Ketorolac Medsurge

Ketorolac Medsurge

Active ingredient(s): Ketorolac Trometamol

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Consumer Medicine Information (CMI)

This leaflet provides important information about using Ketorolac Medsurge. 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 Ketorolac Medsurge.

Where to find information in this leaflet:

1. Why am I using Ketorolac Medsurge?
2. What should I know before I use Ketorolac Medsurge?
3. What if I am taking other medicines?
4. How do I use Ketorolac Medsurge?
5. What should I know while using Ketorolac Medsurge?
6. Are there any side effects?
7. Product details

1. Why am I using Ketorolac Medsurge?

Ketorolac Medsurge contains the active ingredient Ketorolac trometamol. Ketorolac Medsurge belongs to a family of medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).

Ketorolac Medsurge is used to relieve pain and reduce inflammation (swelling and soreness) that may occur following surgery. Although Ketorolac Medsurge can relieve the symptoms of pain and inflammation, it will not cure your condition.

Your doctor may have prescribed Ketorolac Medsurge for another purpose.

Ask your doctor if you have any questions why Ketorolac Medsurge has been prescribed for you.

This medicine is available only with a doctor’s prescription.

Ketorolac Medsurge is not addictive.

2. What should I know before I use Ketorolac Medsurge?

Warnings

Do not use Ketorolac Medsurge if:

• you are allergic to Ketorolac trometamol, or any of the ingredients listed at the end of this leaflet.
  Always check the ingredients to make sure you can use this medicine.
• You are allergic to aspirin or any other NSAID medicine. 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.
• 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
• If you are allergic to aspirin or NSAID medicines and use Ketorolac Medsurge, these symptoms may be severe.
• If you have any other medical conditions-
  – kidney disease
  – severe liver disease
  – severe heart failure
  – recently had or about to have heart bypass surgery
  – peptic ulcer (stomach or duodenal ulcer), a recent history of one, or have had peptic ulcers before.
  – Had any bleeding disorders
  – Asthma
  – Suffer dehydration
  – Nasal polyps syndrome, angioedema
  – History of Stevens-Johnsons (a rare skin condition with severe blisters and bleeding in the lips, eyes, mouth, nose and genitals).
• If you 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
• the packaging is torn or shows signs of tampering.
• the expiry date (EXP) printed on the pack has passed.
  If you use this medicine after the expiry date has passed, it may not work as well.

If you are not sure if you should be given Ketorolac Medsurge, contact your doctor.

Check with your doctor if you:

• have allergies to-
  – any other medicines
  – Any other substances, such as foods, preservatives or dyes
• have any other medical conditions-
  – 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.
• currently have an infection.
  Ketorolac Medsurge 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 Medsurge.

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

Check with your doctor if you are pregnant or intend to become pregnant. Ketorolac Medsurge may affect your developing baby if you use it during pregnancy. It may impair fertility and is not recommended in women attempting to conceive.

If it is necessary for you to be given Ketorolac Medsurge, your doctor will discuss the risks and benefits of receiving it during pregnancy.

Talk to your doctor if you are breastfeeding or intend to breastfeed. Ketorolac Medsurge passes into breast milk. The effect on the baby is not known.

Use in Children

• Do not give Ketorolac Medsurge to a child under 16 years of age.
• The safety and effectiveness in children under 16 have not been established.

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 Medsurge and affect how it works. You may need to use different amounts of your medicine, or you may need to use different medicines. Your doctor will advise you.

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

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 Medsurge.

4. How do I use Ketorolac Medsurge?

How much to take / use

• Your doctor will decide what dose of Ketorolac Medsurge you will receive. This depends on your condition.
• Ketorolac Medsurge 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).
• 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.
• Follow the instructions provided when Ketorolac Medsurge was prescribed, including the number of days it should be taken.

When to take / use Ketorolac Medsurge

• Ketorolac Medsurge injection is given every 4 to 6 hours as required, up to a maximum daily dose of 90 mg.

If you forget to use Ketorolac Medsurge

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Do not take a double dose to make up for the dose you missed.

If you use too much Ketorolac Medsurge

If you think that you have used too much Ketorolac Medsurge, 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 receive too much Ketorolac Medsurge, you may have pain or tenderness in the stomach, stomach upset including nausea (feeling sick), vomiting, heartburn, indigestion or cramps.

If you are not sure what to do, contact your doctor or pharmacist

5. What should I know while using Ketorolac Medsurge?

Things you should do

Call your doctor straight away if you:

• If you become pregnant while receiving Ketorolac Medsurge.
• If you are going to have surgery tell your doctor you are being given Ketorolac Medsurge.
• If you get an infection soon after receiving Ketorolac Medsurge. Ketorolac Medsurge 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 Medsurge.

Things you should not do

• Do not receive Ketorolac Medsurge 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 Ketorolac Medsurge affects you.

As with other NSAID medicines, Ketorolac Medsurge may cause dizziness or light-headedness in some people.

Make sure you know how you react to Ketorolac Medsurge 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.

Alcohol may worsen dizziness or light-headedness.

Looking after your medicine

• Ketorolac Medsurge will be stored in the pharmacy or on the hospital ward at a temperature below 30°C.

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

• in the bathroom or near a sink, or
• in the car or on windowsills.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use 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.

Less serious side effects

Less serious side effects	What to do
stomach upset including nausea (feeling sick), heartburn, indigestion pain in the stomach or wind diarrhoea dizziness drowsiness headache sweating skin rash or hives aching muscles, muscle tenderness or weakness, not caused by exercise pain at site of injection dry mouth feeling extremely thirsty passing more or less urine than normal. These side effects of Ketorolac Medsurge are usually mild.	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

severe pain or tenderness in any part of the stomach or back severe dizziness, spinning sensation severe or persistent headache abnormal vision bleeding or bruising more easily than normal, reddish or purplish blotches under the skin unusual weight gain, swelling of ankles or legs possible signs of liver problems (nausea, tiredness, itchiness, decreased appetite/weight, pale stools, dark urine, fever, tenderness in the upper abdomen, flu-like symptoms) Serious side effects are rare.

Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Very serious side effects

Very serious side effects

What to do

vomiting blood or material that looks like coffee grounds bleeding from the back passage (rectum), black sticky bowel motions (stools) or bloody diarrhoea swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing asthma, wheezing, shortness of breath sudden or severe itching, skin rash or hives fainting, seizures or fits pain or tightness in the chest These are very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are rare.

Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

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.

Ask your doctor or pharmacist if you do not understand anything in this list.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

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.

What Ketorolac Medsurge contains

Active ingredient (main ingredient)	ketorolac trometamol
Other ingredients (inactive ingredients)	ethanol sodium chloride sodium hydroxidehydrochloric acid water for injections

Ketorolac Medsurge does not contain sucrose, gluten, tartrazine or any other azo dyes.

Do not take this medicine if you are allergic to any of these ingredients.

What Ketorolac Medsurge looks like

Ketorolac Medsurge is a clear and slightly yellow solution in 1 mL glass ampoules.

Ketorolac Medsurge is available as:

10 mg/mL solution for injection, 5 ampoules AUST R 370166

30 mg/mL solution for injection, 5 ampoules AUST R 370164

Who distributes Ketorolac Medsurge

Marketed and Distributed by Medsurge Healthcare.
Unit 1&2, 6-7 Gilda Court
Mulgrave, Victoria 3170
Telephone: 1300 788 261
Website: medsurge.com.au

This leaflet was prepared in August 2022.