BRINTELLIX PI PDF

BRINTELLIX safely and effectively. See full prescribing information for BRINTELLIX. BRINTELLIX (vortioxetine) tablets, for oral use. Initial U.S. Approval: Brintellix is not recommended for the treatment of depression in patients aged less than 18 years since the safety and efficacy of vortioxetine have not been. Product details on treatment with TRINTELLIX (vortioxetine), including available savings if eligible, and support sign-up. Watch videos of actual patients. See full.

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As such, no clinically relevant interactions with drugs metabolized by these CYP enzymes would be expected. In the meta-analysis, the overall mean difference to placebo across the studies was statistically significant: These event terms have been aggregated and the overall incidence was as follows. Difficulties in sexual desire, sexual performance and sexual satisfaction often occur as manifestations of psychiatric disorders, but they may also be consequences of pharmacologic treatment.

John’s wort Concomitant use of antidepressants with serotonergic effect and herbal remedies containing St. PPHN occurs in one to two per 1, live births in the general population and is associated with substantial neonatal morbidity and mortality.

CYP2D6 gene types The plasma concentration of vortioxetine was approximately two times higher in CYP2D6 poor metabolisers than in extensive metabolisers. Pooled analyses of short- term placebo-controlled studies of antidepressant drugs selective serotonin reuptake inhibitors [SSRIs] and others showed that these drugs increase the risk of suicidal thinking and behavior suicidality in children, adolescents, and young adults ages 18 to 24 with MDD and other psychiatric disorders.

In clinical studies in children and adolescents treated with other antidepressants, suicide-related behaviour suicide attempt and suicidal thoughts and hostility predominantly aggression, oppositional behaviour, anger were more frequently observed than in those treated with placebo.

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However, there is substantial evidence from placebo-controlled maintenance studies in adults with depression that the use of antidepressants can delay the recurrence of depression.

Serotonin syndrome symptoms may include mental status changes e. The mean volume of distribution V ss is 2, L, indicating extensive extravascular distribution. Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature brintellis, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability and constant crying. Depending on individual patient response, a dose adjustment may be considered if a broad cytochrome P inducer e.

Marketing authorisation number s 9.

The effect of vortioxetine 10 mg and 40 mg administered once daily on QTc interval was evaluated in a randomized, double-blind, placebo- and active-controlled moxifloxacin mgfour-treatment-arm parallel study in male subjects.

Vortioxetine HBr is known chemically as 1-[2- 2,4-Dimethyl-phenylsulfanyl -phenyl]-piperazine, hydrobromide. Tell your doctor if you notice any of the following side effects and they worry you: If you have used moclobemide, one day must elapse after you stop taking moclobemide before you start taking Brintellix.

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Limited data are available for patients with severe renal impairment. Medical follow-up in a specialised environment is recommended. A tendency to bleed or bruise easily Low sodium levels in the blood Seizures or fits A history of suicide-related events or suicidal ideas A history, or family history, of mania or bipolar disorder manic depression Other diseases affecting the brain, including psychiatric conditions Other significant medical illnesses, such as unstable heart disease, stroke or severe liver or kidney disease Tell your doctor if are 65 years of age or older.

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Serotonin Syndrome symptoms include mental status changes e. Sexual dysfunction was defined as a subject scoring any of the following on the ASEX scale at two consecutive visits during the study: You may find it helpful to tell a relative or close friend that you are depressed and ask them to read this leaflet.

Based on results from conventional 2-year carcinogenicity studies in mice or rats, vortioxetine is not considered to pose a risk of carcinogenicity in humans. For information on undesirable effects, see section 4. Discontinuation of vortioxetine should be considered in patients with symptomatic hyponatraemia and appropriate medical intervention should be instituted.

Renal impairment Limited data are available for patients with severe renal impairment. Manufacturer and distributor Brintellix is made by H.

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This page was last edited on 25 Decemberat Summary of the safety profile The most common adverse reaction was nausea. Antidepressants Anxiolytics Piperazines Serotonin reuptake inhibitors Sulfides.

This medicinal product does not require any special pj conditions. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are. The tAccess Support Program offers motivational emails packed with positive tips and support for people with depression.

The safety and efficacy of Brintellix in children and adolescents aged less than 18 years have not been established.