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TORADOL 30 MG/ML SOLUTION FOR INJECTION

Active substance(s): KETOROLAC TROMETAMOL

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New code 28045503

GB 724-6234-APIL

Size: 318 x 420 mm

Date: 21.04.15 Version 6 B/code:
Update: 15.05.15 18.05.15 29.07.15 30.07.15 22.09.15

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Information: Toradol 30mg/ml solution for injection
Pharma code:

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Type size: 11pt.

PL 43252/0009

Folding format: 50 x 53 mm

10140673 GB Drawing Norm E11-363-B
Miles Gray Road, Basildon,
Essex. SS14 3FR United Kingdom © 2015

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28045503

28045503
GB 724-6234-APIL

Package leaflet: Information for the patient

Toradol®

30 mg/ml solution for injection
Ketorolac trometamol

Read all of this leaflet carefully before
you start being given this medicine
because it contains important
information for you.

● Keep this leaflet. You may need to read it
again.
● If you have any further questions, ask your
doctor or nurse.
● If you get any side effects, talk to your
doctor, pharmacist or nurse. This
includes any possible side effects not listed
in this leaflet.
What is in this leaflet:
1. What Toradol is and what it is used for
2. What you need to know before you are
given Toradol
3. How Toradol is given
4. Possible side effects
5. How Toradol is stored
6. Contents of the pack and other information

1. What Toradol is and what
it is used for
Toradol contains a medicine called ketorolac
trometamol. This is a ‘Non Steroidal Anti
Inflammatory Drug’ or NSAID.
Toradol is used in hospital, for pain
relief after operations. Toradol can
lessen pain, swelling, redness and heat
(inflammation).

2. What you need to know
before you are given Toradol
You must not be given Toradol if you are
allergic (hypersensitive) to:

● Ketorolac trometamol or any of the other
ingredients of Toradol (listed in Section 6).
● Aspirin or other NSAIDs (such as ibuprofen
or diclofenac).

You must not be given Toradol if:

Check with your doctor or nurse before being
given Toradol if any of the following apply to
you:
● You are elderly (you are more likely to
suffer problems).
● Problems with your kidneys or liver.
● High blood pressure.
● Problems with the blood vessels (arteries)
anywhere in your body.
● Too much fat (lipid) in your blood
(hyperlipidaemia).
● An autoimmune condition, such as ‘systemic
lupus erythematosus’ (SLE, which causes
joint pain, skin rashes and fever) and colitis
or Crohn’s disease (conditions causing
inflammation of the bowel, bowel pain,
diarrhoea, vomiting and weight loss).
If any of the above apply to you, or if you are
not sure, talk to your doctor or nurse before
you are given Toradol.

● You are aged under 16.
● You now have or have ever had any
problems with your stomach or gut
(intestine) like an ulcer or bleeding.
● You have severe problems with your liver
or heart.
● You have moderate or severe problems
with your kidneys.
● You have ever had bleeding in your brain.
● You have a problem that causes you to
bleed easily, including a condition like
haemophilia.
● You are taking medicines to stop your blood
clotting, like warfarin, heparin or clopidogrel.
● You have a low blood volume (caused by
bleeding or severe dehydration).
● You have asthma or allergies (like hayfever)
or have had swelling of the face, lips, eyes
or tongue in the past.
● You have or have had lumps in your nose
(polyps).
● You are taking other NSAIDs, like
ibuprofen or aspirin.
● You are taking oxpentifylline (for your
circulation), probenecid (for gout) or
lithium (for mental health problems).
● You plan to get pregnant, are pregnant, in
labour or are breast-feeding.
● You are about to have an operation.
● You have been advised you have a high risk
of bleeding after an operation or are still
bleeding after an operation.
You must not be given Toradol if any of the above
apply to you. If you are not sure, talk to your
doctor or nurse before you are given Toradol.

Other medicines and Toradol

Tell your doctor or nurse if you are taking, have
recently taken or might take any other medicines.
In particular, tell your doctor or nurse if you
are taking any of the following medicines
before you are given Toradol:
● Other NSAIDs, like aspirin, ibuprofen or
diclofenac.
● Medicines to stop your blood clotting, like
warfarin, heparin or clopidogrel.
● Oxpentifylline (for your circulation).
● Probenecid (for gout).
● Lithium (for mental health problems).
If you are taking any of the above medicines
you must not be given Toradol.

