausea;
  • vision changes;
  • occasional vomiting; or
  • constipation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect vortioxetine?

Some medicines can interact with vortioxetine and cause a serious condition called serotonin syndrome. Be sure your doctor knows if you also take medicine for mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. Ask your doctor before making any changes in how or when you take your medications.

Many drugs can interact with vortioxetine. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any you start or stop using, especially:

  • any other antidepressant;
  • aspirin or a blood thinner (warfarin, Coumadin, Jantoven);
  • a diuretic or "water pill";
  • fentanyl, tramadol;
  • quinidine;
  • rifampin;
  • St. John's wort, tryptophan (sometimes called L-tryptophan);
  • a "triptan" migraine headache medicine;
  • medicine to treat anxiety or mental illness --buspirone, lithium, and others; or
  • seizure medicine --carbamazepine, phenytoin.

This list is not complete and many other drugs can interact with vortioxetine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

Where can I get more information?

Your pharmacist can provide more information about vortioxetine.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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