Midazolam oral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of midazolam.
Drugs List
Therapeutic Indications
Uses
Premedication for anaesthesia
Sedation for surgical and diagnostic procedures
Sedation and anxiolysis before a therapeutic, surgical, endoscopic or diagnostic procedure or as premedication before anaesthesia for children aged 6 months to 18 years.
Dosage
Doses should be adapted to patients weight.
Children
2mg/ml oral solution
Sedation and anxiolysis before a therapeutic or diagnostic procedure
Children aged 6 months to 18 years: 0.25mg/kg administered 30 minutes before the procedure. Maximum dose of 20mg.
Premedication before anaesthesia
Children aged 6 months to 18 years: 0.25mg/kg administered 30 minutes before the induction of anaesthesia. Maximum dose of 20mg.
5mg/ml oral solution
Sedation and anxiolysis before a therapeutic, surgical, endoscopic or diagnostic procedure
Children aged 6 months to 14 years: 0.25mg/kg to 0.5mg/kg administered 15 to 30 minutes before the procedure. Maximum dose of 20mg.
Premedication before anaesthesia
Children aged 6 months to 14 years: 0.25mg/kg to 0.5mg/kg administered 15 to 30 minutes before the induction of anaesthesia. Maximum dose of 20mg.
Administration
For oral administration.
For guidance on how to use the oral applicator see product literature.
Contraindications
Children under 6 months
Alcoholism
Breastfeeding
Myasthenia gravis
Severe hepatic impairment
Severe respiratory impairment
Sleep apnoea
Precautions and Warnings
Cardiac failure
Chronic renal failure
Hepatic impairment
History of alcohol abuse
History of drug misuse
Pregnancy
Respiratory failure
Advise patient ability to drive or operate machinery may be impaired
Advise patient this medicine may be subject to driving restrictions
Not all available brands are licensed for all age groups
Treatment to be administered by or under supervision of specialist
Amnesia may occur
May cause paradoxical behaviour
Advise that effects are potentiated by CNS depressants (including alcohol)
Paradoxical reactions have been reported, including agitation, involuntary movements, hyperactivity, hostility, rage reaction, aggression and paroxysmal excitement. Evaluation of treatment should be made before proceeding.
It is recommended that patients receiving oral midazolam treatment are discharged with a parent or guardian after surgery.
Pregnancy and Lactation
Pregnancy
Use midazolam with caution in pregnancy.
Some manufacturers suggest midazolam may be used during pregnancy if clinically necessary. At the time of writing there is limited published information regarding the oral use of midazolam during pregnancy, particularly during the first two trimesters. Potential risks are unknown. Animal studies do not indicate reproductive toxicity, but foetotoxicity has been observed in other benzodiazepines. The risk for new born infants should be evaluated if midazolam is administered during the third trimester.
Lactation
Midazolam is contraindicated during breastfeeding.
Some manufacturers advise that the patient discontinues breastfeeding 24 hours before administration of midazolam. Alternatively some manufacturers suggest it is not necessary to stop breastfeeding following a single dose as midazolam is excreted in low quantities in human milk.
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.
Side Effects
Aggression
Agitation
Airway obstruction
Akathisia
Angioedema
Anterograde amnesia
Anxiety
Ataxia
Blurred vision
Bradycardia
Difficulty in walking
Diplopia
Disinhibition
Dizziness
Drowsiness
Dry mouth
Dysarthria
Dysphoria
Dyspnoea
Enuresis
Excitation
Hallucinations
Headache
Hiccups
Hypersensitivity reactions
Involuntary movement disorders
Laryngospasm
Nausea
Pruritus
Respiratory depression
Rhonchi
Salivation
Sleep disturbances
Somnolence
Tachycardia
Tremor
Urticaria
Vertigo
Vomiting
Weakness
Overdosage
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 ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Updated: November 2021
Reference Sources
Summary of Product Characteristics: Ozalin 2mg/ml oral solution in single dose container. Sintetica Ltd. Revised October 2018.
Summary of Product Characteristics: Miprosed 5mg/ml oral solution. Syri Ltd. Revised March 2021.
Gov.uk. 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: https://www.gov.uk/ Last accessed: 18 September 2019
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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