البلد: سنغافورة
اللغة: الإنجليزية
المصدر: HSA (Health Sciences Authority)
Oxycodone Hydrochloride
DKSH SINGAPORE PTE. LTD.
N02AA05
10 mg
CAPSULE
Oxycodone Hydrochloride 10 mg
ORAL
Prescription Only
Bard Pharmaceuticals
ACTIVE
2005-04-07
9831-3 POR No.: Item Description: Pack Size: Country: Item Number: Security Code T ype and No.: Edge Code No(s): Bar Code T ype: Bar d F&P Line/Contractor: Keyline T emplate No.: PMS No.: Drawing No(s).: Pr efixes: Dimensions: Folded Dimensions: Patter n Repeat (mm): Unwind No.: Page Count: Application Used: Cr eated By: Version: Date Cr 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 اقرأ الوثيقة كاملة
_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 اقرأ الوثيقة كاملة