Vortioxetine

pronounced as (vor'' tye ox' e teen)

Brand Name(s): Trintellix®, Brintellix®

Why is this medicine prescribed?

Vortioxetine is used to treat depression in adults. Vortioxetine is in a class of medications called serotonin modulators. It works mainly by increasing the amount of serotonin, a natural substance in the brain that helps maintain mental balance.

Are there other uses for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

How should this medicine be used?

Vortioxetine comes as a tablet to take by mouth. It is usually taken with or without food once a day. Take vortioxetine at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take vortioxetine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor may adjust your dose of vortioxetine depending on how well you respond to treatment and whether you experience side effects. Be sure to talk to your doctor about how you are feeling during your treatment with vortioxetine.

It may take 2 to 4 weeks or longer before you feel the full benefit of vortioxetine. Continue to take vortioxetine even if you feel well. Do not stop taking vortioxetine without talking to your doctor. Your doctor will probably decrease your dose gradually. If you suddenly stop taking vortioxetine, you may experience withdrawal symptoms such as headache, mood changes, irritability, agitation, nausea, dizziness, burning, numbness, or tingling in the hands or feet, anxiety, confusion, sweating, shaking, frenzied or abnormally excited mood, ringing in the ears, tiredness, difficulty falling asleep or staying asleep. and seizures. Tell your doctor if you experience any of these symptoms while you are decreasing your dose of vortioxetine or soon after you stop taking vortioxetine.

What special precautions should I follow?

Before taking vortioxetine,

  • tell your doctor and pharmacist if you are allergic to vortioxetine, any other medications, or any of the ingredients in vortioxetine tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
  • tell your doctor or pharmacist if you are taking the following medications or have stopped taking them within the past two weeks: monoamine oxidase (MAO) inhibitors, including isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), selegiline (Emsam, Zelapar), and tranylcypromine (Parnate) . Your doctor may tell you not to take vortioxetine. If you stop taking vortioxetine, you should wait at least 21 days before you start to take an MAO inhibitor.
  • some medications should not be taken with vortioxetine. Other medications may cause dosing changes or extra monitoring when taken with vortioxetine. Make sure you have discussed any medications you are currently taking or plan to take before starting vortioxetine with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking vortioxetine, please get the advice of your doctor or pharmacists
  • the following nonprescription or herbal products may interact with vortioxetine: St. John's wort; tryptophan. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking vortioxetine. Do not start any of these medications while taking vortioxetine without discussing with your healthcare provider
  • tell your doctor if you have a low level of sodium in your blood, if you drink or have ever drunk large amounts of alcohol, and if you have or have ever had seizures, glaucoma (increased pressure in the eye that may cause loss of sight), or bleeding problems.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking vortioxetine, call your doctor. Vortioxetine may cause problems in newborns following delivery if it is taken during the last few months of pregnancy.
  • you should know that vortioxetine may affect your judgment, thinking, and movements. Do not drive a car or operate machinery until you know how this medication affects you.
  • you should know that vortioxetine may cause angle-closure glaucoma (a condition where the fluid is suddenly blocked and unable to flow out of the eye causing a quick, severe increase in eye pressure which may lead to a loss of vision). Talk to your doctor about having an eye examination before you start taking this medication. If you have nausea, eye pain, changes in vision, such as seeing colored rings around lights, and swelling or redness in or around the eye, call your doctor or get emergency medical treatment right away.
  • if you are having surgery, including dental surgery, or a medical test that involves dyes, tell the doctor or dentist that you are taking vortioxetine.
  • ask your doctor about the safe use of alcoholic beverages while you are taking vortioxetine.

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What should I do in case of overdose?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help . If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

  • nausea
  • dizziness
  • diarrhea
  • stomach pain
  • itching
  • sleepiness
  • flushing
  • agitation, hallucinations, fever, sweating, confusion, fast heartbeat, shivering, severe muscle stiffness or twitching, loss of coordination, nausea, vomiting, or diarrhea
  • seizures

What side effects can this medicine cause?

Vortioxetine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • nausea
  • vomiting
  • diarrhea
  • constipation
  • gas
  • dry mouth
  • dizziness
  • unusual dreams
  • sexual problems in males; decreased sex drive, inability to get or keep an erection, or delayed or absent ejaculation
  • sexual problems in females; decreased sex drive, or delayed orgasm or unable to have an orgasm

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING or SPECIAL PRECAUTIONS sections, call your doctor immediately:

  • rash
  • hives
  • itching
  • swelling of the eyes, face, lips, tongue, or throat
  • hoarseness
  • difficulty breathing or swallowing
  • unusual bruising or bleeding
  • fever, sweating, confusion, fast or irregular heartbeat, severe muscle stiffness or twitching, agitation, hallucinations, loss of coordination, nausea, vomiting, or diarrhea
  • nosebleed
  • headache
  • difficulty concentrating
  • memory problems
  • confusion
  • weakness
  • unsteadiness
  • hallucinations
  • fainting
  • seizures
  • coma (loss of consciousness for a period of time)

Vortioxetine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( http://www.fda.gov/Safety/MedWatch ) or by phone (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website ( http://goo.gl/c4Rm4p ) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

What other information should I know?

Keep all appointments with your doctor.

Before having any laboratory test (especially those that involve methylene blue), tell your doctor and the laboratory personnel that you are taking vortioxetine.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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