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CIPRALEX -10MG 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: CIPRALEX (escitalopram oxalate) is indicated in adults for: • the symptomatic relief of Major Depressive Disorder (MDD). The efficacy of CIPRALEX in maintaining an antidepressant response, in patients with major depressive disorder who responded during an 8-week, acute-treatment phase while taking CIPRALEX and were…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Pediatrics: CIPRALEX 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: CIPRALEX 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: 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. ) 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 CIPRALEX should be administered once daily, in the morning or evening, with or without food: • Usual adult dose: 10 mg/day, orally. • Titration: If initial adverse events are a concern, start at 5 mg/day and titrate upwards as tolerated.
• Maximum dose: 20 mg/day (if needed, and tolerated). • Use lowest effective dose and reassess periodically. Generalized Anxiety Disorder • See dose recommendations under Major Depressive Disorder, above. CIPRALEX® (escitalopram oxalate) Product Monograph Page 7 of 59 Obsessive Compulsive Disorder • See dose recommendations under Major Depressive Disorder, above.
1 Adverse Reaction Overview Adverse events information for CIPRALEX (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 CIPRALEX 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.
CIPRALEX® (escitalopram oxalate) Product Monograph Page 17 of 59 The adverse event information for CIPRALEX 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 01/2022 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 ........................................................ 4 Administration ......................................................................................................... 5 Missed Dose .............................................................................................................
8 5 OVERDOSAGE............................................................................................................ 8 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................ 9 7 WARNINGS AND PRECAUTIONS ...............................................................................
• CIPRALEX 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, CIPRALEX 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 CIPRALEX treatment before starting a MAOI. • Pimozide CIPRALEX 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.
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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. 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 CIPRALEX.
Similarly, at least 14 days should be allowed after stopping CIPRALEX 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.
Depending on individual 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), CIPRALEX 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. 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 CIPRALEX in patients with severe hepatic impairment (Child-Pugh Criteria C). CIPRALEX should be used with additional caution in patients with severe CIPRALEX® (escitalopram oxalate) Product Monograph Page 8 of 59 hepatic impairment.
• CYP2C19 Poor Metabolizers The metabolism of CIPRALEX is mainly mediated by CYP2C19. For patients who are known to be poor metabolizers with respect to CYP2C19, an initial dose of 5 mg daily is recommended. Depending on the individual response, the dose may be increased to a maximum of 10 mg.
4 Administration CIPRALEX should be administered as a single oral daily dose, […]
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.
Table 2 - […]
1 Special Populations ................................................................................................ 1 Pregnant Women ............................................................................................. 2 Breast-feeding ..................................................................................................
3 Pediatrics.......................................................................................................... 4 Geriatrics ..........................................................................................................
16 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.............................................................................
30 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.........................................................................
38 10 CLINICAL PHARMACOLOGY ...................................................................................... 1 Mechanism of Action ....................................................................................... 2 Pharmacodynamics ..........................................................................................
3 Pharmacokinetics ............................................................................................. 38 11 STORAGE, STABILITY AND DISPOSAL ........................................................................ 40 12 SPECIAL HANDLING INSTRUCTIONS..........................................................................
40 PART II: SCIENTIFIC INFORMATION ..................................................................................... 40 13 PHARMACEUTICAL INFORMATION .......................................................................... 40 14 CLINICAL TRIALS ......................................................................................................
1 Clinical Trial by Indication ................................................................................ 41 15 MICROBIOLOGY […]