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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Continue to take Brintellix for as long as your doctor recommends. Vortioxetine is a poor P-gp substrate and inhibitor. The mean terminal half-life is approximately 66 hours, and steady- state plasma concentrations are typically achieved within two weeks of dosing. For elderly people 65 years of briintellix or older, the starting dose is li mg taken once daily. Vortioxetine must not be initiated for at least 14 days after discontinuation of treatment with an irreversible non-selective MAOI.

Your doctor will check your progress at regular intervals. The incidence of self-reported adverse sexual reactions was low and similar to placebo in clinical short- brintelllx long-term studies with vortioxetine.

It is generally agreed that acute episodes of major depression should be followed by several months or longer of sustained pharmacologic therapy. Brintellix 20 mg film-coated tablets Red, almond-shaped 5 x 8.

The safety and efficacy of Brintellix in children and adolescents aged less than 18 years have not been established. Brintellix 5 mg film-coated tablets Brintellix 10 mg film-coated brintellix Brintellix 15 mg film-coated tablets Brintellix 20 mg film-coated tablets.

If you are not sure what to do, ask your doctor or pharmacist. Agomelatine Bupropion Tianeptine Vilazodone Vortioxetine. Psychoanaleptics; Other antidepressants, ATC code: Hepatic impairment Vortioxetine has not been studied in patients with severe hepatic impairment and caution should be exercised when treating these patients see section 5.

Other studies do not show a significant statistical association. Other side effects not listed above may also occur in some people.

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Cytochrome P inducers Brontellix on individual patient response, a dose adjustment of vortioxetine may be considered if a broad brintelliix P inducer e.

Close supervision of patients and in particular those at high risk should accompany treatment especially in early treatment and following dose changes. Brintellix 10 mg film-coated tablets Yellow, almond-shaped 5 x 8.

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. BDBM 1- 2- 2,4-dimethylphenylsulfanyl phenyl piperazine”.

Distribution The mean volume of distribution V ss is 2, L, indicating extensive extravascular distribution. It is recommended that you do not breast-feed while taking Brintellix, as it may be excreted in the milk. Keep all of your doctor’s appointments so that your progress can be checked. It is possible that these symptoms continue or get worse until the full antidepressant effect of the medicine becomes bbrintellix.

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The European Medicines Agency has deferred the obligation to submit the results of brintelix in major depressive disorder with vortioxetine brontellix children and adolescents aged 7 to 18 years see section 4. Caution is advised when concomitantly using other medicinal products capable of lowering the seizure threshold [e. Seizures are a potential risk with antidepressants.

Take the Brintellix container with you when you go to the hospital. Bleeding events related to drugs that inhibit serotonin reuptake have ranged from ecchymosis, hematoma, epistaxis, and petechiae to life-threatening hemorrhages. These findings were mainly attributed to rodent-specific vortioxetine-related crystalline material obstruction of the renal tubules and the bile ducts, respectively, and considered of low risk to humans. Food and Drug Administration Press Announcement.

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Brintellix (vortioxetine) Full Prescribing Information | HealthyPlace

Vortioxetine has been studied in several clinical settings as a potential treatment for generalized anxiety disorder. Pack sizes of 14, 28 and 98 film-coated tablets. Paediatric population The safety and efficacy of Brintellix in children and adolescents aged less than 18 years have not been established.

Elderly patients may be at greater risk of developing hyponatremia with a serotonergic antidepressant. Psychiatric Medications Pharmacology Homepage. The risk of SS or NMS is increased with concomitant use of serotonergic-active substances including triptansmedicinal products that impair the metabolism of serotonin including MAOIsantipsychotics, and other dopamine antagonists.

Find out more here. N06AX26 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. Orange, almond-shaped 5 x 8.

Vortioxetine separated from placebo statistically with results of 8. Take the amount your doctor tells you to. If you have used moclobemide, one day must elapse brnitellix you stop taking moclobemide before you start taking Brintellix. To view the changes to a medicine you must sign up and log in.

Vortioxetine

However, alcohol intake is not advisable during antidepressant treatment. Renal impairment Limited data are available for patients with severe renal impairment. However, as with all medicines in this class, if Vortioxetine is inappropriately prescribed alongside drugs with which it has interactions, then there is potential for the rare but potentially life-threatening drug reaction known as serotonin syndrome.

Page last modified Friday, 10 August 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.

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