Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
After receiving this medicine, the patient should not drive a vehicle, ride a bicycle or operate a machine until they have completely recovered. Please discuss with your doctor if you need further advice.
Midazolam contains a medicine called midazolam. Midazolam belongs to a group of medicines known as benzodiazepines. Midazolam is used to stop a sudden, prolonged, convulsive, seizure in infants, toddlers, children and adolescents (from 3 months to less than 18 years of age).
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Depending on age, your child will have received one of the following doses, in specifically colour labelled packaging: 3 months to less than 1 year: 2.5 mg - yellow labelled packaging 1 year to less than 5 years: 5 mg blue labelled packaging 5 years to less than 10 years: 7.5 mg - purple labelled packaging 10 years to less than 18 years: 10 mg - orange labelled packaging
Do not give Midazolam if the patient has:
• An allergy to midazolam, benzodiazepines (such as diazepam) or any of the other ingredients of this medicine (listed in section 6) • A disease of the nerves and muscles causing muscle weakness (myasthenia gravis) • Severe difficulty breathing at rest Midazolam can make breathing difficulties worse) • An illness causing frequent interruption of breathing during sleep (sleep apnoea syndrome) • Severe liver problems.
The dose is the full contents of one oral syringe. Do not give more than one dose.
Toddlers aged from 3 months to less than 6 months should only be treated in a hospital setting where monitoring is possible and resuscitation equipment is available.
Warnings and precautions Talk to your doctor or pharmacist
before giving Midazolam if the patient has:
Preparing to give this medicine If the child is having a seizure, allow their body to move freely, do not try to restrain them. Only move them if they are in danger from, for example, deep water, fire or sharp objects.
• A kidney, liver or heart condition • A lung condition that causes difficulty breathing on a regular basis.
This medicine may cause people to forget what happened after they have been given it. Patients should be observed carefully after being given the medicine.
Support your child's head with something soft, such as a cushion or your lap. Check that the medicine is the correct dose for your child, according to their age. Do not give this medicine if you notice that the solution is not clear (e.g. if cloudy or particles are present)
This medicine should be avoided in patients with a medical history of alcohol or drug abuse.
Life threatening incidents are more likely in patients with breathing difficulties or heart problems, especially when higher doses of Midazolam are given.
How to give this medicine Ask a doctor, pharmacist or nurse to show you how to take or administer this medicine. Always check with them if you are not sure.
Children younger than 3 months: Midazolam should not be given to children younger than 3 months since there is not enough information in this age group.
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The information on how to give this medicine is also shown on the tube label.
Midazolam must not be injected. Do not attach a needle to the syringe
If you are not sure if any of the above applies to the patient, talk to a doctor or pharmacist before giving this medicine.
Step 1
Other medicines and Midazolam Tell your doctor or pharmacist if the patient is taking, or has recently taken, or might take any other medicines. If you have any doubt about whether any medicine the patient is taking may affect the use of Midazolam, please speak to your doctor or pharmacist.
This is extremely important, as using more than one medicine at the same time can strengthen or weaken the effect of the medicines involved.
Hold the plastic tube, break the seal at one end and pull the cap off. Take
The effects of Midazolam may be intensified by medicines such as:
the syringe out of the tube.
• antiepileptics, (for treating epilepsy) e.g. phenytoin • antibiotics, e.g. erythromycin, clarithromycin • antifungals, e.g. ketoconazole, voriconazole, fluconazole, itraconazole, pozaconazole • anti-ulcer medicines, e.g. cimetidine, ranitidine and omeprazole • medicines used to treat blood pressure, e.g. diltiazem, verapamil • some medicines used to treat HIV and AIDS, e.g. saquinavir, lopinavir/ritonavir combination • narcotic analgesics (very strong pain killers), e.g. fentanyl • medicines used to reduce fat in the blood, e.g. atorvastatin • medicines used to treat nausea, e.g. nabilone • hypnotics (sleep inducing medicines) • sedative antidepressants (medicines used to treat depression that make you sleepy) • sedatives (medicines that relax you) • anaesthetics (for pain relief) • antihistamines (to treat allergies).
