Midazolam Hydrochloride

Midazolam Hydrochloride

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Midazolam hydrochloride is a water-soluble benzodiazepine available as a sterile, non-pyrogenic parenteral dosage form for intravenous or intramuscular injection. Each mL contains midazolam hydrochloride equivalent to 5 mg midazolam compounded with 0.8% sodium chloride and 0.01% edetate disodium, with 1% benzyl alcohol as preservative; the pH is adjusted to 3 to 3.6 with hydrochloric acid and, if necessary, sodium hydroxide.

Midazolam is a white to light yellow crystalline compound, insoluble in water. The hydrochloride salt of midazolam, which is formed in situ, is soluble in aqueous solutions. Chemically, midazolam HCl is 8-chloro-6-(2-fluorophenyl)-1-methyl-4H-imidazo [1,5-a][1,4]benzodiazepine hydrochloride.

Midazolam Injection, USP pharmacy bulk package is a sterile solution dosage form for preparing intravenous (IV) or intramuscular (IM) injections. Each pharmacy bulk package contains 500 mg midazolam in a 100 mL vial. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of IV or IM injection, or preparation of admixture for IV infusion.



• Premedication before induction of anaesthesia.

• Conscious sedation before diagnostic or surgical interventions carried out under local anaesthesia.

• Long-term sedation in intensive care units.

• Induction and maintenance of anaesthesia. As an induction agent in inhalation anaesthesia or a sleep-inducing component in combined anaesthesia.


• Premedication before induction of anaesthesia.

• Conscious sedation before diagnostic or surgical interventions carried out under local anaesthesia.

• Ataralgesia in combination with ketamine.

You must not be given Midazolam Injection

• If you are allergic (hypersensitive) to midazolam or any of the other ingredients of the medicine

• If you are allergic to other benzodiazepine medicines, such as diazepam or nitrazepam.

• If you have severe breathing problems and you are going to have Midazolam Injection for conscious sedation.

Usage in Pregnancy

An increased risk of congenital malformations associated with the use of benzodiazepine drugs (diazepam and chlordiazepoxide) has been suggested in several studies. If this drug is used during pregnancy, the patient should be apprised of the potential hazard to the fetus.

Usage in Preterm Infants and Neonates

Rapid injection should be avoided in the neonatal population. Midazolam administered rapidly as an intravenous injection (less than 2 minutes) has been associated with severe hypotension in neonates, particularly when the patient has also received fentanyl


Likewise, severe hypotension has been observed in neonates receiving a continuous infusion of midazolam who then receive a rapid intravenous injection of fentanyl . Seizures have been reported in several neonates following rapid intravenous administration.

Driving and using machines
Midazolam may make you sleepy, dizzy, and forgetful or affect your concentration and coordination. This may affect your performance at skilled tasks such as driving or using machines.

• Do not drive or use machinery until you are completely recovered. Your doctor should advise you when you can start these again.

• Midazolam Injection may make you sleepy, forgetful or affect your concentration and co-ordination.

High-Risk Patients
Special caution should be exercised when administering midazolam parenterally to patients representing a higher risk group:

• Adults over 60 years of age

• Debilitated or chronically ill patients

• Patients with impaired respiratory function

• Patients with impaired kidney function

• Impaired hepatic function (benzodiazepines may precipitate or exacerbate encephalopathy in patients with severe hepatic impairment).

• Impaired cardiac function

• Paediatric patients with cardiovascular instability

Withdrawal Symptoms

During prolonged treatment with midazolam ampoules in ICU, physical dependence may develop. Therefore, abrupt termination of the treatment will be accompanied by withdrawal symptoms. The following withdrawal symptoms may occur: headaches, diarrhoea, muscle pain, extreme anxiety, tension, restlessness, confusion, irritability, sleep disturbances, mood changes, hallucinations and convulsions.

In severe cases, the following symptoms may occur: depersonalization, numbness and tingling of the extremities, hypersensitivity to light, noise and physical contact.

Concomitant use of Alcohol/CNS Depressants
The concomitant use of midazolam with alcohol and/or CNS depressants should be avoided. Such concomitant use has the potential to increase the clinical effects of midazolam possibly including severe sedation that could result in coma or death, clinically relevant respiratory and/or cardiovascular depression.

Risks from Concomitant Use with Opioids
Concomitant use of benzodiazepines, including midazolam, and opioids may result in profound sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant prescribing of benzodiazepines and opioids for use in patients for whom alternative treatment options are inadequate.


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