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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Vortioxetine had no effect on rat fertility, mating performance, reproductive organs, or sperm morphology and motility. 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. No effect on the pharmacokinetics of vortioxetine or ethanol and no significant impairment, relative to placebo, in cognitive function were observed when vortioxetine in a single dose of 20 mg or 40 mg was co-administered with a single dose of ethanol 0.
Serotonin syndrome symptoms may include mental status changes e.
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The reactions were usually transient and did not generally lead to cessation of therapy. In vitro, vortioxetine did not show any relevant potential for inhibition or induction of cytochrome P isozymes see section 5. 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.
A locked cupboard at least one-and a-half metres above ground is a good place to store medicines. It is thought to be caused by a chemical imbalance in parts of the brinte,lix.
These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a trend toward reduced risk with antidepressant use in patients aged 65 and older [see Warnings and Precautions ]. Pack sizes of 14, 28 and 98 film-coated tablets. If you have not told your doctor about any of the above, tell them before you use Brintellix.
They will tell you exactly how much to take. Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Elderly Data on the use of Brintellix in elderly patients with major depressive episodes are limited. Amoxapine Maprotiline Mianserin Mirtazapine Setiptiline. Pack sizes of 14, 28, 56 and 98 film-coated tablets. Because voluntarily reported adverse sexual reactions are known to be underreported, in part because patients and physicians may be reluctant to discuss them, the Arizona Sexual Experiences Scale ASEXa validated measure designed to identify sexual side effects, was used prospectively in seven placebo-controlled trials.
How to take it Swallow the tablets whole with a full glass of water. If you have used moclobemide, one day must elapse after you stop taking moclobemide before you start taking Brintellix. Women who discontinued antidepressant medication during pregnancy showed a significant increase in relapse of their major depression compared to those women who remained on antidepressant medication throughout pregnancy. Vortioxetine separated from placebo statistically with results of 8.
Retrieved 29 April Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system:. Vortioxetine is used as a treatment for major depressive disorder and due to its unique mechanism of action is often used when other treatments have failed. In many cases, hyponatremia appears to be the result of the syndrome of inappropriate antidiuretic hormone secretion SIADH.
Tell your doctor if you are receiving electroconvulsive therapy. 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.
Brintellix tablets 5, 10 and 20mg
In a thorough QTc study in healthy subjects at doses up to 40 mg daily, no potential for the prolongation of the QTc interval was observed. Brintellix 20 mg film-coated tablets Each film-coated tablet contains vortioxetine hydrobromide equivalent to 20 mg vortioxetine.
Serotonergic antidepressants have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse event [see Warnings and Precautions ]. Studies in animals have shown reproductive toxicity see section 5.
This risk persists until significant remission occurs. Abnormal bleeding or bruising: Cytochrome P substrates In vitro, vortioxetine did not show any relevant potential for inhibition or induction of cytochrome P isozymes see section 5.
Vortioxetine – Wikipedia
These symptoms could be due to either discontinuation effects or excess serotonergic activity. The maximum recommended dose pk not exceed three times the original dose. The combination of vortioxetine with a weak reversible and non-selective MAOI, such as the antibiotic linezolid, is contraindicated see section 4.
Gabapentin Gabapentin enacarbil Phenibut Pregabalin. Taking Bruntellix with MAOIs may cause a serious reaction including sudden changes in mental state, twitching, rapid heartbeat, high blood pressure, fever and diarrhoea.
Medicinal products lowering the seizure threshold Antidepressants with serotonergic effect can lower the seizure threshold. Medical follow-up in a specialised environment is recommended. Monoamine oxidase inhibitors MAOIsincluding selegiline, rasagiline, linezolid and moclobemide.
Bbrintellix is advised when concomitantly using other medicinal products capable of lowering the seizure brintellx [e. Vortioxetine was statistically significantly better than agomelatine as measured by improvement in the MADRS total score and supported by the clinical relevance as demonstrated by the proportions of responders and remitters and improvement in the CGI-I.
In managing over dosage, consider the possibility of multiple drug involvement.
In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. The expiry date refers to the last day of the month. It should be noted that in some cases, the clinical picture is consistent with serotonin syndrome [see Warnings and Precautions brinteolix.
Back to top Lundbeck Limited contact details. Please select “Continue” if you wish to be taken to this third-party website. Therefore, vortioxetine should be introduced cautiously in patients who have a history of seizures or in patients with unstable epilepsy see section 4.