Step 2
Pull the red cap off the tip of the
syringe and dispose of it safely.
Step 3
The effects of Midazolam may be reduced by medicines such as:
• rifampicin (used to treat tuberculosis) • xanthines (used to treat asthma) • St John's Wort (a herbal medicine). This should be avoided in patients taking Midazolam.
Using the finger and thumb gently pinch and pull back the child's cheek. Put the tip of the
Midazolam may increase the effect of some muscle relaxants e.g. baclofen (causing increased drowsiness). This medicine may also stop some other medicines from working as well, e.g. levodopa (used to treat Parkinson's disease).
syringe into the back of the space between the inside of the cheek and the lower gum.
7mm 126 mm
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7mm 7mm 796 mm
Step 4
How to give Midazolam
Always give this medicine exactly as a doctor has told you. Check with a doctor or pharmacist if you are not sure.
In infants from 3 months to less than 6 months it should only be used in a hospital setting where monitoring is possible and resuscitation equipment is available.
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Dosage Your doctor will prescribe the appropriate dose of Midazolam your child needs, generally according to your child's age. The different doses each have a different colour, which is shown on the carton, the tube and the syringe containing the medicine.
This medicine must only be used by parents/carers where the child has been diagnosed to have epilepsy.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects Seek medical advice immediately or telephone for an ambulance if the patient experiences the following:
• Severe breathing difficulties e.g. slow or shallow breathing or blue lips. In very rare cases breathing might stop. • Heart attack. Signs may include chest pain which may spread to the child's neck and shoulders and down their left arm.
Other side effects If the patient gets any side effects, talk to their doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
Common side effects (may affect up to 1 in 10 people):
• Feeling and being sick • Sleepiness or losing consciousness
Uncommon side effects (may affect up to 1 in 100 people):
• Rash, hives (lumpy rash), itchiness
Very rare side effects (may affect up to 1 in 10,000 people):
• Agitation, restlessness, hostility, rage or aggression, excitement, confusion, euphoria (an excessive feeling of happiness or excitement), or hallucinations (seeing and possibly hearing things that are not really there) • Muscle spasms and muscle tremors (shaking of your muscles that you cannot control) • Reduced alertness • Headache • Dizziness • Difficulty co-ordinating muscles • Fits (convulsions) • Temporary memory loss. How long this lasts depends on how much Midazolam was given. • Low blood pressure, slow heart rate, or redness of the face and neck (flushing) • Laryngospasm (tightening of the vocal cords causing difficult and noisy breathing) • Constipation • Dry mouth • Tiredness • Hiccups
Reporting of 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 MHRA Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search the MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not give this medicine after the expiry date which is stated on the carton, tube and oral syringe labels after EXP. The expiry date refers to the last day of that month.
Keep the oral syringe in the protective plastic tube.
Do not use this medicine if the packaging has been opened or damaged.
Disposal of oral syringes
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
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What Midazolam contains
• The active substance is midazolam • Each 2.5 mg pre-filled oral syringe contains 2.5 mg midazolam (as hydrochloride) in 0.5 ml solution. • Each 5 mg pre-filled oral syringe contains 5 mg midazolam (as hydrochloride) in 1 ml solution. • Each 7.5 mg pre-filled oral syringe contains 7.5 mg midazolam (as hydrochloride) in 1.5 ml solution. • Each 10 mg pre-filled oral syringe contains 10 mg midazolam (as hydrochloride) in 2 ml solution. The other ingredients are sodium chloride, water for injections, hydrochloric acid and sodium hydroxide (for pH adjustment).
Slowly press the syringe plunger until
the plunger stops.
The full amount of solution should be inserted slowly into
the space between the gum and the cheek (buccal cavity).
