OXYCODONE WKT oxycodone hydrochloride 10 mg/1 mL solution for injection or infusion glass ampoules

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

oxycodone hydrochloride, Quantity: 10 mg/mL

Available from:

Wockhardt Bio Pty Ltd

INN (International Name):

oxycodone hydrochloride

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: water for injections; sodium citrate; sodium hydroxide; sodium chloride; hydrochloric acid; citric acid monohydrate

Administration route:

Subcutaneous, Intravenous

Units in package:

5 x 1mL ampoules

Prescription type:

(S8) Controlled Drug

Therapeutic indications:

OXYCODONE WKT is indicated for the short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain.

Product summary:

Visual Identification: A clear colourless sterile solution of Oxycodone Hydrochloride in water for injection.; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2017-09-14

Patient Information leaflet

OXYCODONE WKT
1
OXYCODONE WKT
_(Oxycodone hydrochloride) _
_ _
CONSUMER MEDICINE INFORMATION
WARNING:
LIMITATIONS OF USE
Oxycodone WKT should only be used when your doctor decides that other
treatment options are not able to effectively
manage your pain or you cannot tolerate them.
HAZARDOUS AND HARMFUL USE
Oxycodone WKT poses risks of abuse, misuse and addiction which can
lead to overdose and death. Your doctor will
monitor you regularly during treatment.
LIFE THREATENING RESPIRATORY DEPRESSION
Oxycodone WKT can cause life-threatening or fatal breathing problems
(slow, shallow, unusual or no breathing) even
when used as recommended. These problems can occur at any time during
use, but the risk is higher when first starting
Oxycodone WKT and after a dose increase, if you are older, or have an
existing problem with your lungs. Your doctor
will monitor you and change the dose as appropriate.
USE OF OTHER MEDICINES WHILE USING OXYCODONE WKT
Using Oxycodone WKT with other medicines that can make you feel drowsy
such as sleeping tablets (e.g.
benzodiazepines), other pain relievers, antihistamines,
antidepressants, antipsychotics, gabapentinoids (e.g. gabapentin
and pregabalin), cannabis and alcohol may result in severe drowsiness,
decreased awareness, breathing problems,
coma and death. Your doctor will minimise the dose and duration of
use; and monitor you for signs and symptoms of
breathing difficulties and sedation. You must not drink alcohol while
using Oxycodone WKT.
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Oxycodone WKT solution for
injection or infusion.
It does not contain all the
available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have benefits and
risks. Your doctor has weighed
the risks of using Oxycodone
WKT against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, TALK
TO YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET IN A SAFE PLACE.
You may need to read it again.
WHAT

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – OXYCODONE WKT (OXYCODONE
HYDROCHLORIDE) SOLUTION FOR INJECTION OR INFUSION
WARNINGS
_LIMITATIONS OF USE _
Because of the risks associated with the use of opioids, OXYCODONE WKT
should only be used
in patients for whom other treatment options, including non-opioid
analgesics, are ineffective,
not tolerated or otherwise inadequate to provide appropriate
management of pain (see
_section 4.4 Special Warnings and Precautions for Use_).
_HAZARDOUS AND HARMFUL USE _
OXYCODONE WKT poses risks of hazardous and harmful use which can lead
to overdose and
death. Assess the patient’s risk of hazardous and harmful use before
prescribing and monitor
the patient regularly during treatment (see _section 4.4. Special
Warnings and Precautions for _
_Use_).
_LIFE THREATENING RESPIRATORY DEPRESSION _
Serious, life-threatening or fatal respiratory depression may occur
with the use of OXYCODONE
WKT]. Be aware of situations which increase the risk of respiratory
depression, modify dosing in
patients at risk and monitor patients closely, especially on
initiation or following a dose increase
(see _section 4.4 Special Warnings and Precautions for Use_).
_CONCOMITANT USE OF BENZODIAZEPINES AND OTHER CENTRAL NERVOUS SYSTEM
(CNS) _
_DEPRESSANTS, INCLUDING ALCOHOL _
Concomitant use of opioids with benzodiazepines, gabapentinoids,
antihistamines, tricyclic
antidepressants, antipsychotics, cannabis or other central nervous
system (CNS) depressants,
including alcohol, may result in profound sedation, respiratory
depression, coma, and death.
Limit dosages and durations to the minimum required; and monitor
patients for signs and
symptoms of respiratory depression and sedation. Caution patients not
to drink alcohol while
taking OXYCODONE WKT.
OXYCODONE WKT PI-V 4.1
Page
2 of 16
1
NAME OF THE MEDICINE
Oxycodone hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
OXYCODONE WKT 10 mg in 1 mL; 20 mg in 2 mL Solution for injection or
infusion contains 10mg/ml
of oxycodone hydrochloride.
The inactive ingredients i