Download Information for Primary Care. - North Of Tyne Area Prescribing

North of Tyne Area Prescribing Committee
Information Leaflet for Primary Care
North of Tyne Area Prescribing Committee
Shared Care Group
MIDAZOLAM BUCCAL (Epistatus®) –
Information for Primary Care.
Approved Indication
Midazolam Buccal is included in the North of Tyne Formulary for use in febrile
convulsions, status epilepticus and prolonged seizures.
Background
Buccal midazolam has been shown to be as effective as rectal diazepam as a
pharmacological intervention for severe and enduring seizures in children, and
offers a more socially acceptable alternative. Although no trials have been
performed in adults, adults should respond similarly to children, so use can be
recommended in adults too.
Although buccal midazolam (Epistatus) is unlicensed, both the BNF and the
BNF for children recognise buccal administration of midazolam as a valid
pharmacological strategy in the management of status epilepticus. The BNF for
children acknowledges that the buccal route may be more acceptable than the
rectal route in children.
The dose is 300microgram/kg to a maximum of 10mg.
BNF for Children Suggest Dose Range
Age
6-12 months
1-4 years
5-10 years
10 years and over
Dose
2.5mg 0.25ml)
5mg (0.5ml)
7.5mg(0.75ml)
10mg (1ml)
Contra-indications
Midazolam buccal (Epistatus®) is contra-indicated in:
 Known hypersensitivity to the drug or any excipients.
 Acute narrow angle glaucoma.
In pregnancy safety has not been established, and risk/benefit assessment
should be undertaken before use in individual patients.
Method of Administration
Patients prescribed buccal midazolam by a hospital consultant must receive a
protocol for the administration of midazolam from the hospital consultant. This
details the circumstances for which buccal midazolam should be given, the
initial dose and any repeat dose together with advice on administration. Advice
on management, should this not control the seizures, is included in the protocol.
A copy of the protocol should have been sent to the patient’s general
practitioner.
North of Tyne Area Prescribing Committee
Approved: September 2010
Review date: September 2012
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North of Tyne Area Prescribing Committee
Information Leaflet for Primary Care
Carers/relatives should be trained in the administration of buccal midazolam,
and signing of the protocol by the nurse specialist indicates this training has
been undertaken.
Side-effects
The most commonly reported side effect is drowsiness; in some cases this may
be severe. All patients receiving Epistatus® are likely to be drowsy for several
hours after administration.
Agitation, restlessness and disorientation have been reported, although these
are rare.
Drug Interactions
Erythromycin, other macrolides and cimetidine inhibit the metabolism of
midazolam. This may result in prolonged duration of the sedative side effect.
NHS Cost
Midazolam Buccal (Epistatus®) 10mg/ml 5ml bottle = £65.13 (inc. VAT)
Other information
Midazolam is a schedule 3 Controlled Drug with CD register and safe custody
exemptions.
Special Products Ltd.
(01932 690 325) manufacture a midazolam solution, 10mg/ml formulated in a
sugar-free syrup and supplied in a 5 ml bottle with four 10mg doses and 4 x 1
ml oral syringes and full instructions on its use. It is available on NHS
prescription. Written information and verbal explanation on use will be given to
parents/ carers by the Specialist Epilepsy Nurse and/ or hospital pharmacy staff
when initially prescribed.
Store between 15ºC and 25 ºC NOT in a refrigerator as crystallisation may occur.
See the manufacturer’s SPC or BNF for more detailed prescribing information.
North of Tyne Area Prescribing Committee
Approved: September 2010
Review date: September 2012
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