Warnings and precautions

Tell your doctor or nurse if you are taking:
● An ‘ACE inhibitor’ or other medicine for
high blood pressure, like cilazapril,
enalapril or propranolol.
● A diuretic (water tablet) (for high blood
pressure), like furosemide.
● A ‘cardiac glycoside’ (for heart problems),
like digoxin.

Talk to your doctor or nurse before being
given Toradol. If you have heart problems,
previous stroke or think that 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 nurse.

● A steroid (for swelling and inflammation),
like hydrocortisone, prednisolone and
dexamethasone.
● A ‘quinolone antibiotic’ (for infections),
like ciprofloxacin or moxifloxacin.
● Certain medicines for mental health
problems ‘SSRIs’, like fluoxetine
or citalopram.
● Methotrexate (used to treat skin problems,
arthritis or cancer).
● Ciclosporin or tacrolimus (for skin
problems or after an organ transplant).
● Zidovudine (used to treat AIDS and HIV
infections).
● Mifepristone (used to end pregnancy or to
bring on labour if the baby has died).
If any of the above apply to you, or if
you are not sure, talk to your doctor or nurse
before you are given Toradol.

Pregnancy, breast-feeding and fertility

Toradol may make it more difficult to become
pregnant. You should inform your doctor if
you are planning to become pregnant or if you
have problems becoming pregnant.
You must not be given Toradol if you are
pregnant, in labour or are breastfeeding.

Driving and using machines:

Toradol may make you tired, drowsy, dizzy,
have problems with your balance or eyesight,
depressed or have difficulty sleeping. Talk to
your doctor if any of these happen to you and
do not drive or use any tools or machines.

Toradol contains sodium and alcohol:

Toradol is essentially ‘sodium free’
as it contains less than 1 mmol sodium
(23 mg per 1 ml). This medicine contains a
small amount of ethanol (alcohol),
100 mg per dose.

1

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This information is intended for medical or healthcare professionals only:
The tear-off portion above is intended for the patient
INFORMATION FOR HEALTHCARE PROFESSIONALS

Toradol® 30 mg/ml solution for injection
Ketorolac trometamol

Please refer to the Summary of Product Characteristics for full prescribing
information.

Presentation

Glass ampoules containing 30 mg/ml ketorolac
trometamol. The solution is clear and slightly
yellow in colour. Excipients are ethanol
sodium chloride and water. Cartons of 1, 5 or
10 ampoules. Not all pack sizes may be
marketed.
Important information about the
excipients in Toradol Ampoules.
Each Toradol 30 mg/ml ampoule contains
100 mg ethanol and 4.35 mg sodium chloride.

Posology and method of administration

Dosage should be adjusted according to the
severity of the pain and the patient response.

Toradol is for administration by intramuscular
or bolus intravenous injection. Bolus
intravenous doses should be given over no
less than 15 seconds. Toradol should not be
used for epidural or spinal administration.

The administration of continuous multiple
daily doses of ketorolac intramuscularly or
intravenously should not exceed two days
because adverse events may increase with
prolonged usage. There has been limited
experience with dosing for longer periods
since the vast majority of patients have
transferred to oral medication, or no longer
require analgesic therapy after this time.

The time to onset of analgesic effect following
both IV and IM administration is similar and
is approximately 30 minutes, with maximum
analgesia occurring within one to two hours.
The median duration of analgesia is generally
four to six hours.
1

Undesirable effects may be minimised by
using the lowest effective dose for the shortest
duration necessary to control symptoms

Adults

The recommended initial dose of Toradol is
10 mg, followed by 10 to 30 mg every four
to six hours as required. In the initial
post-operative period, Toradol may be given as
often as every two hours if needed. The lowest
effective dose should be given. A total daily
dose of 90 mg for non-elderly and 60 mg for
the elderly, renally-impaired patients and
Please turn over

New code 28045503

GB 724-6234-APIL

Date: 21.04.15 Version 6 B/code:
Update: 15.05.15 18.05.15 29.07.15 30.07.15 22.09.15

Previous ref:

Information: Toradol 30mg/ml solution for injection
Pharma code:

Folding format: 50 x 53 mm

10140673 GB Drawing Norm E11-363-B
Miles Gray Road, Basildon,
Essex. SS14 3FR United Kingdom © 2015

3. How Toradol is given
Medicines such as Toradol may be associated
(linked) with a small increased risk of heart
attack (‘myocardial infarction’) or stroke.
Any risk is more likely with higher doses and
prolonged (longer term) treatment.
Toradol will be given to you by a doctor or nurse.
It will be given to you by injection into a muscle
(such as into your arm) or into a vein. The
maximum length of treatment should be two days.

