SPL Set ID: ebf0f833-c1c0-487c-8f29-01fa8c61b6cb
1 drug(s) with this SPL Set ID
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