Midazolam should be used with caution in:
- patients over 60 years of age,
- patients routinely short of breath,
- myasthenia gravis (a disease causing muscle weakness),
- a kidney, liver or heart condition,
- a history of alcohol or drug abuse,
- patients taking any other medicines including those not prescribed by your doctor (make sure that your doctor knows what other medicines you are taking, including ones you may have bought without a prescription),
- heart problems,
- personality disorder,
- in babies or children. Let your doctor know if your child has a heart condition.
It should not be used in:
- allergies to midazolam, any other benzodiazepines or any of the other ingredients;
- severe difficulty in breathing or those who are very short of breath and are to undergo conscious sedation (a state of calm or drowsiness where you remain awake);
- unstable myasthenia gravis (a condition causing muscle weakness);
- sleep apnoea (a condition causing frequent interrupted breathing during sleep);
- severe liver problems.
Also see list of precautions and interactions
Do not store above 25°C. Keep container in outer carton.
What is it used for?
- Midazolam is used to induce sleep and has a calming effect.
- It is a benzodiazepine, sometimes known as sedatives.
- It is used in adults and children for sedation (calming) and anaesthesia (inducing sleep).
- In general this drug is used as a sedative or anaesthetic during investigations and treatment. It is also used as a premedication to calm patients before treatment and to sedate patients in intensive care units.
- Benefits of being on this drug can include a very relaxed state of calm, drowsiness or sleep and relief of anxiety and muscle tension.
Listed below are the typical uses of midazolam:
- Conscious sedation (an awake but very relaxed state of calm or drowsiness during minor medical, dental and surgical tests or procedures) in adults and children.
- Sedation of adults and children, in intensive care units.
- Anaesthesia (an induced sleep) in adults, used alone or with other medicines.
- Premedication (medicine used to cause relaxation, calm and drowsiness before an anaesthetic) in adults and children.
- Induction of anaesthesia (used at the start of anaesthesia).
On occasion your doctor may prescribe this medicine to treat a condition not on the above list. Such conditions are listed below.
HOW TO USE/TAKE
How often do I take it?
- Your doctor will decide on a suitable dose for you. The dose you are given will depend on why you are being treated and the type of sedation needed. Your weight, age, your state of health, how you respond to midazolam and whether other medicines are needed at the same time will also influence the dose that you are given.
Midazolam is given by different methods of administration:
- by mouth;
- by buccal administration given in the side of the mouth ;
- by slow injection into a vein (intravenous injection);
- through a tube into one of your veins (intravenous infusion);
- by injection into a muscle (intramuscular injection);
- into your back passage (rectum).
You should always be taken home by a responsible adult after your treatment.
Certain medical conditions may require different dosage instructions as directed by your doctor.
- Dosage is based on your age, gender, medical condition, response to therapy, and use of certain interacting medicines.
Do I need to avoid anything?
- You should not drive a vehicle or operate a machine until you are completely recovered. Your doctor will advise you when you can resume these activities. Consult your doctor or pharmacist for more details.
When can I stop?
- If you receive long term treatment with midazolam, you may become tolerant (the medicine becomes less effective) or dependent upon it.
- After treatment for a long time (such as in an intensive care unit) the following withdrawal symptoms may occur: headaches, muscle pain, anxiety, tension, restlessness, confusion, irritability, inability to sleep, mood changes, hallucinations and convulsions. Your doctor will reduce your dose gradually to avoid these effects happening to you.
MIDAZOLAM SIDE EFFECTS
- dizziness (with risk of falls and other accidents in the elderly)
- slurred speech
- trembling hands
- numbed emotion
- reduced alertness
- post-operative delirium
- a hangover effect
- soreness at the injection site.
- See information leaflet for details of other, less common, side effects.
If any of these persist or you consider them severe then inform your doctor.
Tell your doctor immediately if you develop any of the following symptoms:
- a sudden rash, itching or lumpy rash (hives) and swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing.
- Heart attack (cardiac arrest). Signs may include chest pain which may spread to your neck and shoulders and down your left arm.
- Breathing problems or complications (sometimes causing the breathing to stop).
- Choking and sudden blockage of the airway (laryngospasm).
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
The Yellow Card Scheme allows you to report suspected side effects from any type of medicine (which includes vaccines, herbals and over the counter medicines) that you are taking. It is run by the medicines safety watchdog called the Medicines and Healthcare products Regulatory agency (MHRA). Please report any suspected side effect on the Yellow Card Scheme website.
