KETOROLAC JUNO
Active ingredient(s): ketorolac trometamol
Consumer Medicine Information (CMI)
This leaflet provides important information about using ketorolac. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using this medicine.
Where to find information in this leaflet:
1. Why am I using KETOROLAC JUNO?
2. What should I know before I use KETOROLAC JUNO?
3. What if I am taking other medicines?
4. How do I use KETOROLAC JUNO?
5. What should I know while using KETOROLAC JUNO?
6. Are there any side effects?
7. Product details
1. Why am I using KETOROLAC JUNO?
Ketorolac Juno contains the active ingredient ketorolac trometamol. Ketorolac belongs to a group of medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).
Ketorolac is used to relieve pain and reduce inflammation (swelling and soreness) that may occur following surgery. Although ketorolac can relieve the symptoms of pain and inflammation, it will not cure your condition.
Your doctor may have prescribed ketorolac for another purpose.
2. What should I know before I use KETOROLAC JUNO?
Warnings
Do not use Ketorolac Juno if you:
- are allergic to ketorolac, aspirin or any other NSAID medicine, or any of the ingredients listed at the end of this leaflet. Many medicines used to treat headache, period pain and other aches and pains contain aspirin or NSAID medicines. If you are not sure if you are taking any of these medicines, ask your doctor or pharmacist. If you are allergic to aspirin or NSAID medicines and use ketorolac, these symptoms may be severe. Symptoms of an allergic reaction to these medicines may include:
– asthma, wheezing or shortness of breath
– swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing
– hives, itching or skin rash
– fainting
Always check the ingredients to make sure you can use this medicine.
- are pregnant
- are breastfeeding
- have kidney disease
- have severe liver disease
- have severe heart failure
- have recently had or are about to have heart bypass surgery
- have a peptic ulcer (stomach or duodenal ulcer), a recent history of one, or have had peptic ulcers before
- have had any bleeding disorders
- have asthma
- suffer dehydration
- have nasal polyps syndrome, angioedema or bronchospasm (breathing difficulties)
- have a history of Stevens-Johnsons Syndrome (a rare skin condition with severe blisters and bleeding in the lips, eyes, mouth, nose and genitals)
- are receiving the following medicines:
– other NSAID medicines
– probenecid, a medicine used to treat gout
– lithium, a medicine used to treat some types of depression
– oxpentifylline, a medicine used to treat certain blood disorders.
Do not give this Ketorolac Juno to a child under 16 years of age. The safety and effectiveness in children under 16 have not been established.
If you are not sure if you should be given this medicine, contact your doctor.
Check with your doctor if you:
- have any other medical conditions, especially the following:
– heartburn, indigestion, stomach ulcers or other stomach problems
– kidney or liver disease
– heart failure
– high blood pressure or heart problems
– swelling of the ankles or feet
– inflammatory bowel disease, such as Crohn’s disease - take any medicines for any other condition
- you have any allergies to:
– any other medicines
– any other substances, such as foods, preservatives or dyes - you currently have an infection. Ketorolac may hide some of the signs of an infection (eg pain, fever) and may make you think that the infection is not serious or that you are better
- you plan to have surgery
- you have ever smoked or been a heavy alcohol drinker
If you have not told your doctor about any of the above, tell them before you are given ketorolac.
During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?
Pregnancy and breastfeeding
You must not use Ketorolac Juno if you are pregnant. Ketorolac may affect your developing baby if you receive it during pregnancy.
Ketorolac may impair fertility and is not recommended in women attempting to conceive. If it is necessary for you to be given Ketorolac Juno, your doctor will discuss the risks and benefits of receiving it.
Your must not use Ketorolac Juno if you are breast-feeding. Ketorolac passes into breast milk. The effect on the baby is not known.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines may interfere with ketorolac and affect how it works. These include:
- aspirin, salicylates or other NSAID medicines (such as ibuprofen or naproxen)
- warfarin, a medicine used to stop blood clots
- probenecid, a medicine used to treat gout
- oxpentifylline, a medicine used to treat certain blood disorders
- lithium, a medicine used to treat some types of depression
- selective serotonin reuptake inhibitors (SSRIs), medicines used to treat depression (such as fluoxetine, paroxetine or citalopram)
- thiothixene, a medicine used to treat psychosis
- diuretics, also called fluid or water tablets
- phenytoin, a medicine used to treat epilepsy
- carbamazepine, a medicine used to treat epilepsy
- methotrexate, a medicine used to treat arthritis and some cancers
- heparin, a medicine used to treat blood disorders
- medicines used to treat high blood pressure, including ACE inhibitors, angiotensin receptor antagonists and beta-blockers.
