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TRINTELLIX is a brand name for Vortioxetine, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: , 1.1 Pediatrics 05/2024 3 SERIOUS WARNINGS AND PRECAUTIONS BOX 05/2024 7 WARNINGS AND PRECAUTIONS, Dependence/Tolerance 05/2024 7 WARNINGS AND PRECAUTIONS, Hematologic 05/2024 7 WARNINGS AND PRECAUTIONS, Neurologic 05/2024 7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and Male Potential 05/2024 7 WARNINGS…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • TRINTELLIX is not indicated for use in patients below the age of 18 (see 7 WARNINGS AND PRECAUTIONS, Potential Association With Behavioural And Emotional Changes, Including Self-Harm). 2 Recommended Dose and Dosage Adjustment Adults The starting and recommended dose of TRINTELLIX is 10 mg vortioxetine once daily for adults less than 65 years of age.
Depending on individual patient response, the dose may be increased to a maximum of 20 mg vortioxetine once daily, as tolerated. A dose decrease to a minimum of 5 mg vortioxetine once daily may be considered for patients who do not tolerate higher doses.
In clinical trials conducted outside the United States, efficacy was demonstrated with 5 mg/day, 10 mg/day, 15 mg/day and 20 mg/day. 1 Clinical Trials by Indication, Study Results). The efficacy and safety of doses greater than 20 mg/day were not evaluated in controlled clinical trials.
1 Clinical Trials by Indication, Study Results). During long-term therapy, the dosage should be maintained at the lowest effective level and patients should be periodically reassessed to determine the need to continue treatment. • Pediatrics (<18 years of age) Health Canada has not authorized an indication for pediatric use.
• Geriatrics (>65 years of age) The lowest effective dose of 5 mg/day vortioxetine should always be used as the starting dose for patients of 65 years of age or older. 1 Clinical Trials by Indication, Study Results). Dosage Adjustment Patients with Renal Impairment No dose adjustment is recommended for patients with renal impairment or for patients with end- stage renal disease.
3 Pharmacokinetics, Special Populations and Conditions, Renal Insufficiency). Patients with Hepatic Impairment No dose adjustment is recommended for patients with hepatic impairment. 3 Pharmacokinetics, Special Populations and Conditions, Hepatic Insufficiency).
g. 4 Drug-Drug Interactions). g. 4 Drug-Drug Interactions). 2 Clinical Trial Adverse Reactions, Discontinuation Symptoms). Patients should be monitored for discontinuation symptoms when discontinuing treatment with TRINTELLIX. A gradual reduction in the dose, rather than an abrupt cessation, is recommended whenever possible.
3 Pharmacokinetics, Elimination). 3 Reconstitution Not Applicable. 4 Administration TRINTELLIX should be administered as a single daily dose, with or without food. 5 Missed Dose If a dose is missed, the next dose should be taken at the usual time.
). Gastrointestinal and gynaecological bleeding have also been reported following treatment with TRINTELLIX. 1 Pregnant Women). g. thrombocytopenia or coagulation disorders). 2 Drug Interactions Overview). Hepatic/Biliary/Pancreatic Hepatic Impairment Based on studies conducted with TRINTELLIX in patients with mild, moderate or severe hepatic impairment, no dose adjustment is recommended on the basis of hepatic function (see 4.
3 Pharmacokinetics, Special Populations and Conditions, Hepatic Insufficiency). However, due to extensive hepatic metabolism of vortioxetine, caution is advised when TRINTELLIX is prescribed in patients with moderate or severe hepatic impairment.
Musculoskeletal Bone Fracture Risk Elderly patients, patients with osteoporosis and patients with important risk factors for bone fractures should be advised of possible adverse events which increase the risk of falls, such as dizziness and orthostatic hypotension, especially at the early stages of treatment but also soon after withdrawal.
Epidemiological studies show an increased risk of bone fractures following exposure to some antidepressants, including SSRIs and other newer antidepressants. The risks appear to be greater at the initial stages of treatment, but significant increased risks were also observed at later stages of treatment.
The possibility of fracture should be considered in the care of patients treated with TRINTELLIX. Preliminary data from observational studies show association of Selective Serotonin Reuptake Inhibitors (SSRIs)/Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs) and low bone mineral density in older men and women.
Until further information becomes available, a possible effect on bone mineral density with long-term treatment with SSRIs and other newer antidepressants including TRINTELLIX, cannot be excluded. Neurologic Seizures Seizures are a potential risk with antidepressant drugs.
3 Pediatrics 05/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ............................................................................
2 TABLE OF CONTENTS.................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION .................................................... 4 1 INDICATIONS ......................................................................................................
1 Pediatrics ..................................................................................................... 2 Geriatrics ..................................................................................................... 4 2 CONTRAINDICATIONS .......................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................ 5 4 DOSAGE AND ADMINISTRATION ..................................................................... 1 Dosing Considerations.................................................................................
2 Recommended Dose and Dosage Adjustment ............................................ 1 Discontinuing Treatment .......................................................................... 3 Reconstitution ..............................................................................................
4 Administration .............................................................................................. 5 Missed Dose ................................................................................................ 7 5 OVERDOSAGE ....................................................................................................
7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ............. 7 7 WARNINGS AND PRECAUTIONS ...................................................................... 1 Special Populations ...................................................................................
TRINTELLIX is contraindicated in: • patients who are hypersensitive to vortioxetine or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. Angioedema has been reported in patients treated with TRINTELLIX.