Before taking midazolam, tell your doctor or pharmacist if you are allergic to it; or to other benzodiazepine; or if you have any other allergies.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have:
- Allergies to midazolam, any other benzodiazepines or any of the other ingredients
- Severe difficulty in breathing or are very short of breath and are to undergo conscious sedation (a state of calm or drowsiness where you remain awake)
- unstable myasthenia gravis
- sleep apnoea
- Severe liver problems.
Before using this medication, tell your doctor or pharmacist your medical history, especially any of the following:
- If you are over 60 years of age
- If you are routinely short of breath
- If you have myasthenia gravis (a disease causing muscle weakness)
- If you have a kidney, liver or heart condition
- If you have a history of alcohol or drug abuse
- If you are taking any other medicines including those not prescribed by your doctor (make sure that your doctor knows what other medicines you are taking, including ones you may have bought without a prescription)
- If you are pregnant
- If you have a personality disorder
- Let your doctor know if a child requiring this medicine has a heart condition.
Before having surgery, tell your doctor or dentist that you are taking this medication.
Does alcohol intake affect this drug?
- Do not drink alcohol until your doctor tells you it is all right to do so.
- It may increase the sedative effect and may cause problems with your breathing.
The elderly: midazolam should be used with caution in the elderly as it may increase the risk of side effects.
Pregnancy and breastfeeding - please ensure you read the detailed information below
Talk to your doctor if you are pregnant, or think you are pregnant. Your doctor will decide if this medicine is suitable for you. If your doctor has decided that you should be given this medicine during late pregnancy or during labour, your baby might have a low body temperature, floppiness, and breathing or feeding difficulties.
It is sensible to limit use of medication during pregnancy whenever possible. However, your doctor may decide that the benefits outweigh the risks in individual circumstances and after a careful assessment of your specific health situation.
If you have any doubts or concerns you are advised to discuss the medicine with your doctor or pharmacist.
Midazolam is not safe to take if you are breastfeeding, you should not breastfeed for 24 hours after receiving this medication.
It is sensible to limit use of medication during breastfeeding whenever possible. However, your doctor may decide that the benefits outweigh the risks in individual circumstances and after a careful assessment of your specific health situation.
If you have any doubts or concerns you are advised to discuss the medicine with your doctor or pharmacist.
Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.
This drug should not be used with the following medications because very serious, possibly fatal interactions may occur: none.
Before using this medication, tell your doctor or pharmacist of all prescription and non-prescription/herbal products you may use, especially of:
- hypnotics (sleep inducing drugs),
- other benzodiazepines,
- antidepressants (e.g. nefazodone),
- clozapine (and other medications used for mental illness),
- narcotic analgesics (very strong pain killers e.g. codeine),
- antiepileptics (for treating epilepsy e.g. phenytoin),
- anaesthetics (e.g. fentanyl) and drugs used to relax the muscles during an operation (e.g. baclofen),
- some antihistamines (for the treatment of allergies),
- isoniazid and rifampicin, used in the treatment of tuberculosis,
- disulfiram, a drug used for alcohol dependence,
- cimetidine, ranitidine or omeprazole, drugs used to treat stomach ulcers,
- levodopa, a drug used in the treatment of Parkinson's disease,
- theophylline, a drug used for asthma and bronchitis,
- certain antibiotics, used to treat bacterial infections, such as erythromycin, clarithromycin, and quinupristin with dalfopristin,
- drugs used to treat fungal infections, such as ketoconazole, itraconazole and fluconazole,
- certain drugs used to treat virus infections, such as amprenavir and ritonavir,
- diltiazem or verapamil, drugs used to treat heart conditions and high blood pressure,
- other drugs used to lower blood pressure, e.g. moxonidine,
- nabilone, used to treat vomiting due to cancer therapy,
- atorvastatin (used to treat high cholesterol),
- aspirin, taken for headaches, heart disease and as a painkiller,
- probenecid, used for gout,
- the herbal medicine St John’s Wort.
This information does not contain all possible interactions. Therefore, before using midazolam, tell your doctor or pharmacist of all the products you use.
Your medicine will be given to you by a doctor or nurse. If you think you have been given too much medicine please tell your doctor.
If you think you, or someone you care for, might have accidentally taken more than the recommended dose of midazolam or intentional overdose is suspected, contact your local hospital, GP or if in England call 111. In Scotland call NHS 24. In Wales, call NHS Direct Wales. In the case of medical emergencies, always dial 999.
Your medicine will be given to you by a doctor or nurse.