SILENOR TABLET

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

DOXEPIN (DOXEPIN HYDROCHLORIDE)

متاح من:

PALADIN LABS INC.

ATC رمز:

N06AA12

INN (الاسم الدولي):

DOXEPIN

جرعة:

6MG

الشكل الصيدلاني:

TABLET

تركيب:

DOXEPIN (DOXEPIN HYDROCHLORIDE) 6MG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

30/100/500

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS

ملخص المنتج:

Active ingredient group (AIG) number: 0107703008; AHFS:

الوضع إذن:

APPROVED

تاريخ الترخيص:

2012-12-13

خصائص المنتج

_ _
_SILENOR Product Monograph _
_Page 1 of 30_
PRODUCT MONOGRAPH
PR
SILENOR
_® _
_ _
Doxepin tablets
3 and 6 mg doxepin as doxepin hydrochloride
Hypnotic
Paladin Labs Inc.
DATE OF PREPARATION:
6111 Royalmount Ave.
DECEMBER 07, 2012
Montreal, Quebec H4P 2T4
SUBMISSION CONTROL NO: 152398
_®_
_ _
_Trademark of Somaxon Pharmaceuticals, Inc._
_ _
_SILENOR Product Monograph _
_Page 2 of 30_
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
....................................................................................................8
DRUG INTERACTIONS
..................................................................................................13
DOSAGE AND ADMINISTRATION
..............................................................................15
OVERDOSAGE
................................................................................................................15
ACTION AND CLINICAL PHARMACOLOGY
............................................................17
STORAGE AND STABILITY
..........................................................................................19
SPECIAL HANDLING INSTRUCTIONS
.......................................................................20
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................20
PART II: SCIENTIFIC INFORMATION
...............................................................................21
PHARMACEUTICAL INFORMATION
..........................................................................21
CLINICAL