Toradol 30 Mg/Ml Solution For Injection
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Toradol®
30 mg/ml solution for injection
Ketorolac trometamol
Read all of this leaflet carefully before
you start being given this medicine
because it contains important
information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
What is in this leaflet:
1. What Toradol is and what it is used for
2. What you need to know before you are given Toradol
3. How Toradol is given
4. Possible side effects
5. How Toradol is stored
6. Contents of the pack and other information
1. What Toradol is and what it is used for
Toradol contains a medicine called ketorolac trometamol. This is a ‘Non Steroidal Anti Inflammatory Drug’ orNSAlD.
Toradol is used in hospital, for pain relief after operations. Toradol can lessen pain, swelling, redness and heat (inflammation).
2. What you need to know before you are given Toradol
You must not be given Toradol if you are allergic (hypersensitive) to:
• Ketorolac trometamol or any of the other ingredients of Toradol (listed in Section 6).
• Aspirin or other NSAIDs (such as ibuprofen or diclofenac).
You must not be given Toradol if:
• You are aged under 16.
• You now have or have ever had any problems with your stomach or gut (intestine) like an ulcer or bleeding.
• You have severe problems with your liver or heart.
• You have moderate or severe problems with your kidneys.
• You have ever had bleeding in your brain.
• You have a problem that causes you to bleed easily, including a condition like haemophilia.
• You are taking medicines to stop your blood clotting, like warfarin, heparin or clopidogrel.
• You have a low blood volume (caused by bleeding or severe dehydration).
• You have asthma or allergies (like hayfever) or have had swelling of the face, lips, eyes or tongue in the past.
• You have or have had lumps in your nose (polyps).
• You are taking other NSAIDs, like ibuprofen or aspirin.
• You are taking oxpentifylline (for your circulation), probenecid (for gout) or lithium (for mental health problems).
• You plan to get pregnant, are pregnant, in labour or are breast-feeding.
• You are about to have an operation.
• You have been advised you have a high risk of bleeding after an operation or are still bleeding after an operation.
You must not be given Toradol if any of the above apply to you. If you are not sure, talk to your doctor or nurse before you are given Toradol.
Warnings and precautions
Talk to your doctor or nurse before being given Toradol. If you have heart problems, previous stroke or think that you might be at risk of these conditions (for example if you have high blood pressure, diabetes or high cholesterol or are a smoker) you should discuss your treatment with your doctor or nurse.
Check with your doctor or nurse before being given Toradol if any of the following apply to you:
• You are elderly (you are more likely to suffer problems).
• Problems with your kidneys or liver.
• High blood pressure.
• Problems with the blood vessels (arteries) anywhere in your body.
• Too much fat (lipid) in your blood (hyperlipidaemia).
• An autoimmune condition, such as ‘systemic lupus erythematosus’ (SLE, which causes joint pain, skin rashes and fever) and colitis or Crohn’s disease (conditions causing inflammation of the bowel, bowel pain, diarrhoea, vomiting and weight loss).
If any of the above apply to you, or if you are not sure, talk to your doctor or nurse before you are given Toradol.
Other medicines and Toradol
Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines. In particular, tell your doctor or nurse if you are taking any of the following medicines before you are given Toradol:
• Other NSAIDs, like aspirin, ibuprofen or diclofenac.
• Medicines to stop your blood clotting, like warfarin, heparin or clopidogrel.
• Oxpentifylline (for your circulation).
• Probenecid (for gout).
• Lithium (for mental health problems).
If you are taking any of the above medicines you must not be given Toradol.
Tell your doctor or nurse if you are taking:
• An ‘ACE inhibitor’ or other medicine for high blood pressure, like cilazapril, enalapril or propranolol.
• A diuretic (water tablet) (for high blood pressure), like furosemide.
• A ‘cardiac glycoside’ (for heart problems), like digoxin.
• A steroid (for swelling and inflammation), like hydrocortisone, prednisolone and dexamethasone.
• A ‘quinolone antibiotic’ (for infections), like ciprofloxacin or moxifloxacin.
• Certain medicines for mental health problems ‘SSRIs’, like fluoxetine or citalopram.
• Methotrexate (used to treat skin problems, arthritis or cancer).
• Ciclosporin or
tacrolimus (for skin problems or after an organ transplant).
• Zidovudine (used to treat AIDS and HIV infections).
• Mifepristone (used to end pregnancy or to bring on labour if the baby has died).
If any of the above apply to you, or if you are not sure, talk to your doctor or nurse before you are given Toradol.
Pregnancy, breast-feeding and fertility
Toradol may make it more difficult to become pregnant. You should inform your doctor if you are planning to become pregnant or if you have problems becoming pregnant.
You must not be given Toradol if you are pregnant, in labour or are breast-feeding.
Driving and using machines
Toradol may make you tired, drowsy, dizzy, have problems with your balance or eyesight, depressed or have difficulty sleeping. Talk to your doctor if any of these happen to you and do not drive or use any tools or machines.
Toradol contains sodium and alcohol
Toradol is essentially ‘sodium free’ as it contains less than 1 mmol sodium (23 mg per 1 ml). This medicine contains a small amount of ethanol (alcohol),
100 mg per dose.
