BRINTELLIX Vortioxetine Hydrobromide 10mg Film-Coated Tablet 1's
RXDRUG-DR-XY44629-1pc
Discreet Packaging
FDA-registered Products
FDA-licensed Pharmacies
Indications/Uses
Brintellix (Vortioxetine hydrobromide) is indicated for the treatment of major depressive disorder in adults.
Dosage/Direction for Use
Posology (tablet): The starting and recommended dose of Brintellix (Vortioxetine hydrobromide) is 10 mg Vortioxetine once daily.
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.
Treatment discontinuation: Patients treated with Brintellix can abruptly stop taking the medicinal product without the need for a gradual reduction in dose (see Pharmacology: Pharmacodynamics under Actions).
Special population: 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. Caution is advised when treating patients ≥65 years of age with doses higher than 10 mg vortioxetine once daily for which data are limited (see Precautions).
Special population: Cytochrome P450 inhibitors: Depending on individual patient response, a lower dose of vortioxetine may be considered if strong CYP2D6 inhibitors (e.g. bupropion, quinidine, fluoxetine, paroxetine) are added to Brintellix treatment (see Interactions).
Special population: 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 Brintellix (Vortioxetine hydrobromide) treatment (see Interactions).
Special population: Paediatric population: The safety and efficacy of Brintellix in children and adolescents aged less than 18 years have not been established. No data are available (see Precautions).
Method of administration: Brintellix (Vortioxetine hydrobromide) is for oral use. The film-coated tablets can be taken with or without food.
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.
Treatment discontinuation: Patients treated with Brintellix can abruptly stop taking the medicinal product without the need for a gradual reduction in dose (see Pharmacology: Pharmacodynamics under Actions).
Special population: 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. Caution is advised when treating patients ≥65 years of age with doses higher than 10 mg vortioxetine once daily for which data are limited (see Precautions).
Special population: Cytochrome P450 inhibitors: Depending on individual patient response, a lower dose of vortioxetine may be considered if strong CYP2D6 inhibitors (e.g. bupropion, quinidine, fluoxetine, paroxetine) are added to Brintellix treatment (see Interactions).
Special population: 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 Brintellix (Vortioxetine hydrobromide) treatment (see Interactions).
Special population: Paediatric population: The safety and efficacy of Brintellix in children and adolescents aged less than 18 years have not been established. No data are available (see Precautions).
Method of administration: Brintellix (Vortioxetine hydrobromide) is for oral use. The film-coated tablets can be taken with or without food.
Overdosage
Ingestion of vortioxetine in the dose range of 40 to 75 mg have caused an aggravation of the following adverse reactions: nausea, postural dizziness, diarrhoea, abdominal discomfort, generalised pruritus, somnolence and flushing.
Post-marketing experience mainly concerns vortioxetine overdoses of up to 80 mg. In the majority of cases, no symptoms or mild symptoms were reported. The most frequently reported symptoms were nausea and vomiting.
There is limited experience with vortioxetine overdoses above 80 mg. Following dosages several fold higher than the therapeutic dose range, events of seizure and serotonin syndrome have been reported.
Management of overdose should consist of treating clinical symptoms and relevant monitoring.
Medical follow-up in a specialised environment is recommended.
Post-marketing experience mainly concerns vortioxetine overdoses of up to 80 mg. In the majority of cases, no symptoms or mild symptoms were reported. The most frequently reported symptoms were nausea and vomiting.
There is limited experience with vortioxetine overdoses above 80 mg. Following dosages several fold higher than the therapeutic dose range, events of seizure and serotonin syndrome have been reported.
Management of overdose should consist of treating clinical symptoms and relevant monitoring.
Medical follow-up in a specialised environment is recommended.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in Description.
Concomitant use with nonselective monoamine oxidase inhibitors (MAOIs) or selective MAO-A inhibitors.
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 (suicide related events). 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. A meta-analysis of placebo controlled clinical trials of antidepressants in adult patients with psychiatric disorders showed 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. Patients (and caregivers of patients) should be alerted to the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.
Seizures: Seizures are a potential risk with antidepressants. Therefore, Brintellix (Vortioxetine hydrobromide) should be introduced cautiously in patients who have a history of seizures or in patients with unstable epilepsy (see Interactions). Treatment should be discontinued in any patient who develops seizures or for whom there is an increase in seizure frequency.
Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS): Serotonin Syndrome (SS) or Neuroleptic Malignant Syndrome (NMS), potentially life-threatening conditions, may occur with Brintellix (Vortioxetine hydrobromide). 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 (see Contraindications and Interactions).
Serotonin Syndrome symptoms include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g. tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, uncoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea). If this occurs, treatment with Brintellix (Vortioxetine hydrobromide) should be discontinued immediately and symptomatic treatment should be initiated.
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. A meta-analysis of placebo controlled clinical trials of antidepressants in adult patients with psychiatric disorders showed 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. Patients (and caregivers of patients) should be alerted to the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.
Seizures: Seizures are a potential risk with antidepressants. Therefore, Brintellix (Vortioxetine hydrobromide) should be introduced cautiously in patients who have a history of seizures or in patients with unstable epilepsy (see Interactions). Treatment should be discontinued in any patient who develops seizures or for whom there is an increase in seizure frequency.
Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS): Serotonin Syndrome (SS) or Neuroleptic Malignant Syndrome (NMS), potentially life-threatening conditions, may occur with Brintellix (Vortioxetine hydrobromide). 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 (see Contraindications and Interactions).
Serotonin Syndrome symptoms include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g. tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, uncoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea). If this occurs, treatment with Brintellix (Vortioxetine hydrobromide) should be discontinued immediately and symptomatic treatment should be initiated.
Use In Pregnancy & Lactation
Pregnancy: There are limited data from the use of vortioxetine in pregnant women. Animal studies did not demonstrate a teratogenic effect of vortioxetine, but effects on foetal weight and delayed ossification were seen (see Pharmacology: Toxicology: Preclinical safety data under Actions).
The following symptoms may occur in the newborn after maternal use of a serotonergic medicinal product in later stages of pregnancy: respiratory distress, cyanosis, apnoea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycaemia, hypertonia, hypotonia, hyperreflexia, tremor, jitteriness, irritability, lethargy, constant crying, somnolence and difficulty sleeping. These symptoms could be due to either discontinuation effects or excess serotonergic activity. In the majority of instances, such complications began immediately or soon (<24 hours) after delivery.
Epidemiological data suggest that the use of SSRIs in pregnancy, particularly in late pregnancy, may increase the risk of persistent pulmonary hypertension in the newborn (PPHN). Although no studies have investigated the association of PPHN with vortioxetine treatment, this potential risk cannot be ruled out taking into account the related mechanism of action (increase in serotonin concentrations).
Brintellix (Vortioxetine hydrobromide) should only be administered to pregnant women if the expected benefits outweigh the potential risk to the foetus.
Breast-feeding: Available data in animals have shown excretion of vortioxetine/vortioxetine metabolites in milk. It is expected that vortioxetine will be excreted into human milk (see Pharmacology: Toxicology: Preclinical safety data under Actions).
A risk to the breastfeeding child cannot be excluded.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Brintellix (Vortioxetine hydrobromide) treatment taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility: Fertility studies in male and female rats showed no effect of vortioxetine on fertility, sperm quality or mating performance (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Human case reports with medicinal products from the related pharmacological class of antidepressants (SSRIs) have shown an effect on sperm quality that is reversible. Impact on human fertility has not been observed so far.
The following symptoms may occur in the newborn after maternal use of a serotonergic medicinal product in later stages of pregnancy: respiratory distress, cyanosis, apnoea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycaemia, hypertonia, hypotonia, hyperreflexia, tremor, jitteriness, irritability, lethargy, constant crying, somnolence and difficulty sleeping. These symptoms could be due to either discontinuation effects or excess serotonergic activity. In the majority of instances, such complications began immediately or soon (<24 hours) after delivery.
Epidemiological data suggest that the use of SSRIs in pregnancy, particularly in late pregnancy, may increase the risk of persistent pulmonary hypertension in the newborn (PPHN). Although no studies have investigated the association of PPHN with vortioxetine treatment, this potential risk cannot be ruled out taking into account the related mechanism of action (increase in serotonin concentrations).
Brintellix (Vortioxetine hydrobromide) should only be administered to pregnant women if the expected benefits outweigh the potential risk to the foetus.
