What is Buccolam - midazolam?
Buccolam is a medicine that contains the active substance midazolam. It is available as an 'oral mucosal solution' (a solution given into one side of the mouth, in the space between the gum and cheek) in pre-filled syringes. Each syringe contains 2.5 mg, 5 mg, 7.5 mg or 10 mg of midazolam.
What is Buccolam used for - midazolam?
Buccolam is used to stop prolonged, acute (sudden) seizures in children and adolescents (3 months to less than 18 years of age).
The medicine can only be obtained with a prescription.
How is Buccolam used - midazolam?
Buccolam is given into one side of the baby's mouth. The recommended dose varies from 2.5 mg to 10 mg, depending on the age of the child.
The entire contents of the pre-filled syringe should be administered slowly into the space between the gum and cheek. If necessary, the dose can be divided between the two sides of the mouth.
Buccolam should be given by parents or caregivers only to patients who have been diagnosed with epilepsy.
Caregivers should only administer a single dose. If the seizure does not stop within 10 minutes of Buccolam administration, immediate medical attention should be sought.
Because of an increased risk of respiratory depression (inhibition of breathing), Buccolam can only be given in hospital for infants aged 3 to 6 months, where resuscitation devices are available.
How does Buccolam - midazolam work?
The active substance in Buccolam is midazolam, a benzodiazepine which acts as an anticonvulsant. Seizures are caused by an excess of brain electrical activity. Buccolam binds to GABA neurotransmitter receptors in the brain, activating them. Neurotransmitters such as GABA are chemicals that allow nerve cells to communicate with each other. In the brain, GABA reduces electrical activity. By activating the receptors, Buccolam enhances the effects of GABA, arresting the seizure.
How has Buccolam been studied - midazolam?
The pharmaceutical company presented the results of five key studies from the published literature. The studies looked at children with acute seizures by comparing the effects of oromucosal midazolam with those of diazepam (an "other benzodiazepine) given intravenously (into a vein) or rectally (into the rectum). Four of these studies compared Oromucosal midazolam with rectal diazepam. The measure of efficacy was the ability of the treatment to stop the seizure within 10 minutes. The fifth study compared oromucosal midazolam with intravenous diazepam. The measure of effectiveness was the ability of the treatment to stop the seizure within 5 minutes.
What benefit has Buccolam - midazolam shown during the studies?
Reports in published literature have confirmed that oromucosal midazolam is effective in "arresting seizures in children. In the four studies, oromucosal midazolam was effective in arresting a seizure within 10 minutes in 65-78% of patients. children, compared with 41-85% of children who received rectal diazepam. Comparison between oral mucosal midazolam and intravenous diazepam gave very similar results.
What is the risk associated with Buccolam - midazolam?
The most common side effects with Buccolam (seen in more than 1 in 10 patients) are sedation, sleepiness, depressed level of consciousness, respiratory depression, nausea and vomiting. For the full list of side effects reported with Buccolam, see the package leaflet.
Buccolam must not be used in people who may be hypersensitive (allergic) to midazolam or any of the other ingredients. It must not be used in patients with myasthenia gravis (a disease causing muscle weakness), severe respiratory failure (a condition of the lungs that causes difficulty in breathing), sleep apnea syndrome (frequent interruptions in breathing during sleep) or severe liver disease. .
Why has Buccolam - midazolam been approved?
Based on the results of the studies presented, the CHMP concluded that Buccolam is at least as effective as existing treatments for arresting prolonged, acute seizures in children. Although intravenous drugs may act more quickly from the time of injection, access to the veins can take time, especially in children. Buccolam has the advantage that it can be administered more quickly and easily than a rectal or intravenous medicine. As for side effects, the medicine can cause respiratory depression, like other similar medicines, but is generally well tolerated. The Committee therefore decided that Buccolam's benefits are greater than its risks and recommended that it be given a Marketing Authorization for the medicine.
More information about Buccolam - midazolam
On 5 September 2011, the European Commission issued a "Marketing Authorization" for Buccolam, valid throughout the European Union.
For more information about Buccolam therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 09-2011.
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