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AURO-ESCITALOPRAM is a brand name for Escitalopram, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Auro-Escitalopram (escitalopram oxalate) is indicated in adults for: • the symptomatic relief of Major Depressive Disorder (MDD). The efficacy of escitalopram oxalate in maintaining an antidepressant response, in patients with major depressive disorder who responded during an 8-week, acute-treatment phase while taking…
Verbatim from this product's HC label. Tap a section to expand.
1 Pregnant Women 10 /2022 7 WARNINGS AND PRECAUTIONS, Psychiatric 10/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. 2 TABLE OF CONTENTS ............................................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION .................................................................................... 4 1 INDICATIONS .....................................................................................................................................
4 2 CONTRAINDICATIONS ........................................................................................................................ 5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ...................................................................................
5 4 DOSAGE AND ADMINISTRATION........................................................................................................ 8 5 OVERDOSAGE ....................................................................................................................................
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1 Adverse Reaction Overview Adverse events information for escitalopram oxalate was collected from 715 patients with major depressive disorder (MDD) who were exposed to escitalopram oxalate and from 592 patients who were exposed to placebo in double-blind, placebo-controlled trials.
During clinical trials, all treatment groups were comparable with respect to gender, age and race. The mean age of patients was 41 years (18 to 76 years). Of these patients, approximately 66% were females and 34% were males. The adverse event information for escitalopram oxalate in patients with generalized anxiety disorder (GAD) was collected from 832 patients exposed to escitalopram oxalate and from 566 patients exposed to placebo in 8-12 week double-blind, placebo-controlled trials.
A total of 187 patients exposed to escitalopram and 188 patients exposed to placebo in a 24 to 76 week double-blind phase of a placebo-controlled long-term trial were also included. The demographics of the clinical trial population in GAD were similar to the population of patients included in MDD clinical trials.
The adverse event information for escitalopram oxalate in patients with obsessive-compulsive disorder (OCD) was collected from two studies with double-blind, placebo-controlled treatment periods of up to 24 weeks. In the first study, a total of 227 patients were exposed to escitalopram oxalate and 114 patients were exposed to placebo in a 24-week double-blind, placebo- controlled, fixed-dose trial with assessments at weeks 12 and 24.
In the second study, 322 patients who initially responded to 16 weeks of open-label escitalopram oxalate treatment were subsequently randomized to double-blind treatment with escitalopram (n=164) or placebo (n=158) for up to 24 weeks.
In total, 391 patients were exposed to escitalopram oxalate and 272 patients were exposed to placebo in these two long-term studies. The mean age of patients with OCD included in the trials was approximately 36 to 38 years (ranging from 18 to 67 years).
1 Pregnant Women 10 /2022 7 WARNINGS AND PRECAUTIONS, Psychiatric 10/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. 2 TABLE OF CONTENTS ............................................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION .................................................................................... 4 1 INDICATIONS .....................................................................................................................................
4 2 CONTRAINDICATIONS ........................................................................................................................ 5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ...................................................................................
5 4 DOSAGE AND ADMINISTRATION........................................................................................................ 8 5 OVERDOSAGE ....................................................................................................................................
8 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ...................................................... 10 7 WARNINGS AND PRECAUTIONS .......................................................................................................
1 Pregnant Women .............................................................................................................. 2 Breast-feeding ...................................................................................................................
3 Pediatrics ........................................................................................................................... 4 Geriatrics ...........................................................................................................................
• Auro-Escitalopram is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
4 Drug-Drug Interactions, QT Interval Prolongation). 4 Drug-Drug Interactions, Monoamine Oxidase Inhibitors). With the co-administration of an SSRI with MAOI, there have been reports of serious, sometimes fatal reactions including hyperthermia, rigidity, myoclonus, autonomic instability with possible fluctuations of vital signs, and mental status changes, including extreme agitation progressing to delirium and coma.
Some cases presented with features resembling serotonin syndrome. Therefore, Auro-Escitalopram should not be used in combination with a MAOI or within 14 days of discontinuing treatment with a MAOI (including linezolid, an antibiotic which is a reversible non-selective MAOI, and methylene blue, which is a MAOI).
Similarly, at least 14 days should elapse after discontinuing Auro-Escitalopram treatment before starting a MAOI. • Pimozide Auro-Escitalopram should not be used in combination with the antipsychotic drug pimozide, as results from a controlled study with racemic citalopram indicate that concomitant use is associated with an increased risk of QTc prolongation compared to pimozide alone.
4 Drug-Drug Interactions).
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One trial included similar proportions of males and females and the other trial had a slightly higher proportion of females than males (57% females and 43% males). 4% (97/592) on placebo. 2%). 5% vs. 8% vs. 0% of male patients). 2% of 566 patients receiving placebo.
2% vs. 1% vs. 8% vs. 2%). During the first 12 weeks of treatment in the 24-week placebo controlled trial, discontinuation of treatment due to adverse events was reported for 9% and 11% of the 227 OCD patients who were treated with 10 mg/day or 20 mg/day escitalopram oxalate, respectively, compared to 5% of the 114 patients receiving placebo.
All patients who discontinued treatment due to adverse events in the escitalopram oxalate groups did so in the first 12 weeks. Eight percent of patients receiving placebo discontinued treatment due to an adverse event during the 24-week period.
8% vs. 8% vs. 1% vs. 0%). Most Frequent Adverse Events Adverse events that occurred in escitalopram-treated patients in the course of the short-term, placebo-controlled trials with an incidence greater than, or equal to, 10% were: headache and nausea.
The incidence of headache was higher in the placebo group, which suggests that this is a non-specific symptom related to the underlying condition or treatment administration. The point prevalence of nausea increased during the first week (as expected with an SSRI) and then decreased to approach placebo levels by the end of the studies.
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. Major Depressive Disorder Table 2 enumerates the incidence of treatment-emergent adverse events that occurred in 715 depressed patients who received escitalopram oxalate at doses ranging from 10 to 20 mg/day in placebo-controlled trials of up to 8 weeks in duration.
Events included are those occurring in 1% or more of patients treated with escitalopram oxalate, and for which the incidence in patients treated with escitalopram oxalate was greater than the incidence in placebo-treated patients. 1.
Auro-Escitalopram Product Monograph Page 21 of 67 Table 2 - Treatment-Emergent Adverse […]
18 Auro-Escitalopram Product Monograph Page 3 of 67 8 ADVERSE REACTIONS ....................................................................................................................... 1 Clinical Trial Adverse Reactions – Pediatrics ......................................................................
1 Less Common Clinical Trial Adverse Reactions – Pediatrics ............................................... 34 9 DRUG INTERACTIONS ......................................................................................................................
43 10 CLINICAL PHARMACOLOGY ............................................................................................................ 3 Pharmacokinetics […]