OXYNORM 10MG CAPSULE

Țară: Singapore

Limbă: engleză

Sursă: HSA (Health Sciences Authority)

Ingredient activ:

Oxycodone Hydrochloride

Disponibil de la:

DKSH SINGAPORE PTE. LTD.

Codul ATC:

N02AA05

Dozare:

10 mg

Forma farmaceutică:

CAPSULE

Compoziție:

Oxycodone Hydrochloride 10 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

Prescription Only

Produs de:

Bard Pharmaceuticals

Statutul autorizaţiei:

ACTIVE

Data de autorizare:

2005-04-07

Prospect

9831-3
POR No.:
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ype:
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d F&P Line/Contractor:
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emplate No.:
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n Repeat (mm):
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eated:
1147
Oxynorm Capsules PIL
N/A
Malaysia & Singapor
e
9831-3
Datamatrix 9831-3
N/A
N/A
14, 19, 20
460x148mm (LSN-NAPP-02) (P)
PRD-PMS-005
LSN-NAPP-02
N/A
460x148mm
148x36/34mm
N/A
N/A
N/A
Indesign CS4
Charlotte Grant
V2
25-10-11
Non-Printing Colours
Colour(s):
Black
Black 10%
Font(s):
Arial
Lucida
Helvetica Neue
V5-2009
PINK
BLUE
PURPLE
BUFF
460X148MM (LSN-NAPP-02) (P) V1
OXYNORM CAPS PIL MY SG 9831-3 V2.indd   1
25/10/2011   09:46
9831-3
_OXYNORM_
® 
CAPSULES
COMPOSITION
Oxycodone hydrochloride Ph Eur
Oxycodone  hydrochloride  is  a  white,  crystalline 
odourless  powder  readily  soluble  in  water,  sparingly 
soluble  in  ethanol  and  nearly  insoluble  in  ether.  The 
chemical  name  is  4,5
α-epoxy-14-hydroxy-3-methoxy-
17-methylmorphinan-6-one  hydrochloride  (CAS  No: 
124-90-3). The molecular formula is C
18
H
21
NO
4
 HCl and 
molecular weight is 351.83. 
The  inactive  ingredients  in  _OXYNORM_
®
  capsules  are: 
microcrystalline cellulose and magnesium stearate. 
The  capsule  shells  contain  sodium  lauryl  sulfate  and 
gelatin.  Capsule  shell  is  derived  from  animal  origin 
(bovine source).
The  capsule  shells  also  contain  the  following  colouring 
materials:
STRENGTH
COLOURING MATERIAL
5 
MG
10 
MG
20 
MG
Indigo carmine CI73015 (E132)
•
•
•
Iron oxide red CI77491 (E172)
•
•
•
Iron oxide yellow CI77492 (E172)
•
•
•
Sunset yellow FCF CI15985 (E110)
•
Titanium dioxide (E171)
•
•
•
THERAPEUTIC PROPERTIES
Oxycodone  is  a  full  opioid  agon

Caracteristicilor produsului

_OXYNORM_® _Capsules _
_ _
COMPOSITION
Oxycodone hydrochloride Ph Eur
Oxycodone hydrochloride is a white, crystalline odourless powder
readily soluble in water, sparingly
soluble in ethanol and nearly insoluble in ether. The chemical name is
4,5α-epoxy-14-hydroxy-3-methoxy-
17-methylmorphinan-6-one hydrochloride (CAS No: 124-90-3). The
molecular formula is C
18
H
21
NO
4
HCl
and molecular weight is 351.83.
The inactive ingredients in _OXYNORM_® capsules are: microcrystalline
cellulose and magnesium stearate.
The capsule shells contain sodium lauryl sulfate and gelatin. Capsule
shell is derived from animal origin
(bovine source).
The capsule shells also contain the following colouring materials:
STRENGTH
COLOURING MATERIAL
5 MG
10 MG
20 MG
Indigo carmine CI73015 (E132)
•
•
•
Iron oxide red CI77491 (E172)
•
•
•
Iron oxide yellow CI77492 (E172)
•
•
•
Sunset yellow FCF CI15985 (E110)
•
Titanium dioxide (E171)
•
•
•
THERAPEUTIC PROPERTIES
Oxycodone is a full opioid agonist with no antagonist properties whose
principal therapeutic action is
analgesia. It has affinity for kappa, mu and delta opiate receptors in
the brain and spinal cord. Oxycodone
is similar to morphine in its action. Other pharmacological actions of
oxycodone are in the CNS (respiratory
depression, antitussive, anxiolytic, sedative and miosis), smooth
muscle (constipation, reduction in
gastric, biliary and pancreatic secretions, spasm of sphincter of Oddi
and transient elevations in serum
amylase) and cardiovascular system (release of histamine and/ or
peripheral vasodilation, possibly causing
pruritus, flushing, red eyes, sweating and/or orthostatic
hypotension).
PHARMACOKINETICS
_Elimination and Metabolism _
_ _
Oxycodone has an elimination half life of approximately 3 hours and is
metabolised principally to
noroxycodone and oxymorphone. Oxymorphone has some analgesic activity
but is present in plasma in
low concentrations and is not considered to contribute to
oxycodone’s pharmacological effect.
Oxycodone hydrochloride