SPL Set ID: b094e6ba-7cf6-4fb8-8683-73d324650dd3

1 drug(s) with this SPL Set ID

Open DailyMed details

Topotecan Hydrochloride TOPOTECAN HYDROCHLORIDE
FRESENIUS KABI USA, LLC FDA Rx Only

Topotecan is a topoisomerase inhibitor. The chemical name for topotecan hydrochloride is ( S ) - 10-[(dimethylamino)methyl]-4-ethyl-4,9-dihydroxy-1 H -pyrano[3',4':6,7] indolizino [1,2- b ]quinoline-3,14-(4 H ,12 H )-dione 1.25 hydrochloride. It is soluble in water and melts with decomposition at 213° to 218°C. Topotecan hydrochloride has the following structural formula: C 23 H 23 N 3 O 5 • 1.25HCl M.W. 467.02 Topotecan hydrochloride for injection is supplied as a sterile, lyophilized, buffered, light yellow to greenish powder available in single-dose vials. Each vial contains topotecan hydrochloride equivalent to 4 mg of topotecan as free base. The reconstituted solution ranges in color from yellow to yellow green and is intended for administration by intravenous infusion. Inactive ingredients are mannitol, 48 mg, and tartaric acid, 20 mg. Hydrochloric acid and sodium hydroxide may be used to adjust the pH. The solution pH ranges from 2.5 to 3.5. structural formula

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