Patient leaflet - Ketorolac Trometamol 30 mg / ml solution for injection
1. WHAT KETOROLAC INJECTION IS AND WHAT IT IS USED FOR
Ketorolac belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).
Ketorolac Injection is used to relieve moderate or severe pain after a surgical operation.
2. BEFORE YOU ARE GIVEN KETOROLAC INJECTION
You must not be given Ketorolac Injection and you should talk to your doctor immediately if you:
- are allergic to any other NSAID or aspirin
- have previously had or have peptic ulcers (ulcer in your stomach or duodenum), bleeding in your stomach or perforation
- have bleeding from a damaged blood vessel in the brain
- have problems with bleeding or blood clotting disorders
- have nasal polyps, allergic swellings (of the skin, around the mouth, eyes, nose or the genitals)
- have asthma or a history of asthma
- are taking other NSAIDs (such as ibuprofen), aspirin (to treat circulatory disease), probenecid (to treat gout) or lithium salts (to treat nervous disorders)
- are taking medicines to thin the blood
- are dehydrated or have lost a lot of blood
- have severe heart failure
- have liver failure
- have recently had an operation with a high risk of bleeding or bleeding that has not been completely stopped
- are about to have surgery
- have moderate or severe kidney disease or kidney failure
- are under 16 years of age.
You must not be given Ketorolac Injection if any of the above apply to you. If you are not sure, talk to your doctor or nurse before you are given Ketorolac Injection.
Before you are given Ketorolac Injection, tell your doctor if you:
- have stomach problems or are passing black tarry stools or blood
- have problems with breathing
- have problems with your kidneys or liver
- have heart problems or high blood pressure. Medicines such as Ketorolac Injection may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment. If you have heart problems, previous stroke or think 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 pharmacist.
- have a decrease in the usual amount of urine you pass
- have swollen hands, feet or other parts of your body
- have bleeding or bruising at the site of your operation
- are planning to become pregnant.
- recently had or you are going to have a surgery of the stomach or intestinal tract before being given Ketorolac Injection, as Ketorolac Injection can sometimes worsen wound healing in your gut after surgery.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Ketorolac Injection should not be given if you are pregnant, in labour, during delivery or if you are breast-feeding. Ketorolac may make it more difficult to become pregnant. You should tell your doctor if you are planning to become pregnant or if you have problems becoming pregnant. It can cause kidney and heart problems in your unborn baby. It may affect your and your baby’s tendency to bleed and cause labour to be later or longer than expected.
You should not take Ketorolac Injection during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If you need treatment during this period or while you are trying to get pregnant, the lowest dose for the shortest time possible should be used.
If taken for more than a few days from 20 weeks of pregnancy onward, Ketorolac Injection can cause kidney problems in your unborn baby that may lead to low levels of amniotic fluid that surrounds the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the heart of the baby.
If you need treatment for longer than a few days, your doctor may recommend additional monitoring.
Driving and using machines
Ketorolac Injection may make you feel dizzy, tired or drowsy, you may also get headaches, visual disturbances, vertigo or have difficulty sleeping.
Important information about some of the ingredients of Ketorolac Injection
This medicinal product contains 100mg of ethanol (alcohol) per dose, equivalent to 2ml beer or 1 ml wine per dose.
This may be harmful for those suffering from alcoholism, and should be taken into account in children and high-risk groups such as those with liver disease, or epilepsy.
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Technical Leaflet:
KETOROLAC TROMETAMOL 30MG/ML SOLUTION FOR INJECTION
Please read this information carefully before using Ketorolac Injection. Further information is contained in the Summary of Product Characteristics
PRESENTATION
Ketorolac Trometamol 30mg/ml Solution for Injection (referred to as Ketorolac Injection) contains 30mg ketorolac trometamol in each 1 ml ampoule. Also contains ethanol, sodium chloride, sodium hydroxide and water for injections.
DOSAGE AND METHOD OF ADMINISTRATION
Ketorolac Injection is suitable for use as long as it remains clear and free of precipitate. Ketorolac Injection is for administration by intramuscular or bolus intravenous injection. Bolus intravenous doses should be given over at least 15 seconds. Ketorolac Injection should not be used for epidural or spinal administration.
The time to onset of analgesic effect following both IV and IM administration is approximately 30 minutes, maximum analgesia occurs within one to two hours. Analgesia normally lasts for four to six hours.
Adults: The recommended initial dose of Ketorolac Injection is 10mg followed by 10 to 30mg every four to six hours as required. In the initial post-operative period, Ketorolac Injection may be given as often as every two hours if needed. The lowest effective dose should be given. A total daily dose of 90mg for non-elderly and 60mg for the elderly, patients with renal impairment and patients less than 50kg should not be exceeded. The maximum duration of treatment should not exceed two days.
