irinotecan hydrochloride
irinotecan hydrochloride is listed in the FDA National Drug Code directory with 4 NDC codes, marketed under brand names including Camptosar, Irinotecan Hydrochloride. Available dosage form: injection, solution.
Drug Details
- Generic Name
- irinotecan hydrochloride
- Brand Names
- Camptosar, Irinotecan Hydrochloride
- Application Number
- NDA020571
- Sponsor
- Pharmacia & Upjohn Company LLC
- NDC Codes
- 4
- Dosage Forms
- INJECTION, SOLUTION
- Routes
- INTRAVENOUS
- Active Ingredients
- IRINOTECAN HYDROCHLORIDE
Indications and Usage
1 INDICATIONS AND USAGE Irinotecan hydrochloride injection is indicated as a component of first-line therapy in combination with 5-fluorouracil (5-FU) and leucovorin (LV) for patients with metastatic carcinoma of the colon or rectum. Irinotecan hydrochloride injection is indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy. Irinotecan hydrochloride injection is a topoisomerase inhibitor indicated for: First-line therapy in combination with 5-fluorouracil and leucovorin for patients with metastatic carcinoma of the colon or rectum. ( 1 ) Patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy. ( 1 )