product monograph including patient medication remeron® (mirtazapine) page 1 of 38. product...

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  • REMERON® (mirtazapine) Page 1 of 38

    PRODUCT MONOGRAPH

    INCLUDING PATIENT MEDICATION INFORMATION

    REMERON®

    mirtazapine

    Tablets 30 mg

    ANTI-DEPRESSANT

    Merck Canada Inc. 16750 route Transcanadienne Kirkland QC Canada H9H 4M7 www.merck.ca

    Date of Initial Approval: May 18, 2001 Date of Revision: December 23, 2020

    Submission Control No: 242352

  • REMERON® (mirtazapine) Page 2 of 38

    RECENT MAJOR LABEL CHANGES Warnings and Precautions, Skin (7) 12/2020

    TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .................................................................. 4 1 INDICATIONS ................................................................................................................... 4

    1.1 Pediatrics ............................................................................................................... 4 1.2 Geriatrics ............................................................................................................... 4

    2 CONTRAINDICATIONS ................................................................................................... 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ........................................................ 5 4 DOSAGE AND ADMINISTRATION .................................................................................. 5

    4.1 Dosing Considerations .......................................................................................... 5 4.2 Recommended Dose and Dosage Adjustment ..................................................... 5 4.3 Administration ........................................................................................................ 6 4.4 Reconstitution ........................................................................................................ 6 4.5 Missed Dose .......................................................................................................... 6

    5 OVERDOSAGE ................................................................................................................ 6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ......................... 7 7 WARNINGS AND PRECAUTIONS .................................................................................. 7

    7.1 Special Populations ............................................................................................. 13 7.1.1 Pregnant Women ................................................................................................ 13 7.1.2 Breast-feeding ..................................................................................................... 13 7.1.3 Pediatrics ............................................................................................................. 13 7.1.4 Geriatrics ............................................................................................................. 13

    8 ADVERSE REACTIONS ................................................................................................. 14 8.1 Adverse Reaction Overview ................................................................................ 14 8.2 Clinical Trial Adverse Reactions .......................................................................... 14 8.3 Less Common Clinical Trial Adverse Reactions (< 1%) ...................................... 15 8.4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ............................................................................................................ 17 8.5 Clinical Trial Adverse Reactions (Pediatrics) ....................................................... 17 8.6 Post-Market Adverse Reactions .......................................................................... 18

    9 DRUG INTERACTIONS .................................................................................................. 19 9.1 Serious Drug Interactions Box ............................................................................. 19 9.2 Overview ............................................................................................................. 19 9.3 Drug-Drug Interactions ........................................................................................ 19 9.4 Drug-Food Interactions ........................................................................................ 21 9.5 Drug-Herb Interactions ........................................................................................ 22 9.6 Drug-Laboratory Test Interactions ....................................................................... 22 9.7 Drug-Lifestyle Interactions ................................................................................... 22

    10 ACTION AND CLINICAL PHARMACOLOGY ................................................................ 22 10.1 Mechanism of Action ........................................................................................... 22 10.2 Pharmacodynamics ............................................................................................. 22 10.3 Pharmacokinetics ................................................................................................ 23

  • REMERON® (mirtazapine) Page 3 of 38

    11 STORAGE, STABILITY AND DISPOSAL ...................................................................... 24 12 SPECIAL HANDLING INSTRUCTIONS ......................................................................... 24 PART II: SCIENTIFIC INFORMATION ....................................................................................... 25 13 PHARMACEUTICAL INFORMATION ............................................................................ 25 14 CLINICAL TRIALS ......................................................................................................... 25

    14.1 Trial Design and Study Demographics ................................................................ 25 14.2 Study Results ...................................................................................................... 25 14.3 Comparative Bioavailability Studies .................................................................... 26

    15 MICROBIOLOGY ............................................................................................................ 26 16 NON-CLINICAL TOXICOLOGY ..................................................................................... 26 PATIENT MEDICATION INFORMATION .................................................................................. 32

  • REMERON® (mirtazapine) Page 4 of 38

    PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS REMERON® (mirtazapine) is indicated for: • the symptomatic relief of depressive illness. Long-term use of REMERON® The efficacy of REMERON® in maintaining a response in patients with major depressive disorder for up to 40 weeks following 8 - 12 weeks of initial open-label treatment was demonstrated in a placebo-controlled trial. Nevertheless, the physician who elects to use REMERON® for extended periods should periodically evaluate the long-term response of the individual patient to the drug. 1.1 Pediatrics Pediatrics (< 18 years of age): REMERON® is not indicated for use in patients below the age of 18 years (see WARNINGS AND PRECAUTIONS , General, Potential Association with Behavioural and Emotional Changes, Including Self-Harm; see also ADVERSE REACTIONS/Pediatrics, DOSAGE AND ADMINISTRATION and ACTION AND CLINICAL PHARMACOLOGY Special Populations and Conditions/Pediatrics). 1.2 Geriatrics Geriatrics (> 65 years of age): Evidence from clinical trials and experience suggests that use in geriatric populations may be associated with differences in safety or effectiveness. A brief discussion can be found in the appropriate sections [see WARNINGS AND PRECAUTIONS, Neurologic, Somnolence; Special Populations, Geriatrics (> 65 years of age); DOSAGE AND ADMINISTRATION; ACTION AND CLINICAL PHARMACOLOGY, Special Populations and Conditions, Geriatrics]. 2 CONTRAINDICATIONS REMERON® 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 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. Monoamine Oxidase Inhibitors: In patients receiving agents that may affect the serotonergic neurotransmitter systems in combination with a monoamine oxidase (MAO) inhibitor, there have been reports of serious, sometimes fatal, reactions including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to delirium and coma. These reactions have also been reported in patients who have recently discontinued Selective Serotonin Reuptake Inhibitor (SSRI) treatment and have begun treatment on a MAO inhibitor. Some cases presented with features resembling serotonin toxicity or neuroleptic malignant syndrome (see WARNINGS AND PRECAUTIONS, Neurologic, Serotonin Toxicity/Neuroleptic Malignant Syndrome). Therefore, REMERON® should not be used in combination with MAO inhibitors (including the antibiotic linezolid, and the thiazine dye methylthioninium blue (methylene blue), which are less well-known examples of MAO inhibitors) or within a minimum of 2 weeks of

  • REMERON® (mirtazapine) Page 5 of 38

    terminating treatment with MAO inhibitors. Treatment with REMERON® should then be initiated cautiously and dosage increased gradually until optimal re

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