Oxycodone HCl (Medsurge)

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Oxycodone hydrochloride 10 mg/mL;  

Available from:

Medsurge Pharma Limited

Dosage:

20 mg/2mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Oxycodone hydrochloride 10 mg/mL   Excipient: Citric acid monohydrate Hydrochloric acid Nitrogen Sodium chloride Sodium citrate dihydrate Sodium hydroxide Water for injection

Prescription type:

Class B3 Controlled Drug

Therapeutic indications:

Indicated for the management of opioid-responsive moderate to severe pain.

Product summary:

Package - Contents - Shelf Life: Ampoule, glass, Type 1, 20 mg in 2 mL - 5 dose units - 36 months from date of manufacture stored at or below 25°C 24 hours diluted stored at 2° to 8°C (Refrigerate, do not freeze) - Ampoule, glass, Type 1, 20 mg in 2 mL - 10 dose units - 36 months from date of manufacture stored at or below 25°C 24 hours diluted stored at 2° to 8°C (Refrigerate, do not freeze)

Authorization date:

2020-08-18

Patient Information leaflet

OXYCODONE HCL
OX
YCODONE HYDROCHLORIDE
CMI Edition 1.0 September 2022
1 | P a g e
_CONSUMER MEDICINE INFORMATION _
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
take the place of talking to your
doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you being
given this medicine against the
benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, TALK
TO DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET IN A SAFE
PLACE.
You may need to read it again.
WHAT OXYCODONE
HYDROCHLORIDE
INJECTION OR INFUSION
IS GIVEN FOR
Oxycodone hydrochloride
solution for injection or infusion
contains oxycodone
hydrochloride. Oxycodone
belongs to a group of medicines
called opioid analgesics.
Oxycodone hydrochloride
injection or infusion is given to
relieve moderate to severe pain.
It can be given as a single
injection or as an infusion into a
vein or into the tissue under the
skin.
Your doctor, however, may
prescribe it for another purpose.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED
FOR YOU.
As with all strong painkillers, your
body may become used to you
having oxycodone. Being given
this medicine may result in
physical dependence. Physical
dependence means that you may
experience withdrawal symptoms
if you stop having oxycodone
suddenly, so it is important that
you are given Oxycodone
hydrochloride injection or infusion
exactly as directed by your
doctor.
This medicine is only available
with a doctor's prescription.
BEFORE YOU ARE GIVEN
OXYCODONE
HYDROCHLORIDE
INJECTION OR INFUSION
Long term use of Oxycodone
hydrochloride injection or solution
may result in a decrease in sex
hormone levels which may affect
sperm production in men and the
menstrual cycle in females.
TALK TO YOUR DOCTOR IF YOU HAVE
ANY CONCERNS.
WHEN YOU MUST NOT HAVE
THIS MED

Summary of Product characteristics

New Zealand Data Sheet Edition 1- September 2022
Page 1 of 18
NEW ZEALAND DATA SHEET
1 PRODUCT NAME
OXYCODONE HCL 10 mg/1 mL (MEDSURGE) solution for injection or infusion
OXYCODONE HCL 20 mg/2 mL (MEDSURGE) solution for injection or infusion
OXYCODONE HCL 50 mg/1 mL (MEDSURGE) solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Oxycodone hydrochloride 10 mg/1 mL
Oxycodone hydrochloride 20 mg/2 mL (10 mg/ 1 mL)
Oxycodone hydrochloride 50 mg/1 mL
For the full list of excipients, see Section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
Oxycodone hydrochloride 10 mg/1 mL and 20 mg/2 mL; solution for
injection or infusion.
Oxycodone hydrochloride 50 mg/1 mL; solution for infusion.
Oxycodone hydrochloride 10 mg/1 mL, 20 mg/2 mL and 50 mg/1 mL solution
for injection/infusion is a
clear colourless or yellowish solution, practically free from
particulates
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
The management of opioid-responsive moderate to severe pain.
Oxycodone hydrochloride is indicated in adults over 18 years.
4.2
Dose and method of administration
Adults, elderly and children over 18 years:
Prior to initiation and titration of doses, refer to Section 4.4
Special warnings and precautions for use for
information on special risk groups such as females and the elderly.
The lowest dose should be
administered with careful titration to pain control.
Dose:
The dose should be adjusted to the intensity of the pain and the
sensitivity of the individual patient. The
patient's previous history of analgesic requirements, their body
weight, and sex (higher plasma
concentrations are produced in females), should also be taken into
account when determining the dose.
Generally, the lowest effective dose for analgesia should be selected.
If higher doses are necessary,
increases should be made in 25% - 50% increments where possible.
The correct dosage per individual patient is that which controls the
pain with no or tolerable side effects.
Adults over 18 years:
The following doses are recommended. A gradual incre