Midazolam In 0.8% Sodium Chloride
Generic Name: midazolam in 0.8% sodium chloride
Brand Names:
Midazolam In 0.8% Sodium Chloride
11 DESCRIPTION Midazolam in 0.8% Sodium Chloride Injection is a benzodiazepine available as a sterile, preservative-free, nonpyrogenic solution of midazolam and sodium chloride in water for injection for intravenous use. Each single-dose bag of Midazolam in Sodium Chloride Injection contains either 50 mg/50 mL (1 mg/mL) or 100 mg/100 mL (1 mg/mL) of midazolam and 8 mg/mL of sodium chloride in water for injection.
Overview
11 DESCRIPTION Midazolam in 0.8% Sodium Chloride Injection is a benzodiazepine available as a sterile, preservative-free, nonpyrogenic solution of midazolam and sodium chloride in water for injection for intravenous use. Each single-dose bag of Midazolam in Sodium Chloride Injection contains either 50 mg/50 mL (1 mg/mL) or 100 mg/100 mL (1 mg/mL) of midazolam and 8 mg/mL of sodium chloride in water for injection.
Uses
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
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) ].
Side Effects
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.
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.
Warnings
WARNING: PERSONNEL AND EQUIPMENT FOR MONITORING AND RESUSCITATION, AND RISKS FROM CONCOMITANT USE WITH OPIOID ANALGESICS AND OTHER SEDATIVE-HYPNOTICS Personnel and Equipment for Monitoring and Resuscitation 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 [see Dosage and Administration (2.1) , Warnings and Precautions (5.1) ]. 5 WARNINGS AND PRECAUTIONS Cardiorespiratory Adverse Reactions : Serious cardiorespiratory adverse reactions have occurred, sometimes resulting in death or permanent neurologic injury. ( 5.3 ) Paradoxical Behavior : Agitation, involuntary movements (including tonic/clonic movements and muscle tremor), hyperactivity and combativeness have been reported in both adult and pediatric patients. ( 5.4 ) Dependence and Withdrawal with Long-Term Use : Use for several days to weeks may lead to physical dependence to midazolam. Do not abruptly discontinue midazolam. Gradually taper the dosage using a tapering schedule that is individualized to the patient. 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.
Pregnancy
8.1 Pregnancy Risk Summary Neonates born to mothers using benzodiazepines, including midazolam, late in pregnancy have been reported to experience symptoms of sedation and/or neonatal withdrawal [see Warnings and Precautions (5.10) , and Clinical Considerations] . Available data from published observational studies of pregnant women exposed to benzodiazepines do not report a clear association with benzodiazepines and major birth defects (see Data) .
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Midazolam in 0.8% Sodium Chloride Injection is a clear, colorless liquid supplied in 50 mL and 100 mL flexible container (bag), closed with an injection port, each bag is protected with an overwrap available as: Total Strength per Total Volume Strength per mL NDC REF 50 mg per 50 mL 1 mg/mL 0264-8005-31 DM8005 100 mg per 100 mL 1 mg/mL 0264-8002-32 DM8002 The b...
Frequently Asked Questions
What is Midazolam In 0.8% Sodium Chloride used for?▼
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.
What are the side effects of Midazolam In 0.8% Sodium Chloride?▼
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.
Can I take Midazolam In 0.8% Sodium Chloride during pregnancy?▼
8.1 Pregnancy Risk Summary Neonates born to mothers using benzodiazepines, including midazolam, late in pregnancy have been reported to experience symptoms of sedation and/or neonatal withdrawal [see Warnings and Precautions (5.10) , and Clinical Considerations] . Available data from published observational studies of pregnant women exposed to benzodiazepines do not report a clear association with benzodiazepines and major birth defects (see Data) .
What are the important warnings for Midazolam In 0.8% Sodium Chloride?▼
WARNING: PERSONNEL AND EQUIPMENT FOR MONITORING AND RESUSCITATION, AND RISKS FROM CONCOMITANT USE WITH OPIOID ANALGESICS AND OTHER SEDATIVE-HYPNOTICS Personnel and Equipment for Monitoring and Resuscitation 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 [see Dosage and Administration (2.1) , Warnings and Precautions (5.1) ]. 5 WARNINGS AND PRECAUTIONS Cardiorespiratory Adverse Reactions : Serious cardiorespiratory adverse reactions have occurred, sometimes resulting in death or permanent neurologic injury. ( 5.3 ) Paradoxical Behavior : Agitation, involuntary movements (including tonic/clonic movements and muscle tremor), hyperactivity and combativeness have been reported in both adult and pediatric patients. ( 5.4 ) Dependence and Withdrawal with Long-Term Use : Use for several days to weeks may lead to physical dependence to midazolam. Do not abruptly discontinue midazolam. Gradually taper the dosage using a tapering schedule that is individualized to the patient. 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.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.