Breast-feeding: Available data in animals have shown excretion of vortioxetine/vortioxetine metabolites in milk. It is expected that vortioxetine will be excreted into human milk (see Pharmacology: Toxicology: Preclinical safety data under Actions).
A risk to the breastfeeding child cannot be excluded.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Brintellix (Vortioxetine hydrobromide) treatment taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility: Fertility studies in male and female rats showed no effect of vortioxetine on fertility, sperm quality or mating performance (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Human case reports with medicinal products from the related pharmacological class of antidepressants (SSRIs) have shown an effect on sperm quality that is reversible. Impact on human fertility has not been observed so far.
Adverse Reactions
Summary of the safety profile: The most common adverse reaction was nausea.
Tabulated list of adverse reactions: Adverse reactions are listed as follows using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data). The list is based on information from clinical trials and post-marketing experience.
Tabulated list of adverse reactions: Adverse reactions are listed as follows using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data). The list is based on information from clinical trials and post-marketing experience.
Description of selected adverse reactions: Nausea: Nausea was usually mild or moderate and occurred within the first two weeks of treatment. The reactions were usually transient and did not generally lead to cessation of therapy. Gastrointestinal adverse reactions, such as nausea, occurred more frequently in women than men.
Sexual dysfunction: In clinical studies, sexual dysfunction was assessed using the Arizona Sexual Experience Scale (ASEX). Doses of 5 to 15 mg showed no difference to placebo. However, the 20 mg dose of vortioxetine was associated with an increase in treatment-emergent sexual dysfunction (TESD) (see Pharmacology: Pharmacodynamics under Actions).
Class effect: Epidemiological studies, mainly conducted in patients 50 years of age and older, show an increased risk of bone fractures in patients receiving a drug from related pharmacological classes of antidepressants (SSRIs or TCAs). The mechanism behind this risk is unknown, and it is not known if this risk is also relevant for vortioxetine.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.
Sexual dysfunction: In clinical studies, sexual dysfunction was assessed using the Arizona Sexual Experience Scale (ASEX). Doses of 5 to 15 mg showed no difference to placebo. However, the 20 mg dose of vortioxetine was associated with an increase in treatment-emergent sexual dysfunction (TESD) (see Pharmacology: Pharmacodynamics under Actions).
Class effect: Epidemiological studies, mainly conducted in patients 50 years of age and older, show an increased risk of bone fractures in patients receiving a drug from related pharmacological classes of antidepressants (SSRIs or TCAs). The mechanism behind this risk is unknown, and it is not known if this risk is also relevant for vortioxetine.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.
Drug Interactions
Risk of serotonin syndrome w/ irreversible non-selective MAOIs; irreversible MAO-B inhibitors (eg, selegiline or rasagiline); serotonergic medicinal products (eg, tramadol, sumatriptan & other triptans); St. John's wort. May lower seizure threshold w/ antidepressants (TCAs, SSRIs, SNRIs) & neuroleptics (phenothiazines, thioxanthenes & butyrophenones), mefloquin, buproprion, tramadol. Increased exposure w/ strong inhibitors of CYP3A4 (eg, itraconazole, voriconazole, clarithromycin, telithromycin, nefazodone, conivaptan & HIV PIs) & CYP2C9 inhibitors (eg, fluconazole & amiodarone). Decreased AUC w/ rifampicin, carbamazepine, phenytoin. Increased risk of bleeding w/ oral anticoagulants or antiplatelet medicinal products. Enhanced effects w/ lithium or tryptophan. Moclobemide; linezolid; strong CYP2D6 inhibitors (eg, bupropion, quinidine, fluoxetine, paroxetine).
Caution For Usage
Incompatibilities: Not applicable.
Special precautions for disposal: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Special precautions for disposal: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Storage
Store at temperatures not exceeding 30°C.
Shelf-Life: 48 months.
Shelf-Life: 48 months.
Action
Pharmacotherapeutic Group: Other antidepressants. ATC Code: N06AX26.
