Pays: Canada
Langue: anglais
Source: Health Canada
MIRTAZAPINE
ZYMCAN PHARMACEUTICALS INC
N06AX11
MIRTAZAPINE
15MG
TABLET
MIRTAZAPINE 15MG
ORAL
100/500
Prescription
MISCELLANEOUS ANTIDEPRESSANTS
Active ingredient group (AIG) number: 0143928001; AHFS:
CANCELLED POST MARKET
2014-06-16
PRODUCT MONOGRAPH PR ZYM-MIRTAZAPINE (Mirtazapine Tablets) 15 mg and 30 mg ANTI-DEPRESSANT ZYMCAN PHARMACEUTICALS 6111 Royalmount Ave., Suite 100 DATE OF REVISION: Montréal, Québec November 18, 2011 H4P 2T4 CONTROL NO. 150994 _Zym-MIRTAZAPINE Product Monograph _ _Page 2 of 39_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION 3 SUMMARY PRODUCT INFORMATION 3 INDICATIONS AND CLINICAL USE 3 CONTRAINDICATIONS 4 WARNINGS AND PRECAUTIONS 4 ADVERSE REACTIONS 10 DRUG INTERACTIONS 15 DOSAGE AND ADMINISTRATION 18 OVERDOSAGE 20 ACTION AND CLINICAL PHARMACOLOGY 21 STORAGE AND STABILITY 24 DOSAGE FORMS, COMPOSITION AND PACKAGING 24 PART II: SCIENTIFIC INFORMATION 25 PHARMACEUTICAL INFORMATION 25 DETAILED PHARMACOLOGY 27 TOXICOLOGY 30 REFERENCES 34 PART III: CONSUMER INFORMATION 36 _Zym-MIRTAZAPINE Product Monograph _ _Page 3 of 39_ PR ZYM-MIRTAZAPINE (Mirtazapine tablets) PART I: HEALTH PROFESSIONAL INFORMATION SUMMARY PRODUCT INFORMATION ROUTE OF ADMINISTRATION DOSAGE FORM/ STRENGTH CLINICALLY RELEVANT NONMEDICINAL INGREDIENTS oral Tablet,15 and 30 mg Lactose. _For a complete listing see Dosage Forms, _ _Composition and Packaging section._ INDICATIONS AND CLINICAL USE ADULTS Zym-MIRTAZAPINE (mirtazapine) is indicated for the symptomatic relief of depressive illness. LONG-TERM USE OF MIRTAZAPINE The efficacy of mirtazapine 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 Zym-MIRTAZAPINE for extended periods should periodically evaluate the long-term response of the individual patient to the drug. 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-Neurological-Somnolence; Special Populations-Geriatrics (> 65 years Lire le document complet