What Midazolam looks like and contents of the pack Midazolam 2.5 mg - yellow labelled packaging Midazolam 5 mg - blue labelled packaging Midazolam 7.5 mg - purple labelled packaging Midazolam 10 mg - orange labelled packaging
If prescribed by your doctor
(for larger volumes and/or smaller patients), you can give
approximately half the dose
slowly into one side of the mouth, then into the other
side of the child's mouth.
When to call an ambulance
ALWAYS follow the treatment advice provided by the patient's doctor or as explained by a healthcare professional. If in any doubt, call for immediate medical help if:
Midazolam oromucosal solution is a clear colourless liquid. It is supplied in an amber coloured pre- filled, single-use oral syringe. Each oral syringe is individually packed in a protective plastic tube. Midazolam is available in cartons containing 2 and 4 pre-filled oral syringes/tubes (of the same dose).
• The seizure does not stop within 10 minutes • You're unable to empty the syringe or you spill some of the contents • The child's breathing slows down or stops e.g. slow or shallow breathing or blue lips • You observe signs of a heart attack which may include chest pain or pain that spreads to the neck and shoulders and down the left arm • The child is sick (vomits) and the seizure does not stop within 10 minutes • You give too much Midazolam and there are signs of overdose which include:
Marketing Authorisation Holder Laboratorios Liconsa S.A. Dulcinea s/n, 28805 Alcalá de Henares Madrid, Spain.
Manufacturer: Laboratorios Liconsa S.A. Av. de Miralcampo, 7 19200 Azuqueca de Henares Guadalajara SPAIN
• Drowsiness, tiredness, fatigue • Confusion or feeling disorientated • Absence of knee reflex or a response to a pinch • Breathing difficulties (slow or shallow breathing) • Low blood pressure (giddiness and feeling faint) • Coma
This leaflet was last revised in 28/09/2021
Keep the syringe to show to the ambulance staff or doctor.
Do not give more than the amount of medicine prescribed by a doctor for the patient.
If the child is sick (vomits)
• Do not give the patient another dose of Midazolam. • If the seizure does not stop within 10 minutes, call an ambulance.
If you have any further questions on the use of this medicine, ask a doctor or pharmacist.
Midazolam 10 mg oromucosal solution comes as solution containing 10mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Midazolam 10 mg oromucosal solution is midazolam hydrochloride.
Medicines with the same active substance, strength and form include: BUCCOLAM 10 mg oromucosal solution, Epistatus 10 mg oromucosal solution, Midazolam 10 mg oromucosal solution. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Midazolam 10 mg oromucosal solution, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Treatment of prolonged, acute, convulsive seizures in infants, toddlers, children, and adolescents (from 3 months to < 18 years).
Midazolam must only be used by parents/carers where the patient has been diagnosed to have epilepsy.
For infants between 3-6 months of age treatment should be in a hospital setting where monitoring is possible and resuscitation equipment is available. See section 4.2.
Posology
Standard doses are indicated below:
Age range
Dose
Label colour
10 years to < 18 years
10 mg
Orange
Carers should only administer a single dose of midazolam. If the seizure has not stopped within 10 minutes after administration of midazolam, emergency medical assistance must be sought, and the empty syringe given to the healthcare professional to provide information on the dose received by the patient.
A second or repeat dose when seizures re-occur after an initial response should not be given without prior medical advice (see section 5.2).
Special populations
Renal impairment
No dose adjustment is required; however, Midazolam should be used with caution in patients with chronic renal failure as elimination of midazolam may be delayed and the effects prolonged. (see section 4.4)
Hepatic impairment
Hepatic impairment reduces the clearance of midazolam with a subsequent increase in terminal half- life. Therefore, the clinical effects may be stronger and prolonged, hence careful monitoring of the clinical effects and vital signs is recommended following administration of midazolam in patients with hepatic impairment (see section 4.4).
