TRINTELLIX 20MG BLSPK (28 TABLETS)

Generic Name: vortioxetine
Brand Name: Trintellix
Drug class: Antidepressant

WHAT IS THE DOSAGE OF THIS MEDICATION?

Trintellix is available as 5 mg, 10 mg, and 20 mg tablets.

WHAT IS THIS MEDICATION USED FOR?

Vortioxetine belongs to the class of antidepressant medications known as serotonin modulator. This medication is used to treat the symptoms of major depressive disorder, which include persistently low or depressed mood, anhedonia or decreased interest in pleasurable activities, feelings of guilt or worthlessness, lack of energy, poor concentration, appetite changes, psychomotor retardation or agitation, sleep disturbances, or suicidal thoughts.

Serotonin is the chemical produced by the body that is associated with mood and emotion. What this medication does is increase the effectiveness of how that chemical, serotonin, is used in the brain. How vortioxetine works is it simultaneously modulates one or more serotonin receptors and inhibits the reuptake of of serotonin (5-HT) into the presynaptic terminals of serotonergic neurons. This may improve your energy levels, mood, appetite, sensation of anxiety/nervousness, and eventually overall general quality of life.

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.

WHO SHOULD NOT TAKE THIS MEDICATION

Do not take vortioxetine 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)

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POTENTIAL INTERACTION WITH OTHER 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.

Inform your doctor about all prescription, over-the-counter (non-prescription), and herbal medications that 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.

The following medications could potentially interact with vortioxetine:

• 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

WHAT ARE THE SIDE EFFECTS OF 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.

Inform your doctor about all prescription, over-the-counter (non-prescription), and herbal medications that 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.

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.

This is not a complete list of possible side effects. If you notice other effects not listed, please contact your doctor or pharmacist.

Possible side effects include:

• 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

• 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)

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