Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or nurse.
1. Why am I being given MIDAZOLAM INJECTION?
MIDAZOLAM INJECTION contains the active ingredient midazolam. It is used as a sedative
during short medical procedures, or as part of an operation, or may be needed if you
are in intensive care.
2. What should I know before being given MIDAZOLAM INJECTION?
Do not use if you have ever had an allergic reaction to midazolam or any other benzodiazepines
or any of the ingredients listed at the end of the CMI, have mysthenia gravis, short
angle glaucoma or immediate severe alcohol intoxication.
Talk to your doctor if you have any other medical conditions, including epilepsy,
sleep apnoea, kidney, liver, heart or respiratory problems; take any other medicines
or illegal drugs; or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with MIDAZOLAM INJECTION and affect how it works.
4. How is MIDAZOLAM INJECTION given?
5. What should I know during treatment with MIDAZOLAM INJECTION?
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Driving or using machines
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MIDAZOLAM INJECTION can affect driving and safe use of machinery and tools.
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Drinking alcohol
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Do not drink alcohol for at least 12 hours after receiving MIDAZOLAM INJECTION. Alcohol
can increase the risk of side effects including difficulty breathing and prolonged
sedation.
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Consuming caffeine
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Consuming caffeine (e.g. coffee, tea, energy drink, chocolate) may interfere with
MIDAZOLAM INJECTION.
Check with your doctor or nurse before consuming anything containing caffeine
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6. Are there any side effects?
Pain, redness or hardness around the site of injection; muscle stiffness or inflammation;
nausea, vomiting; headache; drowsiness,
tiredness, restlessness; dizziness, unsteadiness; hiccups; coughing; constipation;
dry mouth or excessive saliva, acid taste in mouth; rash, itchiness; problems with
vision; tingling or numbness of the hands or feet; feeling of extreme happiness, emotional,
mood and behavioral disturbances; uncontrollable twitching or jerking movements; nightmares,
abnormal dreams, sleep disturbance; difficulty with speaking; chest pain; trouble
breathing; confusion, hallucinations; signs of allergic reaction (rash, itching or
hives on the skin, swelling of the face, lips, tongue or other parts of the body,
shortness of breath, wheezing or trouble breathing).
Active ingredient(s):
midazolam
Full Consumer Medicine Information (CMI)
This leaflet provides important information about being given MIDAZOLAM INJECTION.
You should also speak to your doctor or nurse if you would like further information
or if you have any concerns or questions about being given MIDAZOLAM INJECTION.
Where to find information in this leaflet:
1. Why am I being given MIDAZOLAM INJECTION?
MIDAZOLAM INJECTION contains the active ingredient midazolam. MIDAZOLAM INJECTION belongs to a group of medicines called benzodiazepines.
MIDAZOLAM INJECTION is used as a sedative during short medical procedures, or it may
be needed if you are in intensive care. MIDAZOLAM INJECTION may also be given to help
induce anaesthesia before you are given another anaesthetic as part of an operation.
2. What should I know before being given MIDAZOLAM INJECTION?
Warnings
MIDAZOLAM INJECTION should not be given to you if:
you are allergic to midazolam or any other benzodiazepines, or any of the ingredients
listed at the end of this leaflet
you have myasthenia gravis
you have acute narrow angle glaucoma
you are in shock, coma or in acute alcoholic intoxication with depression of vital
signs.
Always check the ingredients to make sure you can be given this medicine.
Check with your doctor if you:
have any other medical conditions such as epilepsy, sleep apnoea, kidney, liver and
heart problems
have a history of alcohol or drug abuse
use illegal drugs, or medicines to treat insomnia anxiety, panic attacks, seizures
or tension
have breathing problems such as asthma, bronchitis, emphysema, or chronic obstructive
pulmonary disease
take any medicines for any other condition
Being given MIDAZOLAM INJECTION you may be at risk of developing certain side effects.
It is important you understand these risks. See additional information under Section
6. Are there any side effects?
Safety and effectiveness in children younger than 8 years have not been established.
Pregnancy and breastfeeding
Talk to your doctor if you are pregnant or are breastfeeding.
Your doctor can discuss with you the risks and benefits involved.
Use in the elderly
There is an increased risk for falls and fractures in elderly patients using this
type of medicine. The risk is increased if taking other sedatives.
3. What if I am taking other medicines?
Tell your doctor or nurse if you are taking any other medicines, including vitamins
or supplements that you buy without a prescription from your pharmacy, supermarket
or health food shop.
