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ACT ESCITALOPRAM ODT is a brand name for Escitalopram, supplied as a tablet (orally disintegrating). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: ACT ESCITALOPRAM ODT (escitalopram orodispersible tablets) is indicated in adults for: • the symptomatic relief of Major Depressive Disorder (MDD). The efficacy of escitalopram in maintaining an antidepressant response, in patients with major depressive disorder who responded during an 8-week, acute-treatment phase…
Verbatim from this product's HC label. Tap a section to expand.
Note:
ACT ESCITALOPRAM ODT is only available as 10 mg and 20 mg orodispersible tablets, they cannot be used when 5 mg or 15 mg doses are required. 1 Dosing Considerations Pediatrics: ACT ESCITALOPRAM ODT is not indicated for use in children under 18 years of age.
See 7 WARNINGS AND PRECAUTIONS, Psychiatric, Potential Association with Behavioural and Emotional Changes, Including Self-Harm. • Pregnant Women: ACT ESCITALOPRAM ODT should not be used during pregnancy unless the benefits markedly outweigh the risks, particularly during the third trimester as there are implications for neonatal health.
1 Pregnant Women. • Elderly - Use lower doses. Advise elderly patients of increased risk of falls. Elderly women are at increased risk of hyponatraemia, SIADH. 4 Geriatrics. • Reduced dosing: Use lower initial (5 mg) and maximum (10 mg) daily doses for: ACT ESCITALOPRAM ODT (Escitalopram Orodispersible Tablets) Page 7 of 58 o elderly patients, o patients with mild to moderate hepatic impairment, o CYP2C19 poor metabolizers, or those taking cimetidine, omeprazole or other CYP2C19 inhibitors.
g. elderly females; dehydrated or cirrhotic patients) o severe hepatic impairment, o severe renal impairment. o a pre-existing slow heart rate. • Interactions (See 9. DRUG INTERACTIONS) o Do not co-administer with Monoamine Oxidase Inhibitors (contraindicated).
Allow at least 14 days to elapse when switching to or from a MAOI. o Do not co-administer with pimozide (contraindicated), or citalopram. o Avoid or use caution if patient is concomitantly using: ▪ potent CYP3A4 inhibitors, ▪ other CNS medications, ▪ other serotonergic agents, ▪ drugs that prolong QT interval, ▪ drugs that affect platelet function, or ▪ drugs that cause hyponatraemia, or ▪ alcohol.
▪ A drug metabolized primarily by CYP2D6, if it has a narrow therapeutic index. • Reduce dosage gradually. Do not abruptly discontinue medication. Taper gradually when reducing dose or ending SSRI treatment and monitor for discontinuation symptoms.
2 Recommended Dose and Dosage Adjustment Adults (<65 years of age) Major Depressive Disorder ACT ESCITALOPRAM ODT should be administered once daily, in the morning or evening, with or without food: • Usual adult dose: 10 mg/day, orally.
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. 4% (97/592) on placebo.
2%). 5% vs. 8% vs. 0% of male patients). 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.
1 Pregnant Women 10/2025 TABLE OF CONTENTS Certain sections or subsections that are not applicable at the time of the preparation of the most recent authorized product monograph are not listed. RECENT MAJOR LABEL CHANGES ........................................................................................................
2 TABLE OF CONTENTS........................................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION ....................................................................................
5 1 INDICATIONS ................................................................................................................................... 5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ..................................................................................
6 4 DOSAGE AND ADMINISTRATION....................................................................................................... 9 5 OVERDOSAGE ..................................................................................................................................
9 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ...................................................... 10 7 WARNINGS AND PRECAUTIONS ..............................................................................................................
1 Special Populations .......................................................................................................................... 1 Pregnant Women ..........................................................................................................................
2 Breast-feeding ............................................................................................................................... 3 Pediatrics .......................................................................................................................................
• ACT ESCITALOPRAM ODT 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 ACT ESCITALOPRAM ODT (Escitalopram Orodispersible Tablets) Page 6 of 58 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, ACT ESCITALOPRAM ODT 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 ACT ESCITALOPRAM ODT treatment before starting a MAOI. • Pimozide ACT ESCITALOPRAM ODT 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).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Escitalopram in Canada.
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• Titration: If initial adverse events are a concern, start at 5 mg/day and titrate upwards as tolerated. Since ACT ESCITALOPRAM ODT is only available as 10 mg and 20 mg tablets, they cannot be used when 5 mg doses are required. • Maximum dose: 20 mg/day (if needed and tolerated).
