Midazolam (Midazolam Hydrochloride) - Summary

MIDAZOLAM SUMMARY

MIDAZOLAM HYDROCHLORIDE   CIV
SYRUP

Midazolam HCl is a water-soluble benzodiazepine available as a sterile, nonpyrogenic parenteral dosage form for intravenous or intramuscular injection. Each mL contains midazolam hydrochloride equivalent to 1 mg or 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 2.9-3.7 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.

Midazolam hydrochloride injection is indicated:

· intramuscularly or intravenously for preoperative sedation/anxiolysis/amnesia;

· intravenously as an agent for sedation/anxiolysis/amnesia prior to or during diagnostic, therapeutic or endoscopic procedures, such as bronchoscopy, gastroscopy, cystoscopy, coronary angiography, cardiac catheterization, oncology procedures, radiologic procedures, suture of lacerations and other procedures either alone or in combination with other CNS depressants;

· intravenously for induction of general anesthesia, before administration of other anesthetic agents. With the use of narcotic premedication, induction of anesthesia can be attained within a relatively narrow dose range and in a short period of time. Intravenous midazolam can also be used as a component of intravenous supplementation of nitrous oxide and oxygen (balanced anesthesia);

· continuous intravenous infusion for sedation of intubated and mechanically ventilated patients as a component of anesthesia or during treatment in a critical care setting.

Midazolam HCl is associated with a high incidence of partial or complete impairment of recall for the next several hours (see CLINICAL PHARMACOLOGY).

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NEWS HIGHLIGHTS

Published Studies Related to Midazolam

A trial of midazolam vs diphenhydramine in prophylaxis of metoclopramide-induced akathisia. [2012.01]
STUDY OBJECTIVE: The study aimed to evaluate the effects of midazolam and diphenhydramine for the prevention of metoclopramide-induced akathisia... CONCLUSION: Coadministered midazolam reduced the incidence of akathisia induced by metoclopramide compared to placebo but increased the rate of sedation. No difference was detected from diphenhydramine. Routine coadministered 20 mg diphenhydramine did not prevent metoclopramide-induced akathisia. Copyright (c) 2012 Elsevier Inc. All rights reserved.

Effects of midazolam and nitrous oxide on endocrine and metabolic measurements in children. [2012]
children... CONCLUSIONS: When sedation is insufficient during i.v. access, and blood sampling

Analgesia after feline ovariohysterectomy under midazolam-medetomidine-ketamine anaesthesia with buprenorphine or butorphanol, and carprofen or meloxicam: a prospective, randomised clinical trial. [2012]
One hundred female cats undergoing routine ovariohysterectomy under midazolam-medetomidine-ketamine anaesthesia were included in a blinded, randomised, prospective clinical study to compare postoperative analgesia produced by four analgesic drug combinations given preoperatively (n = 25 per group)...

Systemic lidocaine decreases the Bispectral Index in the presence of midazolam, but not its absence. [2012]
Bispectral Index (BIS) in the presence or absence of midazolam... CONCLUSION: IV lidocaine decreases BIS in the presence of midazolam, suggesting

A placebo- and midazolam-controlled phase I single ascending-dose study evaluating the safety, pharmacokinetics, and pharmacodynamics of remimazolam (CNS 7056): Part I. Safety, efficacy, and basic pharmacokinetics. [2012]
and efficacy of the first human study... CONCLUSIONS: Remimazolam provided sedation with rapid onset and offset, and was

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Clinical Trials Related to Midazolam

Clinical Trial of Oral Midazolam in Pediatric Endoscopy [Completed]
The objective of our study was to compare the safety and efficacy of oral midazolam during pediatric endoscopy.

Safety and Efficacy of Oral Midazolam for Perioperative Anxiety Relief of Patients Undergoing Mohs Micrographic Surgery [Active, not recruiting]
Midazolam is an approved sedative medication used for medical procedures. This study is being done to document the safety and efficacy of midazolam in improving anxiety, heart rate, and blood pressure in the setting of Mohs micrographic surgery performed for the treatment of skin cancer (basal cell carcinoma or squamous cell carcinoma). Midazolam may make a patient relaxed and sleepy. It also has beneficial effects on blood pressure, which may improve surgical results. These effects last for about 2 hours.

If you agree to be in the study and there exist no contraindications to your participation in this study, you will be asked to complete three brief questionnaires as well as have blood pressure and other vital signs checked during surgery. Participation in the study does not require a follow up visit, blood work, or other invasive procedures.

The Efficacy of Midazolam & Ketamine Versus Midazolam & Fentanyl for Sedation in Ambulatory Colonoscopies [Completed]
Providing adequate sedation and analgesia is an integral part of the practice of colonoscopy procedure.

There are various protocols and methods used to prevent discomfort and alleviate pain. Conscious sedation is one of the options recommended by the American Society for Gastrointestinal Endoscopy, although the choice of the exact protocol is left to the physician's discretion.

This study will attempt to recommend a preferred protocol based on a double blind randomized prospective method.

The efficacy of midazolam and ketamine will be compared to the efficacy of midazolam and fentanyl for sedation in ambulatory colonoscopies.

The results will be compiled from objective data and patient and physician interviews.

Remifentanil and Propofol Versus Fentanyl and Midazolam for Sedation During Therapeutic Hypothermia. A Randomised, Controlled Trial [Enrolling by invitation]
The aim of this study is to increase knowledge about drug properties and effects during therapeutic hypothermia. The primary end point of this study is the time from termination of sedation to extubation in patients treated with therapeutic hypothermia, after treatment with the combination remifentanil and propofol versus that of fentanyl and midazolam.

Clonidine Versus Midazolam for Premedication [Completed]
alpha2-agonists like clonidine offer several useful effects that make these drugs an interesting alternative to benzodiazepines for pharmacological premedication. We therefore sought to determine the effect of pre-anesthetic medication with clonidine vs. midazolam in a randomized, double-blind, placebo controlled study. Effects of pre-anesthetic medication were assessed on (1) bispectral index (BIS),(2) sedation score and visual analog scales for anxiety and pain, (3) neuropsychologic tests to assess cognitive function and (4) circulating stress hormones.

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Reports of Suspected Midazolam Side Effects

Drug Rash With Eosinophilia and Systemic Symptoms (27),  Toxicity TO Various Agents (15),  Bradycardia (15),  Disseminated Intravascular Coagulation (13),  Serotonin Syndrome (13),  Ventricular Tachycardia (13),  Intentional Overdose (12),  Drug Interaction (12),  Circulatory Collapse (12),  Coma (11), more >>