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Rx Item-Ifosfamide 3G 60Ml Vial 60Ml By Fresenius Kabi USA

NDC 63323-0174-60 UPC/GTIN No.3-63323-17460-6 Mfg.Part No.107460BRAND: IFOSFAMIDE NDC: 63323-0174-60,63323017460 UPC: 3-63323-17460-6,363323174606 Fresenius Kabi USA LlcOnly 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-Ifosfamide 3G 60Ml Vial 60Ml By Fresenius Kabi USA

$208.98$248.79

Item No.:RX080424 NDC No.63323017460 UPC No.:363323174606 NDC No. 63323-0174-60 UPC/GTIN No. 3-63323-17460-6 MPN 107460 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. Rx080424 Ifosfamide 3G/60ml Vial 60ml by Fresenius Kabi USA Item No. 3080424 NDC No. 63323017460 UPC No. 363323174606 Other Name If

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IFOSFAMIDE- ifosfamide injection
Bedford Laboratories

Rx ONLY

WARNING

Ifosfamide Injection should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Urotoxic side effects, especially hemorrhagic cystitis, as well as CNS toxicities such as confusion and coma have been associated with the use of ifosfamide. When they occur, they may require cessation of ifosfamide therapy. Severe myelosuppression has been reported (see ADVERSE REACTIONS.)

DESCRIPTION



Ifosfamide injection is presented in sterile, single-dose vials for administration by intravenous infusion. Each mL contains ifosfamide, 50 mg, monobasic sodium phosphate monohydrate, 1.035 mg, dibasic sodium phosphate, 3.55 mg and water for injection, qs.. Ifosfamide is a chemotherapeutic agent chemically related to the nitrogen mustards and a synthetic analog of cyclophosphamide. Ifosfamide is 3-(2-ChloroethyI)-2-[(2-chloroethyl)amino]tetrahydro-2H -1,3,2- oxazaphosphorine 2-oxide. Its structural formula is:

structural formula
C7 H15 Cl2 N2 O2 P

M. W. = 261.09

Ifosfamide is a white crystalline powder that is soluble in water.

CLINICAL PHARMACOLOGY

Ifosfamide has been shown to require metabolic activation by microsomal liver enzymes to produce biologically active metabolites. Activation occurs by hydroxylation at the ring carbon atom 4 to form the unstable intermediate 4-hydroxyifosfamide. This metabolite rapidly degrades to the stable urinary metabolite 4-ketoifosfamide. Opening of the ring results in formation of the stable urinary metabolite, 4-carboxyifosfamide. These urinary metabolites have not been found to be cytotoxic. N, N-bis (2-chIoroethyl)-phosphoric acid diamide (ifosphoramide) and acrolein are also found. Enzymatic oxidation of the chloroethyl side chains and subsequent dealkylation produces the major urinary metabolites, dechloroethyl ifosfamide and dechloroethyl cyclophosphamide. The alkylated metabolites of ifosfamide have been shown to interact with DNA.

In vitro incubation of DNA with activated ifosfamide has produced phosphotriesters. The treatment of intact cell nuclei may also result in the formation of DNA-DNA cross-links. DNA repair most likely occurs in G-1 and G-2 stage cells.

Pharmacokinetics

Ifosfamide exhibits dose-dependent pharmacokinetics in humans. At single doses of 3.8 to 5 g/m2 , the plasma concentrations decay biphasically and the mean terminal elimination half-life is about 15 hours. At doses of 1.6 to 2.4 g/m2 /day, the plasma decay is monoexponential and the terminal elimination half-life is about 7 hours. Ifosfamide is extensively metabolized in humans and the metabolic pathways appear to be saturated at high doses.

After administration of doses of 5 g/m2 of 14 C-labeled ifosfamide, from 70% to 86% of the dosed radioactivity was recovered in the urine, with about 61% of the dose excreted as parent compound. At doses of 1.6 to 2.4 g/m2 only 12% to 18% of the dose was excreted in the urine as unchanged drug within 72 hours.

Two different dechloroethylated derivatives of ifosfamide, 4-carboxyifosfamide, thiodiacetic acid and cysteine conjugates of chloroacetic acid have been identified as the major urinary metabolites of ifosfamide in humans and only small amounts of 4-hydroxyifosfamide and acrolein are present. Small quantities (nmole/mL) of ifosfamide mustard and 4-hydroxyifosfamide are detectable in human plasma. Metabolism of ifosfamide is required for the generation of the biologically active species and while metabolism is extensive, it is also quite variable among patients.

In a study at Indiana University, 50 fully evaluable patients with germ cell testicular cancer were treated with ifosfamide injection in combination with cisplatin and either vinblastine or etoposide after failing (47 of 50 patients) at least two prior chemotherapy regimens consisting of cisplatin/vinblastine/bleomycin, (PVB), cisplatin/vinblastine/actinomycin D/bleomycin/cyclophosphamide, (VAB6), or the combination of cisplatin and etoposide. Patients were selected for remaining cisplatin sensitivity because they had previously responded to a cisplatin containing regimen and had not progressed while on the cisplatin containing regimen or within 3 weeks of stopping it. Patients served as their own control based on the premise that long term complete responses could not be achieved by retreatment with a regimen to which they had previously responded and subsequently relapsed.

Ten of 50 fully evaluable patients were still alive 2 to 5 years after treatment. Four of the 10 long term survivors were rendered free of cancer by surgical resection after treatment with the ifosfamide regimen; median survival for the entire group of 50 fully evaluable patients was 53 weeks.

INDICATIONS AND USAGE

Ifosfamide injection, used in combination with certain other approved antineoplastic agents, is indicated for third line chemotherapy of germ cell testicular cancer. It should ordinarily be used in combination with a prophylactic agent for hemorrhagic cystitis, such as mesna.

NDC 63323-0174-60 UPC/GTIN No.3-63323-17460-6 Mfg.Part No.107460
RX ITEM-Ifosfamide 3G 60Ml Vial 60Ml By
NDC 63323-0174-60 UPC/GTIN No.3-63323-17460-6 Mfg.Part No.107460

BRAND: IFOSFAMIDE NDC: 63323-0174-60,63323017460 UPC: 3-63323-17460-6,363323174606 Fresenius Kabi USA Llc
Ifosfamide 3G 60Ml Vial 60Ml By Freseniu
BRAND: IFOSFAMIDE NDC: 63323-0174-60,63323017460 UPC: 3-63323-17460-6,363323174606 Fresenius Kabi USA Llc

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
IFOSFAMIDE INTRAVEN VIAL
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.