<H1>CAMPTOSAR </H1><P>CAMPTOSARInjection (irinotecan hydrochloride injection) is an antineoplastic
agent of the topoisomerase I inhibitor class. Irinotecan hydrochloride was clinically
investigated as CPT-11.
CAMPTOSAR is supplied as a sterile, pale yellow, clear, aqueous solution. It is
available in two single-dose sizes: 2 mL-fill vials contain 40 mg irinotecan hydrochloride
and 5 mL-fill vials contain 100 mg irinotecan hydrochloride. Each milliliter of solution
contains 20 mg of irinotecan hydrochloride (on the basis of the trihydrate salt), 45 mg of
sorbitol NF powder, and 0.9 mg of lactic acid, USP. The pH of the solution has been
adjusted to 3.5 (range, 3.0 to 3.8) with sodium hydroxide or hydrochloric acid.
CAMPTOSAR is intended for dilution with 5% Dextrose Injection, USP (D5W), or 0.9%
Sodium Chloride Injection, USP, prior to intravenous infusion. The preferred diluent is
5% Dextrose Injection, USP.
Irinotecan hydrochloride is a semisynthetic derivative of camptothecin, an alkaloid
extract from plants such as Camptotheca acuminata or is chemically synthesized. The
chemical name is (S)-4,11-diethyl-3,4,12,14-tetrahydro-4-hydroxy-3,14-dioxo1Hpyrano[
3’,4’:6,7]-indolizino[1,2-b]quinolin-9-yl-[1,4’bipiperidine]-1’-carboxylate,
monohydrochloride, trihydrate. Its structural formula is as follows:
Irinotecan hydrochloride is a pale yellow to yellow crystalline powder, with the
empirical formula C33H38N4O6•HCl•3H2O and a molecular weight of 677.19. It is slightly
soluble in water and organic solvents.</P>
agent of the topoisomerase I inhibitor class. Irinotecan hydrochloride was clinically
investigated as CPT-11.
CAMPTOSAR is supplied as a sterile, pale yellow, clear, aqueous solution. It is
available in two single-dose sizes: 2 mL-fill vials contain 40 mg irinotecan hydrochloride
and 5 mL-fill vials contain 100 mg irinotecan hydrochloride. Each milliliter of solution
contains 20 mg of irinotecan hydrochloride (on the basis of the trihydrate salt), 45 mg of
sorbitol NF powder, and 0.9 mg of lactic acid, USP. The pH of the solution has been
adjusted to 3.5 (range, 3.0 to 3.8) with sodium hydroxide or hydrochloric acid.
CAMPTOSAR is intended for dilution with 5% Dextrose Injection, USP (D5W), or 0.9%
Sodium Chloride Injection, USP, prior to intravenous infusion. The preferred diluent is
5% Dextrose Injection, USP.
Irinotecan hydrochloride is a semisynthetic derivative of camptothecin, an alkaloid
extract from plants such as Camptotheca acuminata or is chemically synthesized. The
chemical name is (S)-4,11-diethyl-3,4,12,14-tetrahydro-4-hydroxy-3,14-dioxo1Hpyrano[
3’,4’:6,7]-indolizino[1,2-b]quinolin-9-yl-[1,4’bipiperidine]-1’-carboxylate,
monohydrochloride, trihydrate. Its structural formula is as follows:
Irinotecan hydrochloride is a pale yellow to yellow crystalline powder, with the
empirical formula C33H38N4O6•HCl•3H2O and a molecular weight of 677.19. It is slightly
soluble in water and organic solvents.</P>
