Irita

Irinotecan Hydrochloride USP

Composition: Irita Injection: Each vial contains Irinotecan Hydrochloride USP 40 mg/2 ml Injection.

Irita-100 Injection: Each vial Contains Irinotecan Hydrochloride USP 100 mg/5 ml Injection.

Indications: Irinotecan 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. It is indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial Fluorouracil-based therapy.

Dosage and Administration: Colorectal cancer combination regimen 1: Irinotecan 125 mg/m2 IV infusion over 90 minutes on days 1, 8, 15, 22 with LV 20 mg/m2 IV bolus infusion on days 1, 8, 15, 22 followed by 5-FU IV bolus infusion on days 1, 8, 15, 22 every 6 weeks. Colorectal cancer single agent regimen 1: Irinotecan 125 mg/m2 IV infusion over 90 minutes on days 1, 8, 15, 22 then 2-week rest. Or, as directed by the registered physician.

Use in Pregnancy and Lactation: Pregnancy category D. Irinotecan can cause fetal harm when administered to a pregnant woman. It is not known weather this drug excreted in human milk.

Packaging: Irita Injection: Each box contains 1 vial of 2 ml Irinotecan Hydrochloride USP injection (40 mg).

Irita-100 Injection: Each box contains 1 vial of 5 ml Irinotecan Hydrochloride USP injection (100 mg).

Prescribing Description

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