Naloxonedrug info
naloxone hydrochloride 80 MG/ML Nasal Spray [Kloxxado]
What it is used for
KLOXXADO is indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression, for adult and pediatric patients. KLOXXADO is intended for immediate administration as emergency therapy in settings where opioids may be present. KLOXXADO is not a substitute for emergency medical care. KLOXXADO is an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression, for adult and pediatric patients. KLOXXADO is intended for immediate administration as emergency therapy in settings where opioids may be present. KLOXXADO is not a substitute for emergency medical care.
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective August 25, 2025. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
Description
KLOXXADO (naloxone hydrochloride) nasal spray contains the active moiety naloxone, an opioid antagonist, in the form of hydrochloride salt. The chemical name of Naloxone hydrochloride dihydrate is 17-Allyl-4,5α-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride dihydrate. It has the molecular weight of 399.87 g/mol. Naloxone hydrochloride dihydrate molecular formula is C 19 H 21 NO 4· HCl · 2H 2 O, and it has the following chemical structure, as shown below. Naloxone hydrochloride occurs as a white to slightly off-white powder, and is soluble in water, in dilute acids, and in strong alkali; slightly soluble in alcohol; practically insoluble in ether and in chloroform. KLOXXADO (naloxone hydrochloride) nasal spray is supplied in a pre-filled, single-dose intranasal spray. Each spray or 0.1 mL of KLOXXADO (naloxone hydrochloride) nasal spray contains 8 mg of naloxone hydrochloride (equivalent to 8.79 mg of naloxone hydrochloride dihydrate, USP or 7.2 mg naloxone). Inactive ingredients are dehydrated alcohol (8 mg strength: 20% (w/w)), edetate disodium dihydrate, USP, propylene glycol, USP, and sodium hydroxide, NF and hydrochloric acid, NF as pH adjusters, in purified water, USP. The pH range for KLOXXADO (naloxone hydrochloride) nasal spray is from 4.0 to 5.5. image-chemical-structure-usp.jpg
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective August 25, 2025. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
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