APO-TAPENTADOL TABLET (IMMEDIATE RELEASE)

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

TAPENTADOL (TAPENTADOL HYDROCHLORIDE)

Dostępny od:

APOTEX INC

Kod ATC:

N02AX06

INN (International Nazwa):

TAPENTADOL

Dawkowanie:

100MG

Forma farmaceutyczna:

TABLET (IMMEDIATE RELEASE)

Skład:

TAPENTADOL (TAPENTADOL HYDROCHLORIDE) 100MG

Droga podania:

ORAL

Sztuk w opakowaniu:

100

Typ recepty:

Narcotic (CDSA I)

Podsumowanie produktu:

Active ingredient group (AIG) number: 0152846002; AHFS:

Status autoryzacji:

APPROVED

Data autoryzacji:

2022-02-17

Charakterystyka produktu

N
APO-TAPENTADOL (tapentadol)
Page 1 of 58
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
APO-TAPENTADOL
Tapentadol Tablets
Tablets, 50 mg, 75 mg, and 100 mg Tapentadol (as tapentadol
hydrochloride), oral
Opioid Analgesic
APOTEX INC.
150 Signet Drive
Toronto (Ontario)
M9L 1T9
Date of Initial Authorization:
January 15, 2018
Date of Revision:
February 16, 2022
Submission Control No: 259139
N
APO-TAPENTADOL (tapentadol)
Page 2 of 58
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions, Opioid induced hyperalgesia
02/2022
7 Warnings and Precautions, Serotonin toxicity / Serotonin syndrome
02/2022
7 Warnings and Precautions, Reproductive Health: Female and Male
Potential, Fertility
02/2022
7 Warnings and Precautions, Sleep apnea
02/2022
TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES
..............................................................................
2
TABLE OF CONTENTS
................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 4
1.
INDICATIONS
...........................................................................................................
4
1.1
Pediatrics (<18 years)
.........................................................................................
4
1.2
Geriatrics (≥ 65 years of age)
..............................................................................
4
2.
CONTRAINDICATIONS
.............................................................................................
4
3.
SERIOUS WARNINGS AND PRECAUTIONS BOX
..................................................... 5
4.
DOSAGE AND ADMINISTRATION
...........................................................................
6
4.1
Dosing Considerations
........................................................................................
6
4.2
Recommended Dose and Dosage Adjustment
................................................... 7
4.4
Administration
..................................