Pharmacology: Pharmacodynamics: Mechanism of action: The mechanism of action of vortioxetine is thought to be related to its direct modulation of serotonergic receptor activity and inhibition of the serotonin (5-HT) transporter. Non-clinical data indicate that vortioxetine is a 5-HT3, 5-HT7, and 5-HT1D receptor antagonist, 5-HT1B receptor partial agonist, 5-HT1A receptor agonist and inhibitor of the 5-HT transporter, leading to modulation of neurotransmission in several systems, including the serotonin, norepinephrine, dopamine, histamine, acetylcholine, GABA and glutamate systems. This multimodal activity is considered responsible for the antidepressant and anxiolytic-like effects and the improvement of cognitive function, learning and memory observed with vortioxetine in animal studies. In addition, a nonclinical behavioural study in male animals indicates that vortioxetine does not induce sexual dysfunction. However, the precise contribution of the individual targets to the observed pharmacodynamic profile remains unclear and caution should be applied when extrapolating animal data directly to man.
In humans, two positron emission tomography (PET) studies have been conducted using 5-HT transporter ligands (11C-MADAM or 11C-DASB) to quantify the 5-HT transporter occupancy in the brain across different dose levels. The mean 5-HT transporter occupancy in the specific regions of interest was approximately 50% at 5 mg/day, 65% at 10 mg/day and increased to above 80% at 20 mg/day.
Vortioxetine has shown clinical antidepressant effects at 5-HT transporter occupancies as low as 50%.
Clinical efficacy and safety: The efficacy and safety of vortioxetine have been studied in a clinical programme that included more than 6,700 patients, of whom more than 3,700 were treated with vortioxetine in short-term (≤12 weeks) studies in major depressive disorder (MDD). Twelve double-blind, placebo controlled, 6/8-week, fixed-dose studies have been conducted to investigate the short-term efficacy of vortioxetine in MDD both in adults and in the elderly. The efficacy of vortioxetine was demonstrated across 9 of the 12 studies, as measured by improvement in the Montgomery and Åsberg Depression Rating Scale (MADRS) or Hamilton Depression Rating Scale 24-item (HAM-D24) total score, and supported by clinical relevance as demonstrated by the proportions of responders and remitters and the improvement in Clinical Global Impression - Global Improvement (CGI-I) score. The efficacy of vortioxetine increased with increasing dose.
Furthermore, vortioxetine, in the dose range of 5-20 mg/day, demonstrated efficacy on the broad range of depressive symptoms (assessed by improvement in all MADRS single-item scores) and on the anxiety symptoms in depression (assessed using the HAM-A total score).
Maintenance: The maintenance of antidepressant efficacy was demonstrated in a relapse-prevention study. Patients in remission after an initial 12-week open-label treatment period with vortioxetine were randomised to vortioxetine 5 or 10 mg/day or placebo and observed for relapse during a double-blind period of at least 24 weeks (24 to 64 weeks). Vortioxetine was superior (p=0.004) to placebo on the primary outcome measure, the time to relapse of MDD, with a hazard ratio of 2.0; that is, the risk of relapse was two times higher in the placebo group than in the vortioxetine group.
Elderly: In the double-blind, placebo-controlled, 8-week, fixed-dose study in elderly (aged ≥65 years) depressed patients, vortioxetine 5 mg/day was superior to placebo as measured by improvement in the MADRS and HAM-D24 total scores.
In the dose range of 5 to 20 mg/day vortioxetine, efficacy and tolerability in the elderly was in line with the results in the adult population.
Patients with severe depression or high levels of anxiety symptoms: Antidepressant efficacy was also demonstrated in severely depressed patients (baseline MADRS total score ≥30) and in depressed patients with a high level of anxiety symptoms (baseline HAM-A total score ≥20) in short-term studies including the study in the elderly and in the long-term relapse-prevention study.
Effects of vortioxetine on the Digit Symbol Substitution Test (DSST), the University of California San Diego Performance-Based Skills Assessment (UPSA) (objective measures) and Perceived Deficits Questionnaire (PDQ) and Cognitive and Physical Functioning Questionnaire CPFQ (subjective measures) scores: The efficacy of vortioxetine (5-20 mg/day) in patients with MDD has been investigated in 2 adult and 1 elderly short-term, placebo-controlled studies.
