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Trintellix

(vortioxetine)

How does this medication work? What will it do for me?

Vortioxetine belongs to the family of medications known as antidepressants. More specifically, it is a serotonin modulator. It works by increasing the effectiveness of how serotonin is used in the brain. Serotonin is a chemical produced by the body that is associated with mood and emotion.

Vortioxetine is used to treat the symptoms of major depressive disorder for adults and to keep the symptoms of depression from returning.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

How should I use this medication?

The recommended dose of this medication for adults less than 65 years of age is 10 mg taken once daily. For adults 65 years of age or older the starting dose is 5 mg taken once daily. Depending on how well it works for you and the level of side effects you experience, your doctor may suggest that you increase the dose to a maximum of 20 mg daily.

Vortioxetine may be taken with or without food.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor.

If you miss a dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

What form(s) does this medication come in?

5 mg
Each pink, almond-shaped, biconvex film-coated tablet engraved with "TL" on one side and "5" on the other side contains 6.355 mg of vortioxetine hydrobromide equivalent to 5 mg of vortioxetine. Nonmedicinal ingredients: hydroxypropylcellulose, hypromellose, iron oxide red, Macrogol 400, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate (Type A), and titanium dioxide (E 171).

10 mg
Each yellow, almond-shaped, biconvex, film-coated tablet engraved with "TL" on one side and "10" on the other side contains 12.71 mg of vortioxetine hydrobromide equivalent to 10 mg of vortioxetine. Nonmedicinal ingredients: hydroxypropylcellulose, hypromellose, iron oxide yellow, Macrogol 400, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate (Type A), and titanium dioxide (E 171).

15 mg
Each orange, almond-shaped, biconvex, film-coated tablet engraved with "TL" on one side and "15" on the other side contains 19.065 mg of vortioxetine hydrobromide equivalent to 15 mg of vortioxetine. Nonmedicinal ingredients: hydroxypropylcellulose, hypromellose, iron oxide red, iron oxide yellow, Macrogol 400, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate (Type A), and titanium dioxide (E 171).

20 mg
Each red, almond-shaped, biconvex, film-coated tablet engraved with "TL" on one side and "20" on the other side contains 25.42 mg of vortioxetine hydrobromide equivalent to 20 mg of vortioxetine. Nonmedicinal ingredients: hydroxypropylcellulose, hypromellose, iron oxide red, Macrogol 400, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate (Type A), and titanium dioxide (E 171).

Who should NOT take this medication?

Do not take this medication if you:

  • are allergic to vortioxetine or any ingredients of the medication
  • are taking an MAO inhibitor (e.g., phenelzine, tranylcypromine, moclobemide) or have taken an MAO inhibitor within the past 2 weeks (do not start treatment with an MAO inhibitor until at least 3 weeks after stopping vortioxetine treatment)

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • abdominal pain
  • abnormal dreams
  • bloating
  • cold and flu symptoms (e.g., sore throat, runny nose, nasal congestion, cough, fever)
  • constipation
  • cough
  • decreased appetite
  • diarrhea
  • dizziness
  • drowsiness
  • dry eyes
  • dry mouth
  • fatigue
  • feeling sedated or unusually calm
  • grinding teeth
  • increased sweating
  • itchiness
  • muscle twitching
  • nausea
  • nightmares
  • night sweats
  • reddening skin
  • trouble sleeping
  • unusual tiredness or weakness
  • vomiting
  • weight gain
  • yawning

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • abdominal swelling
  • agitation
  • back or joint pain
  • breast sensitivity
  • feelings of paranoia
  • late menstrual periods
  • mood swings
  • muscle pain or weakness
  • new or worsening signs of depression (such as feeling sad, losing interest in things you used to enjoy, weight changes, changes in sleep habits, feelings of guilt or worthlessness, thoughts of suicide)
  • signs of bleeding (e.g., bloody nose, blood in urine, coughing blood, bleeding gums, cuts that don't stop bleeding)
  • signs of dehydration (e.g., decreased urine, dry skin, dry and sticky mouth, sleepiness, dizziness, headache, thirst, confusion)
  • symptoms of glaucoma (e.g., eye pain, blurred vision)
  • symptoms of low blood pressure (e.g., fainting, dizziness, lightheadedness, blurred vision, nausea)
  • symptoms of low blood sodium (confusion, seizures, drowsiness, dryness of mouth, increased thirst, lack of energy)
  • symptoms of mania (e.g., talking, feeling, and acting with excitement and activity you cannot control)
  • symptoms of a urinary tract infection (e.g., pain when urinating, urinating more often than usual, low back or flank pain)

