Dormilat 15 mg/3 ml Injection

Dormilat 15 mg/3 ml injection by Advanced Chemical Industries Limited is a medicine containing Midazolam. In Bangladesh, it is mainly used for sedation, anxiety relief, and amnesia before or during medical procedures, and as part of anaesthesia or seizure management when prescribed.

Midazolam works by enhancing the calming effect of GABA in the brain, which slows nerve activity and causes sedation, muscle relaxation, and anticonvulsant effects. A key caution is that it can cause serious drowsiness and breathing depression, especially with alcohol, opioids, or other sedatives.

• Sedation and anxiolysis before diagnostic, dental, or surgical procedures.
• Premedication before anaesthesia and as an adjunct for induction or maintenance of anaesthesia.
• Sedation of ventilated patients in intensive care settings.
• Emergency treatment of prolonged acute seizures or status epilepticus when an appropriate route and formulation are used by trained personnel.

The dose of Midazolam depends on the indication, route, age, body weight, general health, and response. Injection should be given only by trained healthcare professionals with monitoring and resuscitation facilities available. Tablets should be taken exactly as prescribed, usually for short-term use or before a planned procedure. Do not increase the dose, repeat a dose, or stop long-term use suddenly without the prescribing doctor’s advice.

• Common effects include drowsiness, dizziness, reduced alertness, confusion, headache, nausea, hiccups, and impaired coordination.
• Memory loss or amnesia may occur, especially around the time of procedures.
• Injection may cause pain, redness, or irritation at the injection site.
• Serious effects include slow or shallow breathing, low blood pressure, severe sedation, loss of consciousness, paradoxical agitation or aggression, allergic reactions, dependence, withdrawal symptoms, and seizures after abrupt withdrawal in dependent patients.

Use Midazolam with extra caution in elderly or frail patients, children, people with breathing problems, sleep apnoea, chronic lung disease, heart disease, liver or kidney impairment, myasthenia gravis, history of alcohol or drug dependence, depression, or suicidal thoughts. Avoid driving, operating machinery, alcohol, and other sedatives unless the doctor allows it. Use this medicine only under a registered doctor’s or pharmacist’s guidance.

• Alcohol, opioids, sleeping pills, antipsychotics, antidepressants, sedating antihistamines, and other CNS depressants can greatly increase sedation and breathing depression.
• Strong CYP3A inhibitors such as ketoconazole, itraconazole, voriconazole, clarithromycin, erythromycin, HIV protease inhibitors, and grapefruit juice may increase midazolam levels and toxicity.
• CYP3A inducers such as rifampicin, carbamazepine, phenytoin, phenobarbital, and St John’s wort may reduce its effect.
• Other anaesthetic medicines and muscle relaxants may have additive effects and require close monitoring.

• Known allergy or hypersensitivity to midazolam, other benzodiazepines, or any component of the formulation.
• Severe respiratory depression or acute severe breathing insufficiency unless airway support and monitoring are available.
• Severe sleep apnoea syndrome.
• Severe liver impairment where benzodiazepines may worsen brain function.
• Myasthenia gravis, unless a specialist decides the benefit outweighs the risk.
• Acute narrow-angle glaucoma.
• Use with strong CYP3A inhibitors for oral midazolam is generally contraindicated in many references because of the risk of prolonged excessive sedation.

Midazolam should be used during pregnancy only when clearly needed and prescribed by a doctor. Use near delivery may cause newborn drowsiness, breathing difficulty, low muscle tone, or withdrawal symptoms. Midazolam passes into breast milk in small amounts; breastfeeding mothers should use it only on medical advice, and infants should be observed for unusual sleepiness, poor feeding, or breathing problems. Temporary interruption of breastfeeding may be advised after high or repeated doses.

Store tablets and injections as directed on the pack, generally at room temperature away from excess heat, moisture, and direct light. Keep out of reach of children. Do not use if the injection is discoloured, contains particles, the container is damaged, or the expiry date has passed.