Opioid analgesics (e.g. morphine, pethidine) may be used concomitantly. When used with ketorolac, the daily dose of opioid is usually less than that normally required but opioid side effects should still be considered. Elderly patients should be monitored for GI bleeding.
Patients receiving Ketorolac Injection and oral ketorolac should receive a total combined daily dose not exceeding 90mg (60mg for the elderly, patients with renal impairment and patients less than 50kg). The oral component should not exceed 40mg on the day the change of formulation is made. Patients should be converted to oral treatment as soon as possible.
Children: Ketorolac Injection is not recommended for use in children under 16 years of age.
CONTRA-INDICATIONS
- active or previous peptic ulcer. History of upper gastrointestinal bleeding, ulceration or perforation
- suspected or confirmed cerebrovascular bleeding
- haemorrhagic diatheses, including coagulation disorders
- hypersensitivity to ketorolac trometamol or other NSAIDs and those patients in whom aspirin or other prostaglandin synthesis inhibitors induce allergic reactions
- the complete or partial syndrome of nasal polyps, angioedema or bronchospasm
- concurrent treatment with other NSAIDs including cylcooxygenase 2 specific inhibitors, aspirin, pentoxifylline, probenecid or lithium salts
- hypovolaemia from any cause or dehydration moderate or severe renal impairment (serum creatinine> 160 micromol/l)
- a history of asthma
- patients who have had operations with a high risk of haemorrhage or incomplete haemostasis
- patients on anti-coagulants including low dose heparin (2500 - 5000 units twelve hourly
- moderate or severe renal impairment or failure, severe heart failure, severe liver failure
Taking/using other medicines
Tell your doctor if you are taking, or have recently taken, any other medicine – even those not prescribed. This is important because ketorolac could alter how other medicines work.
These include medicines for:
- blood clots (anti-coagulants, pentoxifylline, antiplatelet agents)
- heart failure (furosemide, diuretics or cardiac glycosides such as digoxin)
- depression (lithium, selective serotonin reuptake inhibitors - SSRIs)
- high blood pressure (propranolol and other beta-blockers, ACE inhibitors)
- gout (probenecid), psoriasis (methotrexate) or arthritis (steroids)
- other NSAIDs (such as ibuprofen) or aspirin
- acute organ rejection (ciclosporin, tacrolimus)
- infections (quinolone antibacterials)
- HIV and AIDs (zidovudine)
- swelling and inflammation (steroids, like hydrocortisone, prednisolone and dexamethasone)or a drug called mifepristone (used to induce abortion, usually through hospitals). Ketorolac should not be used for 8 - 12 days after taking mifepristone.
- If any of the above apply to you, or if you are not sure, talk to your doctor or nurse before you are given Ketorolac Injection.
3. HOW KETOROLAC INJECTION SHOULD BE GIVEN
You will normally be given Ketorolac Injection whilst in hospital. A doctor or nurse will give the injection into a muscle or a vein.
The usual dose is 10mg initially, followed by 10-30mg every 4 to 6 hours. The dose may be lowered if you are over 65 years of age, you have kidney problems or if you weigh less than 50kg.
The maximum duration of treatment should not be more than 2 days.
Ketorolac Injection is not recommended for use in children under 16 years of age.
If you have the impression that the effect of Ketorolac Injection is too strong or too weak, talk to your doctor.
4. POSSIBLE SIDE EFFECTS
Like other medicines, Ketorolac Injection may cause side effects in some patients. Most patients are given ketorolac without experiencing problems.
Serious side effects
Tell your doctor IMMEDIATELY if any of the following occur:
- difficulty in breathing or wheezes, severe allergic reactions. You may have a hypersensitivity reaction, which can be very serious
- you pass blood in your faeces (stools/motions)
- you pass black tarry stools
- you vomit any blood or dark particles that look like coffee grounds.
- swelling of skin (hives), itching, rash, skin lesions, flaky skin or spots, blisters on skin, severe skin reactions including ulceration and peeling, skin sensitivity to light.
Other side effects
Tell your doctor or nurse if you have any of the following:
- sickness, indigestion or heart burn, stomach pain or discomfort, inflammation of the stomach, bleeding, problems with the pancreas, stomach ulcer, diarrhoea, belching, constipation or wind
- anxiety, drowsiness, tiredness, dizziness, headache, sweating, fever, agitation, nervousness, mental disturbances, mood changes, confusion, abnormal thinking and feelings, inability to concentrate, inability to sleep, convulsions, giddiness, hyperactivity, a mild form of meningitis, hallucinations, abnormal dreams
- headache, fit or seizures, difficulty with your memory
- dry mouth, mouth ulcers, sore throat, excessive thirst, alterations of vision, taste or hearing
- muscle pain, numbness or tingling, muscle spasms or weakness. Swelling of your hands, feet or legs (oedema). This may be with chest pains, tiredness, shortness of breath (cardiac failure).
