OXYCODONE HCl 20 mg/2 mL MEDSURGE oxycodone hydrochloride 20 mg/2 mL solution for injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

oxycodone hydrochloride, Quantity: 20 mg

Available from:

Medsurge Pharma Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

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

Administration route:

Subcutaneous, Intravenous

Units in package:

5 X 20 mg/2 mL, 10 x 20 mg/2 mL

Prescription type:

(S8) Controlled Drug

Therapeutic indications:

Oxycodone HCL Medsurge solution for injection or infusion 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: Clear colourless or yellowish solution; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2020-07-23

Patient Information leaflet

OXYCODONE HCL
OXYCODONE HYDROCHLORIDE
CMI Edition 2.0 October 2020
1 | P a g e
_CONSUMER MEDICINE INFORMATION _
WARNING
LIMITATIONS OF USE
Oxycodone hydrochloride solution for injection or infusion 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 hydrochloride solution for injection or infusion 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 hydrochloride solution for injection or infusion 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
hydrochloride solution for injection or infusion 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 hydrochloride solution
for injection or infusion
Using Oxycodone hydrochloride solution for injection or infusion 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
hydrochloride solution for injection or infusion.
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Oxycodone hydrochloride
solution for injection or infusion
("injection or infusion").
It does not contain all the
available information. It does not
t

Summary of Product characteristics

OXYCODONE HYDROCHLORIDE
_ _
PRODUCT INFORMATION
Edition 3.0 January 2022
Page
1
of
19
AUSTRALIAN PRODUCT INFORMATION
OXYCODONE HCL 10 MG/1 ML MEDSURGE
OXYCODONE HCL 20 MG/2 ML MEDSURGE
OXYCODONE HCL 50 MG/1 ML MEDSURGE
(OXYCODONE HYDROCHLORIDE)
SOLUTION FOR INJECTION OR INFUSION
WARNINGS
_LIMITATIONS OF USE _
Because of the risks associated with the use of opioids, Oxycodone
hydrochloride injection or infusion
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 hydrochloride injection or infusion 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
hydrochloride injection or infusion. 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
on Oxycodone hydrochloride
injection or infu