Pharmacology: Pharmacodynamics: Mechanism of action: The mechanism of action of vortioxetine is thought to be related to its direct modulation of serotonergic receptor activity and inhibition of the serotonin (5-HT) transporter. Non-clinical data indicate that vortioxetine is a 5-HT3, 5-HT7, and 5-HT1D receptor antagonist, 5-HT1B receptor partial agonist, 5-HT1A receptor agonist and inhibitor of the 5-HT transporter, leading to modulation of neurotransmission in several systems, including the serotonin, norepinephrine, dopamine, histamine, acetylcholine, GABA and glutamate systems. This multimodal activity is considered responsible for the antidepressant and anxiolytic-like effects and the improvement of cognitive function, learning and memory observed with vortioxetine in animal studies. In addition, a nonclinical behavioural study in male animals indicates that vortioxetine does not induce sexual dysfunction. However, the precise contribution of the individual targets to the observed pharmacodynamic profile remains unclear and caution should be applied when extrapolating animal data directly to man.
In humans, two positron emission tomography (PET) studies have been conducted using 5-HT transporter ligands (11C-MADAM or 11C-DASB) to quantify the 5-HT transporter occupancy in the brain across different dose levels. The mean 5-HT transporter occupancy in the specific regions of interest was approximately 50% at 5 mg/day, 65% at 10 mg/day and increased to above 80% at 20 mg/day.
Vortioxetine has shown clinical antidepressant effects at 5-HT transporter occupancies as low as 50%.
Clinical efficacy and safety: The efficacy and safety of vortioxetine have been studied in a clinical programme that included more than 6,700 patients, of whom more than 3,700 were treated with vortioxetine in short-term (≤12 weeks) studies in major depressive disorder (MDD). Twelve double-blind, placebo controlled, 6/8-week, fixed-dose studies have been conducted to investigate the short-term efficacy of vortioxetine in MDD both in adults and in the elderly. The efficacy of vortioxetine was demonstrated across 9 of the 12 studies, as measured by improvement in the Montgomery and Åsberg Depression Rating Scale (MADRS) or Hamilton Depression Rating Scale 24-item (HAM-D24) total score, and supported by clinical relevance as demonstrated by the proportions of responders and remitters and the improvement in Clinical Global Impression - Global Improvement (CGI-I) score. The efficacy of vortioxetine increased with increasing dose.
Furthermore, vortioxetine, in the dose range of 5-20 mg/day, demonstrated efficacy on the broad range of depressive symptoms (assessed by improvement in all MADRS single-item scores) and on the anxiety symptoms in depression (assessed using the HAM-A total score).
Maintenance: The maintenance of antidepressant efficacy was demonstrated in a relapse-prevention study. Patients in remission after an initial 12-week open-label treatment period with vortioxetine were randomised to vortioxetine 5 or 10 mg/day or placebo and observed for relapse during a double-blind period of at least 24 weeks (24 to 64 weeks). Vortioxetine was superior (p=0.004) to placebo on the primary outcome measure, the time to relapse of MDD, with a hazard ratio of 2.0; that is, the risk of relapse was two times higher in the placebo group than in the vortioxetine group.
Elderly: In the double-blind, placebo-controlled, 8-week, fixed-dose study in elderly (aged ≥65 years) depressed patients, vortioxetine 5 mg/day was superior to placebo as measured by improvement in the MADRS and HAM-D24 total scores.
In the dose range of 5 to 20 mg/day vortioxetine, efficacy and tolerability in the elderly was in line with the results in the adult population.
Patients with severe depression or high levels of anxiety symptoms: Antidepressant efficacy was also demonstrated in severely depressed patients (baseline MADRS total score ≥30) and in depressed patients with a high level of anxiety symptoms (baseline HAM-A total score ≥20) in short-term studies including the study in the elderly and in the long-term relapse-prevention study.
Effects of vortioxetine on the Digit Symbol Substitution Test (DSST), the University of California San Diego Performance-Based Skills Assessment (UPSA) (objective measures) and Perceived Deficits Questionnaire (PDQ) and Cognitive and Physical Functioning Questionnaire CPFQ (subjective measures) scores: The efficacy of vortioxetine (5-20 mg/day) in patients with MDD has been investigated in 2 adult and 1 elderly short-term, placebo-controlled studies.
MedsGo Class
Antidepressants
Features
Brand
Brintellix
Full Details
Dosage Strength
10 mg
Drug Ingredients
- Vortioxetine
Drug Packaging
Film-Coated Tablet 1's
Generic Name
Vortioxetine Hydrobromide
Dosage Form
Film-Coated Tablet
Registration Number
DR-XY44629
Drug Classification
Prescription Drug (RX)
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