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Ketorolac APOTEX

Contains the active ingredient ketorolac trometamol
Consumer Medicine Information
 

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about Ketorolac APOTEX. It does not contain all the information that is known about Ketorolac APOTEX. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, you may need to read it again.

What this medicine is used for

The name of your medicine is KETOROLAC APOTEX solution for injection. It contains the active ingredient ketorolac trometamol.
Ketorolac belongs to a family of medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).
Ketorolac relieves pain and reduces 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.
Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed this medicine for another reason.
This medicine is available only with a doctor's prescription.
There is no evidence that ketorolac is addictive.

Use in children

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

Before you are given this medicine

When you must not be given it

Do not use ketorolac if:
You have an allergy to:
ketorolac or any ingredients listed at the end of this leaflet
aspirin or any other NSAID medicine
Many medicines used to treat headache, period pain and other aches and pains contains 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.
You are pregnant or intend to be pregnant.
Ketorolac may affect your developing baby if you take it during pregnancy.
You are breastfeeding or intend to breastfeed.
Ketorolac may pass into human breast milk.
You have or have had any of the following:
kidney disease
severe heart failure
high blood pressure
a peptic ulcer (stomach or duodenal ulcer), a recent history of one, or have had peptic ulcers before
any bleeding disorders
asthma
you suffer dehydration
nasal polyps syndrome, angioedema or bronchospasm (breathing difficulties)
a history of Stevens-Johnsons Syndrome (a rare skin condition with severe blisters and bleeding in the lips, eyes, mouth, nose and genitals).
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
You are hypersensitive to, or have had an allergic reaction to, ketorolac or any of the ingredients listed at the end of this leaflet.
Symptoms of an allergic reaction may include: cough, shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue, throat or other parts of the body; rash, itching or hives on the skin; fainting; or hay fever-like symptoms.
If you think you are having an allergic reaction, tell your doctor immediately or go to the Accident and Emergency department at the nearest hospital.
Do not give ketorolac to a child under 16 years of age.
The safety and effectiveness in children under 16 have not been established.

Before you are given it

Before you are given this medicine, tell your doctor if:

1. You have allergies to:

any other medicines
any other substances, such as foods, preservatives or dyes.

2. You have or have had any 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.

3. You currently have an infection ketorolac may hide some of the signs of an infection (e.g. pain, fever) and may make you think that the infection is not serious or that you are better.

4. You intend to become pregnant ketorolac may impair fertility and is not recommended in women attempting to conceive.

5. You are planning to have surgery.

6. You are currently receiving or are planning to receive dental treatment.

7. You are taking or are planning to take any other medicines. This includes vitamins and supplements that are available from your pharmacy, supermarket or health food shop.

8. 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.
Some medicines may interact with ketorolac. 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
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
diuretics, also called fluid or water tablets
medicines used to treat high blood pressure, including ACE inhibitors, angiotensin receptor antagonists and beta-blockers
certain antibiotics called aminoglycosides
If you are taking any of these you may need a different dose or you may need to take different medicines.
Your doctor will advise you.
Other medicines not listed above may also interact with ketorolac.

How this medicine is given

How much is given

Your doctor will decide what dose of ketorolac 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.

How it is given

Ketorolac 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).

How long it is given for

Do not receive ketorolac for longer than 5 days.
Prolonged use may increase the occurrence of side effects.

If you receive too much (overdose)

If you think that you or anyone else may have been given too much of this medicine, tell your doctor, or go to the Accident and Emergency department at your nearest hospital.
Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
If you receive too much ketorolac, you may have pain or tenderness in the stomach, stomach upset including nausea (feeling sick), vomiting, heartburn or cramps.
If you are not sure what to do, contact your doctor or pharmacist.

While you are being given this medicine

Things you must do

Tell your doctor that you have been given this medicine if:
you are about to be started on any new medicine
you are pregnant or are planning to become pregnant tell your doctor immediately
you are breastfeeding or are planning to breastfeed
you are about to have any blood tests
you are going to have surgery or an anaesthetic or are going into hospital.
if you get an infection soon after receiving ketorolac, tell your doctor.
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.
Tell any other doctors, dentists and pharmacists who are treating you that you take this medicine.

Things to be careful of

Be careful when driving or operating machinery until you know how this medicine 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.
If you drink alcohol, dizziness or light-headedness may be worse.

Possible side effects

Tell your doctor as soon as possible if you do not feel well while you are receiving ketorolac or if you have any questions or concerns.
Do not be alarmed by the following lists of side effects. You may not experience any of them. All medicines can have side effects. Sometimes they are serious but most of the time they are not.
Tell your doctor if you notice any of the following:
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.
Tell your doctor as soon as possible if you notice any of the following.
These may be serious side effects and you may need medical attention:
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
If you experience any of the following, tell your doctor immediately or go to the Accident and Emergency department at your nearest hospital.
These are very serious side effects and you may need urgent medical attention or hospitalisation:
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
Other side effects not listed above may occur in some patients.

Allergic reactions

If you think you are having an allergic reaction to ketorolac tell your doctor immediately or go to the Accident and Emergency department at your nearest hospital.
Symptoms of an allergic reaction may include some or all of the following:
cough, shortness of breath, wheezing or difficulty breathing
swelling of the face, lips, tongue, throat or other parts of the body
rash, itching or hives on the skin
fainting
hay fever-like symptoms.

Storage and disposal

Storage

Ketorolac will be stored in the pharmacy or on the hospital ward. It is kept in a cool dry place where the temperature stays below 30°C. It should be protected from light.

Disposal

KETOROLAC solution for injection is used for one dose in one patient only. Any remaining contents should be discarded.

Product description

What KETOROLAC APOTEX Solution for Injection looks like

10mg/mL and 30mg/ml solutions for injection are clear and slightly yellow in colour.
Blister pack of 5 ampoules
* Not all strengths, pack types and/or pack sizes may be available.

Ingredients

Each ampoule contains 10 mg/mL KETOROLAC Solution for injection contains 10 mg of ketorolac trometamol
Each 30 ampoules contain mg/mL KETOROLAC Solution for injection contains 30 mg of ketorolac trometamol
It also contains the following inactive ingredients:
ethanol
sodium chloride
sodium hydroxide or hydrochloric acid
water for injections
This medicine is gluten-free, lactose-free, sucrose-free, tartrazine-free and free of other azo dyes.

Australian Registration Numbers

KETOROLAC APOTEX 10mg/mL solution for injection ampoules: AUST R 217074
KETOROLAC APOTEX 30mg/mL solution for injection ampoules: AUST R 217079

Sponsor

Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park NSW 2113
APO and APOTEX are registered trade marks of Apotex Inc.
APO and APOTEX are registered trade marks of Apotex Inc.
This leaflet was last updated in February 2015.