Midazolam 5 mg/mL
Midazolam · INJECTION, SOLUTION · Micro Labs Limited
Midazolam injection is a prescription sedative medication given by intramuscular injection, commonly used to reduce anxiety and induce sedation before medical procedures or surgery. This medication belongs to a class of drugs called benzodiazepines.
Key Facts
- Brand Name
- Midazolam
- Generic Name
- Midazolam
- NDC Code (Product)
42571-415- Manufacturer
- Micro Labs Limited
- Strength
- 5 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR, INTRAVENOUS
- Marketing Status
- DEA Schedule
- Schedule IV (Controlled)
- Application #
- ANDA217504
- Marketing Start
- 01/01/2024
Recall History
Central Admixture Pharmacy Services Inc
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Avella of Deer Valley, Inc. Store 38
Lack of Assurance of Sterility: Potential leakage of bags.
Pharmakon Pharmaceuticals, Inc.
Lack of Assurance of Sterility
Pharmakon Pharmaceuticals, Inc.
Lack of Assurance of Sterility
Pharmedium Services, LLC
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Pharmakon Pharmaceuticals, Inc.
Lack of Assurance of Sterility
Pharmakon Pharmaceuticals
Stability data does not support expiry.
Fresenius Kabi USA, LLC
Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.
Pharmedium Services, LLC
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Central Admixture Pharmacy Services Inc
Lack of assurance of sterility:
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 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.
Dosage & Administration
DOSAGE AND ADMINISTRATION Note: CONTAINS BENZYL ALCOHOL (see WARNINGS and PRECAUTIONS , Pediatric Use ) Midazolam hydrochloride injection is a potent sedative agent that requires slow administration and individualization of dosage. Clinical experience has shown midazolam hydrochloride to be 3 to 4 times as potent per mg as diazepam. BECAUSE SERIOUS AND LIFE-THREATENING CARDIORESPIRATORY ADVERSE EVENTS HAVE BEEN REPORTED, PROVISION FOR MONITORING, DETECTION AND CORRECTION OF THESE REACTIONS MUST BE MADE FOR EVERY PATIENT T0 WHOM MIDAZOLAM HYDROCHLORIDE INJECTION IS ADMINISTERED, REGARDLESS OF AGE OR HEALTH STATUS. Excessive single doses or rapid intravenous administration may result in respiratory depression, airway obstruction and/or arrest. The potential for these latter effects is increased in debilitated patients, those receiving concomitant medications capable of depressing the CNS, and patients without an endotracheal tube but undergoing a procedure involving the upper airway such as endoscopy or dental (see Boxed WARNING and WARNINGS ). Reactions such as agitation, involuntary movements, hyperactivity and combativeness have been reported in adult and pediatric patients. Shoul…
Warnings
WARNINGS Personnel and Equipment for Monitoring and Resuscitation Prior to the intravenous administration of midazolam in any dose, the immediate availability of oxygen, resuscitative drugs, age- and size-appropriate equipment for bag/valve/mask ventilation and intubation, and skilled personnel for the maintenance of a patent airway and support of ventilation should be ensured. Patients should be continuously monitored for early signs of hypoventilation, airway obstruction, or apnea with means readily available (e.g., pulse oximetry). Hypoventilation, airway obstruction, and apnea can lead to hypoxia and/or cardiac arrest unless effective countermeasures are taken immediately. The immediate availability of specific reversal agents (flumazenil) is highly recommended. Vital signs should continue to be monitored during the recovery period. Because intravenous midazolam can depress respiration (see CLINICAL PHARMACOLOGY ), especially when used concomitantly with opioid agonists and other sedatives (see DOSAGE AND ADMINISTRATION ), it should be used for sedation/anxiolysis/amnesia only in the presence of personnel skilled in early detection of hypoventilation, maintaining a patent airwa…
Contraindications
CONTRAINDICATIONS Midazolam injection is contraindicated in patients with a known hypersensitivity to the drug. 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 with midazolam hydrochloride; patients with glaucoma have not been studied. Midazolam is not intended for intrathecal or epidural administration due to the presence of the preservative benzyl alcohol in the dosage form. Midazolam injection is contraindicated for use in premature infants because the formulation contains benzyl alcohol (see WARNINGS and PRECAUTIONS , Pediatric Use ).
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. Limit dosage and duration of concomitant use of benzodiazepines and opioids, and monitor patients closely for respiratory depression and sedation. Other CNS Depressants The sedative effect of intravenous midazolam is accentuated by any concomitantly administered medication, which depresses the central nervous system, particularly narcotics (e.g., morphine, meperidine and fentanyl) and also secobarbital and droperidol. Consequently, the dosage of midazolam should be adjusted according to the type and amount of concomitant medications administered and the desired clinical response (see DOSAGE AND ADMINISTRATION ). Other Drug Interactions Caution is advised when midazolam is administered concomitan…
Adverse Reactions
ADVERSE REACTIONS See WARNINGS concerning serious cardiorespiratory events and possible paradoxical reactions. Fluctuations in vital signs were the most frequently seen findings following parenteral administration of midazolam in adults and included decreased tidal volume and/or respiratory rate decrease (23.3% of patients following IV and 10.8% of patients following IM administration) and apnea (15.4% of patients following IV administration), as well as variations in blood pressure and pulse rate. The majority of serious adverse effects, particularly those associated with oxygenation and ventilation, have been reported when midazolam hydrochloride is administered with other medications capable of depressing the central nervous system. The incidence of such events is higher in patients undergoing procedures involving the airway without the protective effect of an endotracheal tube, (e.g., upper endoscopy and dental procedures). Adults: The following additional adverse reactions were reported after intramuscular administration: headache (1.3%) Local effects at IM Injection site pain (3.7%) induration (0.5%) redness (0.5%) muscle stiffness (0.3%) Administration of IM midazolam hydroc…
Frequently Asked Questions
What is Midazolam used for?
Midazolam injection is a prescription sedative medication given by intramuscular injection, commonly used to reduce anxiety and induce sedation before medical procedures or surgery. This medication belongs to a class of drugs called benzodiazepines.
Is Midazolam a controlled substance?
Yes, Midazolam is classified as CIV under the DEA Controlled Substances Act.
What is the generic name for Midazolam?
The generic name for Midazolam is Midazolam. There are 7 other brand versions of Midazolam.
What is the NDC code for Midazolam 5 mg/mL?
The NDC (National Drug Code) for Midazolam 5 mg/mL is 42571-415, listed by Micro Labs Limited.