OXYNORM® Oral Solution 1mgml

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Oxycodone base 0.9mg/ml eqv. Oxycodone Hydrochloride

Available from:

MUNDIPHARMA PHARMACEUTICALS PTE. LTD.

ATC code:

N02AA05

Dosage:

1mg per ml

Pharmaceutical form:

SOLUTION

Composition:

Oxycodone base 0.9mg/ml eqv. Oxycodone Hydrochloride 1mg per ml

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Mundipharma Pharmaceuticals Limited

Authorization status:

ACTIVE

Authorization date:

2012-03-28

Patient Information leaflet

_OXYNORM_
® 
ORAL SOLUTION 1MG/ML 
_OXYNORM_
® 
CONCENTRATE ORAL SOLUTION 10MG/ML 
NAME OF THE MEDICINAL PRODUCT 
_OXYNORM_
®
 oral solution 1mg/ml 
_OXYNORM_
® 
concentrate oral solution 10mg/ml 

QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each 5 ml _OXYNORM_
®
 oral solution 1mg/ml contains oxycodone base 4.5 mg
as oxycodone 
hydrochloride 5 mg.  
Each 1 ml _OXYNORM_
®
 concentrate oral solution 10mg/ml contains oxycodone base 9 mg
as 
oxycodone hydrochloride 10 mg.  
Go to top of the page
[http://emc.medicines.org.uk/medicine/3507/SPC/OxyNorm+liquid+and+OxyNorm+concentrate/#tableOfContents#tableOfContents]

[http://emc.medicines.org.uk/medicine/3507/SPC/OxyNorm+liquid+and+OxyNorm+concentrate/#tableOfContents#tableOfContents] 
PHARMACEUTICAL FORM 
_OXYNORM_
®
 oral solution 1mg/ml is a clear colourless/straw-coloured
solution.  
_OXYNORM_
®
 concentrate oral solution 10mg/ml is a clear, orange
solution. 
Go to top of the page
[http://emc.medicines.org.uk/medicine/3507/SPC/OxyNorm+liquid+and+OxyNorm+concentrate/#tableOfContents#tableOfContents]

[http://emc.medicines.org.uk/medicine/3507/SPC/OxyNorm+liquid+and+OxyNorm+concentrate/#tableOfContents#tableOfContents] 
CLINICAL PARTICULARS 

THERAPEUTIC INDICATION  

The management of acute exacerbation of moderate to severe
chronic pain unresponsive to non-
narcotic analgesia, and post-operative pain. 
POSOLOGY AND METHOD OF ADMINISTRATION 

_Route of administration:_

Oral  
_Post-operative pain: _ 
In common with other strong opioids, the need for continued
treatment should be assessed at 
regular intervals.  
_Elderly and adults over 18 years:_ 
_OXYNORM_
®
 oral solutions should be taken at 4-6 hourly intervals. The
dosage is dependent on 
the severity of the pain, and
the patient's previous history of analgesic requirements.  
Increasing severity of pain will require an
increased dosage of _OXYNOR

Summary of Product characteristics

_OXYNORM_® oral solution 1mg/ml
NAME OF THE MEDICINAL PRODUCT
_OXYNORM_® oral solution 1mg/ml
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of _OXYNORM_® oral solution 1mg/ml contains oxycodone base
0.9 mg as oxycodone
hydrochloride 1 mg. Excipient with known effect: Each ml _OXYNORM_®
oral solution 1mg/ml contains 1
mg sodium benzoate.
PHARMACEUTICAL FORM
_OXYNORM_® oral solution 1mg/ml is a clear colourless/straw-coloured
solution.
CLINICAL PARTICULARS
THERAPEUTIC INDICATION
The management of acute exacerbation of moderate to severe chronic
pain unresponsive to non-
narcotic analgesia, and post-operative pain.
POSOLOGY AND METHOD OF ADMINISTRATION
_Route of administration: _
Oral
_Post-operative pain: _
In common with other strong opioids, the need for continued treatment
should be assessed at regular
intervals.
_Elderly and adults over 18 years: _
_OXYNORM_® oral solutions should be taken at 4-6 hourly intervals.
The dosage is dependent on the
severity of the pain, and the patient's previous history of analgesic
requirements.
Increasing severity of pain will require an increased dosage of
_OXYNORM_® oral solutions. The correct
dosage for any individual patient is that which controls the pain and
is well tolerated throughout the
dosing period. Patients should be titrated to pain relief unless
unmanageable adverse drug reactions
prevent this.
_OXYNORM_® oral solutions will generally be used in a short term
trial (4-6 weeks) to determine if the pain
is opioid responsive, before transferring to a longer acting oxycodone
preparation such as _OXYCONTIN_®
tablets, in accordance with the clinical guidelines on the use of
opioid analgesics in such patients.
The usual starting dose for opioid naïve patients or patients
presenting with severe pain uncontrolled by
weaker opioids is 5 mg, 4-6 hourly. The dose should then be carefully
titrated, as frequently as once a
day if necessary, to achieve pain relief. The majority of patients
will not require a daily dose greater than
400 mg. However, a few patients may