Midazolam is contraindicated in patients with severe hepatic impairment (see section 4.3).
Paediatric population
The safety and efficacy of midazolam in children aged 0 to 3 months has not been established. No data are available.
Method of administration
Midazolam is for oromucosal use. The full amount of solution should be inserted slowly into the space between the gum and the cheek. Laryngo-tracheal insertion should be avoided to prevent accidental aspiration of the solution. If necessary (for larger volumes and/or smaller patients), approximately half the dose should be given slowly into one side of the mouth, then the other half given slowly into the other side.
For detailed instructions on how to administer the medicinal product, see section 6.6.
Precautions to be taken before handling or administering the medicinal product
No needle, intravenous tubing or any other device for parenteral administration should be attached to the oral syringe.
Midazolam is not for intravenous use.
The oral syringe cap should be removed before use to avoid risk of choking.
Hypersensitivity to the active substance, benzodiazepines or to any of the excipients listed in section 6.1.
Myasthenia gravis.
Severe respiratory insufficiency.
Sleep apnoea syndrome.
Severe hepatic impairment.
Respiratory insufficiency
Midazolam should be used with caution in patients with chronic respiratory insufficiency because midazolam may further depress respiration.
Paediatric patients aged 3 to 6 months
Given the higher metabolite to parent drug ratio in younger children, a delayed respiratory depression as a result of high active metabolite concentrations in the 3-6 months age group cannot be excluded. Therefore, the use of Midazolam in the 3–6-month age group should be limited for use only under the supervision of a health care professional where resuscitation equipment is available and where respiratory function can be monitored and equipment for respiratory assistance, if needed, is available.
Altered elimination of midazolam
Midazolam should be used with caution in patients with chronic renal failure, impaired hepatic or cardiac function. Midazolam may accumulate in patients with chronic renal failure or impaired hepatic function whilst in patients with impaired cardiac function it may cause decreased clearance of midazolam.
Concomitant use with other benzodiazepines
Debilitated patients are more prone to the central nervous system (CNS) effects of benzodiazepines and, therefore, lower doses may be required.
Medical history of alcohol or drug abuse
Midazolam should be avoided in patients with a medical history of alcohol or drug abuse.
Amnesia
Midazolam may cause anterograde amnesia.
Midazolam is metabolized by CYP3A4. Inhibitors and inducers of CYP3A4 have the potential to respectively increase and decrease the plasma concentrations and, subsequently, the effects of midazolam thus requiring dose adjustments accordingly. Pharmacokinetic interactions with CYP3A4 inhibitors or inducers are more pronounced for oral as compared to oromucosal or parenteral midazolam as CYP3A4 enzymes are also present in the upper gastro-intestinal tract. After oromucosal administration, only systemic clearance will be affected. After a single dose of oromucosal midazolam, the consequence on the maximal clinical effect due to CYP3A4 inhibition will be minor while the duration of effect may be prolonged. Hence, a careful monitoring of the clinical effects and vital signs is recommended during the use of midazolam with a CYP3A4 inhibitor even after a single dose.
Anaesthetics and narcotic analgesics
Fentanyl may reduce midazolam clearance.
Antiepileptics
Co-administration with midazolam may cause enhanced sedation or respiratory or cardiovascular depression. Midazolam may interact with other hepatically metabolised medicinal products, e.g., phenytoin, causing potentiation.
Calcium-channel blockers
Diltiazem and verapamil have been shown to reduce the clearance of midazolam and other benzodiazepines and may potentiate their actions.
Ulcer-healing medicinal products
Cimetidine, ranitidine and omeprazole have been shown to reduce the clearance of midazolam and other benzodiazepines and may potentiate their actions.
Xanthines
Metabolism of midazolam and other benzodiazepines is accelerated by xanthines.
Dopaminergic medicinal products
Midazolam may cause inhibition of levodopa.
