Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. Brintellix

Descriptions


Vortioxetine is used to treat depression.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

  • Tablet

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of vortioxetine in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of vortioxetine in the elderly. However, elderly patients are more likely to have hyponatremia (low sodium in the blood), which may require caution for patients receiving vortioxetine.

Pregnancy

Information about this vortioxetine-oral-route
Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Furazolidone
  • Iproniazid
  • Isocarboxazid
  • Linezolid
  • Methylene Blue
  • Moclobemide
  • Pargyline
  • Phenelzine
  • Procarbazine
  • Rasagiline
  • Selegiline
  • Tranylcypromine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Abciximab
  • Abiraterone Acetate
  • Aceclofenac
  • Acemetacin
  • Acenocoumarol
  • Almotriptan
  • Amineptine
  • Amitriptyline
  • Amitriptylinoxide
  • Amoxapine
  • Amphetamine
  • Amtolmetin Guacil
  • Anagrelide
  • Apixaban
  • Ardeparin
  • Argatroban
  • Aspirin
  • Bivalirudin
  • Bromfenac
  • Brompheniramine
  • Bufexamac
  • Bupropion
  • Buspirone
  • Carbamazepine
  • Celecoxib
  • Certoparin
  • Chlorpheniramine
  • Choline Salicylate
  • Cilostazol
  • Citalopram
  • Clomipramine
  • Clonixin
  • Clopidogrel
  • Cocaine
  • Cyclobenzaprine
  • Dabigatran Etexilate
  • Dalteparin
  • Danaparoid
  • Desipramine
  • Desirudin
  • Desvenlafaxine
  • Dexamethasone
  • Dexibuprofen
  • Dexketoprofen
  • Dextroamphetamine
  • Dextromethorphan
  • Dibenzepin
  • Diclofenac
  • Diflunisal
  • Dipyridamole
  • Dipyrone
  • Doxepin
  • Drotrecogin Alfa
  • Duloxetine
  • Eletriptan
  • Enoxaparin
  • Enzalutamide
  • Eptifibatide
  • Escitalopram
  • Etodolac
  • Etofenamate
  • Etoricoxib
  • Felbinac
  • Fenoprofen
  • Fentanyl
  • Fepradinol
  • Feprazone
  • Floctafenine
  • Flufenamic Acid
  • Fluoxetine
  • Flurbiprofen
  • Fluvoxamine
  • Fondaparinux
  • Fosphenytoin
  • Frovatriptan
  • Heparin
  • Hydroxytryptophan
  • Ibuprofen
  • Ibuprofen Lysine
  • Imipramine
  • Indomethacin
  • Ketoprofen
  • Ketorolac
  • Lepirudin
  • Levomilnacipran
  • Lithium
  • Lofepramine
  • Lorcaserin
  • Lornoxicam
  • Loxoprofen
  • Lumiracoxib
  • Meclofenamate
  • Mefenamic Acid
  • Melitracen
  • Meloxicam
  • Meperidine
  • Methadone
  • Milnacipran
  • Mirtazapine
  • Morniflumate
  • Nabumetone
  • Nadroparin
  • Naproxen
  • Naratriptan
  • Nefazodone
  • Nepafenac
  • Niflumic Acid
  • Nimesulide
  • Nortriptyline
  • Opipramol
  • Oxaprozin
  • Oxyphenbutazone
  • Parecoxib
  • Parnaparin
  • Paroxetine
  • Pentazocine
  • Phenindione
  • Phenobarbital
  • Phenprocoumon
  • Phenylbutazone
  • Phenytoin
  • Piketoprofen
  • Piroxicam
  • Pixantrone
  • Pranoprofen
  • Prasugrel
  • Primidone
  • Proglumetacin
  • Propyphenazone
  • Proquazone
  • Protein C, Human
  • Protriptyline
  • Quinidine
  • Reviparin
  • Rifabutin
  • Rifampin
  • Rifapentine
  • Rivaroxaban
  • Rizatriptan
  • Rofecoxib
  • Salicylic Acid
  • Salsalate
  • Sertraline
  • Sibutramine
  • Sodium Salicylate
  • St John's Wort
  • Sulfinpyrazone
  • Sulindac
  • Sumatriptan
  • Tapentadol
  • Tenoxicam
  • Tianeptine
  • Tiaprofenic Acid
  • Ticagrelor
  • Ticlopidine
  • Tinzaparin
  • Tirofiban
  • Tolfenamic Acid
  • Tolmetin
  • Tramadol
  • Trazodone
  • Treprostinil
  • Trimipramine
  • Valdecoxib
  • Valproic Acid
  • Venlafaxine
  • Warfarin
  • Zolmitriptan

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Bipolar disorder (mood disorder with mania and depression), or risk of or
  • Bleeding problems or
  • Hyponatremia (low sodium in the blood) or
  • Mania, history of or
  • Seizures, history of—Use with caution. May make these conditions worse.

