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Midazolam oromucosal solution


Oromucosal solution containing midazolam in pre-filled oral syringe

Drugs List

  • BUCCOLAM 10mg/2ml oromucosal solution
  • BUCCOLAM 2.5mg/0.5ml oromucosal solution
  • BUCCOLAM 5mg/1ml oromucosal solution
  • BUCCOLAM 7.5mg/1.5ml oromucosal solution
  • EPISTATUS 10mg/ml oromucosal solution sugar-free
  • midazolam 10mg/2ml oromucosal solution sugar-free
  • midazolam 10mg/ml oromucosal solution sugar-free
  • midazolam 2.5mg/0.5ml oromucosal solution sugar-free
  • midazolam 5mg/1ml oromucosal solution sugar-free
  • midazolam 7.5mg/1.5ml oromucosal solution sugar-free
  • Therapeutic Indications


    Status epilepticus

    Unlicensed Uses

    Febrile convulsions
    Sedative cover for minor medical, dental, and surgical procedures


    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.

    Carers should only administer a single dose of midazolam. If the seizure has not stopped within 10 minutes after administration of midazolam, seek emergency medical assistance and provide the empty syringe to the healthcare professional for 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.


    Children aged 10 years to 18 years
    10mg as a single dose.

    Children aged 5 years to 10 years
    7.5mg as a single dose.

    Children aged 1 year to 5 years
    5mg as a single dose.

    Children aged 3 months to 1 year
    2.5mg as a single dose.

    Children aged 1 month to 3 months (unlicensed)
    300micrograms/kg as a single dose. Maximum dose of 2.5mg. If necessary, repeat once only after 10 minutes.

    Children under 1 month (unlicensed)
    300micrograms/kg as a single dose. If necessary, repeat once only after 10 minutes.

    Additional Dosage Information

    Some licensed midazolam products are only half the strength of some other unlicensed preparations. Licensed midazolam products also contain the hydrochloride salt, whereas some other preparations contain the maleate salt.


    Acute respiratory impairment
    Myasthenia gravis
    Severe hepatic impairment
    Severe respiratory impairment
    Sleep apnoea

    Precautions and Warnings

    Adults aged 18 years and above
    Children under 6 months
    Chronic illness
    Cardiac impairment
    Children with cardiovascular impairment
    Chronic renal failure
    Chronic respiratory impairment
    Hepatic impairment
    Hereditary fructose intolerance
    History of alcohol abuse
    History of drug misuse
    Peripheral vasoconstriction
    Renal impairment
    Respiratory depression

    Advise ability to drive/operate machinery may be affected by side effects
    Advise patient not to drive or operate machinery until assessed
    Advise patient not to drive until they know how the medicine affects them
    Advise patient this medicine may be subject to driving restrictions
    Oral solution with maltitol unsuitable in hereditary fructose intolerance
    Children aged up to 6 months to be treated in a hospital environment
    Monitor patient for signs and symptoms of respiratory depression
    Monitor patients with a history of alcoholism and drug abuse
    Monitor patients with hepatic impairment for toxic effects
    Tolerance and dependence may occur
    Amnesia may occur
    May cause paradoxical behaviour
    Not licensed for all indications in all age groups
    Advise patient not to take St John's wort concurrently
    Advise patient to avoid alcohol during treatment
    Advise patient to avoid grapefruit products

    Use with caution in children with cardiovascular impairment. There is a risk of airways obstruction and hypoventilation in children under 6 months - respiratory rate and oxygen saturation should be monitored.

    Pregnancy and Lactation


    Use midazolam with caution in pregnancy.

    Highly limited data are available on midazolam to assess its safety during pregnancy. Animal studies do not indicate a teratogenic effect, but foetotoxicity was observed 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). The manufacturer suggests midazolam may be used during pregnancy if clearly necessary
    The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( ) or if this is unavailable at the backup site ( ).


    Use midazolam with caution in pregnancy.

    Midazolam passes in low quantities (0.6%) into breast milk. As a result it may not be necessary to stop breast feeding following a single dose of midazolam.

    Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
    Specialist advice is available from the UK Drugs in Lactation Advisory Service at

    Effects on Ability to Drive and Operate Machinery

    This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988 (England and Wales). When prescribing this medicine: Advise patient the medicine can affect cognitive function and is likely to affect ability to drive. Advise patient not to drive until they know how the medicine affects them.


    Advise carers that if the seizure has not stopped within 10 minutes, 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.

    Advise patients not to drive a vehicle or operate machinery until completely recovered.

    Risk of inhalation/ingestion of tip cap of prefilled plastic syringes. Advise patients and carers to check the syringe before administering and remove the translucent tip cap if it is still on the syringe after the red cap has been removed.

    Side Effects

    Anterograde amnesia
    Blood disorders
    Blood dyscrasias
    Cardiac arrest
    Changes in libido
    Dry mouth
    Excitement (paradoxical)
    Gastro-intestinal disturbances
    Impaired consciousness
    Increased appetite
    Involuntary movement disorders
    Muscle weakness
    Paradoxical reactions
    Reduced alertness
    Respiratory arrest
    Respiratory depression
    Salivation changes
    Skin reactions
    Urinary retention
    Variation in heart rate
    Visual disturbances


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: February 2015

    Reference Sources

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.
    Summary of Product Characteristics: Buccolam oromucosal solution. Viropharma Ltd. Revised March 2014.

    Summary of Product Characteristics: Epistatus 10mg Oromucosal Solution. Veriton Pharma Ltd. Revised February 2019.

    MHRA Drug Safety Update Vol 5, Issue 3, October 2011
    Buccal midazolam (Buccolam): new authorised medicine for paediatric use - care needed when transferring from unlicensed formulations
    Available at:
    Last accessed: October 24, 2011 Government departments. Department for Transport. Publications. Drug driving and medicine: advice for healthcare professionals. Drug driving: Guidance for healthcare professionals on drug driving. Available at: Last accessed: 6 January 2015 New drug driving offence implications for medicines packaging. Medicines Regulatory News. 10 December 2013. Available at: Last accessed: 6 January 2015

    NICE Evidence Services Available at: Last accessed: 07 August 2017

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