Special Products Limited
Orion House, 49 High Street, Addlestone, Surrey KT15 1TU
Telephone: 01932 820666 Fax: 01932 850444
DATA SHEET
EPISTATUS
MIDAZOLAM BUCCAL LIQUID
10mg (base) in 1ml sugar-free syrup
Chemical Name
8-chloro-6-(2-fluorophenyl)-1-methyl-4H-imidazo[1,5-a][1,4]-benzodiazepine
Chemical Group
Midazolam is a short-acting benzodiazepine.
Indication
Treatment of status epilepticus by buccal administration as an alternative to rectal administration of
diazepam.
Presentation
Carton with instructions for use containing 5ml of liquid (sufficient to deliver 4 x 1ml doses) in an amber
glass bottle with a child-resistant closure, together with 4 x 1ml oral syringes
Storage of the Pack
Store 15-250C. The cap must be replaced immediately. Otherwise, the liquid will evaporate and some of
the Midazolam will precipitate. This will be exhibited as white particles in the liquid. The pack must be
discarded if the solution is not clear.
Route of Administration
Using the oral syringe provided, administer half of the prescribed dose to each side of the buccal cavity.
As a last resort, EPISTAT can be administered intra-nasally if the patient foams at the mouth.
Onset of Action
Initial effects become apparent after approximately 5 minutes.
Duration of Action
Patient will be drowsy for several hours after administration.
Pharmacokinetics
Principally cleared by hepatic enzymes with a mean elimination half-life of approximately 3 hours.
Steady state volume of distribution is large: 1.24 - 2.02 litres/kg.
Dosage for status epilepticus
New patients should be given a test dose by a consultant whilst in hospital.
0.3mg/kg (maximum single dose = 10mg)
For simplicity, the following regime can also be adopted:
Age of patient
6-12 months
1-4 years
5-9 years
10 years and over
Dose of Buccal Midazolam
2.5mg (0.25ml)
5mg (0.5ml)
7.5mg (0.75ml)
10mg (1.0ml)
Tolerance to benzodiazepines develops so a patient who has been regularly treated effectively
with rectal diazepam should receive the same dose of buccal midazolam, although it may be
higher than these recommendations.
Repeat doses
Children under 16 years:
Children at Lower End of Age Band
If no effect is apparent after 10 minutes, then call an ambulance. If the child is small and
towards the lower end of the age range, then a further single dose of either buccal Midazolam or
rectal diazepam could be administered whilst en route for the local Accident and Emergency
Department. A third dose must not be administered sooner than 6 hours after the second dose.
Children at Upper End of Age Band
If no effect is apparent after 10 minutes, check that the patient is breathing normally and
administer another dose. If the patient is breathing shallowly, call an ambulance and do not
administer a second dose
If no effect is apparent 5 minutes after the second dose, call an ambulance
A third dose must not be administered sooner than 6 hours after the second dose
Adults and children over 16 years:
If no effect is apparent after 10 minutes, administer another dose
If no effect is apparent 5 minutes after the second dose, call an ambulance
A third dose must not be administered sooner than 6 hours after the second dose
Side-Effects and Adverse Reactions
Paradoxical reactions, e.g., agitation, restlessness and disorientation have been reported,
although these are rare.
Somnolence for 1-2 hours. If this is last longer than 2 hours, then the dose should be reduced to
one that stops the seizures without excessive somnolence.
All benzodiazepines are muscle relaxants and have the following effects at high doses:
Relaxation of the inter-costal muscles causes shallow breathing.
Relaxation of the heart reduces blood pressure.
These effects have to be checked for, but are not normally observed at the recommended
doses.
Contraindications and Precautions
Contraindications include hypersensitivity and acute narrow angle glaucoma.
The safety of Midazolam in pregnancy has not been established.
Treatment of Overdoses
Overdoses of benzodiazepines may be manifested by excessive somnolence, confusion,
hypotension and paradoxical excitation.
Overdoses can be treated with Flumazenil, which is a short-acting benzodiazepine antagonist.
Flumazenil is administered as a 0.2mg i/v bolus over 15 seconds at one minute intervals until
the desired level of consciousness is obtained (maximum 1mg).
Legal Category
Midazolam Buccal Liquid is an 'Unlicensed Medicine' within the meaning of current legislation
governed by the UK Medicines Acts and EU Pharmaceutical Directives.
Excipients
Sodium Saccahrine
Sodium Methylhydroxybutyrate
Sodium Propylhydroxybutyrate
Glycerol
Mannitol
This publication is solely for the technical guidance of prescribers and dispensers of
Midazolam Buccal Liquid and must not be considered as a recommendation or
endorsement for the clinical use of the product.
Further Technical Information
For further technical information regarding Midazolam Buccal Liquid, contact the Technical
Director, Special Products Limited, Orion House, 49 High Street, Addlestone, Surrey KT15 1TU,
Great Britain.
Telephone: 01932 820666; Fax: 01932 850444. E-mail: Graham.March@specprod.co.uk
References:
1. Physicians Desk Reference. 49 ed. Montvale, N.J.:Medical Economics; 1995.
2. Miller RD. Anesthesia. 4 ed. New York: Churchill Livingstone Inc.; 1994.
3. Gilman AG. The Pharmacological Basis of Therapeutics. 8 ed. New York.
Pergamon Press Inc.; 1990.
4. The Merck Index. 11 ed. Rahway, NJ: Merck and Co. Inc.; 1989.
G. A. March
Technical Director