What to Know About Trintellix (Vortioxetine)

Vortioxetine (Trintellix): Uses, Side Effects & Dosage

What to Know About Trintellix (Vortioxetine)

  • Vortioxetine (Trintellix) is an antidepressant used for treating a certain type of depression known as major depressive disorder (MDD). Vortioxetine decreases the reuptake of serotonin just selective serotonin reuptake inhibitors (SSRIs). It also stimulates various serotonin receptors in the brain.
  • The exact mechanism by which vortioxetine helps to improve mood in patients a major depressive disorder is not known. It may have a role in enhancing the activity of the neurotransmitter serotonin in the brain by inhibiting the transport of serotonin. Additionally, vortioxetine appears to block or stimulate some serotonin receptors. The exact contribution of the respective activity of vortioxetine at these receptor sites remain to be understood.
  • Vortioxetine was approved by the FDA in September 2013.

What are the uses for vortioxetine?

Vortioxetine is used for the treatment of a certain type of depression known as major depressive disorder (MDD).

What are the side effects of vortioxetine?

The most common side effects of vortioxetine treatment are:

What is the dosage for vortioxetine?

  • The recommended starting dose for most adult patients is 10 mg once daily. The dose should then be increased to 20 mg per day as tolerated. Vortioxetine may be administered without regard to meals.
  • Since vortioxetine is extensively broken down by a group of liver enzymes known as CYP2D6, patients with reduced activity of these enzymes should not be treated with doses higher than 10 mg/day.
  • Although vortioxetine may be discontinued without tapering, manufacturer recommends reducing doses of 15 mg/day or 20 mg/day to 10 mg/day for 1 week prior to discontinuation.
  • The safety and effectiveness of vortioxetine treatment as not been studied in pediatric patients. The use of vortioxetine in this patient population is not recommended.

Which drugs or supplements interact with vortioxetine?

To avoid the risk of serotonin syndrome, a rare but serious disorder caused by abnormally high levels of serotonin in the body, vortioxetine should not be used in combination or within 14 days of treatment with monoamine oxidase inhibitors (MOAI). Conversely, treatment with MAOI should not be started until 21 days have passed after stopping vortioxetine.

The potential risk of serotonin syndrome also exists when vortioxetine is co-administered with other drugs that also affect serotonin levels in the brain. Examples of such drugs include:

Serotonin plays an important role in forming blood clots. Use of vortioxetine may increase the risk of bleeding, especially if taken with:

Vortioxetine is extensively metabolized or broken down by the CYP2D6 liver enzymes.

Strong CYP2D6 inhibitors may increase the blood levels of vortioxetine, and consequently increase the risk for side effects.

Examples of strong CYP2D6 inhibitors are bupropion (Wellbutrin), paroxetine (Paxil), and quinidine (Quin-Tab). The dose of vortioxetine should be reduced by half when co-administered with such agents.

Conversely, strong CYP2D6 inducers may decrease the blood levels of vortioxetine, resulting in poor treatment outcomes. Dose of vortioxetine should be increased when administered with strong CYP2D6 inducers such as rifampin (Rimactane), carbamazepine (Tegretol), and phenytoin (Dilantin).

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Is vortioxetine safe to take if I'm pregnant or breastfeeding?

  • Vortioxetine has not been adequately evaluated in pregnant women. Due to the lack of conclusive safety data, vortioxetine should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus. Vortioxetine is classified as FDA pregnancy risk category C.
  • It is not known if vortioxetine is excreted in breast milk. Due to the lack of safety data, vortioxetine should be used cautiously in females who are breastfeeding.

What preparations of vortioxetine are available?

Immediate release oral tablets: 5, 10, 15, and 20 mg.

How should I keep vortioxetine stored?

Tablets should be stored at room temperature between 15 C to 30 C (59 F to 86 F).

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References

FDA Pescribing Information.

Источник: https://www.medicinenet.com/vortioxetine/article.htm

Dosing & Administration | TRINTELLIX (vortioxetine)

What to Know About Trintellix (Vortioxetine)

  • Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies.
  • Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors.
  • TRINTELLIX is not approved for use in pediatric patients.

  • Hypersensitivity: Hypersensitivity to vortioxetine or any component of the TRINTELLIX formulation. Hypersensitivity reactions including anaphylaxis, angioedema, and urticaria have been reported in patients treated with TRINTELLIX.