Proper Use

Take this medicine only as directed by your doctor to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine should come with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

You may take this medicine with or without food. Also, take this medicine at the same time each day.

You may have to take vortioxetine for a month or longer before you begin to feel better.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For depression:
      • Adults—At first, 10 milligrams (mg) once a day. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 20 mg per day.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions

It is important that your doctor check your progress at regular visits to allow changes in your dose and help reduce any side effects.

Do not take vortioxetine if you have taken a monoamine oxidase (MAO) inhibitor (such as Eldepryl®, Marplan®, Nardil®, or Parnate®), methylene blue, or linezolid in the past 2 weeks. Do not start taking a MAO inhibitor within 21 days of stopping vortioxetine. If you do, you may develop confusion, agitation, restlessness, sudden high body temperature, extremely high blood pressure, or severe convulsions.

Vortioxetine may cause some teenagers and young adults to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Some people may have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. If you or your caregiver notice any of these unwanted effects, tell your doctor right away. Let the doctor know if you or anyone in your family has bipolar disorder (manic-depressive) or has tried to commit suicide.

Vortioxetine may cause a serious condition called serotonin syndrome if taken together with some medicines such as buspirone (Buspar®), fentanyl (Abstral®, Duragesic®), linezolid (Zyvox®), lithium (Eskalith®, Lithobid®), methylene blue injection, tryptophan, St. John's wort, other medicines for depression (such as amitriptyline, nortriptyline), or some pain or migraine medicines (eg, rizatriptan, sumatriptan, tramadol, Frova®, Imitrex®, Maxalt®, Relpax®, Ultram®, Zomig®). Check with your doctor first before taking any other medicines with vortioxetine.

This medicine may increase your risk for bleeding problems. Make sure your doctor knows if you are also taking other medicines that thin the blood, such as aspirin, nonsteroidal antiinflammatory agents, also called NSAIDs (eg, diclofenac, ibuprofen, naproxen, Advil®, Aleve®, Celebrex®, Voltaren®), or warfarin (Coumadin®, Jantoven®).

Hyponatremia (low sodium in the blood) may occur with this medicine. Check with your doctor right away if you have confusion, difficulty concentrating, headaches, memory problems, weakness, and unsteadiness.

Do not suddenly stop taking this medicine without checking first with your doctor . Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This will decrease the chance of having withdrawal symptoms such as headache, muscle tension, mood swings, dizziness, runny nose, or sudden outbursts of anger.

This medicine may cause some people to become dizzy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known

  1. Agitation
  2. blood in the stool or urine
  3. coma
  4. confusion
  5. convulsions
  6. decreased urine output
  7. diarrhea
  8. dizziness
  9. fast or irregular heartbeat
  10. fever
  11. headache
  12. increased thirst
  13. large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  14. muscle pain or cramps
  15. nausea or vomiting
  16. nose bleeds
  17. overactive reflexes
  18. poor coordination
  19. red or purple spots on the skin
  20. restlessness
  21. shivering
  22. shortness of breath
  23. sweating
  24. swelling of the face, ankles, or hands
  25. talking or acting with excitement you cannot control
  26. trembling or shaking
  27. twitching
  28. unusual bruising
  29. unusual tiredness or weakness
  30. vomiting blood

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  1. Difficulty having a bowel movement (stool)
  2. dry mouth

Less common

  1. Bloated or full feeling
  2. excess air or gas in the stomach or intestines
  3. itching skin
  4. passing gas
  5. unusual dreams

Incidence not known

  1. Acid or sour stomach
  2. belching
  3. change in taste
  4. dizziness or lightheadedness
  5. feeling of constant movement of self or surroundings
  6. feeling of warmth
  7. heartburn
  8. indigestion
  9. loss of taste
  10. redness of the face, neck, arms, and occasionally, upper chest
  11. sensation of spinning
  12. stomach discomfort, upset, or pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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