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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Doses of 5 to 15 mg showed no difference to placebo.

The oral dose of 40 mg is sufficient to assess the effect of metabolic inhibition. Vortioxetine was discovered brinhellix scientists at Lundbeck who reported the rationale and synthesis for the drug then called Lu AA in a paper.

However, prior to initiating treatment with an antidepressant, patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a brinetllix history of suicide, bipolar disorder, and depression.

A major depressive episode may be the initial presentation of bipolar disorder. Brintellix should not be given to children under 18 years of age. Vortioxetine is a poor P-gp substrate and inhibitor.

Brintellix tablets 5, 10 and 20mg – Summary of Product Characteristics (SmPC) – (eMC)

Other studies do not show a significant statistical association. You are now leaving lundbeck. What Brintellix is used for Brintellix contains vortioxetine, which is used to treat major depression in adults.

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No clinically significant changes were observed in hepatic or renal assessments in clinical studies. Marketing authorisation holder 8.

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Brintellix description What Brintellix tablets look like Brintellix 5 mg tablets are pink, almond-shaped, biconvex filmcoated tablet engraved with “TL” on one side and “5” on the other side.

In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered [see Contraindications ].

Bleeding events related to drugs that inhibit serotonin reuptake have ranged from ecchymosis, hematoma, epistaxis, and petechiae to life-threatening hemorrhages. The authors suggest that vortioxetine is currently a good second-line antidepressant option and shows promise, pending additional long-term data, to become a first-line antidepressant option.

Treatment discontinuation Patients treated with vortioxetine can abruptly stop taking the medicinal product without the need for a gradual reduction in dose see section 5. Tell your doctor if you brkntellix any of the following side effects and they worry you: You brintellis encouraged to report p side effects of prescription drugs to the FDA.

Review of Preclinical and Clinical Data”. It is possible that these symptoms continue or get worse until the full antidepressant effect of the medicine becomes apparent.

Vortioxetine – Wikipedia

The pharmacokinetics of vortioxetine 2. CYP2D6 inhibitors The exposure to vortioxetine increased 2. Before you start to take it Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes. Hypersensitivity to the active substance or to any of the excipients brrintellix in section 6. Occasionally, the symptoms of depression may include thoughts of suicide or self-harm.

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Brintellix tablets 5, 10 and 20mg

Data on the use of Brintellix in elderly patients with major depressive episodes are limited. Do not change the dose or stop taking brintwllix medicine without first checking with your doctor.

This medicinal product may pose a risk to the environment see section 5. Do not take Brintellix to treat any other complaints unless your doctor tells you to. This information is intended for use by health professionals.

Tell your doctor immediately, or go to Accident and Emergency at your nearest hospital, if you notice any of the following: Epidemiological studies, mainly conducted in patients 50 years of age and older, show an increased risk of bone fractures in patients receiving a medicinal product from related pharmacological classes of antidepressants SSRIs or TCAs.

;i 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 ]. It is recommended that you do not breast-feed while taking Brintellix, as it may be excreted in the milk.