MIDAZOLAM IN 0.8% SODIUM CHLORIDE 1 mg/mL
MIDAZOLAM IN 0.8% SODIUM CHLORIDE · INJECTION, SOLUTION · B. Braun Medical Inc.
MIDAZOLAM IN 0.8% SODIUM CHLORIDE is a injection, solution containing midazolam in 0.8% sodium chloride at 1 mg/mL, taken intravenous. Manufactured by B. Braun Medical Inc..
Key Facts
- Brand Name
- MIDAZOLAM IN 0.8% SODIUM CHLORIDE
- Generic Name
- MIDAZOLAM IN 0.8% SODIUM CHLORIDE
- NDC Code (Product)
0264-8005- Manufacturer
- B. Braun Medical Inc.
- Strength
- 1 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- DEA Schedule
- Schedule IV (Controlled)
- Application #
- ANDA218454
- Drug Class
- Benzodiazepine [EPC]
- Marketing Start
- 10/15/2025
Recall History
Exela Pharma Sciences LLC
Presence of Particulate Matter: Silicone
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Midazolam in Sodium Chloride Injection is indicated: Continuous intravenous infusion for sedation of intubated and mechanically ventilated adult, pediatric, and neonatal patients as a component of anesthesia or during treatment in a critical care setting. Midazolam in Sodium Chloride Injection is a benzodiazepine indicated for: • Continuous intravenous infusion for sedation of intubated and mechanically ventilated adult, pediatric, and neonatal patients as a component of anesthesia or during treatment in a critical care setting.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • For intravenous injection only. Avoid intra-arterial injection or extravasation. ( 2.1 ) • Individualize dosing and titrate to desired clinical response, taking into account patient age, clinical status, and concomitant use of other CNS depressants. ( 2.1 ) • See Full Prescribing Information for complete dosage and administration information. ( 2 ) 2.1 Important Dosage and Administration Instructions Midazolam in Sodium Chloride Injection should only be administered intravenously. Avoid intra-arterial injection or extravasation [see Warnings and Precautions (5.7) ]. Only personnel trained in the administration of procedural sedation, and not involved in the conduct of the diagnostic or therapeutic procedure, should administer Midazolam in Sodium Chloride Injection. Administering personnel must be trained in the detection and management of airway obstruction, hypoventilation, and apnea, including the maintenance of a patent airway, supportive ventilation, and cardiovascular resuscitation. Supplemental oxygen, resuscitative drugs, and age- and size-appropriate equipment for bag/valve/mask assisted ventilation must be immediately available during administ…
Contraindications
4 CONTRAINDICATIONS Midazolam in Sodium Chloride Injection is contraindicated in patients with: Known hypersensitivity to midazolam Acute narrow-angle glaucoma Midazolam in Sodium Chloride Injection is contraindicated in patients with: • known hypersensitivity to midazolam. (4) • acute narrow-angle glaucoma.
Drug Interactions
7 DRUG INTERACTIONS Opioid Analgesics and Other Sedative Hypnotics : Risk of respiratory depression is increased ( 7.1 ) Cytochrome P450-3A4 Inhibitors : May result in prolonged sedation due to decreased plasma clearance of midazolam. ( 7.2 ) 7.1 Opioid Analgesics and Other Sedative Hypnotics 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. The sedative effect of intravenous midazolam is accentuated by any concomitantly administered medication which depresses the central nervous system, particularly opioids (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 D…
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections: Cardiorespiratory Adverse Reactions [see Warnings and Precautions (5.3) ] Paradoxical Behavior [see Warnings and Precautions (5.4) ] Dependence and Withdrawal [see Warnings and Precautions (5.5) ] Impaired Cognitive Function [see Warnings and Precautions (5.8) ] Hypotension and Seizure in Preterm Infants and Neonates [see Warnings and Precautions (5.9) ] Neonatal Sedation and Withdrawal Syndrome [see Warnings and Precautions (5.10) , Use in Specific Populations (8.1) ] Pediatric Neurotoxicity [see Warnings and Precautions (5.11) ] The following adverse reactions have been identified from literature or postmarketing reports of midazolam. Because some of these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. 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 intravenou…
Frequently Asked Questions
What is MIDAZOLAM IN 0.8% SODIUM CHLORIDE used for?
MIDAZOLAM IN 0.8% SODIUM CHLORIDE contains MIDAZOLAM IN 0.8% SODIUM CHLORIDE. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is MIDAZOLAM IN 0.8% SODIUM CHLORIDE a controlled substance?
Yes, MIDAZOLAM IN 0.8% SODIUM CHLORIDE is classified as CIV under the DEA Controlled Substances Act.
What is the generic name for MIDAZOLAM IN 0.8% SODIUM CHLORIDE?
The generic name for MIDAZOLAM IN 0.8% SODIUM CHLORIDE is MIDAZOLAM IN 0.8% SODIUM CHLORIDE. There are no other listed brand versions of MIDAZOLAM IN 0.8% SODIUM CHLORIDE.
What is the NDC code for MIDAZOLAM IN 0.8% SODIUM CHLORIDE 1 mg/mL?
The NDC (National Drug Code) for MIDAZOLAM IN 0.8% SODIUM CHLORIDE 1 mg/mL is 0264-8005, listed by B. Braun Medical Inc..
Other MIDAZOLAM IN 0.8% SODIUM CHLORIDE Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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