Muscle relaxants
E.g. baclofen. Midazolam may cause potentiation of muscle relaxants, with increased CNS depressant effects.
Nabilone
Co-administration with midazolam may cause enhanced sedation or respiratory and cardiovascular depression.
Medicinal products that inhibit CYP3A4
Medicinal product interactions following oromucosal administration of midazolam are likely to be similar to those observed after intravenous midazolam rather than oral administration.
Food
Grapefruit juice reduces the clearance of midazolam and potentiates its action.
Azole antifungals
Ketoconazole increased the plasma concentrations of intravenous midazolam by 5-fold while the terminal half-life increased by about 3-fold.
Voriconazole increased the exposure of intravenous midazolam by 3-fold whereas its elimination half- life increased by about 3-fold.
Fluconazole and itraconazole both increased the plasma concentrations of intravenous midazolam by 2 to 3-fold associated with an increase in terminal half-life by 2.4-fold for itraconazole and 1.5-fold for fluconazole.
Posaconazole increased the plasma concentrations of intravenous midazolam by about 2-fold.
Macrolide antibiotics
Erythromycin resulted in an increase in the plasma concentrations of intravenous midazolam by about 1.6 to 2 –fold associated with an increase of the terminal half-life of midazolam by 1.5 to 1.8-fold.
Clarithromycin increased the plasma concentrations of intravenous midazolam by up to 2.5-fold associated with an increase in terminal half-life by 1.5 to 2-fold.
HIV Protease inhibitors
Co-administration with protease inhibitors (e.g., Saquinavir and other HIV protease inhibitors) may cause a large increase in the concentration of midazolam. Upon co-administration with ritonavir- boosted lopinavir, the plasma concentrations of intravenous midazolam increased by 5.4-fold, associated with a similar increase in terminal half-life.
Calcium-channel blockers
A single dose of diltiazem increased the plasma concentrations of intravenous midazolam by about 25% and the terminal half-life was prolonged by 43%.
Various medicinal products
Atorvastatin showed a 1.4-fold increase in plasma concentrations of intravenous midazolam compared to control group.
Medicinal products that induce CYP3A4
Rifampicin
7 days of 600 mg once daily decreased the plasma concentrations of intravenous midazolam by about 60%. The terminal half-life decreased by about 50-60%.
Herbs
St John's Wort decreased plasma concentrations of midazolam by about 20-40% associated with a decrease in terminal half life of about 15-17%. Depending on the specific St John's Wort extract, the CYP3A4-inducing effect may vary.
Pharmacodynamic Drug-Drug Interactions (DDI)
The co-administration of midazolam with other sedative/hypnotic medicinal products and CNS depressants, including alcohol, is likely to result in enhanced sedation and respiratory depression.
Examples include opiate derivatives (used as analgesics, antitussives, or substitutive treatments), antipsychotics, other benzodiazepines used as anxiolytics or hypnotics, barbiturates, propofol, ketamine, etomidate; sedative antidepressants, non-recent H1-antihistamines and centrally acting antihypertensive medicinal products.
Alcohol (including alcohol-containing medicinal products may markedly enhance the sedative effect of midazolam. Alcohol intake should be strongly avoided in case of midazolam administration (see section 4.4).
Midazolam decreases the minimum alveolar concentration (MAC) of inhalation anaesthetics.
The effect of CYP3A4 inhibitors may be larger in infants since part of the oromucosal dose is probably swallowed and absorbed in the gastro-intestinal tract.
Pregnancy
There are no or limited amount of data from the use of midazolam in pregnant women. Animal studies do not indicate a teratogenic effect with respect to reproductive toxicity, but foetotoxicity has been observed in humans as with other benzodiazepines. No data on exposed pregnancies are available for the first two trimesters of pregnancy.
