Buccolam pre-filled oral syringes contain the active ingredient midazolam, which is a type of medicine called a benzodiazepine.
What is Buccolam used for?
- Treatment of prolonged convulsive epileptic seizures in children aged three months to 18 years.
How does Buccolam work?
- Buccolam pre-filled oral syringes contain the active ingredient midazolam, which is a type of medicine called a benzodiazepine. Midazolam acts on nerve cells in the brain and is used to control convulsions (fits or seizures) in children with epilepsy.
- The brain and nerves are made up of many nerve cells that communicate with each other through electrical signals. These signals must be carefully regulated for the brain and nerves to function properly.
- When abnormally rapid and repetitive electrical signals are released in the brain, it becomes over-stimulated and normal function is disturbed. This results in fits or seizures.
- Midazolam works by acting on receptors in the brain called GABA receptors.
How is Buccolam given?
- The medicine in Buccolam oral syringe is administered into the side of the mouth to stop a seizure. The midazolam is absorbed into the bloodstream through the rich supply of blood vessels in this area. Some of the medicine may also be swallowed and absorbed from the gut.
- Carers of children with epilepsy will be trained by the child's epilepsy specialists to recognise when this medicine should be given and how. Follow their instructions carefully.
- Your doctor will prescribe the most appropriate dose of Buccolam for the age of the child.
- Remove the oral syringe cap before giving the medicine. The tip of the syringe should then be put gently into the child's mouth, to the inside of the child's cheek. Slowly and gently push the plunger down to gently squirt the medicine into the inside of the child's cheek.
- The full contents of one syringe should be given. If necessary (for larger volumes and/or smaller children), approximately half the dose can be given slowly into one side of the mouth, then the other half given slowly into the other side.
- DO NOT forcefully push down the plunger, or squirt the medicine to the back of the child's mouth or throat, as your child may choke.
- Carers must only give one dose of Buccolam. If this doesn't stop the seizure within 10 minutes, you must get emergency medical assistance. Give the empty syringe to the healthcare professional so they know what dose has already been given to the child.
If the seizure is initially controlled after giving a dose of this medicine, but then starts again, you must get medical advice. Do not give another dose unless instructed to by a doctor.
Important information about Buccolam
- Buccolam is for administration into the mouth only. Do not put a needle on the oral syringe. The medicine must not be injected.
- Do not give more medicine than has been prescribed by a doctor for the patient.
- You should telephone for an ambulance immediately if any of the following occur:
- You cannot give Buccolam.
- There is a possibility that you may have given too much Buccolam.
- You cannot give all of the contents of the oral syringe.
- The child's breathing slows down or stops.
- The seizure does not stop within 10 minutes of giving Buccolam.
- Babies between three and six months of age should be only be treated with this medicine by a healthcare professional in a hospital, where monitoring is possible and resuscitation equipment is available.
- The safety and effectiveness of this medicine in babies under three months of age have not been studied.
- After being given Buccolam, children may be sleepy, forgetful or have problems with concentration and co-ordination. This may affect their ability to perform skilled tasks such as driving, riding a bike, or using machines.After receiving Buccolam, the child should not ride a bike, drive a vehicle or operate a machine until they have completely recovered.
- Alcohol will increase the sedative effect of this medicine and should be avoided.
- Grapefruit juice can reduce the breakdown of the medicine in the body and should also be avoided because it can increase sleepiness.
Buccolam should be used with caution in
- Chronic lung disease.
- Chronic kidney failure.
- Liver disease.
- Heart disease.
- Weak or debilitated children.
- History of alcohol or drug abuse.
Buccolam should not be used in
- Allergy to other benzodiazepines, eg diazepam.
- Severely decreased liver function.
- Children with a disease called myasthenia gravis, which involves abnormal muscle weakness.
- Children with severe breathing difficulties.
- Children with a syndrome involving short spells when breathing stops during sleep (sleep apnoea syndrome).
This medicine should not be used if your child is allergic to one or any of its ingredients. Please inform your doctor or pharmacist if your child has previously experienced such an allergy. If you feel your child has experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.
Pregnancy and breastfeeding
Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.
- It is important to tell your doctor if the girl who needs treatment with this medicine is or could be pregnant. The safety of this medicine for use in the first two trimesters of pregnancy has not been established. Your doctor will need to decide if this treatment is essential. If this medicine is used in late pregnancy or during labour it may cause an irregular heartbeat, floppiness, low body temperature and breathing or feeding difficulties in the baby after birth. Ask your doctor for further information.
- Midazolam passes into breast milk in small amounts. However, it may not be necessary to avoid breastfeeding after a single dose. Ask your doctor for advice.
Possible side effects of Buccolam
Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.
Common (affect between 1 in 10 and 1 in 100 people)
- Reduced levels of consciousness.
- Feeling sick or vomiting. (If the child is sick you should not give them another dose. If the seizure is not controlled you should call an ambulance.)
- Slow, shallow breathing (call for an ambulance if the child is having breathing problems).
Uncommon (affect between 1 in 100 and 1 in 1000 people)
- Itchy skin.
Very rare (affect fewer than 1 in 10,000 people)
- Aggression or anger.
- Temporary memory loss.
- Difficulty co-ordinating muscles.
- Muscle spasms or tremor.
- Dry mouth.
- Low blood pressure.
- Slow heart rate, heart attack.
- Shortness of breath.
- Breathing stopping.
The side effects listed above may not include all of the side effects reported by the medicine's manufacturer. For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.
How can Buccolam affect other medicines?
It is important to tell your doctor or pharmacist what medicines your child is already taking, including those bought without a prescription and herbal medicines, before treatment with this medicine is prescribed. Similarly, check with your doctor or pharmacist before giving your child any new medicines, to make sure that the combination is safe.
There may be an increased risk of drowsiness and sedation if this medicine is given to children who have taken any of the following (which can also cause drowsiness):
- antipsychotics, eg chlorpromazine, clozapine
- barbiturates, eg phenobarbital
- other benzodiazepines, eg temazepam, diazepam
- MAOI antidepressants, eg phenelzine
- sedating antihistamines, eg chlorphenamine
- sleeping tablets, eg zopiclone
- strong opioid painkillers, eg morphine, codeine, dihydrocodeine
- tricyclic antidepressants, eg amitriptyline.
The following medicines may slow down the breakdown of midazolam in the body and so may prolong its effects and increase sedation:
- azole antifungals such as ketoconazole, itraconazole, fluconazole, posaconazole, voriconazole
- macrolide antibiotics such as clarithromycin and erythromycin
- protease inhibitors for HIV infection, such as ritonavir, indinavir and saquinavir
The following medicines may reduce the effect of midazolam and your doctor may need to prescribe a higher than normal dose of Buccolam if your child is also taking one of these medicines:
- the herbal remedy St John's wort (Hypericum perforatum)