  • Monoamine Oxidase Inhibitors (MAOIs): Do not use MAOIs intended to treat psychiatric disorders with TRINTELLIX or within 21 days of stopping treatment with TRINTELLIX, due to an increased risk of serotonin syndrome. Do not use TRINTELLIX within 14 days of stopping an MAOI intended to treat psychiatric disorders.
  • Linezolid and Methylene Blue: Do not start TRINTELLIX in a patient being treated with MAOIs such as linezolid or intravenous methylene blue, due to an increased risk of serotonin syndrome.
  • Suicidal Thoughts and Behaviors in Adolescents and Young Adults: Monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy, and at times of dosage changes.

    Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider. Consider changing the therapeutic regimen, including possibly discontinuing TRINTELLIX, in patients whose depression is persistently worse, or who are experiencing emergence of suicidal thoughts and behaviors.

    In pooled analyses of placebo-controlled trials of antidepressants, the incidence of suicidal thoughts and behaviors in antidepressant-treated patients ages 24 and younger was greater than in placebo-treated patients.

  • Serotonin Syndrome: The development of a potentially life-threatening serotonin syndrome has been reported with serotonergic antidepressants, including TRINTELLIX, when used alone but more often when used concomitantly with other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St.

     John's Wort), and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g.

    , tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).
    Monitor patients for emergence of serotonin syndrome.

    If concomitant use of serotonergic antidepressants, including TRINTELLIX, is clinically warranted, make patients aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases. If symptoms occur, immediately discontinue TRINTELLIX and any concomitant serotonergic agents, and initiate supportive symptomatic treatment.

  • Increased Risk of Bleeding: The use of drugs that interfere with serotonin reuptake inhibition, including TRINTELLIX, may increase the risk of bleeding events. Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), warfarin, and other anticoagulants may add to this risk.

    Inform patients about the increased risk of bleeding when TRINTELLIX is coadministered with NSAIDs, aspirin, or other drugs that affect coagulation or bleeding.

  • Activation of Mania/Hypomania: In patients with bipolar disorder, treating a depressive episode with TRINTELLIX or another antidepressant may precipitate a mixed/manic episode.

    Prior to initiating treatment with TRINTELLIX, screen patients for any personal or family history of bipolar disorder, mania, or hypomania.

  • Discontinuation Syndrome: Adverse reactions have been reported upon abrupt discontinuation of treatment with TRINTELLIX at doses of 15 mg/day and 20 mg/day.

    A gradual reduction in dosage rather than abrupt cessation is recommended whenever possible.

  • Angle-Closure Glaucoma: The pupillary dilation that occurs following use of many antidepressant drugs, including TRINTELLIX, may trigger an angle-closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy.

  • Hyponatremia: Hyponatremia has occurred as a result of treatment with serotonergic drugs, including TRINTELLIX, and in many cases appears to be the result of the syndrome of inappropriate antidiuretic hormone secretion (SIADH). Elderly patients and patients taking diuretics or who are otherwise volume-depleted can be at greater risk. Symptoms of hyponatremia include headache, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness, which can lead to falls. More severe and/or acute cases have included hallucination, syncope, seizure, coma, respiratory arrest, and death. Discontinue TRINTELLIX in patients with symptomatic hyponatremia and institute appropriate medical intervention.

The most commonly observed adverse reactions for TRINTELLIX in 6‑ to 8‑week placebo‑controlled studies (incidence ≥5% and at least twice the rate of placebo) were: nausea, constipation, and vomiting.

DRUG INTERACTIONS

Concomitant administration of TRINTELLIX and strong CYP2D6 inhibitors or strong CYP inducers may require a dose adjustment of TRINTELLIX.

PREGNANCY

Exposure to serotonergic antidepressants, including TRINTELLIX, in late pregnancy may increase the risk for neonatal complications requiring prolonged hospitalization, respiratory support, and tube feeding, and/or persistent pulmonary hypertension of the newborn (PPHN). Monitor neonates who were exposed to TRINTELLIX in the third trimester for PPHN and drug discontinuation syndrome.

INDICATION

TRINTELLIX is indicated for the treatment of Major Depressive Disorder (MDD) in adults.

Please click for Full Prescribing Information.


There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy.

Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.

org/clinical-and-research-programs/pregnancyregistry/antidepressants/

Источник: https://www.trintellixhcp.com/dosing

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