JAMP-MIRTAZAPINE TABLET

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

MIRTAZAPINE

Предлага се от:

JAMP PHARMA CORPORATION

АТС код:

N06AX11

INN (Международно Name):

MIRTAZAPINE

дозиране:

15MG

Лекарствена форма:

TABLET

Композиция:

MIRTAZAPINE 15MG

Начин на приложение:

ORAL

Броя в опаковка:

100

Вид предписание :

Prescription

Терапевтична област:

MISCELLANEOUS ANTIDEPRESSANTS

Каталог на резюме:

Active ingredient group (AIG) number: 0143928001; AHFS:

Статус Оторизация:

APPROVED

Дата Оторизация:

2011-06-16

Данни за продукта

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