On January 25, the FDA announced approval of 3 drugs — Nesina (alogliptin) tablets, the fixed-dose combinations Kazano (alogliptin and metformin hydrochloride) tablets, and Oseni (alogliptin and pioglitazone) tablets for use with diet and exercise to improve blood … It is used along with diet and exercise to improve control of blood sugar in adults with type 2 diabetes mellitus.
Some degree of testicular atrophy may occur. The possibility of cyclophosphamide-induced malignancy should be considered in any benefit-to-risk assessment for use of the drug.Cyclophosphamide can cause fetal harm when administered to a pregnant woman and such abnormalities have been reported following cyclophosphamide therapy in pregnant women. This helps to prevent cystitis. Vials containing melted substance can be visually differentiated. Urine should also be examined regularly for red cells which may precede hemorrhagic cystitis.The rate of metabolism and the leukopenic activity of cyclophosphamide reportedly are increased by chronic administration of high doses of phenobarbital.The physician should be alert for possible combined drug actions, desirable or undesirable, involving cyclophosphamide even though cyclophosphamide has been used successfully concurrently with other drugs, including other cytotoxic drugs.Cyclophosphamide treatment, which causes a marked and persistent inhibition of cholinesterase activity, potentiates the effect of succinylcholine chloride.If a patient has been treated with cyclophosphamide within 10 days of general anesthesia, the anesthesiologist should be alerted.Since cyclophosphamide has been reported to be more toxic in adrenalectomized dogs, adjustment of the doses of both replacement steroids and cyclophosphamide may be necessary for the adrenalectomized patient.Cyclophosphamide may interfere with normal wound healing.Cyclophosphamide is excreted in breast milk. In patients treated with cyclophosphamide-containing regimens for a variety of solid tumors, isolated case reports of secondary malignancies have been published. These adverse drug effects generally remit when cyclophosphamide treatment is stopped.Alopecia occurs commonly in patients treated with cyclophosphamide. The total leukocyte count is a good, objective guide for regulating dosage. Cytoxan Tablets (cyclophosphamide tablets, USP) are for oral use and contain 25 mg or 50 mg cyclophosphamide (anhydrous).
In two clinical trials in which cyclophosphamide was compared with paclitaxel, each in combination with cisplatin, for the treatment of advanced ovarian carcinoma, 154 (28%) of 552 patients who received cyclophosphamide plus cisplatin were 65 years or older.
In males, the incidence of oligospermia and azoospermia increases if the duration of Cytoxan treatment exceeds 60 days. Inactive ingredients in Cytoxan Tablets are: acacia, FD&C Blue No. An official website of the United States government: Urinary bladder malignancies generally have occurred in patients who previously had hemorrhagic cystitis. In children whose disease fails to respond adequately to appropriate adrenocorticosteroid therapy or in whom the adrenocorticosteroid therapy produces or threatens to produce intolerable side effects, Cytoxan may induce a remission. The unchanged drug has an elimination half-life of 3 to 12 hours.
Cyclophosphamide is contraindicated in patients who have demonstrated a previous hypersensitivity to it. Regulatory History of Pioglitazone from Drugs@FDA Includes approval letters and labeling Actos - Prescribing Information Actos labeling with boxed warning approved (8/14/2007) Contact FDA . Ovarian fibrosis with apparently complete loss of germ cells after prolonged cyclophosphamide treatment in late prepubescence has been reported. Cyclophosphamide is a synthetic antineoplastic drug chemically related to the nitrogen mustards. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range and adjusting as necessary based on patient response (see Information on adverse reactions associated with the use of Cytoxan (cyclophosphamide) is arranged according to body system affected or type of reaction.
In a single breast cancer trial utilizing two to four times the standard dose of cyclophosphamide in conjunction with doxorubicin a small number of cases of secondary acute myeloid leukemia occurred within two years of treatment initiation. Duetact FDA Approval History. Initial U.S. Approval: 1959 _____ _____ HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE safely and effectively. The Cytoxan brand name has been discontinued in the U.S. Several cytotoxic and noncytotoxic metabolites have been identified in urine and in plasma. Leukopenia of less than 2000 cells/mmThrombocytopenia or anemia develop occasionally in patients treated with Cytoxan.