Vortioxetine

Vortioxetine is a prescription medication used to treat major depressive disorder (MDD).

Vortioxetine belongs to a group of drugs called serotonin modulators. These work by increasing serotonin, a natural substance in the brain.

This medication comes in tablet form and is taken usually once a day, with or without food.

Common side effects of nausea, constipation and vomiting.

Vortioxetine can also cause dizziness. Do not drive or operate heavy machinery until you know how vortioxetine affects you.

Vortioxetine is a prescription medication used to treat major depressive disorder (MDD).

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

Serious side effects have been reported with vortioxetine. See the “Vortioxetine Precautions” section.

Common side effects of vortioxetine include the following:

• Nausea
• Constipation 
• Diarrhea
• Vomiting
• Dry mouth
• Dizziness
• Sexual Dysfunction

This is not a complete list of vortioxetine side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• medications that block a protein in the body (CYP2D6) such as bupropion, quinidine (Qualaquin), fluoxetine (Prozac,Sarafem), amitriptyline (Elavil, Amitril, Amitid), and paroxetine (Paxil)
• medications that increase the activity of the CYP pathway such as carbamazepine (Tegretol, Equetro, Carbatrol), phenobarbital, phenytoin (Dilantin), rifampin (Rifadin), St John's wort, and nimodipine (Nimotop)

This is not a complete list of vortioxetine drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with vortioxetine including the following:

• Hypersensitivity. Tell your healthcare provider right away if you have some or all of the following symptoms of hypersensitivity.
  • chest pain
  • swelling of the face, eyes, lips, tongue, arms, or legs
  • difficulty breathing or swallowing
  • rash
• Angioedema. Tell your healthcare provider right away if you have signs or symptoms of angioedema, which include the following:
  • swelling of face, eyes, lips, tongue, larynx and extremities
  • difficulty in swallowing or breathing
  • hoarseness (having difficulty making sounds when trying to speak)

• Low levels of salt (sodium) in your blood. Symptoms of this may include the following:
  • headache
  • difficulty concentrating
  • memory changes
  • confusion
  • weakness and unsteadiness on your feet

• Serotonin syndrome. Tell your healthcare provider right away if you have signs or symptoms of serotonin syndrome, which include the following:
  • agitation, hallucinations, coma or other changes in mental status
  • problems controlling your movements or muscle twitching
  • fast heartbeat
  • high or low blood pressure
  • sweating or fever
  • nausea or vomiting
  • diarrhea
  • muscle stiffness or tightness
• Abnormal bleeding. Tell your healthcare provider right away if you have signs or symptoms of bleeding.
• Suicide risk. Tell your healthcare provider right away if you have sudden changes in mood, behavior, thoughts, or feelings, which may include the following:
  • attempts to commit suicide
  • acting aggressive, being angry or violent
  • thoughts about suicide or dying
  • new or worse depression
• Hypomania (manic episodes). Tell your healthcare provider right away if you have any of the following signs or symptoms:
  • greatly increased energy
  • severe problems sleeping
  • racing thoughts
  • reckless behavior
  • unusually grand ideas
  • excessive happiness or irritability
  • talking more or faster than usual

Vortioxetine can cause dizziness. Do not drive or operate heavy machinery until you know how vortioxetine affects you.

Do not take vortioxetine if you:

• are allergic to vortioxetine or to any of its ingredients
• take a monoamine oxidase inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid
• if you stopped taking an MAOI in the last 14 days

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of vortioxetine, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking vortioxetine, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to vortioxetine or to any of its ingredients
• have liver problems
• have or had seizures or convulsions
• have mania or bipolar disorder (manic depression)
• have low salt (sodium) levels in your blood
• have or had bleeding problems
• drink alcohol
• have any other medical conditions
• are pregnant or plan to become pregnant. It is not known if vortioxetine will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if vortioxetine passes into breast milk. Talk to your healthcare provider about the best way to feed your baby if you take vortioxetine.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Vortioxetine falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if vortioxetine crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using vortioxetine.

Take vortioxetine exactly as prescribed.

Vortioxetine comes in tablet form and is taken usually once a day.

Take vortioxetine with or without food.

Avoid drinking alcohol while taking vortioxetine.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of vortioxetine at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• how well you can metabolize vortioxetine

The recommended dose of vortioxetine for the treatment of major depressive disorder (MDD) is 20 mg/day.

If you take too much vortioxetine, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

 If vortioxetine is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store vortioxetine at room temperature between 59°F to 86°F (15°C to 30°C).
• Keep vortioxetine and all medicines out of the reach of children.

WARNINGS: Suicidality and Antidepressant Drugs

Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a trend toward reduced risk with antidepressant use in patients aged 65 and older.
In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber.
Vortioxetine has not been evaluated for use in pediatric patients.