Some medicines may interfere with MIDAZOLAM INJECTION and affect how it works. These
include:
ketoconazole, voriconazole, fluconazole, itraconazole and posaconazole, medicines
for fungal infection.
rifampicin, erythromycin, clarithromycin, telithromycin, and roxithromycin, medicines
for bacterial infection.
ritonavir and saquinavir, efavirenz, medicines for viral infection including HIV.
cimetidine, medicine used for heartburn and stomach ulcers.
diltiazem, verapamil and ticagrelor, medicines for heart problems.
atorvastatin, medicine to lower cholesterol.
fentanyl, ketamine, propofol, medicines for anesthesia or pain relief.
fluvoxamine, nefazodone, and other medicines for mental health and emotional disorders.
imatinib, lapatinib, idelalisib, aprepitant, netupitant, bicalutamide, everolimus,
enzalutamide, vemurafenib, medicines used in cancer treatment.
ciclosporine, medicine used after transplant.
carbamazepine, phenytoin, valproic acid, medicines used to control epilepsy/seizure.
medicines to treat strong pain.
antihistamines, medicine used for allergies and colds.
physostigmine used to treat glaucoma.
St John’s wort, echinacea, quercetin, panax ginseng, berberine - herbal medicines.
Check with your doctor or nurse if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect MIDAZOLAM INJECTION.
4. How is MIDAZOLAM INJECTION given?
How much is given
Your doctor will decide what dose, how often and how long you will receive it. This
depends on your condition and other factors, such as your age, how well your kidneys
and liver are working, and whether other medicines are being given at the same time.
How is MIDAZOLAM INJECTION given
MIDAZOLAM INJECTION must only be given by a doctor or nurse.
MIDAZOLAM INJECTION is given as a single dose before a medical procedure, or continuously
by infusion. It is stopped once there is no further need for sedation.
It may be given as an injection into a vein or muscle, or given through slow infusion
“drip” into a vein.
If you are given too much MIDAZOLAM INJECTION
As MIDAZOLAM INJECTION is given under the close supervision of your doctor, it is
very unlikely that you will receive too much. Your condition will be carefully monitored
following administration.
However, if you are given too much midazolam, you may feel drowsy, tired, confused,
dizzy, weak or become unconscious.
Tell your doctor or nurse immediately if you are concerned that you may have been
given too much MIDAZOLAM INJECTION.
5. What should I know during treatment with MIDAZOLAM INJECTION?
Driving or using machines
Be careful before you drive or use any machines or tools until you know how MIDAZOLAM
INJECTION affects you.
After having MIDAZOLAM INJECTION, you may be drowsy or not fully alert. Your ability
to drive a car or to operate machinery may be affected for some time. MIDAZOLAM INJECTION
has the potential to affect driving and has an associated risk with road safety.
You should arrange to be accompanied home by a responsible adult. Ask your doctor when you can return to activities such as driving a vehicle or operating
machinery.
Drinking alcohol
Tell your doctor if you drink alcohol.
Do not drink alcohol for at least 12 hours after receiving MIDAZOLAM INJECTION.
Alcohol can increase the risk of side effects including difficulty breathing and prolonged
sedation.
Consuming Caffeine
Consuming caffeine (e.g. coffee, tea, energy drink, chocolate) may interfere with
MIDAZOLAM INJECTION. Check with your doctor or nurse before consuming anything containing
caffeine.
Looking after your medicine
MIDAZOLAM INJECTION is stored in the pharmacy or on the hospital ward under the correct
conditions.
Disposal of MIDAZOLAM INJECTION
The hospital staff will dispose of any leftover MIDAZOLAM INJECTION.
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 nurse if you have
any further questions about side effects.
Side effects
Tell your doctor or nurse 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/safety/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 nurse before you decide to stop taking
any of your medicines.
7. Product details
What MIDAZOLAM INJECTION contains
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Active ingredient
(main ingredient)
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1 mg/mL or 5 mg/mL of midazolam (as hydrochloride)
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Other ingredients
(inactive ingredients)
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sodium chloride
sodium hydroxide
hydrochloric acid
Water for Injections.
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Do not take this medicine if you are allergic to any of these ingredients.
MIDAZOLAM INJECTION does not contain lactose, sucrose, gluten, tartrazine or any other
azo dyes.
What MIDAZOLAM INJECTION looks like
MIDAZOLAM INJECTION is a clear, colourless to pale yellow solution supplied in an
ampoule.
5mg/1mL (AUST R 72213)
5mg/5mL (AUST R 72214)
50mg/10mL (AUST R 72207)
Who distributes MIDAZOLAM INJECTION
Pfizer Australia Pty Ltd
Sydney NSW
This leaflet was prepared in March 2025.