Երկիր: Կանադա
Լեզու: անգլերեն
Աղբյուրը: Health Canada
MIRTAZAPINE
JAMP PHARMA CORPORATION
N06AX11
MIRTAZAPINE
30MG
TABLET
MIRTAZAPINE 30MG
ORAL
30/100
Prescription
MISCELLANEOUS ANTIDEPRESSANTS
Active ingredient group (AIG) number: 0143928002; AHFS:
APPROVED
2011-06-16
1 PRODUCT MONOGRAPH PR JAMP-MIRTAZAPINE (Mirtazapine Tablets) 15 mg and 30 mg ANTIDEPRESSANT JAMP PHARMA CORPORATION DATE OF PREPARATION: 1380 – 203 Newton Street June 13, 2011 Boucherville, Quebec J4B 5H2 CONTROL NO. 147516 2 TABLE OF CONTENTS PR PMS-MIRTAZAPINE 3 PART I: HEALTH PROFESSIONAL INFORMATION 3 SUMMARY PRODUCT INFORMATION 3 INDICATIONS AND CLINICAL USE 3 CONTRAINDICATIONS 4 WARNINGS AND PRECAUTIONS 4 ADVERSE REACTIONS 9 DRUG INTERACTIONS 14 DOSAGE AND ADMINISTRATION 15 OVERDOSAGE 16 ACTION AND CLINICAL PHARMACOLOGY 17 STORAGE AND STABILITY 20 DOSAGE FORMS, COMPOSITION AND PACKAGING 20 PART II: SCIENTIFIC INFORMATION 21 PHARMACEUTICAL INFORMATION 21 DETAILED PHARMACOLOGY 22 TOXICOLOGY 25 REFERENCES 29 PART III: CONSUMER INFORMATION 31 3 PR JAMP-MIRTAZAPINE (Mirtazapine) 15 mg and 30 mg Tablets Antidepressant PART I: HEALTH PROFESSIONAL INFORMATION SUMMARY PRODUCT INFORMATION ROUTE OF ADMINISTRATION DOSAGE FORM/ STRENGTH CLINICALLY RELEVANT NONMEDICINAL INGREDIENTS Oral tablet 15 mg, 30 mg None. _For a complete listing see Dosage Forms, _ _Composition and Packaging section._ INDICATIONS AND CLINICAL USE JAMP-MIRTAZAPINE (Mirtazapine) is indicated for the symptomatic relief of depressive illness. 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 mirtazapine for extended periods should periodically evaluate the long-term response of the individual patient to the drug. GERIATRICS (> 65 YEARS OF AGE): Pharmacokinetic studies revealed a decreased clearance in the elderly, especially elderly females. Elderly patients may be more susceptible to adverse events such as sedation, dizziness or confusion. Care should be exercised in dosage and titration to higher doses. [See CLINICAL PHARMACOLOGY, DOSAGE and ADMINISTRATION and WARNINGS AND PRECAUTIONS (Somnolence)]. In elderly patients, and patients wi Կարդացեք ամբողջական փաստաթուղթը