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • chest pain
  • seizure or convulsions
  • signs of serotonin syndrome (e.g., agitation, confusion, diarrhea, fever, overactive reflexes, poor coordination, restlessness, shivering, sweating, talking or acting with excitement you cannot control, trembling or shaking, twitching)
  • signs of a severe allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
  • signs of bleeding in the stomach (e.g., bloody, black, or tarry stools; spitting up of blood; vomiting blood or material that looks like coffee grounds)
  • signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen)
  • thoughts of suicide or hurting yourself

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Abnormal bleeding: Vortioxetine, like other similar medications, may cause abnormal bleeding, including bleeding in the stomach or intestines. If you have or have had a history of bleeding disorders, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Report any unusual bruising or bleeding to your doctor, especially if you are taking other medications that affect blood clotting. These medications include acetylsalicylic acid (ASA), clopidogrel, dipyridamole, nonsteroidal anti-inflammatory drugs (NSAIDs; e.g., ibuprofen or naproxen), other anticoagulant medications (e.g., warfarin), and certain antipsychotic medications.

Bone health: Like other similar medications, vortioxetine may increase the risk of bone fracture, especially if you are a senior or have osteoporosis or other major risk factors for breaking a bone. Your doctor may monitor your bones while you are taking this medication.

Drowsiness/reduced alertness: Although vortioxetine is not known to cause drowsiness, avoid driving, operating machinery, or performing other hazardous tasks until you have determined how this medication affects you.

Glaucoma: Vortioxetine can cause an increase in the pressure in the eye, making symptoms of glaucoma worse. If you have narrow-angle glaucoma, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver function: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.

Vortioxetine is not recommended for people with severe liver disease.

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Mania: Vortioxetine may cause symptoms of mania to worsen or return. If you have a history of mania or bipolar disorder, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Seizures: Medications to treat depression may cause an increased risk of seizures. If you have a history of seizures, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Anyone who develops seizures should seek immediate medical attention.

Serotonin syndrome: Severe reactions are possible when vortioxetine is combined with other medications that act on serotonin, such as tricyclic antidepressants, "triptan" medications for migraine, and some medications to treat nausea due to chemotherapy. These combinations should be avoided. Symptoms of a reaction may include muscle rigidity and spasms, difficulty moving, and changes in mental state including delirium and agitation. Coma and death are possible.

If you are taking other medications that affect serotonin, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Stopping the medication: Stopping this medication suddenly may lead to side effects such as dizziness, abnormal dreams, numbness or tingling sensations, agitation, anxiety, nausea, vomiting, sweating, or other symptoms. If you are thinking of stopping the medication, check with your doctor first. Your doctor may want you to decrease the dose of the medication gradually when it is time to stop taking vortioxetine.

Suicidal or agitated behaviour: People taking this medication may feel agitated (restless, anxious, aggressive, emotional, and feeling not like themselves), or they may want to hurt themselves or others. These behavioural changes may be more likely to occur for children and adolescents, but they are possible for all age groups that use this medication. These symptoms may occur within several weeks after starting this medication. If you experience these side effects or notice them in a family member who is taking this medication, contact your doctor immediately. You should be closely monitored by your doctor for emotional and behaviour changes while taking this medication.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. It has also been reported that babies born to women who took medications similar to vortioxetine during the last trimester of their pregnancy may experience adverse effects (such as breathing problems, seizures, trouble feeding, vomiting, low blood sugar, shaking, jitteriness, irritability, and constant crying) that result in an increase in the length of hospital stay. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: This medication passes into breast milk. If you are breast-feeding and are taking vortioxetine, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of vortioxetine for people less than 18 years of age have not been established. The use of this medication by children and adolescents less than 18 years old may cause behavioural and emotional changes, such as suicidal thoughts and behaviour.

