TORADOL Ketorolac Trometamol 30mg/1mL injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ketorolac trometamol, Quantity: 30 mg/mL

Available from:

Atnahs Pharma Australia Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: ethanol; sodium chloride; sodium hydroxide; hydrochloric acid; water for injections

Administration route:

Intramuscular

Units in package:

5 x 1mL

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

TORADOL is indicated for the short-term management of moderately severe, acute pain following surgical procedures. The total duration of ketorolac use should not exceed five days. It is recommended that ketorolac parenteral be used in the immediate post-operative period. Patients can then be converted to the oral formulation (dependent on their analgesic needs), as outlined in the Dosage and Administration Section (Refer to Conversion from Parenteral to Oral Therapy). The total period of treatment utilising the oral and /or intramuscular route of administration is not to exceed five days. General: TORADOL is not recommended for use as an obstetrical pre-operative medication or for obstetrical analgesia because it has not been adequately studied for use in these circumstances and because the known effects of drugs that inhibit prostaglandin biosynthesis on uterine contraction and foetal circulation. There is no satisfactory evidence for the use of TORADOL in acute exacerbations of chronic painful inflammatory

Product summary:

Visual Identification: Slightly yellow clear solution.; Container Type: Ampoule; Container Material: Glass Type I Coloured; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

1992-04-02

Patient Information leaflet

TORADOL
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING TORADOL?
TORADOL contains the active ingredient ketorolac trometamol. TORADOL
is used to relieve pain and reduce inflammation (swelling
and soreness) that may occur following surgery. For more information,
see Section 1. Why am I using TORADOL? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE TORADOL?
Do not TORADOL if you are pregnant or intend to become pregnant, or if
you are breastfeeding or intend to breastfeed. Do not use
TORADOL if you are allergic to TORADOL, aspirin or any other NSAID
medicine, or any of the ingredients listed at the end of this
leaflet. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS
OR TAKE ANY OTHER MEDICINES. For more information, see
Section 2. What should I know before I use TORADOL? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with TORADOL and affect how it works. A
list of these medicines is in Section 3. What if I am taking
other medicines? in the full CMI.
4.
HOW DO I USE TORADOL?
•
TORADOL is given as an injection, into a muscle by a doctor or trained
nurse. The usual dose for healthy adults is 10 mg to
30 mg every 4 to 6 hours, up to a maximum daily dose of 90 mg. More
information can be found in Section 4. How do I use
TORADOL? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING TORADOL?
THINGS YOU
SHOULD DO
•
Call your doctor straight away if you become pregnant while receiving
TORADOL.
•
Tell your doctor if you get an infection soon after taking TORADOL.
THINGS YOU
SHOULD NOT DO
•
Do not receive TORADOL for longer than 5 days. Prolonged use may
increase the occurrence of side
effects.
DRIVING
OR USING
MACHINES
•
Be careful before you drive or use any machines or tools until you
know how TORADOL affects you.
•
As with other NSAID medicines, TORADOL may cause dizzi

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION - TORADOL
®
(KETOROLAC TROMETAMOL)
1. NAME OF THE MEDICINE
Ketorolac trometamol
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
TORADOL is available as ketorolac trometamol 10 mg/1 mL (1%) and 30
mg/1 mL (3%) sterile solutions for
injection for intramuscular (IM) administration only or as a
film-coated tablet containing 10 mg of ketorolac
trometamol.
Excipients with known effect in injections: alcohol present as 12.7%
v/v of ethanol
Excipients with known effect in tablets: sugars as lactose
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
TORADOL Intramuscular Injection: 10 mg/1 mL and 30 mg/1 mL clear and
slightly yellow in colour sterile
solutions.
TORADOL Tablets: White to creamy white film coated tablets imprinted
“KET 10” in black.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
TORADOL is indicated for the short-term management of moderately
severe, acute pain following surgical
procedures. The total duration of ketorolac use should not exceed five
days.
_IT IS RECOMMENDED THAT KETOROLAC PARENTERAL BE USED IN THE IMMEDIATE
POST-OPERATIVE PERIOD. _
_PATIENTS CAN THEN BE CONVERTED TO THE ORAL FORMULATION (DEPENDENT ON
THEIR ANALGESIC NEEDS), AS _
_OUTLINED IN SECTION 4.2 DOSE AND METHOD OF ADMINISTRATION (REFER TO
CONVERSION FROM _
_INTRAMUSCULAR TO ORAL THERAPY). THE TOTAL PERIOD OF TREATMENT
UTILISING THE ORAL AND/OR INTRAMUSCULAR _
_ROUTE OF ADMINISTRATION IS NOT TO EXCEED FIVE DAYS. _
GENERAL
TORADOL is not recommended for use as an obstetrical pre-operative
medication or for obstetrical
analgesia because it has not been adequately studied for use in these
circumstances and because the
known effects of drugs that inhibit prostaglandin biosynthesis on
uterine contraction and foetal circulation.
There is no satisfactory evidence for the use of TORADOL in acute
exacerbations of chronic painful
inflammatory conditions (e.g. rheumatoid or osteoarthritis).
WARNING
TORADOL is a potent NSAID analgesic and the resulting NSAID-related