Toradol

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Ketorolac trometamol

Available from:

Roche Products Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

TORADOL
®
 TABLETS

_contains the active ingredient ketorolac trometamol_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about TORADOL tablets.
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 taking TORADOL
tablets against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT TORADOL IS
USED FOR
TORADOL belongs to a family of
medicines called Non-Steroidal Anti-
Inflammatory Drugs (NSAIDs).
TORADOL relieves pain and reduces
inflammation (swelling and soreness)
that may occur following surgery.
Although TORADOL can relieve the
symptoms of pain and inflammation,
it will not cure your condition.
Your doctor may have prescribed
TORADOL for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS WHY TORADOL HAS
BEEN PRESCRIBED FOR YOU.
This medicine is available only with
a doctor's prescription.
TORADOL is not addictive.
BEFORE YOU TAKE
TORADOL
_WHEN YOU MUST NOT TAKE IT_
1. DO NOT TAKE TORADOL IF: YOU
HAVE AN ALLERGY TO:
-
TORADOL OR ANY
INGREDIENTS LISTED AT THE END
OF THIS LEAFLET
-
ASPIRIN OR ANY OTHER NSAID
MEDICINE
Many medicines used to treat
headache, period pain and other
aches and pains contain aspirin or
NSAID medicines. If you are not
sure if you are taking any of these
medicines, ask your pharmacist.
Symptoms of an allergic reaction to
these medicines may include:
•
asthma, wheezing or shortness of
breath
•
swelling of the face, lips or
tongue which may cause
difficulty in swallowing or
breathing
•
hives, itching or skin rash
•
fainting
If you are allergic to aspirin or
NSAID medicines and take
TORADOL, these symptoms may be
severe.
2. YOU ARE PREGNANT, OR INTEND TO
BECOME PREGNANT
 TORADOL may affect your
developing baby if you

Summary of Product characteristics

 
TORADOL

 PI 120203                                     

 Page 1 of 16 

NAME OF THE MEDICINE 

TORADOL
® 

(KETOROLAC  TROMETAMOL) 

_CAS Registry number:  74103-07-4 _
_ _

DESCRIPTION 

TORADOL
®
 (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. 

TORADOL is a member of the pyrrolo-pyrrole group of NSAIDs. 
Ketorolac trometamol is (_RS_)-5-
benzoyl-2,3-dihydro-1_H_-pyrrolizine-1-carboxylic
acid, 2-amino-2-(hydroxymethyl)propane-1,3-diol 
salt.  The  medicine  is structurally and pharmacologically related to
tolmetin and indomethacin, 
however, unlike these pyrrole acetic acid derivatives,
ketorolac is a cyclic propionic derivative.  
TORADOL 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. 

TORADOL is available as 10 mg/mL (1%) and 30 mg/mL (3%) sterile solutions for injection
for 
intramuscular  (IM)  administration only.
 The  injection  solutions  are clear and slightly yellow in 
colour.  Excipients for the injections are: ethanol,
sodium chloride, water for injections and sodium 
hydroxide or hydrochloric acid to adjust pH. 

TORADOL is also available as a 10 mg white to creamy white,
round, bi-convex, film-coated tablet 
imprinted in black ink with "KET 10" on
one side. Excipien