Vortioxetine Hydrobromide

Uses

Adults: Vortioxetine hydrobromide is indicated for the treatment of Major Depressive Disorder (MDD) in adults. Physicians who elect to use Vortioxetine for extended periods should periodically re-evaluate the usefulness of the drug for individual patients.Pediatrics (<18 years of age) ... Read more

Dosage

Vortioxetine Hydrobromide dosage

Vortioxetine should be administered as a single daily dose, with or without food.General Instruction for Use: The recommended starting dose is 10 mg administered orally once daily without regard to meals. Dosage should then be increased to 20 mg/day, as tolerated, because higher doses demonstrated better treatment effects in trials conducted. A dose decrease down to 5 mg/day may be considered for patients who do not tolerate higher doses.Maintenance/Continuation/Extended Treatment: It is generally agreed that acute episodes of major depression should be followed by several months or longer of sustained pharmacologic therapy. A maintenance study of Vortioxetine demonstrated that Vortioxetine decreased the risk of recurrence of depressive episodes compared to placebo.Discontinuing Treatment: Although Vortioxetine can be abruptly discontinued, in placebo-controlled trials patients experienced transient adverse reactions such as headache and muscle tension following abrupt discontinuation of Vortioxetine 15 mg/day or 20 mg/day. To avoid these adverse reactions, it is recommended that the dose be decreased to 10 mg/day for one week before full discontinuation of Vortioxetine 15 mg/day or 20 mg/day.Switching a Patient to or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders: At least 14 days should elapse between discontinuation of a MAOI intended to treat psychiatric disorders and initiation of therapy with Vortioxetine to avoid the risk of Serotonin Syndrome. Conversely, at least 21 days should be allowed after stopping Vortioxetine before starting an MAOI intended to treat psychiatric disorders.

Side Effects

HypersensitivityClinical Worsening and Suicide RiskSerotonin SyndromeAbnormal BleedingActivation of Mania/HypomaniaAngle Closure GlaucomaHyponatremia

Precaution

Clinical Worsening and Suicide Risk All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases. Families and caregivers of patients being treated with antidepressants for MDD or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior, and the other symptoms, as well as the emergence of suicidality, and to report such symptoms immediately to healthcare providers. Such monitoring should include daily observation by families and caregivers.Serotonin Syndrome: The development of a potentially life-threatening serotonin syndrome has been reported with serotonergic antidepressants including Vortioxetine, 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).Abnormal Bleeding: The use of drugs that interfere with serotonin reuptake inhibition, including Vortioxetine, 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.Activation of Mania/Hypomania: As with all antidepressants, use Vortioxetine cautiously in patients with a history or family history of bipolar disorder, mania, or hypomania.Angle Closure Glaucoma: The pupillary dilation that occurs following use of many antidepressant drugs, including Vortioxetine, may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy.Hyponatremia: Hyponatremia has occurred because of treatment with serotonergic drugs.

Interaction

Monoamine Oxidase Inhibitors: Adverse reactions, some of which are serious or fatal, can develop in patients who use MAOIs or who have recently been discontinued from an MAOI and start on a serotonergic antidepressant(s) or who have recently had SSRI or SNRI therapy discontinued prior to initiation of an MAOI.Serotonergic Drugs: Based on the mechanism of action of Vortioxetine and the potential for serotonin toxicity, serotonin syndrome may occur when Vortioxetine is co-administered with other drugs that may affect the serotonergic neurotransmitter systems (e.g., SSRIs, SNRIs, triptans, buspirone, tramadol, and tryptophan products etc.). Closely monitor symptoms of serotonin syndrome if Vortioxetine is co-administered with other serotonergic drugs. Treatment with Vortioxetine and any concomitant serotonergic agents should be discontinued immediately if serotonin syndrome occurs.Other CNS Active Agents: No clinically relevant effect was observed on steady-state lithium exposure following coadministration with multiple daily doses of Vortioxetine. Multiple doses of Vortioxetine did not affect the pharmacokinetics or pharmacodynamics. Potential for Other Drugs to Affect Vortioxetine Reduce Vortioxetine dose by half when a strong CYP2D6 inhibitor (e.g., bupropion, fluoxetine, paroxetine, quinidine) is co-administered. Consider increasing the Vortioxetine dose when a strong CYP inducer (e.g., rifampin, carbamazepine, phenytoin) is co-administered. The maximum dose is not recommended to exceed three times the original dose.

Pregnancy & Breastfeeding use

Pregnancy: The safety of Vortioxetine in human pregnancy has not been established. Therefore, Vortioxetine should not be used during pregnancy or in women intending to become pregnant, unless the benefit outweighs the possible risk to the fetus. Patients should be advised to notify their physician if they become pregnant or intend to become pregnant. If Vortioxetine is used until or shortly before birth, discontinuation symptoms in the newborn should be considered.Nursing Women: Available data in animals have shown the excretion of Vortioxetine/Vortioxetine metabolites in milk. It is expected that Vortioxetine will be excreted into human milk. Because a risk to the nursing child cannot be excluded, breastfeeding is not recommended during treatment with Vortioxetine.

Contraindication

Vortioxetine Hydrobromide is contraindicated in: Patients with known hypersensitivity to Vortioxetine or any of the excipients of the drug product. Angioedema has been reported in patients treated with Vortioxetine. Patients with concomitant use of Monoamine Oxidase Inhibitors (MAOIs).

Special Warning

Pediatric Use (<18 years of age): Clinical studies on the use of Vortioxetine in pediatric patients have not been conducted; therefore, the safety and effectiveness of Vortioxetine in the pediatric population have not been established.Geriatrics Use (≥65 years of age): No dose adjustment is recommended on the basis of age. Results from a single-dose pharmacokinetic study in elderly (>65 years old) vs young (24 to 45 years old) subjects demonstrated that the pharmacokinetics were generally similar between the two age groups.Renal Impairment: No dose adjustment is needed.Hepatic Impairment: No dose adjustment is recommended for patients with mild or moderate hepatic impairment. Vortioxetine is not recommended in patients with severe hepatic impairment.CYP2D6 Poor Metabolizers: The plasma concentration of Vortioxetine was approximately two times higher in CYP2D6 poor metabolizers than in extensive metabolizers. In the presence of strong CYP3A4/2C9-inhibitors, the exposure could potentially be higher, and a dosage adjustment may be required.Use in Other Patient Populations: No dose adjustment of Vortioxetine is needed on the basis of race, gender, ethnicity.

Acute Overdose

There is limited experience with Vortioxetine overdose. Medical follow-up in a specialized environment is recommended.

Storage Condition

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

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