REXTOVY NALOXONE 4MG NASAL SPRAY (2 PACK)

REXTOVY NALOXONE 4MG NASAL SPRAY (2 PACK)

Rx

DESCRIPTION

Naloxone hydrochloride is an opioid antagonist. It is chemically identified as 17-allyl-4,5α-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride dihydrate. Its molecular formula is C19H21NO4 • HCl • 2H2O and has a molecular weight of 399.87 g/mol. It has the following structural formula:

Naloxone hydrochloride dihydrate occurs as a white to slightly off-white powder. It is soluble in water, in dilute acids, and in strong alkali; slightly soluble in alcohol; practically insoluble in ether and in chloroform. REXTOVY Nasal Spray is a prefilled unit-dose intranasal spray. Naloxone hydrochloride is contained as a solution in a stoppered glass vial within the nasal spray device. Each REXTOVY device delivers a single spray containing 4 mg of naloxone hydrochloride (equivalent to 3.6 mg of naloxone) in 0.25 mL of aqueous solution with a pH of 3.5 to 5.0. Inactive ingredients include sodium chloride, sodium hydroxide to adjust pH, and water for injection USP.

INDICATIONS AND USAGE

REXTOVY Nasal Spray is indicated for emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression, for adult and pediatric patients. REXTOVY Nasal Spray is intended for immediate administration as emergency therapy in settings where opioids may be present. REXTOVY Nasal Spray is not a substitute for emergency medical care.