Topotecan Hydrochloride Recall
Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Topotecan hydrochloride is indicated for the treatment of:
- small cell lung cancer sensitive disease after failure of first-line chemotherapy. In clinical studies submitted to support approval, sensitive disease was defined as disease responding to chemotherapy but subsequently progressing at least 60 days (in the Phase 3 study) or at least 90 days (in the Phase 2 studies) after chemotherapy [see Clinical Studies (14)].
Topotecan hydrochloride in combination with cisplatin is indicated for the treatment of:
- stage IV-B, recurrent, or persistent carcinoma of the cervix which is not amenable to curative treatment with surgery and/or radiation therapy.
There is currently no drug history available for this drug.
Topotecan Hydrochloride for Injection is a semi-synthetic derivative of camptothecin and is an anti-tumor drug with topoisomerase I-inhibitory activity.
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.
The chemical name for topotecan hydrochloride is (S)-10-[(dimethylamino)methyl]-4-ethyl-4,9-dihydroxy-1H-pyrano[3’,4’:6,7] indolizino [1,2-b]quinoline-3,14-(4H,12H)-dione monohydrochloride.
Topotecan hydrochloride has the following structural formula:
C23H23N3O5·HCl M.W. 457.9
It is soluble in water and melts with decomposition at 213° to 218°C.
Topotecan Hydrochloride Manufacturers
App Pharmaceuticals, Llc
Three Rivers Pharmaceuticals, Llc.
Pfizer Laboratories Div Pfizer Inc.
Accord Healthcare Inc.
Fresenius Kabi Usa, Llc
Sun Pharmaceutical Industries Limited
Mylan Institutional Llc
Login To Your Free Account