IRINOTECAN HYDROCHLORIDE injection solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Irinotecan Hydrochloride (UNII: 042LAQ1IIS) (Irinotecan - UNII:7673326042)

Available from:

Sandoz Inc

INN (International Name):

Irinotecan Hydrochloride

Composition:

Irinotecan Hydrochloride 20 mg in 1 mL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

IRINOTECAN HYDROCHLORIDE- IRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION
SANDOZ 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, FOR INTRAVENOUS INFUSION
INITIAL U.S. APPROVAL: 1996
WARNING: DIARRHEA AND MYELOSUPPRESSION
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
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INDICATIONS AND USAGE
Irinotecan hydrochloride injection, USP is a topoisomerase inhibitor
indicated for:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Irinotecan hydrochloride injection is available in two single-dose
sizes: (3)
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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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 and
reduce subsequent doses if severe diarrhea occurs.
Severe myelosuppression may occur.
Patients with metastatic carcinoma of the colon or rectum whose
disease has recurred or progressed following initial
fluorouracil-based therapy. (1)
Colorectal cancer single agent regimen 1: Irinotecan hydrochloride
injection 125 mg/m intravenous infusion over 90
minutes on days 1, 8, 15, 22 then 2-week rest. (2.2)
2
Colorectal cancer single agent regimen 2: Irinotecan hydrochloride
injection 350 mg/m intravenous infusion over 90
minutes on day 1 every 3 weeks. (2.2)
2
2 mL-fill vial containing 40 mg irinotecan hydrochloride
5 mL-fill vial containing 100 mg irinotecan hydrochloride
Hypersensitivity to irinotecan hydrochloride or its excipients (4)
D