Cyclophosphamide-induced sterility may be irreversible in some patients. Cyclophosphamide is primarily excreted as metabolites. 10 to 20% is excreted unchanged in the urine and 4% is excreted in the bile following IV administration.The pharmacokinetics of cyclophosphamide were determined following one-hour intravenous infusion to renally impaired patients. 9 0 obj << /Linearized 1 /O 11 /H [ 1215 235 ] /L 51275 /E 30800 /N 2 /T 50978 >> endobj xref 9 39 0000000016 00000 n
Cyclophosphamide Injection is a 200 mg/mL sterile clear colorless solution available as 500 mg and 1 … 0000021993 00000 n Auto-induction results in an increase in the total clearance, increased formation of 4-hydroxyl metabolites and shortened t 0000006487 00000 n %PDF-1.4 %���� During transport or storage of cyclophosphamide vials, temperature influences can lead to melting of the active ingredient, cyclophosphamide.
0000022787 00000 n Volume of distribution approximates total body water (30 to 50 L).The liver is the major site of cyclophosphamide activation.
0000004586 00000 n Renal Impairment.
However, Sandoz reported that the ester analogue of metoclopramide, SDZ 205-570 was an antagonist at the 5-HT 4 receptor .In our model we found the compound had a pIC 50 of 6.7 and a pA 2 of 7.8, about 10 fold more potent than metoclopramide as an antagonist. Store at 20 to 25°C (68 to 77°F). 0000011662 00000 n CYTOXAN® (cyclophosphamide for injection, USP) CYTOXAN® Tablets (cyclophosphamide tablets, USP) DESCRIPTION CYTOXAN® (cyclophosphamide for injection, USP) is a sterile white powder containing cyclophosphamide mono- hydrate. 0000003554 00000 n 0000015977 00000 n trailer << /Size 48 /Info 7 0 R /Root 10 0 R /Prev 50969 /ID[<1e7f19d262aae823193b089a1393926d> 0000002946 00000 n
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Dialysis clearance calculated by arterial-venous difference and actual drug recovery in dialysate averaged 104 mL/min, which is in the range of the metabolic clearance of 95 mL/min for the drug. 0000004525 00000 n
A mean of 37% of the administered dose of cyclophosphamide was removed during hemodialysis. The pharmacokinetics of cyclophosphamide were determined following one-hour intravenous infusion to renally impaired patients. Cyclophosphamide administered by different routes, including intravenous, subcutaneous or intraperitoneal injection, or in drinking water, caused tumors in both mice and rats.
Cyclophosphamide is soluble in water, saline, or ethanol. Follow special handling and disposal procedures. However, the N-dechloroethylation process, which produces a therapeutically inactive but neurotoxic metabolite, appears to be primarily catalyzed by CYP3A4. 4-hydroxycyclophosphamide and aldophosphamide can undergo oxidation by aldehyde dehydrogenases to form the inactive metabolites 4-ketocyclophosphamide and carboxyphosphamide, respectively.
Cyclophosphamide is genotoxic in male and female germ cells. 1.2 Chronic Lymphocytic Leukemia (CLL) RITUXAN, in combination with fludarabine and cyclophosphamide (FC), is indicated for the treatment of adult patients with previously untreated and previously treated CD20-positive CLL. Container Concentration Size Quantity.
It may cause sterility in both sexes. This site is provided for educational and informational purposes only, in accordance with our 0000022879 00000 n Cyclophosphamide was mutagenic and clastogenic in multiple 0000017062 00000 n 0000002604 00000 n In the prescribing label information (metoclopramide (Reglan®) package insert), the most commonly reported side effects from metoclopramide (Reglan®) are shown here: Diarrhea (common) Restlessness (10%) Drowsiness or sleepiness (10%) Fatigue (10%) Menu. Cyclophosphamide has a molecular formula of C 7 H 15 Cl 2 N 2 O 2 P•H 2 O and a molecular weight of 279.1. 0000001656 00000 n Some metabolites are protein bound to an extent greater than 60%.
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Cyclophosphamide appears to induce its own metabolism. Animal data indicate that exposure of oocytes to cyclophosphamide during follicular development may result in a decreased rate of implantations and viable pregnancies, and in an increased risk of malformations. 0000001450 00000 n Package insert (cyclophosphamide) Basics Coupons Reviews Alternatives FDA label. 0000008770 00000 n Cyclophosphamide is soluble in water, saline, or ethanol.
Aldophosphamide can undergo β-elimination to form active metabolites phosphoramide mustard and acrolein. 0000007174 00000 n 0000006085 00000 n In addition to leukemia and lymphoma, benign and malignant tumors were found at various tissue sites, including urinary bladder, mammary gland, lung, liver, and injection site cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens.
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CYTOXAN Tablets (cyclophosphamide tablets, USP) are for oral use and contain 25 mg or 50 mg cyclophosphamide The mechanism of action is thought to involve cross-linking of tumor cell DNA.Cyclophosphamide is biotransformed principally in the liver to active alkylating metabolites by a mixed function microsomal oxidase system. After oral administration, peak concentrations of cyclophosphamide occurred at one hour. 0000007196 00000 n 0000004103 00000 n 0000026014 00000 n
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