For a complete listing of excipients, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. 2 Drug Interactions Overview; 7 WARNINGS AND PRECAUTIONS, Neurologic, Serotonin Toxicity/Neuroleptic Malignant Syndrome). TRINTELLIX® (vortioxetine) Product Monograph Page 5 of 46 Monoamine Oxidase Inhibitors (MAOIs) Vortioxetine increases serotonergic neurotransmission and must not be used concomitantly in patients taking MAOIs, including linezolid, an antibiotic, methylene blue, a dye used in certain surgeries, or in patients who have taken MAOIs within the preceding 14 days due to the risk of serious, sometimes fatal, drug interactions.
These interactions have been associated with symptoms that include tremor, myoclonus, diaphoresis, nausea, vomiting, flushing, dizziness, hyperthermia with features resembling neuroleptic malignant syndrome or serotonin toxicity, seizures, rigidity, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to delirium and coma.
Therefore, at least 14 days should be allowed after discontinuing treatment with a MAOI before starting treatment with vortioxetine. 2 Drug Interactions Overview).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Vortioxetine in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Patients should not take a double dose to make up for a missed dose.
1% of patients that received TRINTELLIX compared to 0% that received placebo. As with other antidepressants, TRINTELLIX should be introduced cautiously in patients who have a history of seizures or in patients with unstable epilepsy.
Treatment should be discontinued in any patient who develops seizures or for whom there is an increase in seizure frequency. 2 Drug Interactions Overview, Serotonergic Medicinal Products). g. g. anxiety, agitation, hypomania). In accordance with the Hunter criteria, serotonin toxicity diagnosis is likely when, in the presence of at least one serotonergic agent, one of the following is observed: • Spontaneous clonus • Inducible clonus or ocular clonus with agitation or diaphoresis • Tremor and hyperreflexia • Hypertonia and body temperature > 38°C and ocular clonus or inducible clonus Neuroleptic malignant syndrome has also been rarely reported with TRINTELLIX, particularly during combined use with neuroleptic/antipsychotic drugs.
The clinical manifestations of neuroleptic malignant syndrome often overlap with those of serotonin toxicity, including hyperthermia, hypertonia, altered mental status, and autonomic instability. In contrast to serotonin toxicity, patients with neuroleptic malignant syndrome may present with “lead pipe” muscle rigidity as well as hyporeflexia.
The concomitant use of TRINTELLIX with monoamine oxidase inhibitors, including linezolid and methylthioninium chloride (methylene blue), is contraindicated (see 2 CONTRAINDICATIONS, Monoamine Oxidase Inhibitors (MAOIs)). TRINTELLIX should be used with caution in patients receiving other serotonergic drugs or antipsychotics/neuroleptics.
2 Drug Interactions Overview, Serotonergic Medicinal Products). Serotonin toxicity and neuroleptic malignant syndrome may result in potentially life-threatening conditions. If serotonin toxicity or neuroleptic malignant syndrome is suspected, discontinuation of TRINTELLIX should be considered.
Cognitive and Motor Disturbances In a study of 21 healthy subjects who were administered single and multiple doses of 10 mg/day TRINTELLIX in the evening, there was no significant impairment, relative to placebo, in mean parameters of driving performance, cognitive function or other psychomotor skills using a battery of neuropsychological tests on the following morning.
However, some individuals may show impairment after taking TRINTELLIX (see 7 WARNINGS AND PRECAUTIONS, Driving and Operating Machinery). Ophthalmologic Angle-Closure Glaucoma As with other antidepressants, TRINTELLIX can cause mydriasis, which may trigger an angle- closure attack in a patient with anatomically narrow ocular angles.
Healthcare providers should inform patients to seek immediate medical assistance if they experience eye pain, changes in vision or swelling or redness in or around the eye. Psychiatric Potential Association with […]
1 Pregnant Women ................................................................................... 2 Breast-feeding ........................................................................................ 3 Pediatrics ...............................................................................................
4 Geriatrics ................................................................................................ 14 8 ADVERSE REACTIONS .................................................................................... 1 Adverse Reaction Overview ......................................................................
2 Clinical Trial Adverse Reactions ................................................................ 1 Clinical Trial Adverse Reactions – Pediatrics ......................................... 3 Less Common Clinical Trial Adverse Reactions ........................................
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other TRINTELLIX® (vortioxetine) Product Monograph Page 3 of 46 Quantitative Data ................................................................................................
5 Post-Market Adverse Reactions ................................................................ 22 9 DRUG INTERACTIONS ..................................................................................... 1 Serious Drug Interactions ..........................................................................
2 Drug Interactions Overview ....................................................................... 3 Drug-Behavioural Interaction ..................................................................... 4 Drug-Drug Interactions ..............................................................................
5 Drug-Food Interactions .............................................................................. 6 Drug-Herb Interactions .............................................................................. 7 Drug-Laboratory Test Interactions .............................................................
28 10 ACTION AND CLINICAL PHARMACOLOGY ................................................... 1 Mechanism of Action .............................................................................. 2 Pharmacodynamics ................................................................................
3 Pharmacokinetics ................................................................................... 29 Special Populations and Conditions ................................................................... 30 11 STORAGE, STABILITY AND DISPOSAL .........................................................
32 12 SPECIAL HANDLING INSTRUCTIONS ............................................................ 32 PART II: SCIENTIFIC INFORMATION ......................................................................... 33 13 PHARMACEUTICAL INFORMATION ...............................................................
33 14 CLINICAL TRIALS ............................................................................................. 1 Clinical Trials by Indication ..................................................................... 33 Major Depressive Disorder .................................................................................
33 15 MICROBIOLOGY ............................................................................................... 36 16 NON-CLINICAL TOXICOLOGY […]