The administration of high doses of midazolam in the last trimester of pregnancy or during labour has been reported to produce maternal or foetal adverse reactions (risk of aspiration of fluids and stomach contents during labour in the mother, irregularities in the foetal heart rate, hypotonia, poor suckling, hypothermia and respiratory depression in the new-born infant).
Midazolam may be used during pregnancy if clearly necessary. The risk for new-born infants should be taken into account in the event of administration of midazolam in the third trimester of pregnancy.
Breast-feeding
Midazolam is excreted in low quantities (0.6%) in human milk. As a result it may not be necessary to stop breast feeding following a single dose of midazolam.
Fertility
Animal studies did not show an impairment of fertility (see section 5.3).
Midazolam has a major influence on the ability to drive and use machines.
Sedation, amnesia, impaired attention, and impaired muscular function may adversely affect the ability to drive, ride a bicycle or use machines. After receiving midazolam, the patient should be warned not to drive a vehicle or operate a machine until completely recovered.
Summary of the safety profile
Published clinical studies show that oromucosal midazolam was administered to approx. 443 children with seizures. Respiratory depression occurs at a rate of up to 5%, although this is a known complication of convulsive seizures as well as being related to midazolam use. One episode of pruritus was possibly attributed to the use of buccal midazolam.
Tabulated list of adverse reactions
The table below lists the adverse reactions reported to occur when oromucosal midazolam was administered to children in clinical studies.
The frequency of adverse reactions is classified as follows:
Common:
Uncommon:
Very rare:
≥ 1/100 to < 1/10
≥ 1/1,000 to < 1/100
< 1/10,000
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness:
System Organ Class
Frequency: Adverse Drug Reaction
Psychiatric disorders
Very rare:
Aggression**, agitation**, anger**, confusional state**, euphoric mood**, hallucination**, hostility**, movement disorder**, physical assault**
Nervous system disorders
Common:
Sedation, somnolence, depressed levels of consciousness Respiratory depression
Very rare:
Anterograde amnesia**, ataxia**, dizziness**, headache**, seizure**, paradoxical reactions**
Cardiac disorders
Very rare:
Bradycardia**, cardiac arrest**, hypotension**, vasodilatation**
Respiratory, thoracic and mediastinal disorders
Very rare:
Apnoea**, dyspnea**, laryngospasm**, respiratory arrest**
Gastrointestinal disorders
Common:
Nausea and vomiting
Very rare:
Constipation**, dry mouth**
Skin and subcutaneous tissue disorders
Uncommon:
Pruritus, rash and urticarial
General disorders and administration site conditions
Very rare:
Fatigue**, hiccups**
**These adverse reactions have been reported to occur when midazolam is injected in children and/or adults, which may be of relevance to oromucosal administration.
Description of selected adverse reactions
An increased risk for falls and fractures has been recorded in elderly benzodiazepine users.
Life-threatening incidents are more likely to occur in those with pre-existing respiratory insufficiency or impaired cardiac function, particularly when a high dosage is administered (see section 4.4).
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Symptoms
Midazolam overdose can present a threat to life if the patient has pre-existing respiratory or cardiac insufficiency, or when combined with other CNS depressants (including alcohol).
Overdose of benzodiazepines is usually manifested by degrees of central nervous system depression ranging from drowsiness to coma. In mild cases, symptoms include drowsiness, mental confusion and lethargy, in more serious cases, symptoms may include ataxia, hypotonia, hypotension, respiratory depression, rarely coma and very rarely death.
Management
In the management of overdose with any medicinal product, it should be borne in mind that multiple agents may have been taken.
Following overdose with oral midazolam, vomiting should be induced (within one hour) if the patient is conscious or gastric lavage undertaken with the airway protected if the patient is unconscious. If there is no advantage in emptying the stomach, activated charcoal should be given to reduce absorption. Special attention should be paid to respiratory and cardiovascular functions in intensive care.
Flumazenil may be useful as an antidote.
Ask anything about Midazolam 10 mg oromucosal solution. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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