NORFLEX LIQUID

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

ORPHENADRINE CITRATE

Disponible depuis:

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

Code ATC:

M03BC01

DCI (Dénomination commune internationale):

ORPHENADRINE (CITRATE)

Dosage:

30MG

forme pharmaceutique:

LIQUID

Composition:

ORPHENADRINE CITRATE 30MG

Mode d'administration:

INTRAMUSCULAR

Unités en paquet:

6X2ML

Type d'ordonnance:

Ethical

Domaine thérapeutique:

MISCELLANEOUS SKELETAL MUSCLE RELAXANTS

Descriptif du produit:

Active ingredient group (AIG) number: 0102078002; AHFS:

Statut de autorisation:

CANCELLED POST MARKET

Date de l'autorisation:

2014-07-30

Résumé des caractéristiques du produit

(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