Concomitant use increases risk of respiratory depression due to actions at different CNS receptor sites. Sedative effect of midazolam is accentuated.
Source: NLP:midazolam in 0.8% sodium chloride
Midazolam In 0.8% Sodium Chloride Interactions
Brand names: Midazolam In 0.8% Sodium Chloride
Benzodiazepine
Route: Intravenous
FDA Black Box Warning
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) ]. 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 [see Dosage and Administration (2.1) , Warnings and Precautions (5.1) ]. Resuscitative drugs, and age- and size-appropriate equipment for bag/ valve/mask assisted ventilation must be immediately available during administration of Midazolam in Sodium Chloride Injection [see Dosage and Administration (2.1) , Warnings and Precautions (5.1) ]. Continuously monitor vital signs during sedation and during the recovery period [see Dosage and Administration (2.1) , Warnings and Precautions (5.1) ]. Risks from Concomitant Use with Opioid Analgesics and Other Sedative Hypnotics Concomitant use of benzodiazepines, including Midazolam in Sodium Chloride Injection, and opioids may result in profound sedation, respiratory depression, coma, and death. Continuously monitor patients for respiratory depression and depth of sedation [see Warnings and Precautions (5.2) and Drug Interaction (7.1) ]. WARNING: PERSONNEL AND EQUIPMENT FOR MONITORING AND RESUSCITATION, AND RISKS FROM CONCOMITANT USE WITH OPIOID ANALGESICS AND OTHER SEDATIVE-HYPNOTICS See full prescribing information for complete boxed warning. 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 Chlorid
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.
Pregnancy & Breastfeeding
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) . In pregnant rats and rabbits, midazolam did not cause adverse effects to the fetus at doses of up to 1.85 times the human induction dose of 0.35 mg/kg based on body surface area comparisons. Published studies in pregnant primates demonstrate that the administration of anesthetic and sedation drugs that block NMDA receptors and/or potentiate GABA activity during the period of peak brain development increases neuronal apoptosis in the developing brain of the offspring when used for longer than 3 hours. There are no data on pregnancy exposures in primates corresponding to periods prior to the third trimester in humans (see Data) . The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Benzodiazepines cross the placenta and may produce respiratory depression, hypotonia, and sedation in neonates. Monitor neonates exposed to midazolam during pregnancy and labor for signs of sedation, respiratory depression, hypotonia, and feeding problems. Monitor neonates exposed to midazolam during pregnancy for signs of withdrawal. Manage these neonates accordingly [see Warnings and Precautions (5.2) ]. Data Human Data Published data from observational studies on the use of benz
16 interactions on record
Concomitant use increases risk of respiratory depression due to actions at different CNS receptor sites. Sedative effect of midazolam is accentuated.
Source: NLP:midazolam in 0.8% sodium chloride
Concomitant use increases risk of respiratory depression due to actions at different CNS receptor sites. Sedative effect of midazolam is accentuated.
Source: NLP:midazolam in 0.8% sodium chloride
P450-3A4 inhibitor may result in prolonged sedation due to decreased plasma clearance of midazolam.
Source: NLP:midazolam in 0.8% sodium chloride
P450-3A4 inhibitor may result in prolonged sedation. Increases midazolam half-life from 5 to 7 hours.
Source: NLP:midazolam in 0.8% sodium chloride
CNS depressant that accentuates the sedative effect of intravenous midazolam. Dosage adjustment recommended.
Source: NLP:midazolam in 0.8% sodium chloride
P450-3A4 inhibitor may result in prolonged sedation. Reduces clearance of midazolam and approximately doubles half-life.
Source: NLP:midazolam in 0.8% sodium chloride
P450-3A4 inhibitor may result in prolonged sedation due to decreased plasma clearance of midazolam.
Source: NLP:midazolam in 0.8% sodium chloride
P450-3A4 inhibitor may result in prolonged sedation due to decreased plasma clearance of midazolam.
Source: NLP:midazolam in 0.8% sodium chloride
Reduces clearance of midazolam by 56% and approximately doubles half-life, resulting in prolonged sedation.
Source: NLP:midazolam in 0.8% sodium chloride
CNS depressant that accentuates the sedative effect of intravenous midazolam. Dosage adjustment recommended.
Source: NLP:midazolam in 0.8% sodium chloride
Moderate reduction in induction dosage requirements of thiopental (about 15%) when used concomitantly with midazolam.
Source: NLP:midazolam in 0.8% sodium chloride
P450-3A4 inhibitor may result in prolonged sedation. Increases midazolam half-life from 5 to 7 hours.
Source: NLP:midazolam in 0.8% sodium chloride
7.7 Other Drugs Used in the Surgical Setting No significant adverse interactions with commonly used premedications or drugs used during anesthesia and surgery (including atropine, scopolamine, glycopyrrolate, diazepam, hydroxyzine, d-tubocurarine, succinylcholine and other nondepolarizing muscle relaxants) or topical local anesthetics (including lidocaine, dyclonine HCl and Cetacaine) have been observed in adults or pediatric patients.
Source: FDA drug label - midazolam in 0.8% sodium chloride
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. 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 Dosage and Administration (2) ].
Source: FDA drug label - midazolam in 0.8% sodium chloride
No interaction was observed in healthy subjects between midazolam and nifedipine.
Source: FDA drug label - midazolam in 0.8% sodium chloride