Rx Item-Mesna PPX 100Mg/Ml Vial 10Ml By Sagent Pharma

MESNA � mesna injection, solution
Fresenius Kabi USA, LLC


1 INDICATIONS AND USAGE

Mesna injection is indicated as a prophylactic agent in reducing the incidence of ifosfamide-induced hemorrhagic cystitis.
Limitation of Use:Mesna injection is not indicated to reduce the risk of hematuria due to other pathological conditions such as thrombocytopenia.

2 DOSAGE AND ADMINISTRATION

2.1 Intravenous Dosing
Mesna injection may be given on a fractionated dosing schedule of three bolus intravenous injections as outlined below.



Mesna injection is given as intravenous bolus injections in a dosage equal to 20% of the ifosfamide dosage weight by weight (w/w) at the time of ifosfamide administration and 4 and 8 hours after each dose of ifosfamide. The total daily dose of mesna injection is 60% of the ifosfamide dose Intravenous and Oral Dosing

Mesna injection may be given on a fractionated dosing schedule of a single bolus injection followed by two oral administrations of mesna tablets as outlined below. Mesna injection is given as intravenous bolus injections in a dosage equal to 20% of the ifosfamide dosage (w/w) at the time of ifosfamide administration. Mesna tablets are given orally in a dosage equal to 40% of the ifosfamide dose 2 and 6 hours after each dose of ifosfamide. The total daily dose of mesna is 100% of the ifosfamide dose. DESCRIPTION

Mesna Injection is a detoxifying agent to inhibit the hemorrhagic cystitis induced by ifosfamide. The active ingredient, mesna, is a synthetic sulfhydryl compound designated as sodium-2-mercaptoethane sulfonate with a molecular formula of C2 H5 NaO3 S2 and a molecular weight of 164.18. Its structural formula is as follows:
HS�CH2 �CH2 SO3 �Na+ Mesna injection is a sterile, nonpyrogenic, aqueous solution of clear and colorless appearance in clear glass multiple dose vials for intravenous administration. Mesna injection contains 100 mg/mL mesna, 0.25 mg/mL edetate disodium and sodium hydroxide for pH adjustment. Mesna injection multiple dose vials also contain 10.4 mg/mL of benzyl alcohol as a preservative. The solution has a pH range of 6.5 to 8.5.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action
Mesna reacts chemically with the urotoxic ifosfamide metabolites, acrolein and 4-hydroxy-ifosfamide, resulting in their detoxification. The first step in the detoxification process is the binding of mesna to 4-hydroxy-ifosfamide forming a non-urotoxic 4-sulfoethylthioifosfamide. Mesna also binds to the double bonds of acrolein and to other urotoxic metabolites and inhibits their effects on the bladder.

RX ITEM-Mesna PPX 100Mg/Ml Vial 10Ml By
NDC 25021-0201-68 UPC/GTIN No. Mfg.Part No.20168

Mesna PPX 100Mg/Ml Vial 10Ml By Sagent P
BRAND: MESNA NDC: 25021-0201-68,25021020168 UPC: , Sagent Pharmaceuticals, Inc

MESNA INTRAVEN VIAL 100 M
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