IRINOTECAN HYDROCHLORIDE- irinotecan hydrochloride injection

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

IRINOTECAN HYDROCHLORIDE (UNII: 042LAQ1IIS) (IRINOTECAN - UNII:7673326042)

Tillgänglig från:

Heritage Pharmaceuticals Inc.

INN (International namn):

IRINOTECAN HYDROCHLORIDE

Sammansättning:

IRINOTECAN HYDROCHLORIDE 20 mg in 1 mL

Administreringssätt:

INTRAVENOUS

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

- Irinotecan hydrochloride injection, USP 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, USP is contraindicated in patients with a known hypersensitivity to the drug or its excipients. Pregnancy Category D [see Warnings and Precautions (5.9)] Irinotecan hydrochloride injection can cause fetal harm when administered to a pregnant woman. Radioactivity related to 14 C-irinotecan crosses the placenta of rats following intravenous administration of 10 mg/kg (which in separate studies produced an irinotecan Cmax and AUC about 3 and 0.5 times, respectively, the corresponding values in patients administered 125 mg/m2 ). Intravenous administration of irinotecan 6 mg/kg/day to rats and rabbits during the period of organogenesis resulted in increased post-implantation loss and decreased numbers of live fetuses. In separate studies in rats, this dose produced an irinote

Produktsammanfattning:

Each mL of Irinotecan Hydrochloride Injection, USP contains 20 mg irinotecan hydrochloride USP (on the basis of the trihydrate salt); 45 mg sorbitol NF; and 0.9 mg lactic acid USP. When necessary, pH has been adjusted to 3.5 (range, 3.0 to 3.8) with sodium hydroxide NF and/or hydrochloric acid NF. Irinotecan Hydrochloride Injection, USP is available in single-dose amber glass vials in the following package sizes: 2 mL         NDC 23155-179-31 5 mL         NDC 23155-179-32 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light. It is recommended that the vial should remain in the carton until the time of use. Inspect the vial for damage and visible signs of leaks before removing from the carton. If damaged, incinerate the unopened package.

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

IRINOTECAN HYDROCHLORIDE- IRINOTECAN HYDROCHLORIDE INJECTION
HERITAGE PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
IRINOTECAN HYDROCHLORIDE INJECTION, USP
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
IRINOTECAN HYDROCHLORIDE INJECTION, USP.
IRINOTECAN HYDROCHLORIDE INJECTION, USP, INTRAVENOUS INFUSION
INITIAL U.S. APPROVAL: 1996
WARNING: DIARRHEA AND MYELOSUPPRESSION
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
EARLY AND LATE FORMS OF DIARRHEA CAN OCCUR. EARLY DIARRHEA MAY BE
ACCOMPANIED BY CHOLINERGIC
SYMPTOMS WHICH MAY BE PREVENTED OR AMELIORATED BY ATROPINE. LATE
DIARRHEA CAN BE LIFE THREATENING
AND SHOULD BE TREATED PROMPTLY WITH LOPERAMIDE. MONITOR PATIENTS WITH
DIARRHEA AND GIVE FLUID AND
ELECTROLYTES AS NEEDED. INSTITUTE ANTIBIOTIC THERAPY IF PATIENTS
DEVELOP ILEUS, FEVER, OR SEVERE
NEUTROPENIA. INTERRUPT IRINOTECAN HYDROCHLORIDE INJECTION AND REDUCE
SUBSEQUENT DOSES IF SEVERE
DIARRHEA OCCURS.
SEVERE MYELOSUPPRESSION MAY OCCUR.
INDICATIONS AND USAGE
Irinotecan is a topoisomerase inhibitor indicated for:
Patients with metastatic carcinoma of the colon or rectum whose
disease has recurred or progressed following initial
fluorouracil-based therapy. (1)
DOSAGE AND ADMINISTRATION
Colorectal cancer single agent regimen 1: Irinotecan hydrochloride
injection, USP 125 mg/m intravenous infusion
over 90 minutes on days 1, 8, 15, 22 then 2-week rest. (2.2)
Colorectal cancer single agent regimen 2: Irinotecan hydrochloride
injection, USP 350 mg/m intravenous infusion
over 90 minutes on day 1 every 3 weeks. (2.2)
DOSAGE FORMS AND STRENGTHS
Irinotecan hydrochloride injection is available in two single-dose
sizes: (3)
2 mL-fill vial containing 40 mg irinotecan hydrochloride injection
5 mL-fill vial containing 100 mg irinotecan hydrochloride injection
CONTRAINDICATIONS
Hypersensitivity to Irinotecan hydrochloride injection, USP or its
excipients (4)
WARNINGS AND PRECAUTIONS
DIARRHEA AND CHOLINERGIC R