Ketorolac trometamol 30mg/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 Ketorolac, 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, pentoxifylline (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
• are pregnant, in labour, in delivery or breast feeding
• are under 16 years of age.
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.
Pregnancy and breast-feeding
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.
Driving and using machines
Ketorolac Injection may make you feel dizzy or drowsy, you may also get headaches, visual disturbances, vertigo or have difficulty sleeping. If you experience any of these you should not drive or operate machines.
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.
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)
• or a drug called mifepristone (used to induce abortion, usually through hospitals). Ketorolac should not be used for 8 -12 days after taking mifepristone.
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.
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, abnormal thinking and feelings, inability to concentrate, inability to sleep, convulsions, giddiness, hyperactivity, a mild form of meningitis, hallucinations, abnormal dreams
• dry mouth, mouth ulcers, sore throat, excessive thirst, alterations of vision, taste or hearing
• muscle pain, numbness or tingling, muscle spasms or weakness
• 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 or kidney pain
• 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
• 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.
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.