Midazolam Hydrochloride 5 mg/mL
Midazolam Hydrochloride · INJECTION, SOLUTION · Henry Schein, Inc.
Midazolam Hydrochloride is a injection, solution containing midazolam hydrochloride at 5 mg/mL, taken intramuscular. Manufactured by Henry Schein, Inc..
Key Facts
- Brand Name
- Midazolam Hydrochloride
- Generic Name
- Midazolam Hydrochloride
- NDC Code (Product)
0404-9916- Manufacturer
- Henry Schein, Inc.
- Strength
- 5 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR, INTRAVENOUS
- Marketing Status
- DEA Schedule
- Schedule IV (Controlled)
- Application #
- ANDA075857
- Marketing Start
- 01/17/2022
Recall History
Fresenius Kabi USA, LLC
Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Midazolam HCl syrup is indicated for use in pediatric patients for sedation, anxiolysis and amnesia prior to diagnostic, therapeutic or endoscopic procedures or before induction of anesthesia. Midazolam HCl syrup is intended for use in monitored settings only and not for chronic or home use [see WARNINGS] .
Dosage & Administration
DOSAGE AND ADMINISTRATION Midazolam HCl syrup is indicated for use as a single dose (0.25 to 1.0 mg/kg with a maximum dose of 20 mg) for preprocedural sedation and anxiolysis in pediatric patients. Midazolam HCl syrup is not intended for chronic administration. Monitoring Midazolam HCl syrup should only be used in hospital or ambulatory care settings, including physicians’ and dentists’ offices that can provide for continuous monitoring of respiratory and cardiac function. Immediate availability of resuscitative drugs and age- and size-appropriate equipment for bag/valve/mask ventilation and intubation, and personnel trained in their use and skilled in airway management should be assured [see WARNINGS] . For deeply sedated patients, a dedicated individual whose sole responsibility it is to observe the patient, other than the practitioner performing the procedure, should monitor the patient throughout the procedure. Continuous monitoring of respiratory and cardiac function is required. Midazolam HCl syrup must be given only to patients if they will be monitored by direct visual observation by a health care professional. Midazolam HCl syrup should only be administered by persons spec…
Warnings
WARNINGS Personnel and Equipment for Monitoring and Resuscitation Midazolam HCl syrup should be used only in hospital or ambulatory care settings, including physicians’ and dentists’ offices, that are equipped to provide continuous monitoring of respiratory and cardiac function. Midazolam HCl syrup must only be administered to patients if they will be monitored by direct visual observation by a health care professional. If midazolam HCl syrup will be administered in combination with other anesthetic drugs or drugs which depress the central nervous system, patients must be monitored by persons specifically trained in the use of these drugs and, in particular, in the management of respiratory effects of these drugs, including respiratory and cardiac resuscitation of patients in the age group being treated. For deeply sedated patients, a dedicated individual whose sole responsibility is to observe the patient, other than the practitioner performing the procedure, should monitor the patient throughout the procedure. Patients should be continuously monitored for early signs of hypoventilation, airway obstruction, or apnea with means for detection readily available (eg, pulse oximetry). …
Contraindications
CONTRAINDICATIONS Midazolam HCl syrup is contraindicated in patients with a known hypersensitivity to the drug or allergies to cherries or formulation excipients. Benzodiazepines are contraindicated in patients with acute narrow-angle glaucoma. Benzodiazepines may be used in patients with open-angle glaucoma only if they are receiving appropriate therapy. Measurements of intraocular pressure in patients without eye disease show a moderate lowering following induction of general anesthesia with injectable midazolam; patients with glaucoma have not been studied.
Drug Interactions
Drug Interactions Effect of Concomitant Use of Benzodiazepines and Opioids The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions at different receptor sites in the CNS that control respiration. Benzodiazepines interact at GABA A sites, and opioids interact primarily at mu receptors. When benzodiazepines and opioids are combined, the potential for benzodiazepines to significantly worsen opioid-related respiratory depression exists. Monitor patients closely for respiratory depression and sedation. Other CNS Depressants One case was reported of inadequate sedation with chloral hydrate and later with oral midazolam due to a possible interaction with methylphenidate administered chronically in a 2-year-old boy with a history of Williams syndrome. The difficulty in achieving adequate sedation may have been the result of decreased absorption of the sedatives due to both the gastrointestinal effects and stimulant effects of methylphenidate. The sedative effect of midazolam HCl syrup is accentuated by any concomitantly administered medication which depresses the central nervous system, particularly opioids (e.g., morphine, meperid…
Adverse Reactions
ADVERSE REACTIONS The distribution of adverse events occurring in patients evaluated in a randomized, double-blind, parallel- group trial are presented in Tables 5 and 6 by body system in order of decreasing frequency: for the premedication period (eg, sedation period prior to induction of anesthesia) alone, see Table 5; for over the entire monitoring period including premedication, anesthesia and recovery, see Table 6. The distribution of adverse events occurring during the premedication period, before induction of anesthesia, is presented in Table 5. Emesis, which occurred in 31/397 (8%) patients over the entire monitoring period, occurred in 3/397 (0.8%) of patients during the premedication period (from midazolam administration to mask induction). Nausea, which occurred in 14/397 (4%) patients over the entire monitoring period (premedication, anesthesia and recovery), occurred in 2/397 (0.5%) patients during the premedication period. This distribution of all adverse events occurring in ≥1% of patients over the entire monitoring period are presented in Table 6. For the entire monitoring period (premedication, anesthesia and recovery), adverse events were reported by 82/397 (21%) …
Frequently Asked Questions
What is Midazolam Hydrochloride used for?
Midazolam Hydrochloride contains Midazolam Hydrochloride. It is a injection, solution taken intramuscular. Consult your doctor for specific uses.
Is Midazolam Hydrochloride a controlled substance?
Yes, Midazolam Hydrochloride is classified as CIV under the DEA Controlled Substances Act.
What is the generic name for Midazolam Hydrochloride?
The generic name for Midazolam Hydrochloride is Midazolam Hydrochloride. There are 9 other brand versions of Midazolam Hydrochloride.
What is the NDC code for Midazolam Hydrochloride 5 mg/mL?
The NDC (National Drug Code) for Midazolam Hydrochloride 5 mg/mL is 0404-9916, listed by Henry Schein, Inc..