• Use lowest effective dose and reassess periodically. Long-Term Treatment 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.
ACT ESCITALOPRAM ODT (Escitalopram Orodispersible Tablets) Page 8 of 58 Switching Patients to or From a Monoamine Oxidase Inhibitor (MAOI) At least 14 days should elapse between discontinuation of a MAOI and initiation of therapy with ACT ESCITALOPRAM ODT.
Similarly, at least 14 days should be allowed after stopping ACT ESCITALOPRAM ODT before starting a MAOI (see 2 CONTRAINDICATIONS). Discontinuation of Escitalopram Treatment Adverse events are common within the first few days of SSRI treatment discontinuation and have also been reported following a missed dose or dose reduction.
• Do not discontinue treatment abruptly. A gradual dose reduction over several weeks, is recommended to reduce the risk of discontinuation symptoms. • Patients should be monitored for discontinuation symptoms when stopping treatment or during dosage reduction.
• If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, dose titration should be managed on the basis of the patient’s clinical response. 2 Clinical Trial Adverse Reactions, Adverse Reactions following Discontinuation of Treatment (or Dose Reduction).
Special Populations • Pediatrics (<18 years of age) Health Canada has not authorized an indication for pediatric use. 4 Geriatrics. 3 Pharmacokinetics, Special Populations and Conditions, Geriatrics). Initial dosage is 5 mg once daily.
Since ACT ESCITALOPRAM ODT is only available as 10 mg and 20 mg tablets, they cannot be used when 5 mg doses are required. Depending on individual patient response and tolerance the dose may be increased to 10 mg daily. • Renal Impairment No dosage adjustment is necessary for patients with mild or moderate renal impairment.
Since no information is available on the pharmacokinetic or pharmacodynamic effects of either escitalopram or racemic citalopram in patients with severely reduced renal function (creatinine clearance < 30 mL/min), ACT ESCITALOPRAM ODT should be used with caution in these patients.
• Hepatic Impairment Dosages should be restricted to the lower end of the dose range in patients with mild to moderate hepatic insufficiency. Accordingly, an initial single oral dose of 5 mg daily is recommended. Since ACT ESCITALOPRAM ODT is only available as 10 mg and 20 mg tablets, they cannot be used when 5 mg doses are required.
Subsequently, the dose may be increased based on the patient’s response and clinical judgement. A daily dose of 10 mg is the recommended maximum dose for most patients with hepatic impairment. No information is available about the pharmacokinetics of escitalopram in patients with severe hepatic impairment (Child-Pugh Criteria C).
ACT ESCITALOPRAM ODT should be used with additional caution in patients with severe hepatic impairment. ACT […]
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.
0 *Events included are those occurring in 1% or more of patients treated with escitalopram, and for which the incidence in patients treated with escitalopram was greater than the incidence in placebo- treated patients. 1Denominator used was for females only (n=490 for escitalopram; n=404 for Placebo).
2Denominator used was for males only (n=225 for escitalopram; n=188 for Placebo). The following events had a higher incidence in the placebo group compared to the escitalopram oxalate group: vomiting, abdominal pain, flatulence, upper respiratory tract infection, bronchitis, back pain, neck pain, headache.
Adverse reactions observed with escitalopram oxalate are in general mild and transient. They are most frequent during the first and/or second week of treatment and usually decrease in intensity and frequency with continued treatment and do not generally lead to a cessation of therapy.
In a clinical trial involving patients with MDD that compared fixed doses of escitalopram (10 mg/day and 20 mg/day) with placebo, the most common adverse events that occurred in patients […]
4 Geriatrics ....................................................................................................................................... 18 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 .................................................................................
1 Less Common Clinical Trial Adverse Reactions – Pediatrics .......................................................... 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ..... 5 Post-Market Adverse Reactions........................................................................................................
26 9 DRUG INTERACTIONS .............................................................................................................................. 1 Serious Drug Interactions .................................................................................................................
2 Drug Interactions Overview.............................................................................................................. 3 Drug-Behavioural Interactions .........................................................................................................
4 Drug-Drug Interactions ..................................................................................................................... 5 Drug-Food Interactions ....................................................................................................................
6 Drug-Herb Interactions..................................................................................................................... 7 Drug-Laboratory Test Interactions ....................................................................................................
34 10 CLINICAL PHARMACOLOGY ................................................................................................................... 1 Mechanism of Action .....................................................................................................................
2 Pharmacodynamics […]