KETOROLAC APOTEX ketorolac trometamol 10 mg/1 mL solution for injection ampoule
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
10-08-2015
Summary of Product characteristics
(SPC)
11-08-2015
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
Ketorolac trometamol
Available from:
Apotex Pty Ltd
INN (International Name):
Ketorolac trometamol
Patient Information leaflet
KETOROLAC APOTEX
SOLUTION FOR INJECTION
_Contains the active ingredient ketorolac trometamol_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY FOR
INFORMATION ON YOUR MEDICINE.
This leaflet answers some common
questions about KETOROLAC
solution for injection. It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information.
You can also download the most up
to date leaflet from
www.apotex.com.au.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
Keep this leaflet with you. You may
want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is
KETOROLAC APOTEX solution
for injection. It contains the active
ingredient ketorolac trometamol.
Ketorolac belongs to a family of
medicines called Non-Steroidal Anti-
Inflammatory Drugs (NSAIDs).
Ketorolac relieves pain and reduces
inflammation (swelling and soreness)
that may occur following surgery.
Although ketorolac can relieve the
symptoms of pain and inflammation,
it will not cure your condition.
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you. Your
doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
There is no evidence that ketorolac is
addictive.
_USE IN CHILDREN_
DO NOT GIVE KETOROLAC TO A CHILD
UNDER 16 YEARS OF AGE.
The safety and effectiveness in
children under 16 have
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Summary of Product characteristics
Product Information – Australia
KETOROLAC APOTEX Solution for Injection
Page 1
KETOROLAC APOTEX SOLUTION FOR INJECTION
NAME OF THE MEDICINE
Ketorolac trometamol.
Chemical Name:
2-Amino-2-(Hydroxyethyl) propane-1, 3-diol (1_RS_)-5-benzoyl-2,
3-dihydro-1_H_
pyrrolizine-1-carboxylate.
Structural Formula:
And enantiomer
WARNING
Ketorolac is a potent NSAID analgesic and the resulting NSAID-related
adverse effects can be
serious, for example gastrointestinal haemorrhage, surgical
haemorrhage and renal impairment.
Increasing the dose of ketorolac beyond the recommendations in the
product information will not
provide better efficacy but will result in increasing risk of
developing serious adverse effects.
Molecular Formula:
C
19
H
24
N
2
O
6
Molecular Weight:
376.41
CAS Registry Number:
74103-07-4
DESCRIPTION
Ketorolac Solution for Injection
(ketorolac trometamol; synonym ketorolac tromethamine) is a non-
narcotic analgesic belonging to the non-steroidal anti-inflammatory
drug (NSAID) class of medicines
with analgesic, anti-inflammatory and antipyretic properties.
Ketorolac Solution for Injection is a member of the pyrrolo-pyrrole
group of NSAIDs. Ketorolac
trometamol
is
2-Amino-2-(Hydroxyethyl)
propane-1,
3-diol
(1_RS_)-5-benzoyl-2,
3-dihydro-1_H_
pyrrolizine-1-carboxylate. The medicine is structurally and
pharmacologically related to tolmetin and
indomethacin, however, unlike these pyrrole acetic acid derivatives,
ketorolac is a cyclic propionic
derivative. Ketorolac solution for injection is a racemic mixture of
[-] S and [+] R enantiomers, with the
S-form
having
analgesic
activity.
Ketorolac
is
a
white
to
off-white
crystalline
substance
which
discolours on exposure to light. It is soluble in water and has a pKa
of 3.54.
Each ampoule contains ketorolac as the active ingredient as a sterile
solution for intramuscular (IM)
administration only. The injection solutions are clear and slightly
yellow in colour. In addition, each
ampoule contains the following inactive ingredients: ethanol, sodium
chloride, water for injec
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