MIRTAZAPINE TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

MIRTAZAPINE

Saatavilla:

MELIAPHARM INC

ATC-koodi:

N06AX11

INN (Kansainvälinen yleisnimi):

MIRTAZAPINE

Annos:

30MG

Lääkemuoto:

TABLET

Koostumus:

MIRTAZAPINE 30MG

Antoreitti:

ORAL

Kpl paketissa:

30/100

Prescription tyyppi:

Prescription

Terapeuttinen alue:

MISCELLANEOUS ANTIDEPRESSANTS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0143928002; AHFS:

Valtuutuksen tilan:

CANCELLED POST MARKET

Valtuutus päivämäärä:

2014-06-25

Valmisteyhteenveto

PRODUCT MONOGRAPH
PR
MIRTAZAPINE
(Mirtazapine Tablets)
15 mg and 30 mg
ANTI-DEPRESSANT
MELIAPHARM INC.
6111 Royalmount Ave., Suite 100
DATE OF REVISION:
Montréal, Québec
November, 2011
H4P 2T4
CONTROL NO. 150992
_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
_MIRTAZAPINE Product Monograph _
_Page 3 of 39_
PR
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
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
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 of age); DOSAGE AND ADMINISTRATIO