Midolam 15 mg/3 ml is indicated for

• short-term management of insomnia.
• It is also used for sedation as premedication prior to surgical or diagnostic procedures.

Midazolam is a fast-acting hypnotic agent with a rapid onset and short duration of action. It also has anxiolytic, anticonvulsant, and muscle relaxant properties.

Midazolam, a benzodiazepine, exerts its effects through gamma-aminobutyric acid (GABA), the principal inhibitory neurotransmitter in the central nervous system. It enhances GABA activity, leading to sedation, muscle relaxation, sleep induction, anesthesia, and amnesia. It binds to benzodiazepine sites on GABA-A receptors, increasing the frequency of chloride channel opening and thereby potentiating the inhibitory effects of GABA. These receptors are widely distributed in the body, particularly in the central nervous system.

Oral dosage:

• For adults: 7.5–15 mg daily.
• In elderly and debilitated patients: The recommended dose is 7.5 mg.
• In premedication: 15 mg of Midazolam should be given 30–60 minutes before the procedure.

Intravenous administration:

• Endoscopic or Cardiovascular Procedures: In healthy adults, the initial dose is approximately 2.5 mg. In cases of severe illness and in elderly patients, the initial dose must be reduced to 1 to 1.5 mg.
• Induction of Anesthesia: The dose is 10–15 mg.

Intramuscular administration:

• Adult: 0.07–0.1 mg/kg body weight. The usual dose is about 5 mg.
• Children: 0.15–0.20 mg/kg
• Elderly and debilitated patients: 0.025–0.05 mg/kg

Rectal administration in children:

• For preoperative sedation: Rectal administration of the ampoule solution (0.35–0.45 mg/kg) 20–30 min. before induction of general anesthesia.

Midazolam must not be given to patients with severe respiratory insufficiency, severe hepatic insufficiency, myasthenia gravis, sleep apnea syndrome and with known hypersensitivity to benzodiazepines or to any component of the product.

At the start of therapy, drowsiness during daytime, confusion, fatigue, headache and muscle weakness may occur which usually disappear with repeated administration. Following parenteral (IV or IM) administration of Midazolam, fluctuations in vital signs have been noted including respiratory depression, apnea, variations in blood pressure and pulse rate.

Midazolam should be avoided during pregnancy unless there is no safer alternative. Since Midazolam passes into breast milk, it should not be administered to breast-feeding mothers.

Midazolam IV should be administered very slowly.

Extreme overdosage may lead to coma, areflexia, cardiorespiratory depression and apnea. The effects of overdosage can be controlled with benzodiazepine antagonist flumazenil.

Benzodiazepine hypnotics, Benzodiazepine sedatives

Protect from light and moisture, store in cool and dry place. Keep out of the reach of children.