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RX ITEM-Fluorouracil 500Mg 10Ml Vial 10X10Ml By Mylan Institutional

NDC 10139-0063-11 UPC/GTIN No.3-10139-06311-2 Mfg.Part No.6311BRAND: FLUOROURACIL NDC: 10139-0063-11,10139006311 UPC: 3-10139-06311-2,310139063112 Mylan Institutional/GenOnly Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

RX ITEM-Fluorouracil 500Mg 10Ml Vial 10X10Ml By Mylan Institutional

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item No.:RX595417 NDC No.10139006311 UPC No.:310139063112 NDC No. 10139-0063-11 UPC/GTIN No. 3-10139-06311-2 MPN 6311 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,ResearchCo.,Uni.,VA,Vet & Wholesalers in scope of practice can order this RX item. Rx Item No. Rx595417 Fluorouracil 500mg/10ml Vial 10X10ml by Mylan Institutional Item No. 3595417 NDC No. 10139006311 UPC No. 310139063112 Oth

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FLUOROURACIL- fluorouracil injection, solution
Accord Healthcare, Inc.

1 INDICATIONS AND USAGE

Fluorouracil is indicated for the treatment of patients with:

1.1 Adenocarcinoma of the Colon and Rectum
1.2 Adenocarcinoma of the Breast
1.3 Gastric Adenocarcinoma
1.4 Pancreatic Adenocarcinoma
2 DOSAGE AND ADMINISTRATION



2.1 General Dosage Information
? Fluorouracil is recommended for administration either as an intravenous bolus or as an intravenous infusion. Do not inject the entire contents of the vial directly into patients. Individualize the dose and dosing schedule of fluorouracil based on tumor type, the specific regimen administered, disease state, response to treatment, and patient risk factors.

2.2 Recommended Dosage for Adenocarcinoma of the Colon and Rectum
? The recommended dose of fluorouracil, administered in an infusional regimen in combination with leucovorin alone, or in combination with leucovorin and oxaliplatin or irinotecan, is 400 mg/m 2 by intravenous bolus on Day 1, followed by 2400 mg/m 2 to 3000 mg/m 2 intravenously as a continuous infusion over 46 hours every two weeks. The recommended dose of fluorouracil, administered in an infusional regimen in combination with leucovorin alone, or in combination with leucovorin and oxaliplatin or irinotecan, is 400 mg/m 2 by intravenous bolus on Day 1, followed by 2400 mg/m 2 to 3000 mg/m 2 intravenously as a continuous infusion over 46 hours every two weeks.
? The recommended dose of fluorouracil, if administered in a bolus dosing regimen in combination with leucovorin, is 500 mg/m 2 by intravenous bolus on Days 1, 8, 15, 22, 29, and 36 in 8-week cycles. The recommended dose of fluorouracil, if administered in a bolus dosing regimen in combination with leucovorin, is 500 mg/m 2 by intravenous bolus on Days 1, 8, 15, 22, 29, and 36 in 8-week cycles.
2.3 Recommended Dosage for Adenocarcinoma of the Breast
? The recommended dose of fluorouracil, administered as a component of a cyclophosphamide-based multidrug regimen, is 500 mg/m 2 or 600 mg/m 2 intravenously on Days 1 and 8 every 28 days for 6 cycles. The recommended dose of fluorouracil, administered as a component of a cyclophosphamide-based multidrug regimen, is 500 mg/m 2 or 600 mg/m 2 intravenously on Days 1 and 8 every 28 days for 6 cycles.
?

2.4 Recommended Dosage for Gastric Adenocarcinoma
? The recommended dose of fluorouracil, administered as a component of a platinum-containing multidrug chemotherapy regimen, is 200 mg/m 2 to 1000 mg/m 2 intravenously as a continuous infusion over 24 hours. The frequency of dosing in each cycle and the length of each cycle will depend on the dose of fluorouracil and the specific regimen administered. The recommended dose of fluorouracil, administered as a component of a platinum-containing multidrug chemotherapy regimen, is 200 mg/m 2 to 1000 mg/m 2 intravenously as a continuous infusion over 24 hours. The frequency of dosing in each cycle and the length of each cycle will depend on the dose of fluorouracil and the specific regimen administered.
2.5 Recommended Dosage for Pancreatic Adenocarcinoma
? The recommended dose of fluorouracil, administered as an infusional regimen in combination with leucovorin or as a component of a multidrug chemotherapy regimen that includes leucovorin, is 400 mg/m 2 intravenous bolus on Day 1, followed by 2400 mg/m 2 intravenously as a continuous infusion over 46 hours every two weeks. The recommended dose of fluorouracil, administered as an infusional regimen in combination with leucovorin or as a component of a multidrug chemotherapy regimen that includes leucovorin, is 400 mg/m 2 intravenous bolus on Day 1, followed by 2400 mg/m 2 intravenously as a continuous infusion over 46 hours every two weeks. DESCRIPTION

Fluorouracil injection, USP a nucleoside metabolic inhibitor, is a colorless to faint yellow, aqueous, sterile, nonpyrogenic injectable solution available in 10 mL and 20 mL, a sterile preparation that contains single dose vial for intravenous administration. Each mL contains 50 mg fluorouracil in water for injection, USP. The pH is adjusted to approximately 9.2 with sodium hydroxide. Chemically, fluorouracil, a fluorinated pyrimidine, is 5-fluoro-2,4 (1H,3H)-pyrimidinedione. Its structural formula is:

fluorouracil structure
(click image for full-size original)
Molecular formula: C 4 H 3 FN 2 O 2
Molecular weight: 130.08 g/mole

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action
Fluorouracil is a nucleoside metabolic inhibitor that interferes with the synthesis of deoxyribonucleic acid (DNA) and to a lesser extent inhibits the formation of ribonucleic acid (RNA); these affect rapidly growing cells and may lead to cell death. Fluorouracil is converted to three main active metabolites: 5-fluoro-2?-deoxyuridine-5?-monophosphate (FdUMP), 5-fluorouridine-5?triphosphate (FUTP) and 5-fluoro-2?-deoxyuridine-5?-triphosphate (FdUTP). These metabolites have several effects including the inhibition of thymidylate synthase by FdUMP, incorporation of FUTP into RNA and incorporation of FdUTP into DNA.

NDC 10139-0063-11 UPC/GTIN No.3-10139-06311-2 Mfg.Part No.6311
RX ITEM-Fluorouracil 500Mg 10Ml Vial 10X
NDC 10139-0063-11 UPC/GTIN No.3-10139-06311-2 Mfg.Part No.6311

BRAND: FLUOROURACIL NDC: 10139-0063-11,10139006311 UPC: 3-10139-06311-2,310139063112 Mylan Institutional/Gen
Fluorouracil 500Mg 10Ml Vial 10X10Ml By
BRAND: FLUOROURACIL NDC: 10139-0063-11,10139006311 UPC: 3-10139-06311-2,310139063112 Mylan Institutional/Gen

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
FLUOROURACIL INTRAVEN VIA
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.
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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.