Children

Toradol is not recommended for use in
children under 16 years of age.

Adults

● The usual starting dose is 10 mg.
● This can be followed by a dose of 10 to
30 mg every 4 to 6 hours, as needed.
● The maximum dose is 90 mg each day.
● Your doctor may also give you other pain
killers (such as pethidine or morphine) if
your pain is severe.

People over 65 years of age, or with
kidney problems or who weigh less than
50 kg.
● Your doctor will usually give you doses
lower than those described for adults.
● The maximum dose is 60 mg each day.
● Your doctor may also give you other pain
killers (such as pethidine or morphine) if
your pain is severe.

If you have any further questions on the use of
this medicine, ask your doctor or nurse.

4. Possible side effects
Like all medicines Toradol can cause side
effects, although not everyone will get them.
Medicines such as Toradol may be associated
with a small increased risk of heart attack
(‘myocardial infarction’) or stroke.

Important side effects to look out for:
Tell a doctor or nurse straight away if
any of the following side effects happen.
You may need urgent medical treatment:
Serious stomach or gut problems,
signs include:
● Bleeding from the stomach, seen as vomit
which has blood in it, or bits that look like
coffee grounds.
● Bleeding from your back passage (anus),
seen as passing black sticky bowel motions
(stools) or bloody diarrhoea.
● Ulcers or holes forming in your stomach or
gut. This may be seen as upset stomach with
stomach pain, fever, feeling or being sick.
● Problems with your pancreas, seen as severe
stomach pain which spreads to your back.

PAGE 2 of 2

PL 43252/0009

Colour PMS

Notes: Special instructions:
Type size: 11pt.

Size: 318 x 420 mm

Black

Technical approval

‘OK for printing PDF’

Date:.......................

Date:.......................

Signed:...................

Signed:...................

● Worsening of ulcerative colitis or Crohn’s
disease, seen as pain, diarrhoea, vomiting
and weight loss.

● Blood problems, like anaemia,
not enough platelets or changes to the
numbers of white blood cells.

Allergic reactions, signs include:
● Sudden swelling of your throat, face, hands
or feet.
● Difficulty breathing, tightness in your chest.
● Skin rashes, blisters or itching.

Mental illness

● Having difficulty sleeping or changes
in your patterns of dreaming.
● Depression.
● Feeling worried (anxious) or nervous
or extremely happy (euphoria).
● Seeing and possibly hearing things that are
not really there (hallucinations).
● Mental problems which may make you feel
confused, restless and disturbed (agitated)
and lose contact with reality.

Severe skin rashes, signs include:
● A severe rash that develops quickly,
with blisters or peeling of your skin and
possibly blisters in your mouth,
throat or eyes. Fever, headache, cough and
aching body may happen at the same time.

Nervous system

Heart attack, signs include:
● Chest pain which may spread to your neck
and shoulders and down your left arm.

● Headache.
● Fits or seizures, feeling dizzy
or light-headed or sleepy.
● Pins and needles or numbness
of your hands and feet.
● Difficulty with your memory
or concentration.

Stroke, signs include:
● Muscle weakness and numbness.
This may only be on one side of your body.
● A suddenly altered sense of smell,
taste, hearing or vision, confusion.

Eyes and ears

● Changes to your eyesight, eye pain.
● Changes to your hearing, including ringing
in the ears (tinnitus) and hearing loss.
● Dizziness that causes problems with your
balance.

Meningitis, signs include:
● Fever, feeling or being sick, a stiff neck,
headache, sensitivity to bright light
and confusion (most likely in people with
autoimmune conditions such as ‘systemic
lupus erythematosus’).

Heart and circulation

● Swelling of your hands, feet or legs (oedema).
This may be with chest pains, tiredness,
shortness of breath (cardiac failure).
● A fluttering feeling in your heart
(palpitations) slow heart beat or high blood
pressure.
● Problems with the way your heart pumps
blood around the body.
Signs may include tiredness, shortness of
breath, feeling faint.

Liver problems, signs include:
● Yellowing of your skin or the whites
of your eyes (jaundice).
● Feeling tired, loss of appetite, feeling
or being sick and pale coloured stools
(hepatitis) and problems (including
hepatitis), shown in blood tests.
Problems passing water (urine),
signs include:
● A feeling of fullness and a need to empty
your bladder, but then difficulty in
emptying it.

