Cyclophosphamide is a pro-drug that is activated by cytochrome P450s An increase of the concentration of cytotoxic metabolites may occur with: Combined or sequential use of cyclophosphamide and other agents with similar toxicities can potentiate toxicities. Monitor patients for signs and symptoms of pulmonary toxicity. Cyclophosphamide is activated to form 4-hydroxycyclophosphamide, which is in equilibrium with its ring-open tautomer aldophosphamide. 0000000976 00000 n The chemical name for cyclophosphamide is 2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate, and has the following structural formula: Each capsule for oral administration contains 25 mg or 50 mg cyclophosphamide (anhydrous, USP) and the following inactive ingredients: corn starch, pregelatinized starch, and sodium stearyl fumarate.

In addition to the ingredients listed above, each capsule contains Opacode (Black) ink containing; ethanol, D&C Yellow #10, FD&C Blue #1, FD&C Blue # 2, FD&C Red #40, iron oxide black, isopropyl alcohol, methanol, N-butyl alcohol, propylene glycol, and shellac glaze ethanol. Pigmentation of the skin and changes in nails can occur.The following adverse reactions have been identified from clinical trials or post-marketing surveillance. The mechanism of action is thought to involve cross-linking of tumor cell DNA. Fever without documented infection has been reported in neutropenic patients.Nausea and vomiting occur with cyclophosphamide therapy.

0000003404 00000 n If you are a consumer or patient please visit Because of the potential for serious adverse reactions in a breastfed child from Cyclophosphamide Capsules, advise lactating women not to breastfeed during the treatment and for 1 week after the last dose.Verify the pregnancy status of females of reproductive potential prior to the initiation of Cyclophosphamide Capsules Cyclophosphamide Capsules can cause fetal harm. The recommended dosage of cyclophosphamide capsules is 2 mg per kg orally once daily for 8 to 12 weeks (maximum cumulative dose 168 mg per kg). 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. Prolonged apnea may occur with concurrent depolarizing muscle relaxants (e.g., succinylcholine). The chemical name for cyclophosphamide is 2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate, and has the following structural formula:Each capsule for oral administration contains 25 mg or 50 mg cyclophosphamide (anhydrous, USP) and the following inactive ingredients: pregelatinized starch and sodium stearyl fumarate.Each gelatin capsule shell contains FD&C Blue #1, FD&C Red #3, gelatin and titanium dioxide.In addition to the ingredients listed above, each capsule contains TekPrint (SW-9008 Black Ink) monogramming ink. color white shape oblong imprint 60, RD203 This medicine is a white, oblong, capsule imprinted with "60" and "RD203". cyclophosphamide 25 mg capsule.

0000001672 00000 n

Therefore, rapid hemodialysis is indicated when treating any suicidal or accidental overdose or intoxication. Cyclophosphamide-induced sterility may be irreversible in some patients. Based on its mechanism of action and published reports of effects in pregnant patients or animals, cyclophosphamide capsules can cause fetal harm when administered to a pregnant woman [The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

These metabolites interfere with the growth of susceptible rapidly proliferating malignant cells.Following IV administration, elimination half-life (tAfter oral administration, peak concentrations of cyclophosphamide occurred at one hour. It may cause sterility in both sexes. 0000029281 00000 n Neutropenia, thrombocytopenia, low hemoglobin, and diarrhea have been reported in infants breast fed by women treated with cyclophosphamide. Myelosuppression, Immunosuppression, and InfectionsHydration and Important Administration Instructions trailer <<6BFB2C65BC2F4527ABF2B754D4AD00D0>]>> startxref 0 %%EOF 48 0 obj <>stream 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. The degree of neutropenia is particularly important because it correlates with a reduction in resistance to infections. Hyponatremia associated with increased total body water, acute water intoxication, and a syndrome resembling SIADH (syndrome of inappropriate secretion of antidiuretic hormone), which may be fatal, has been reported.

Anorexia and, less frequently, abdominal discomfort or pain and diarrhea may occur. Causal association is unclear. 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 was mutagenic and clastogenic in multiple Cyclophosphamide is genotoxic in male and female germ cells. 0000002600 00000 n Before starting treatment, exclude or correct any urinary tract obstructions Myocarditis, myopericarditis, pericardial effusion including cardiac tamponade, and congestive heart failure, which may be fatal, have been reported with cyclophosphamide therapy. Girls treated with cyclophosphamide who have retained ovarian function after completing treatment are at increased risk of developing premature menopause.Pre-pubescent boys treated with cyclophosphamide develop secondary sexual characteristics normally, but may have oligospermia or azoospermia and increased gonadotropin secretion. Urotoxicity can occur with short-term or long-term use of cyclophosphamide. To view updated drug label links, paste the RSS feed address (URL) shown below into a RSS reader, or use a browser which supports RSS feeds, such as Safari for Mac OS X.If you no longer wish to have this DailyMed RSS service, simply delete the copied URL from your RSS Reader. 0000002046 00000 n This spontaneous conversion can be catalyzed by albumin and other proteins.