This information is intended for medical or healthcare professionals only: The tear-off portion above is intended for the patient
INFORMATION FOR HEALTHCARE PROFESSIONALS
Toradol® 30 mg/ml solution for injection
Ketorolac trometamol
Please refer to the Summary of Product Characteristics for full prescribing information.
Presentation
Glass ampoules containing 30 mg/ ml ketorolac trometamol. The solution is clear and slightly yellow in colour. Excipients are ethanol, sodium chloride and water. Cartons of 1, 5 or 10 ampoules. Not all pack sizes may be marketed.
Important information about the excipients in Toradol Ampoules.
Each Toradol 30 mg/ ml ampoule contains 100 mg ethanol and 4.35 mg sodium chloride.
Posology and method of administration
Toradol is for administration by intramuscular or bolus intravenous injection. Bolus intravenous doses should be given over no less than 15 seconds. Toradol should not be used for epidural or spinal administration.
The time to onset of analgesic effect following both IV and IM administration is similar and is approximately 30 minutes, with maximum analgesia occurring within one to two hours. The median duration of analgesia is generally four to six hours.
Dosage should be adjusted according to the severity of the pain and the patient response.
The administration of continuous multiple daily doses of ketorolac intramuscularly or intravenously should not exceed two days because adverse events may increase with prolonged usage. There has been limited experience with dosing for longer periods since the vast majority of patients have transferred to oral medication, or no longer require analgesic therapy after this time.
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms
Adults
The recommended initial dose of Toradol is 10 mg, followed by 10 to 30 mg every four to six hours as required. In the initial post-operative period, Toradol may be given as often as every two hours if needed. The lowest effective dose should be given. A total daily dose of 90 mg for non-elderly and 60 mg for the elderly, renally-impaired patients and
3. How Toradol is given
Medicines such as Toradol may be associated (linked) with a small increased risk of heart attack (‘myocardial infarction’) or stroke.
Any risk is more likely with higher doses and prolonged (longer term) treatment.
Toradol will be given to you by a doctor or nurse. It will be given to you by injection into a muscle (such as into your arm) or into a vein. The maximum length of treatment should be two days.
Children
Toradol is not recommended for use in children under 16 years of age.
Adults
• The usual starting dose is 10 mg.
• This can be followed by a dose of 10 to 30 mg every 4 to 6 hours, as needed.
• The maximum dose is 90 mg each day.
• Your doctor may also give you other pain killers (such as pethidine or morphine) if your pain is severe.
People over 65 years of age, or with kidney problems or who weigh less than 50 kg
• Your doctor will usually give you doses lower than those described for adults.
• The maximum dose is 60 mg each day.
• Your doctor may also give you other pain killers (such as pethidine or morphine) if your pain is severe.
If you have any further questions on the use of this medicine, ask your doctor or nurse.
4. Possible side effects
Like all medicines Toradol can cause side effects, although not everyone will get them. Medicines such as Toradol may be associated with a small increased risk of heart attack ("myocardial infarction’) or stroke.
Important side effects to look out for:
Tell a doctor or nurse straight away if any of the following side effects happen. You may need urgent medical treatment:
Serious stomach or gut problems,
signs include:
• Bleeding from the stomach, seen as vomit which has blood in it, or bits that look like coffee grounds.
• Bleeding from your back passage (anus), seen as passing black sticky bowel motions (stools) or bloody diarrhoea.
• Ulcers or holes forming in your stomach or gut. This may be seen as upset stomach with stomach pain, fever, feeling or being sick.
• Problems with your pancreas, seen as severe stomach pain which spreads to your back.
• Worsening of ulcerative colitis or Crohn’s disease, seen as pain, diarrhoea, vomiting and weight loss.
Allergic reactions, signs include:
• Sudden swelling of your throat, face, hands or feet.
• Difficulty breathing, tightness in your chest.
• Skin rashes, blisters or itching.
Severe skin rashes, signs include:
• A severe rash that develops quickly, with blisters or peeling of your skin and possibly blisters in your mouth,
throat or eyes. Fever, headache, cough and aching body may happen at the same time.
Heart attack, signs include:
• Chest pain which may spread to your neck and shoulders and down your left arm.
Stroke, signs include:
• Muscle weakness and numbness.
This may only be on one side of your body.
• A suddenly altered sense of smell, taste, hearing or vision, confusion.
Meningitis, signs include:
• Fever, feeling or being sick, a stiff neck, headache, sensitivity to bright light
and confusion (most likely in people with autoimmune conditions such as ‘systemic lupus erythematosus’).
Liver problems, signs include:
• Yellowing of your skin or the whites of your eyes (jaundice).
• Feeling tired, loss of appetite, feeling or being sick and pale coloured stools (hepatitis) and problems (including hepatitis), shown in blood tests.
Problems passing water (urine),
signs include:
• A feeling of fullness and a need to empty your bladder, but then difficulty in emptying it.
If you notice any of the serious side effects
mentioned above, tell your doctor or nurse
straight away.
Other possible side effects:
Stomach and gut
• Heartburn, indigestion, stomach ache, feeling sick or being sick, constipation, diarrhoea, wind.
