VINCRISTINE SULFATE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

VINCRISTINE SULFATE (UNII: T5IRO3534A) (VINCRISTINE - UNII:5J49Q6B70F)

Available from:

Hospira, Inc.

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Vincristine Sulfate Injection is indicated in acute leukemia. Vincristine Sulfate Injection has also been shown to be useful in combination with other oncolytic agents in Hodgkin's disease, non–Hodgkin's malignant lymphomas, rhabdomyosarcoma, neuroblastoma, and Wilms' tumor. Patients with the demyelinating form of Charcot–Marie–Tooth syndrome should not be given Vincristine Sulfate Injection. Careful attention should be given to those conditions listed under WARNINGS and PRECAUTIONS .

Product summary:

Vincristine Sulfate Injection, USP, is available as follows: Unit of Sale Total Strength/Total Volume (Concentration) NDC 61703–309–26 Carton of 1 single-dose flip-top vial (blue cap) 1 mg/mL NDC 61703–309–25 Carton of 1 single-dose flip-top vial (blue cap) 2 mg/2 mL (1 mg/mL) This product should be refrigerated between 2°C–8°C (36°F–46°F). Discard unused solution. Protect from light. Store Upright.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

VINCRISTINE SULFATE- VINCRISTINE SULFATE INJECTION, SOLUTION
HOSPIRA, INC.
----------
VINCRISTINE SULFATE
INJECTION, USP
Rx only
PRESERVATIVE FREE SOLUTION
WARNINGS
CAUTION–THIS PREPARATION SHOULD BE ADMINISTERED BY INDIVIDUALS
EXPERIENCED IN THE ADMINISTRATION OF VINCRISTINE SULFATE INJECTION,
USP. IT
IS EXTREMELY IMPORTANT THAT THE INTRAVENOUS NEEDLE OR CATHETER BE
PROPERLY POSITIONED BEFORE ANY VINCRISTINE IS INJECTED. LEAKAGE INTO
SURROUNDING TISSUE DURING INTRAVENOUS ADMINISTRATION OF VINCRISTINE
SULFATE INJECTION, USP MAY CAUSE CONSIDERABLE IRRITATION. IF
EXTRAVASATION
OCCURS, THE INJECTION SHOULD BE DISCONTINUED IMMEDIATELY, AND ANY
REMAINING PORTION OF THE DOSE SHOULD THEN BE INTRODUCED INTO ANOTHER
VEIN. LOCAL INJECTION OF HYALURONIDASE AND THE APPLICATION OF MODERATE
HEAT TO THE AREA OF LEAKAGE HELP DISPERSE THE DRUG AND ARE THOUGHT TO
MINIMIZE DISCOMFORT AND THE POSSIBILITY OF CELLULITIS.
FOR INTRAVENOUS USE ONLY – FATAL IF GIVEN BY OTHER ROUTES.
SEE OVERDOSAGE SECTION FOR THE TREATMENT OF PATIENTS GIVEN
INTRATHECAL VINCRISTINE SULFATE INJECTION, USP.
DESCRIPTION
Vincristine Sulfate Injection, USP is the salt of an alkaloid obtained
from a common
flowering herb, the periwinkle plant (_Vinca rosea_ Linn). Originally
known as leurocristine,
it has also been referred to as LCR and VCR.
The molecular formula for Vincristine Sulfate, USP is C
H
N O
∙H SO . It has a
molecular weight of 923.04.
The structural formula is as follows:
46
56
4
10
2
4
Vincristine Sulfate, USP is a white to off–white powder. It is
soluble in methanol, freely
soluble in water, but only slightly soluble in 95% ethanol. In 98%
ethanol, Vincristine
Sulfate, USP has an ultraviolet spectrum with maxima at 221 nm
(ϵ+47,100).
Vincristine Sulfate Injection, USP is a sterile, preservative–free,
single-dose only solution
available for intravenous use in 1 mg/mL and 2 mg/2 mL (1 mg/mL)
vials. Each mL
contains 1 mg Vincristine Sulfate, USP, 100 mg mannitol and Water for
Injection, USP.
Q.S. Sulfuric acid or sodium hydroxide have been