- certain antibiotics called aminoglycosides
You may need to use different amounts of your medicine, or you may need to use different medicines. Your doctor will advise you.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Ketorolac Juno.
4. How do I use KETOROLAC JUNO?
How Ketorolac Juno is given
- Ketorolac Juno is given as an injection, into a muscle by a doctor or trained nurse.
- The injection should not be injected directly into the veins (intravenously).
- Your doctor will decide what dose you will receive.
This depends on your condition. - 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.
- If you are over 65 years old or have reduced kidney function, your doctor may prescribe a lower dose.
When Ketorolac Juno is given
- Ketorolac Juno is given every 4 to 6 hours as required, up to a maximum daily dose of 90 mg.
How long Ketorolac Juno is given for
- Ketorolac Juno is not given for longer than five days.
Prolonged use may increase the occurrence of side effects.
If you receive too much Ketorolac Juno
If you receive too much ketorolac, you may have pain or tenderness in the stomach, stomach upset including nausea (feeling sick), vomiting, heartburn, indigestion or cramps. If you think that you have used too much ketorolac, you may need urgent medical attention.
You should immediately:
- phone the Poisons Information Centre (by calling 13 11 26), or
- contact your doctor, or
- go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
If you are not sure what to do, contact your doctor or pharmacist.
5. What should I know while using KETOROLAC JUNO?
Things you should do
Call your doctor straight away if you:
- become pregnant
- get an infection soon after receiving ketorolac.
Ketorolac may hide some of the signs of an infection and may make you think, mistakenly, that the infection is not serious or that you are better. Signs of an infection may include fever, pain, swelling and redness.
Remind any doctor, dentist or pharmacist you visit that you are using ketorolac.
If you are going to have surgery, tell the surgeon or anaesthetist that you are being given this medicine.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how ketorolac affects you.
As with other NSAID medicines, ketorolac may cause dizziness or light-headedness in some people. Make sure you know how you react to ketorolac before you drive a car, operate machinery, or do anything else that could be dangerous if you are dizzy or light-headed. If this occurs do not drive.
Drinking alcohol
Tell your doctor if you drink alcohol.
If you drink alcohol, dizziness or light-headedness may be worse.
Looking after your medicine
Ketorolac Juno will be stored in the pharmacy or on the hospital ward. It is kept in a cool dry place where the temperature stays below 25°C. It should be protected from light.
Getting rid of any unwanted medicine
If your no longer need this medicine or it is out of date, take it to any pharmacy for safe disposal.
Do not use this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.
Other side effects not listed here may occur in some people. Tell your doctor if you notice anything else that is making you feel unwell.
Less serious side effects
| Less serious side effects | What to do |
Gastrointestinal or gut related:
Head related:
Skin related:
Muscle related:
Injection related:
Urinary or bladder related:
|
Speak to your doctor if you have any of these less serious side effects and they worry you. |
Serious side effects
| Serious side effects | What to do |
Head related:
Bleeding related:
Pain related:
Other:
|
Tell your doctor immediately if you notice any of these side effects. You may need urgent medical attention. These are serious side effects. Serious side effects are rare. |
Very serious side effects
| Very serious side effects | What to do |
Gastrointestinal or gut related:
Allergic reaction related:
|
Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are rare. |
Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.
7. Product details
This medicine is only available with a doctor’s prescription.
Ketorolac Juno is not addictive
What Ketorolac Juno contains
| Active ingredient (main ingredient) |
Each 30 mg/mL Ketorolac Juno ampoule contains 30 mg of ketorolac trometamol |
| Other ingredients (inactive ingredients) |
ethanol sodium chloride sodium hydroxide water for injections |
| Allergen information | This medicine does not contain lactose, sucrose, gluten, tartrazine or other azo dyes. |
Do not take this medicine if you are allergic to any of the ingredients contained in this product.
What Ketorolac Juno looks like
A clear, colourless to slight yellow solution in 1 mL glass ampoules.
Australian registration numbers
AUST R 211626
Who distributes Ketorolac Juno
Juno Pharmaceuticals Pty Ltd
42 Kelso Street,
Cremorne,
VIC – 3121
This leaflet was prepared in February 2022.