Chest

● Difficulty breathing, including
shortness of breath, wheezing or coughing.
● Swelling of your lungs.

If you notice any of the serious side effects
mentioned above, tell your doctor or nurse
straight away.

Skin and hair

● Light sensitivity, skin rashes
including redness, hives, pimples and
blisters on your body and face.
● Itching or sweating, pale skin or
redness of the face and neck (flushing).

Other possible side effects:
Stomach and gut
● Heartburn, indigestion, stomach ache,
feeling sick or being sick, constipation,
diarrhoea, wind.
● Burping or a feeling of fullness.

Urinary

● Blood in your water (urine) or kidney
problems.
● Going to the toilet more often to pass water,
or going less often.
● Pain in your side.

Blood

● Bleeding from your wound after
an operation or nosebleeds.
● A swelling filled with blood.
● Blood problems, like too much potassium
or not enough sodium.

Other

● Pain where the injection was given.
● Thirst, dry mouth, taste changes, fever,
weight gain or weight loss.
2

patients less than 50 kg should not be
exceeded. The maximum duration of treatment
should not exceed two days.
Reduce dosage in patients under 50 kg.

Elderly

The elderly are at increased risk of the serious
consequences of adverse reactions. If an
NSAID is considered necessary, the lowest
effective dose should be used and for the
shortest possible duration. The patient should
be monitored regularly for GI bleeding during
NSAID therapy. A total daily dose of 60 mg
should not be exceeded.

Children

Safety and efficacy in children have not been
established. Therefore, Toradol is not
recommended for use in children under
16 years of age.

Mode of administration

Renal impairment

Contra-indicated in moderate to severe renal
impairment; reduce dosage in lesser
impairment (not exceeding 60 mg/day
IV or IM).

Toradol is for administration by intramuscular
or bolus intravenous injection. Bolus
intravenous doses should be given over no
less than 15 seconds. Toradol should not be
used for epidural or spinal administration.

Special dosage instructions

Do not use Toradol Ampoules if particulate
matter is present.

Opioid analgesics (e.g. morphine, pethidine)
may be used concomitantly, and may be
required for optimal analgesic effect in the
early post-operative period when pain is most
severe. Toradol does not interfere with opioid
binding and does not exacerbate opioidrelated respiratory depression or sedation.
When used in association with Toradol
ampoules, the daily dose of opioid is usually
less than that normally required. However,
opioid side-effects should still be considered,
especially in day-case surgery.

Toradol is compatible with normal saline, 5%
dextrose, Ringer’s, lactated Ringer’s or
Plasmalyte solutions. Compatibility of
Toradol with other drugs is unknown.






Feeling tired or generally unwell.
A sore mouth.
Muscle spasms, pain or weakness.
Problems for women in getting pregnant.

If any of the side effects become serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or nurse.

Reporting 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
By reporting side effects you can help provide
more information on the safety of this medicine.
5. How Toradol is stored
● Your doctor or pharmacist is responsible for
storing Toradol. They are also responsible for
disposing of any unused Toradol correctly.
● Keep out of the sight and reach of children.
● Do not use Toradol after the expiry date
printed on the pack.

6. Contents of the pack and
other information
What Toradol contains

The active substance in ‘Toradol 30 mg/ml
solution’ is ketorolac trometamol.
Each 1 ml of liquid medicine contains
30 mg (milligrams) of ketorolac trometamol.
Other ingredients are ethanol, sodium chloride
and water.

What Toradol looks like and contents of
the pack
Toradol is a clear, slightly yellow liquid
(‘solution for injection’). This liquid
may be further diluted to make it weaker
before it is given to you.

Toradol is supplied in glass ampoules (small
bottles) containing 1 ml of solution, in packs
of 1, 5 or 10. Not all packs may be marketed.

Marketing Authorisation Holder

Atnahs Pharma UK Limited
Sovereign House, Miles Gray Road,
Basildon, Essex SS14 3FR
United Kingdom.

Manufacturer

Cenexi
52 rue Marcel et Jacques Gaucher
94120 FONTENAY SOUS BOIS
France

This leaflet was last revised in
September 2015
Shelf life

Unopened: 3 years.

Special precautions for storage

Keep the ampoules in the outer carton.
Do not refrigerate or freeze.
Do not use if particulate matter is present.

Date of preparation of leaflet
September 2015

Incompatibilities

Toradol 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.

2

GB 724-6234-APIL 28045503

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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