Dormicum- Midazolam by Roche – Patient Information Leaflet

Dormicum belongs to a group of medicines known as benzodiazepines. It is a short acting medicine that is used to induce sedation (a very relaxed state of calm, drowsiness or sleep) and relieves anxiety and muscle tension. Dormicum Injection is used for:

  • Conscious sedation (an awake but very relaxed state of calm or drowsiness during a medical test or procedure) in adults and children.
  • Sedation of adults and children, in intensive care units.
  • Injection form used in anaesthesia in adults, used alone or with other medicines.
  • Premedication (medicine used to cause relaxation, calm and drowsiness before an anaesthetic) in adults and children.
  • Dormicum injection is used in children before a procedure or anesthesia to cause drowsiness, decrease anxiety, and cause forgetfulness of the surgery or procedure. It should be used while the child is under the care of a health professional. It is not for home or long-term use. For more information- Click Here to read Dormicum Injection – Patient Information Leaflet.

Composition and availability

  • Dormicum 2 mg/ml Solution for Injection or Infusion.
  • Dormicum 5 mg/ml Solution for Injection or Infusion.
  • Dormicum 15 mg/3ml Solution for Injection or Infusion.

Warnings and precautions

Talk to your doctor or nurse before using Dormicum Injection.

Children and babies- If your child is going to be given this medicine:

  • It is particularly important to tell your doctor or nurse if your child has cardiovascular disease (heart problems). Your child will be carefully monitored and the dose will be adjusted specially.
  • Children must be carefully monitored. For infants and babies under 6 months this will include monitoring of breathing and oxygen levels.

Adults: Talk to your doctor or nurse before you are given Dormicum if:

  • You are over 60 years of age.
  • You have a long term illness (such as breathing problems or kidney, liver or heart problems).
  • You are debilitated (have an illness that makes you feel very weak, run down and short of
  • energy).
  • You have a condition called ‘sleep apnoea syndrome’ (where your breathing stops when
  • you are asleep), so you may be closely monitored.
  • You have myasthenia gravis (a neuromuscular disease causing muscle weakness).
  • You regularly drink large amounts of alcohol or you have had problems with alcohol use in the past. Alcohol can increase the clinical effects of midazolam, possibly including severe
  • sedation that could result in coma or death.
  • You regularly take recreational drugs or you have had problems with drug use in the past.
  • You are pregnant or think you may be pregnant .

If any of the above apply to you, or if you are not sure, talk to your doctor or nurse before you are given Dormicum Injection. For more information- Click Here to read Dormicum Injection – Patient Information Leaflet.

How to use Dormicum Injection?

Dormicum Injection should be given only by experienced healthcare professionals (doctor or nurse). It should be given in a place (hospital, clinic or surgery) equipped to monitor and support the patient’s breathing, heart and circulation (cardiovascular function) and recognise the signs of and manage the expected side effects of anaesthesia.

Normal adult dose: 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 Injection and whether other medicines are needed at the same time will also influence the dose that you are given.

If you need strong painkillers, you will be given these first and then be given Dormicum Injection. Your doctor will decide on a suitable dose for you. Dormicum Injection may be given to you in one of four different ways:

  • 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).
  • Intranasal (unlabeled route).

You should always be taken home by a responsible adult after your treatment.

Children and babies: In infants and babies under 6 months of age Dormicum Injection is only recommended for sedation in intensive care units. The dose will be given gradually into a vein.

Children 12 years and under will usually be given Dormicum Injection into a vein. When Dormicum Injection is used for premedication (to cause relaxation, calm and drowsiness before an anaesthetic) it may be given into the back passage (rectum). For more information- Click Here to read Dormicum Injection – Patient Information Leaflet.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects have been reported with this medicine (frequency not known). Stop having Dormicum Injection and see a doctor straight away if you notice any of the following side effects. They can be life-threatening and you may need urgent medical treatment:

  • Anaphylactic shock (a life-threatening allergic reaction). Signs may include a sudden rash, itching or
  • lumpy rash (hives) and swelling of the face, lips, tongue or other parts of the body. You may also have
  • 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).

Life-threatening side effects are more likely to occur in adults over 60 years of age and those who already have breathing difficulties or heart problems, particularly if the injection is given too fast or at a high dose.

Other possible side effects on  Immune system problems: general allergic reactions (skin reactions, heart and blood system reactions, wheezing)

Effects on behaviour:

  • restlessness, agitation, irritability
  • nervousness, anxiety
  • agitation
  • restlessness
  • hostility, anger, aggression or assault
  • excitement.
  • hyperactivity
  • changes in libidoinappropriate behaviour

Muscle problems: muscle spasms and muscle tremors (shaking of your muscles that you cannot control).

Mental and Nervous system problems:

  • confusion , disorientation
  • emotional and mood disturbances
  • involuntary movements
  • euphoria (an excessive feeling of happiness or excitement)
  • nightmares, abnormal dreams
  • hallucinations (seeing and possibly hearing things that are not really there)
  • psychoses (losing contact with reality)
  • drowsiness and prolonged sedation
  • reduced alertness
  • headache
  • dizziness
  • difficulty coordinating muscles
  • fits (convulsions) in premature infants and new-born babies.
  • temporary memory loss. How long this lasts depends on how much Dormicum Injection you were given. You may experience this after your treatment. In isolated cases this has been prolonged (lasted for a long time). For more information- Click Here to read Dormicum Injection – Patient Information Leaflet.

Dosage and administration

The dose of midazolam needs to be individualized based on the patient’s age, underlying diseases, and concurrent medications. Consider reducing dose by 20% to 50% in elderly, chronically ill, or debilitated patients and those receiving opioids or other CNS depressants. 

Preoperative/preprocedural sedation in  Healthy adults <60 years

  • I.M.: 0.07-0.08 mg/kg 30-60 minutes prior to surgery/procedure; usual dose: 5 mg.
  • I.V.: 0.02-0.04 mg/kg; repeat every 5 minutes as needed to desired effect or up to 0.1-0.2 mg/kg.
  • Intranasal (unlabeled route): 0.1 mg/kg; administer 10-20 minutes prior to surgery/procedure (Uygur-Bayramiçli, 2002). Note: Use 5 mg/mL injectable concentrated solution to deliver dose. Due to the low pH of the solution, burning upon administration is likely to occur.

Conscious sedation: I.V. injection in Healthy adults <60 years

  • Initial: Some patients respond to doses as low as 1 mg; no more than 2.5 mg should be
  • administered over a period of 2 minutes. Additional doses of midazolam may be administered after a 2-minute waiting period and evaluation of sedation after each dose increment. A total dose >5 mg is generally not needed.

Maintenance: 25% of dose used to reach a sedative effect.

Dormicum – Patient Information Leaflet

F. Hoffmann-La Roche SA, bASEL, Switzerland
F. Hoffmann-La Roche SA, bASEL, Switzerland
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