OXYCONTIN 40mg prolonged release tablets

البلد: سنغافورة

اللغة: الإنجليزية

المصدر: HSA (Health Sciences Authority)

العنصر النشط:

Oxycodone hydrochloride

متاح من:

MUNDIPHARMA PHARMACEUTICALS PTE. LTD.

ATC رمز:

N02AA05

جرعة:

40mg

الشكل الصيدلاني:

TABLET, FILM COATED, EXTENDED RELEASE

تركيب:

Oxycodone hydrochloride 40mg

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

Prescription Only

المصنعة من قبل:

Bard Pharmaceuticals

الوضع إذن:

ACTIVE

تاريخ الترخيص:

2005-04-07

نشرة المعلومات

3082-3
OXYCONTIN
® 
TABLETS
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 351.87.
The  inactive  ingredients  in  OxyContin
®
  tablets  are  : 
lactose,  povidone,  Eudragit  RS  30D  (solids),  glycerol 
triacetate, stearyl alcohol, talc and magnesium stearate.  
All of the tablets are coated with hypromellose, titanium 
dioxide  and  macrogol  400.    The  tablet  coatings  also 
contain  :  hydroxypropylcellulose  (10  &  80  mg  tablets); 
polysorbate  80  (20  &  40  mg  tablets);  iron  oxide  red 
CI77491 (20 mg tablets); iron oxide yellow CI77492 (40 
& 80 mg tablets); indigo carmine CI73015 aluminium lake 
(80 mg tablets) and brilliant blue CI42090 (5 mg tablets).
THERAPEUTIC PROPERTIES
Oxycodone  is  a  full  opioid  agonist  with  no  antagonist 
properties whose principal therapeutic action is analgesia.  
It has an 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  pe

خصائص المنتج

OXYCONTIN
®
TABLETS
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-
methoxy17-methylmorphinan-6-one hydrochloride (CAS No: 124-90-3). The
molecular formula is
C
18
H
21
NO
4
. HCl and molecular weight is 351.87.
The inactive ingredients in OxyContin
®
tablets are: lactose, povidone, Eudragit RS 30D (solids), glycerol
triacetate, stearyl alcohol, talc and magnesium stearate. All of the
tablets are coated with hypromellose,
titanium dioxide and macrogol 400. The tablet coatings also contain:
hydroxypropylcellulose (10 & 80
mg tablets); polysorbate 80 (20 & 40 mg tablets); iron oxide red
CI77491 (20 mg tablets); iron oxide
yellow CI77492 (40 & 80 mg tablets); indigo carmine CI73015 aluminium
lake (80 mg tablets) and
brilliant blue CI42090 (5 mg tablets).
THERAPEUTIC PROPERTIES
Oxycodone is a full opioid agonist with no antagonist properties whose
principal therapeutic action is
analgesia. It has an 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.
_Absorption _
Compared