- kidney problems, a change in the amount of urine passed or frequency in going to the toilet, blood in the urine, fluid retention, weight gain, kidney pain or kidney failure
- facial redness or paleness, bruising, anaemia, changes in the blood
- changes in blood pressure, palpitations, chest pain or slow heart beat. Medicines such as Ketorolac Injection may be associated with a small risk of increased heart attack (“myocardial infarction”) or stroke
- bleeding from the site of the operation or bruising or a nose bleed
- pain at the site of injection
- Problems for women in getting pregnant.
- jaundice (yellowing of the skin and whites of the eyes) and inflammation of the liver have been reported very rarely.
If you are concerned about any other side effects talk to your doctor.
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. STORING KETOROLAC INJECTION
The hospital will store the medicines. Ketorolac Injection should not be stored above 30°C. It should be kept in the original container and protected from light. Keep out of reach and sight of children.
Use by date: Ketorolac Injection should not be used after the date on the carton.
6. FURTHER INFORMATION
What is in this medicine:
Each 1 ml ampoule contains 30mg of the active ingredient ketorolac trometamol.
The ampoules also contain ethanol, sodium chloride, sodium hydroxide and water for injections.
What this medicine looks like and contents of the pack:
Ketorolac Injection is a colourless or slightly yellowish solution in amber glass ampoules. Each pack contains 6 or 100 ampoules.
Marketing authorisation holder: Kent Pharma UK Limited, 2nd Floor, Connect 38, 1 Dover Place, Ashford, Kent, England, TN23 1FB.
Manufacturer: Laboratorio Reig Jofré S.A, Barcelona, Spain.
Date of approval: 04/2024
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- during pregnancy, labour, delivery or lactation
- children under 16 years of age
- Ketorolac is contra-indicated as prophylactic analgesia before surgery intra-operatively.
INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION
Ketorolac should not be used with other NSAIDs or in patients receiving aspirin because of the potential for additive side-effects.
Ketorolac injection is contraindicated in combination with anti-coagulants such as warfarin since co-administration may cause an enhanced anti-coagulant effect.
Ketorolac may reduce the diuretic response to furosemide (approx. 20%) so particular care should be taken in patients with cardiac decompensation.
Ketorolac and other non-steroidal anti-inflammatory drugs can reduce the anti-hypertensive effect of beta-blockers and may increase the risk of renal impairment when administered concurrently with ACE inhibitors, particularly in volume depleted patients.
NSAIDs may exacerbate cardiac failure, reduce GFR and increase plasma cardiac glycoside levels when co-administered with cardiac glycosides.
Care is advised when methotrexate is co-administered. Some prostaglandin synthesis inhibiting drugs may reduce the clearance of methotrexate, possibly enhancing its toxicity.
Probenecid should not be administered concurrently with ketorolac because of increases in ketorolac plasma level and half-life.
As with all NSAIDs caution is advised when ciclosporin or tacrolimus is co-administered because of the increased risk of nephrotoxicity.
NSAIDs should not be used for 8-12 days after mifepristone. NSAIDs can reduce the effects of mifepristone.
Caution should be taken when co-administering with cortico-steroids because of the increased risk of GI bleeding.
Patients taking quinolones may have an increased risk of developing convulsions.
Co-administration with diuretics can lead to a reduced diuretic effect, and increase the risk of nephrotoxicity of NSAIDs.
Because of an increased tendency to bleeding co-administration with pentoxifylline should be avoided.
In patients receiving lithium there is a possible inhibition of renal lithium clearance, increased plasma lithium concentration and potential lithium toxicity.
Antiplatelet agents and SSRIs may increase the risk of GI bleeding.
Co-administration with Zidovudine may result in haematological toxicity.
INCOMPATIBILITIES
Ketorolac Injection should not be mixed in a small volume (e.g. in a syringe) with morphine sulphate, pethidine hydrochloride, promethazine hydrochloride or hydroxyzine hydrochloride, as precipitation of ketorolac will occur.
Ketorolac Injection is compatible with normal saline, 5% dextrose, Ringer's, lactated Ringer's or Plasmacyte solutions. Compatibility of Ketorolac Injection with other drugs is unknown.