くすりのしおり

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Published: 12/2020

The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.
Brand name :
BUCCOLAM oromucosal solution 7.5mg
 Active ingredient:
Midazolam
 Dosage form:
limpid and colorless solution
 Print on wrapping:

Effects of this medicine

This medicine suppresses epileptic seizure by sedating excessive nerve excitement in the brain.
It is usually used to treat status epilepticus.

Before using this medicine, be sure to tell your doctor and pharmacist

  • If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.
    If you have: myasthenia gravis, glaucoma, acute alcoholic poisoning, respiratory function disorder, sleep apnea syndrome, heart disease, a history of alcohol or drug abuse, fluid or electrolyte disturbance, brain disorder, renal dysfunction or liver dysfunction.
    If you are in a state of shock, in a state of coma or debilitated.
  • If you are pregnant or breastfeeding.
  • If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)

Dosing schedule (How to take this medicine)

  • Your dosing schedule prescribed by your doctor is ((        to be written by a healthcare professional))
  • In general, inject this medicine into the buccal mucosa at the following doses: 2.5 mg as the active ingredient at a time for infants of modified gestational age of 52 weeks (gestational age + weeks after birth) or over and under 1 year old; 5 mg at a time for children aged 1 year or over and under 5 years old; 7.5 mg at a time for children aged 5 years or over and under 10 years old; 10 mg at a time for children aged 10 years or over and under 18 years old. This preparation contains 7.5 mg of the active ingredient in a syringe. Strictly follow the instructions.
  • This medicine may be used outside the medical institution by parental guardians or proper substitutional persons who have shared the understanding of status epilepticus symptoms requiring administration of this medicine with the doctor, and received proper instructions on how to use this medicine, adverse effects which may occur at usage of this medicine, how to deal with it, etc. However, for infants aged 3 to 6 months, this medicine needs to be used with the doctor.
  • For patients with non-convulsive status epilepticus, parental guardians or proper substitutional persons who have received proper instructions can use this medicine outside the medical institution only if your doctor has considered it appropriate to use this medicine.
  • Hold one cheek to stretch, put the tip of the syringe between the lower gum and cheek, and inject the whole contents of the syringe slowly. For patients with small physique or patients who need much dosage, the half of the dose may be injected into the one side of the cheeks and the other half into the other side according to the doctor's instruction.
  • Parental guardians or proper substitutional persons can use one dose (one syringe) only. Even if seizures recur, do not use additional dose of this medicine.
  • Since this medicine is absorbed through the buccal mucosa, pay attention not to swallow this medicine as much as possible in use.
  • To avoid incidental aspiration, do not inject this medicine into the pharyngeal trachea.
  • This medicine is an oromucosal solution filled with one prescribed dose and used into the buccal mucosa. This medicine is not an injection. Do not attach needles, etc. to the syringe.
  • Be sure to check if the two caps (red cap and white cap inside of it) come off before use to avoid accidental ingestion and swallowing.
  • If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist.

Precautions while taking this medicine

  • This medicine may cause sleepiness/lack of attention, concentration and reflex action ability, etc. Avoid operating dangerous machinery, such as driving a car.
  • Refrain from drinking alcohol and grapefruit juice with this medicine, because the effect of this medicine is affected.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include sedation, sleepiness, nausea and vomiting. If any of these symptoms occur, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
  • reduced respiratory rate, shallow breathing [respiratory depression]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.

Storage conditions and other information

  • Keep out of reach of children. Store away from direct sunlight, heat and moisture.
  • Put the syringe enclosed in the plastic tube and keep it at a standing position with the cap up.
  • Do not reuse the syringe, and discard it safely.
  • Discard the remainder. Do not store them. Seek advice of your pharmacy or medical institution about proper disposal of the unused medicines.
  • [To parental guardians or substitutional persons] Read the instruction leaflet, etc. about this medicine carefully and understand the usage of this medicine. In principle, arrange emergency transport to a hospital after using this medicine. If seizures do not stop within 10 minutes, the full dosage cannot be administered or shallow breathes or loss of consciousness is noted, transport the patient emergently to an institution. In this case, present the used syringe to the medical professions to make them understand the situation using this medicine. Check the respiratory rate and pulse rate and observe the patient carefully for any signs of apnea, respiratory depression, decreased pulse, etc.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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