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    / Lundbeck


    Active Ingredient
    Vortioxetine (as Hydrobromide) 5, 10, 15, 20 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Film Coated Tablets

    28 X 5 mg

    not in the basket chart 85109 2586

    Film Coated Tablets

    28 X 10 mg

    not in the basket chart 85110 2587

    Film Coated Tablets

    28 X 15 mg

    not in the basket chart 85111 2588

    Film Coated Tablets

    28 X 20 mg

    not in the basket chart 85112 2589

    Dosage

    The starting and recommended dose of Vortioxetine is 10 mg vortioxetine once daily in adults less than 65 years of age. Depending on individual patient response, the dose may be increased to a maximum of 20 mg vortioxetine once daily or decreased to a minimum of 5 mg vortioxetine once daily. After the depressive symptoms resolve, treatment for at least 6 months is recommended for consolidation of the antidepressive response.
    Special populations: Elderly patients: The lowest effective dose of 5 mg vortioxetine once daily should always be used as the starting dose in patients ≥ 65 years of age.
    Cytochrome P450 inhibitors: Depending on individual patient response, a lower dose of vortioxetine may be considered if a strong CYP2D6 inhibitor (e.g. bupropion, quinidine, fluoxetine, paroxetine) is added to Vortioxetine treatment.
    Cytochrome P450 inducers: Depending on individual patient response, a dose adjustment of vortioxetine may be considered if a broad cytochrome P450 inducer (e.g., rifampicin, carbamazepine, phenytoin) is added to Vortioxetine treatment.
    Paediatric population: The safety and efficacy of Vortioxetine in children and adolescents aged less than 18 years have not been established. No data are available.
    See prescribing information for full details.


    Indications

    Treatment of major depressive episodes in adults.


    Contra-Indications

    Hypersensitivity to the active substance or to any of the excipients. Concomitant use with nonselective monoamine oxidase inhibitors (MAOIs) or selective MAO-A inhibitors.


    Special Precautions

    Suicide/suicidal thoughts or clinical worsening: Depression is associated with an increased risk of suicidal thoughts, self-harm and suicide. This risk persists until significant remission occurs. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs. It is general clinical experience that the risk of suicide may increase in the early stages of recovery. Patients with a history of suicide-related events or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment are known to be at greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment. There is an increased risk of suicidal behaviour with antidepressants compared to placebo, in patients less than 25 years old. Close supervision of patients and in particular those at high risk should accompany treatment especially in early treatment and following dose changes.
    Seizures: Seizures are a potential risk with antidepressants.
    Serotonin Syndrome (SS) or Neuroleptic Malignant Syndrome (NMS): Potentially life-threatening conditions may occur with Vortioxetine. The risk of SS or NMS is increased with concomitant use of serotonergic-active substances (including triptans), medicinal products that impair the metabolism of serotonin (including MAOIs), antipsychotics, and other dopamine antagonists. Patients should be monitored for the emergence of signs and symptoms of SS or NMS.
    Mania/hypomania: Vortioxetine should be used with caution in patients with a history of mania/hypomania and should be discontinued in any patient entering a manic phase.
    Hemorrhage: Bleeding abnormalities have been reported rarely with the use of antidepressants with serotonergic effect (SSRIs, SNRIs). Caution is advised in patients taking anticoagulants and/or medicinal products known to affect platelet function and in patients with known bleeding tendencies/disorders.
    Hyponatraemia: Hyponatraemia has been reported rarely with the use of antidepressants with serotonergic effect (SSRIs, SNRIs). Caution should be exercised in patients at risk, such as the elderly, patients with cirrhosis of the liver or patients concomitantly treated with medications known to cause hyponatraemia.
    Elderly: Data on the use of Vortioxetine in elderly patients are limited.
    Renal impairment: Limited data are available.
    Hepatic impairment: Vortioxetine has not been studied in patients with severe hepatic impairment.
    See prescribing information for full details.


    Side Effects

    Most common: Decreased appetite, dizziness, abnormal dreams, nausea, and diarrhea.
    See prescribing information for full details.


    Drug interactions

    Vortioxetine is extensively metabolised in the liver, primarily through oxidation catalysed by CYP2D6and to a minor extent CYP3A4/5and CYP2C9. Potential for other medicinal products to affect vortioxetine.
    Irreversible non-selective MAOIs: Due to the risk of Serotonin Syndrome, vortioxetine is contraindicated in any combination with irreversible non-selective MAOIs. Vortioxetine must not be initiated for at least 14 days after discontinuation of treatment with an irreversible non-selective MAOI. Vortioxetine must be discontinued for at least 14 days before starting treatment with an irreversible non-selective MAOI.
    Reversible, selective MAO-A inhibitor (moclobemide): The combination of vortioxetine with a reversible and selective MAO-A inhibitor, such as moclobemide, is contraindicated .If the combination proves necessary, the added medicinal product should be given with minimum dosage and under close clinical monitoring for Serotonin Syndrome.
    Reversible, non-selective MAOI (linezolid): The combination of vortioxetine with a weak reversible and non-selective MAOI, such as the antibiotic linezolid, is contraindicated. If the combination proves necessary, the added medicinal product should be given with minimum dosage and under close clinical monitoring for Serotonin Syndrome.
    See prescribing information for full details.


    Pregnancy and Lactation

    Pregnancy: There is limited data from the use of vortioxetine in pregnant women.
    Lactation: It is expected that vortioxetine will be excreted into human milk.
    See prescribing information for full details.                


    Overdose

    There is limited experience with vortioxetine overdose. Ingestion of vortioxetine in the dose range of 40 to 75 mg has caused an aggravation of the following adverse reactions: nausea, postural dizziness, diarrhoea, abdominal discomfort, generalised pruritus, somnolence and flushing. Management of overdose should consist of treating clinical symptoms and relevant monitoring. Medical follow-up in a specialised environment is recommended.


    Important notes

    Storage: Store below 30ºC.


    Manufacturer
    H. Lundbeck A/S, Denmark
    Licence holder
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