Screen Shot 2017-12-07 at 15.52.14BUCCOLAM 2.5 mg, 5 mg, 7.5 mg and 10 mg Oromuscosal Solution Pre-filled Syringes

  •   Shire has distributed the Direct Healthcare Professional Communication (DHCP) attached due to reports that the translucent tip-cap sometimes remains on the syringe tip when pulling the red cap off, as shown in the DHCP diagrams.
  •   If this occurs, the translucent tip cap needs to be removed manually to enable administration of BUCCOLAM and to prevent it falling into the patient’s mouth upon application of extreme pressure. There have not yet been any reports of the translucent tip-cap falling into a patient’s mouth but this cannot theoretically be excluded.
  •   This issue is applicable to all unexpired batches of BUCCOLAM currently in the marketplace.

This is a good time to share how to use the use buccal mizolam – from Great Ormand Street. 

Buccal (oromucosal) midazolam

Buccal midazolam is a drug used to stop seizures.

What is midazolam?

Midazolam belongs to a group of medicines called benzodiazepines, which are used to treat a number of different conditions, including seizures. If a seizure lasts for more than five minutes, it may be difficult to stop unless treatment is given. It is therefore important that rapid treatment is given to stop the seizures and therefore prevent status epilecticus. Status epilepticus is a condition where a person has a seizure (convulsion or fit) or a series of seizures that last for 30 minutes or more, without a complete recovery of consciousness.

Midazolam is chemically related to diazepam, which is another medicine used to treat seizures.

How is buccal midazolam given?

The midazolam solution should be placed against the sides of the gums and cheek so that the medicine is absorbed directly into the bloodstream. This is known as the buccal or oromucosal route. If the medicine is swallowed accidentally, it might not work as quickly.

Buccal midazolam is available as:

  • Buccolam® contains Midazolam Hydrochloride 5mg in 1ml in pre-filled oral syringes of 2.5mg, 5mg, 7.5mg and 10mg.
  • Epistatus® contains Midazolam Maleate 10mg in 1ml. It is a preparation in a 5ml bottle with four oral syringes in the packaging. Epistatus® is also available as pre-filled oral syringes of 2.5mg, 5mg, 7.5mg and 10mg. This is an unlicensed product, available as a ‘special’.

It is important to remember which brand and dose your child uses.

Instructions for giving buccal midazolam

  • Your local medical team will train you how to prepare and give buccal midazolam.
  • Always check the dose and expiry date before use.
  • Give the medicine slowly to stop your child swallowing the medicine as this may cause them to choke.
  • If buccal midazolam does not control the seizure within five minutes, follow the advice given by your doctor or call 999 for an ambulance.
  • If you cannot give buccal midazolam for any reason, give first aid and call 999 for an ambulance.

Using Buccolam® pre-filled oral syringes or Epistatus® pre-filled oral syringes

  • Check the dose and expiry date of the pre-filled syringe provided.
  • Remove the oral syringe from the packaging.
  • Place the syringe into the side of your child’s mouth, between the gums and teeth.
  • If possible, divide the dose so you give half into one cheek and the remaining half into the other cheek.
  • Slowly push the plunger of the syringe down until the syringe is empty.
  • Watch for any breathing difficulties.
  • Confirm that the seizure has stopped.
  • Dispose of the syringe safely.

Using Epistatus® buccal liquid (Midazolam Maleate 10mg/1ml) 5ml bottle

  • You will need the following equipment:
    • bottle of Epistatus®
    • oral syringe provided
  • Check that the liquid is clear with no crystals visible. Discard if you can see crystals.
  • Unscrew the bottle cap, keeping the bottle upright.
  • Insert a syringe into the centre of the stopper.
  • Turn the bottle upside down.
  • Pull the plunger of the syringe back slowly and then push back to prevent any air bubbles.
  • Pull the plunger back again slowly and draw up the prescribed amount of liquid.
  • Turn the bottle the right way up before removing the syringe.
  • Put the cap back on the bottle to stop spillages.
  • Place the syringe into the side of your child’s mouth, between the gums and teeth.
  • If possible, divide the dose so give half into one cheek and the remaining half into the other cheek.
  • Slowly push the plunger of the syringe down until the syringe is empty.
  • Watch for any breathing difficulties.
  • Confirm that the seizure has stopped.
  • Dispose of the syringe safely.

What are the side effects of buccal midazolam?

  • Drowsiness and sedation – recovery is usually fast.
  • Amnesia or short-term memory loss – your child may not remember having had a seizure.
  • Breathing difficulties – your child is unlikely to have breathing difficulties if midazolam is given at the correct dosage. If breathing difficulties do develop, seek medical assistance.
  • Restlessness, agitation and disorientation – these can occur but are usually rare.

Important information about buccal midazolam

Give the medicine as prescribed by your doctor.

  • If your child stops using midazolam or it passes its expiry date, please return it to your pharmacist. Do not flush it down the toilet or throw it away.
  • Keep midazolam in a safe place where children cannot see it or reach it.
  • Keep midazolam at room temperature (not in a fridge), away from bright light or direct sunlight and away from heat.
  • Always check you have enough medicine and remember to order a new prescription in plenty of time.