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Nayzilam

Last reviewed on RxList: 5/22/2019

NAYZILAM®
(midazolam) Nasal Spray

WARNING

RISKS FROM CONCOMITANT USE WITH OPIOIDS

Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death [see WARNINGS AND PRECAUTIONS, DRUG INTERACTIONS].

  • Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate.
  • Limit dosages and durations to the minimum required.
  • Follow patients for signs and symptoms of respiratory depression and sedation.

DESCRIPTION

NAYZILAM contains midazolam, a compound of the benzodiazepine class. Midazolam is chemically designated as 8-Chloro-6-(ο-fluorophenyl)-1-methyl-4H-imidazo[1,5a][1,4]benzodiazepine, and it has the following structure:

NAYZILAM® (midazolam) Structural Formula Illustration

The empirical formula is C18H13ClFN3 representing a molecular weight of 325.8. Midazolam, USP is a white or yellowish, crystalline powder that is practically insoluble in water, soluble in methanol, and freely soluble in acetone and in alcohol.

NAYZILAM nasal spray is a clear, colorless to yellowish colored liquid. Each single-dose NAYZILAM unit is for nasal administration and delivers 5 mg of midazolam in 0.1 mL of solution containing ethanol; PEG-6 methyl ether; polyethylene glycol 400; propylene glycol; and purified water.

The pH range of solution is approximately 5.0 to 9.0.

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