Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
ketorolac trometamol, Quantity: 10 mg
Atnahs Pharma Australia Pty Ltd
Tablet, film coated
Excipient Ingredients: microcrystalline cellulose; lactose monohydrate; magnesium stearate; titanium dioxide; macrogol 8000; hypromellose
Oral
20 tablets
(S4) Prescription Only Medicine
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 conditions (e.g. rheumatoid or osteoarthritis)
Visual Identification: White to creamy white film coated tablets engraved 'KET 10' on one side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
1998-10-12
TORADOL ® TABLETS T O R A D O L ® T A B L E T S 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? • Your doctor will tell you how many TORADOL tablets to take each day. The usual dose is 1 tablet every 4 to 6 hours (maximum of 4 tablets per day). 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 taking TORADOL. • Tell your doctor is you get an infection soon after receiving 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 dizziness or light-headedness in some people. DRINK Read the complete document
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 Read the complete document