Seniors: Seniors may be more at risk of side effects from this medication. If you are over 65 and using this medication, lower doses are recommended.

What other drugs could interact with this medication?

There may be an interaction between vortioxetine and any of the following:

  • abiraterone
  • acetylsalicylic acid (ASA)
  • alcohol
  • amphetamines (e.g., dextroamphetamine, lisdexamfetamine)
  • anagrelide
  • antihistamines (e.g., cetirizine, doxylamine, diphenhydramine, hydroxyzine, loratadine)
  • anti-psychotics (e.g., chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, risperidone)
  • apalutamide
  • apixaban
  • "azole" antifungal medications (e.g., fluconazole, itraconazole, voriconazole)
  • bosentan
  • bromocriptine
  • bupropion
  • buspirone
  • cabergoline
  • celecoxib
  • chloroquine
  • cinacalcet
  • clarithromycin
  • clopidogrel
  • cobicistat
  • cyclobenzaprine
  • dabigatran
  • darifenacin
  • desmopressin
  • dexmethylphenidate
  • dextromethorphan
  • diabetes medications (e.g., acarbose, canagliflozin, glyburide, insulin, lixisenatide, linagliptin, metformin, rosiglitazone)
  • dipyridamole
  • disopyramide
  • edoxaban
  • elagolix
  • enzalutamide
  • ergot alkaloids (e.g., ergotamine, dihydroergotamine)
  • glucosamine
  • heparin
  • HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., efavirenz, etravirine)
  • HIV protease inhibitors (e.g., atazanavir, darunavir, indinavir, ritonavir, saquinavir)
  • hydroxychloroquine
  • lanreotide
  • linezolid
  • lithium
  • low molecular weight heparins (e.g., dalteparin, enoxaparin, tinzaparin)
  • lumacaftor and ivacaftor
  • mefloquine
  • methylene blue
  • methylphenidate
  • methadone
  • mifepristone
  • mirabegron
  • mirtazapine
  • mitotane
  • modafinil
  • monoamine oxidase inhibitors (MAOIs; e.g., moclobemide, phenelzine, rasagiline, selegiline, tranylcypromine)
  • narcotic pain relievers (e.g., codeine, fentanyl, morphine, oxycodone)
  • non-steroidal anti-inflammatory medications (NSAIDs; e.g., diclofenac, ibuprofen, naproxen)
  • obinutuzumab
  • octreotide
  • omega-3 fatty acids
  • ozanimod
  • pasireotide
  • pentamidine
  • pentoxifylline
  • prasugrel
  • propranolol
  • protein kinase inhibitors (e.g., dabrafenib, dasatinib, imatinib, nilotinib, sunitinib)
  • quinidine
  • quinine
  • rifabutin
  • rifampin
  • rivaroxaban
  • St. John's wort
  • seizure medications (e.g., carbamazepine, clobazam, levetiracetam, phenobarbital, phenytoin, primidone, topiramate, valproic acid, zonisamide)
  • other selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluoxetine, paroxetine, sertraline)
  • serotonin antagonists (anti-emetic medications; e.g., granisetron, ondansetron)
  • serotonin/norepinephrine reuptake inhibitors (SNRIs; e.g., desvenlafaxine, duloxetine, venlafaxine)
  • tapentadol
  • terbinafine
  • thiazide diuretics (water pills; e.g., hydrochlorothiazide, indapamide, metolazone)
  • thyroid replacements (e.g., desiccated thyroid, levothyroxine)
  • ticagrelor
  • ticlopidine
  • tramadol
  • trazodone
  • tricyclic antidepressants (e.g., amitriptyline, clomipramine, desipramine, trimipramine)
  • "triptan" migraine medications (e.g., almotriptan, eletriptan, sumatriptan)
  • tryptophan
  • vitamin E
  • warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2024. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Trintellix

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