NORFLEX TABLET (EXTENDED-RELEASE)

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

ORPHENADRINE CITRATE

Доступно од:

VALEANT CANADA LP / VALEANT CANADA S.E.C.

АТЦ код:

M03BC01

INN (Међународно име):

ORPHENADRINE (CITRATE)

Дозирање:

100MG

Фармацеутски облик:

TABLET (EXTENDED-RELEASE)

Састав:

ORPHENADRINE CITRATE 100MG

Пут администрације:

ORAL

Јединице у пакету:

8/100/500

Тип рецептора:

OTC

Терапеутска област:

MISCELLANEOUS SKELETAL MUSCLE RELAXANTS

Резиме производа:

Active ingredient group (AIG) number: 0102078001; AHFS:

Статус ауторизације:

CANCELLED POST MARKET

Датум одобрења:

2014-07-30

Карактеристике производа

(1)
NORFLEX
®
(ORPHENADRINE CITRATE
)
Manufactured by:
Medicis Pharmaceutical Corporation
7720 N. Dobson Road
Scottsdale, AZ 85256
Distributed by:
Medicis Canada Ltd.,
Toronto, Ontario M5V 1Y6
Canada
Date of Preparation: January 3, 2012
CONTROL # 152408, 152409
(2)
FACT SHEET
Norflex® Tablets and Injectable
Generic/Non-proprietary name:
Orphenadrine Citrate
Brand/Proprietary name:
Norflex®
Manufacturer:
Medicis Pharmaceutical Corporation
Chemical Name and Composition:
Tablets, 100 mg.
Injectable, 60 mg/ampule.
N,N-Dimethyl-2-[(O-methyl-α-phenylbenzyl)
oxy] ethylamine citrate (or, the citric acid salt of
orphenadrine, [2-dimethyl-aminoethyl 2-
methylbenzhydryl ether])
C
24
H
31
NO
8
Structural Formula:
Molecular Weight:
461,57
Pharmacologic Classification:
“Skeletal muscle relaxant”
Structurally Related Drugs:
Diphenhydramine analogues
What Drug is Considered Standard:
Mephenesin
Physical Properties:
The pure drug substance is a white, crystalline
powder having a bitter taste and practically no
odour.
Macroscopic Appearance:
Tablet – A white tablet, 11/32” diameter,
standard cup
Solubility:
Water:
Alcohol:
Chloroform:
Ether:
Sparingly soluble
Slightly soluble
Insoluble
Insoluble
(3)
Dye Content:
None
Carbohydrate Content:
Tablets – 169 mg lactose
Injectable – None
Sodium Content:
Tablets – None
Injectable – 2.9 mg NaCl per mL
1.0 mg Sodium Bisulfide per mL
NaOH as needed to buffer to 5.5 pH
Stability:
Recommended Storage Conditions:
Tablets: Preserve in tight, light resistant
containers. Store at room temperature
(below 30°C).
Injectable: Preserve in original ampule. Store at
room temperature (below 30 °C).
Shelf Life (Expiration Dating):
Under Above Conditions:
Tablets: 5 ½ years
Injectable: 5 ½ years
Site and Mechanism of Action:
Orphenadrine is a centrally acting (brain stem)
compound which selectively blocks facilitatory
functions of the reticular formation.
Site of Absorption:
Tablets: Primarily small bowel.
Onset of Action:
Tablets – Following a single oral dose of
Norflex, onset of