• Burping or a feeling of fullness.
Blood
• Bleeding from your wound after an operation or nosebleeds.
• A swelling filled with blood.
• Blood problems, like too much potassium or not enough sodium.
• Blood problems, like anaemia,
not enough platelets or changes to the number of white blood cells.
Mental illness
• Having difficulty sleeping or changes in your patterns of dreaming.
• Depression.
• Feeling worried (anxious) or nervous or extremely happy (euphoria).
• Seeing and possibly hearing things that are not really there (hallucinations).
• Mental problems which may make you feel confused, restless and disturbed (agitated) and lose contact with real ity.
Nervous system
• Headache.
• Fits or seizures, feeling dizzy or light-headed or sleepy.
• Pins and needles or numbness of your hands and feet.
• Difficulty with your memory or concentration.
Eyes and ears
• Changes to your eyesight, eye pain.
• Changes to your hearing, including ringing in the ears (tinnitus) and hearing loss.
• Dizziness that causes problems with your balance.
Heart and circulation
• Swelling of your hands, feet or legs (oedema). This may be with chest pains, tiredness, shortness of breath (cardiac failure).
• A fluttering feeling in your heart (palpitations) slow heart beat or high blood pressure.
• Problems with the way your heart pumps blood around the body.
Signs may include tiredness, shortness of breath, feeling faint.
Chest
• Difficulty breathing, including shortness of breath, wheezing or coughing.
• Swelling of your lungs.
Skin and hair
• Light sensitivity, skin rashes including redness, hives, pimples and blisters on your body and face.
• Itching or sweating, pale skin or redness of the face and neck (flushing).
Urinary
• Blood in your water (urine) or kidney problems.
• Going to the toilet more often to pass water, or going less often.
• Pain in your side.
Other
• Pain where the injection was given.
• Thirst, dry mouth, taste changes, fever, weight gain or weight loss.
• Feeling tired or generally unwell.
• A sore mouth.
• Muscle spasms, pain or weakness.
• Problems for women in getting pregnant.
If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
5. How Toradol is stored
• Your doctor or pharmacist is responsible for storing Toradol. They are also responsible for disposing of any unused Toradol correctly.
• Keep out of the sight and reach of children.
• Do not use Toradol after the expiry date printed on the pack.
6. Contents of the pack and other information
What Toradol contains
The active substance in ‘Toradol 30 mg/ ml solution’ is ketorolac trometamol.
Each 1 ml of liquid medicine contains 30 mg (milligrams) of ketorolac trometamol.
Other ingredients are ethanol, sodium chloride and water.
What Toradol looks like and contents of the pack
Toradol is a clear, slightly yellow liquid (‘solution for injection’). This liquid may be further diluted to make it weaker before it is given to you.
Toradol is supplied in glass ampoules (small bottles) containing 1 ml of solution, in packs of 1, 5 or 10. Not all packs may be marketed.
Marketing Authorisation Holder and Manufacturer
Roche Products Limited 6 Falcon Way, Shire Park Welwyn Garden City, AL7 1TW United Kingdom
This leaflet was last revised in August 2013
patients less than 50 kg should not be exceeded. The maximum duration of treatment should not exceed two days.
Reduce dosage in patients under 50 kg.
Elderly
The elderly are at increased risk of the serious consequences of adverse reactions. If an NSAID is considered necessary, the lowest effective dose should be used and for the shortest possible duration. The patient should be monitored regularly for GI bleeding during NSAID therapy. A total daily dose of 60 mg should not be exceeded.
Children
Safety and efficacy in children have not been established. Therefore, Toradol is not recommended for use in children under 16 years of age.
Renal impairment
Contra-indicated in moderate to severe renal impairment; reduce dosage in lesser impairment (not exceeding 60 mg/day IV or IM).
Special dosage instructions
Opioid analgesics (e.g. morphine, pethidine) may be used concomitantly, and may be required for optimal analgesic effect in the early post-operative period when pain is most severe. Toradol does not interfere with opioid binding and does not exacerbate opioid-related respiratory depression or sedation. When used in association with Toradol ampoules, the daily dose of opioid is usually less than that normally required. However, opioid side-effects should still be considered, especially in day-case surgery.
Mode of administration
Toradol is for administration by intramuscular or bolus intravenous injection. Bolus intravenous doses should be given over no less than 15 seconds. Toradol should not be used for epidural or spinal administration.
Do not use Toradol Ampoules if particulate matter is present.
Toradol is compatible with normal saline, 5% dextrose, Ringer’s, lactated Ringer’s or
Plasmalyte solutions. Compatibility of Toradol with other drugs is unknown.
Incompatibilities
Toradol should not be mixed in a small volume (e.g. in a syringe) with morphine sulfate, pethidine hydrochloride, promethazine hydrochloride or hydroxyzine hydrochloride as precipitation of ketorolac will occur.
Shelf life
Unopened: 3 years.
Special precautions for storage
Keep the ampoules in the outer carton.
Do not refrigerate or freeze.
Do not use if particulate matter is present.
Date of preparation of leaflet
August 2013
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