DRUGS & SUPPLEMENTS
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Cyclophosphamide Monohydrate tablets, although effective alone in susceptible malignancies, are more frequently used concurrently or sequentially with other antineoplastic drugs. The following malignancies are often susceptible to Cyclophosphamide Monohydrate treatment:
Cyclophosphamide Monohydrate tablets are useful in carefully selected cases of biopsy proven “minimal change” nephrotic syndrome in children but should not be used as primary therapy. 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, Cyclophosphamide Monohydrate may induce a remission. Cyclophosphamide Monohydrate is not indicated for the nephrotic syndrome in adults or for any other renal disease.
Continued use of Cyclophosphamide Monohydrate is contraindicated in patients with severely depressed bone marrow function. Cyclophosphamide Monohydrate is contraindicated in patients who have demonstrated a previous hypersensitivity to it. See WARNINGS and PRECAUTIONS sections.
Second malignancies have developed in some patients treated with Cyclophosphamide Monohydrate used alone or in association with other antineoplastic drugs and/or modalities. Most frequently, they have been urinary bladder, myeloproliferative, or lymphoproliferative malignancies. Second malignancies most frequently were detected in patients treated for primary myeloproliferative or lymphoproliferative malignancies or nonmalignant disease in which immune processes are believed to be involved pathologically. In some cases, the second malignancy developed several years after Cyclophosphamide Monohydrate treatment had been discontinued. In a single breast cancer trial utilizing two to four times the standard dose of Cyclophosphamide Monohydrate in conjunction with doxorubicin a small number of cases of secondary acute myeloid leukemia occurred within two years of treatment initiation. Urinary bladder malignancies generally have occurred in patients who previously had hemorrhagic cystitis. In patients treated with cyclophosphamide-containing regimens for a variety of solid tumors, isolated case reports of secondary malignancies have been published. One case of carcinoma of the renal pelvis was reported in a patient receiving long-term Cyclophosphamide Monohydrate therapy for cerebral vasculitis. The possibility of cyclophosphamide-induced malignancy should be considered in any benefit-to-risk assessment for use of the drug.
Cyclophosphamide Monohydrate can cause fetal harm when administered to a pregnant woman and such abnormalities have been reported following Cyclophosphamide Monohydrate therapy in pregnant women. Abnormalities were found in two infants and a six-month old fetus born to women treated with Cyclophosphamide Monohydrate. Ectrodactylia was found in two of the three cases. Normal infants have also been born to women treated with Cyclophosphamide Monohydrate during pregnancy, including the first trimester. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant. Cyclophosphamide interferes with oogenesis and spermatogenesis. It may cause sterility in both sexes. Development of sterility appears to depend on the dose of Cyclophosphamide Monohydrate, duration of therapy, and the state of gonadal function at the time of treatment. Cyclophosphamide-induced sterility may be irreversible in some patients. Amenorrhea associated with decreased estrogen and increased gonadotropin secretion develops in a significant proportion of women treated with Cyclophosphamide Monohydrate. Affected patients generally resume regular menses within a few months after cessation of therapy. Girls treated with Cyclophosphamide Monohydrate during prepubescence generally develop secondary sexual characteristics normally and have regular menses. Ovarian fibrosis with apparently complete loss of germ cells after prolonged Cyclophosphamide Monohydrate treatment in late prepubescence has been reported. Girls treated with Cyclophosphamide Monohydrate during prepubescence subsequently have conceived. Men treated with Cyclophosphamide Monohydrate may develop oligospermia or azoospermia associated with increased gonadotropin but normal testosterone secretion. Sexual potency and libido are unimpaired in these patients. Boys treated with Cyclophosphamide Monohydrate during prepubescence develop secondary sexual characteristics normally, but may have oligospermia or azoospermia and increased gonadotropin secretion. Some degree of testicular atrophy may occur. Cyclophosphamide-induced azoospermia is reversible in some patients, though the reversibility may not occur for several years after cessation of therapy. Men temporarily rendered sterile by Cyclophosphamide Monohydrate have subsequently fathered normal children.
Hemorrhagic cystitis may develop in patients treated with Cyclophosphamide Monohydrate. Rarely, this condition can be severe and even fatal. Fibrosis of the urinary bladder, sometimes extensive, also may develop with or without accompanying cystitis. Atypical urinary bladder epithelial cells may appear in the urine. These adverse effects appear to depend on the dose of Cyclophosphamide Monohydrate and the duration of therapy. Such bladder injury is thought to be due to Cyclophosphamide Monohydrate metabolites excreted in the urine. Forced fluid intake helps to assure an ample output of urine, necessitates frequent voiding, and reduces the time the drug remains in the bladder. This helps to prevent cystitis. Hematuria usually resolves in a few days after Cyclophosphamide Monohydrate treatment is stopped, but it may persist. Medical and/or surgical supportive treatment may be required, rarely, to treat protracted cases of severe hemorrhagic cystitis. It is usually necessary to discontinue Cyclophosphamide Monohydrate therapy in instances of severe hemorrhagic cystitis.
Although a few instances of cardiac dysfunction have been reported following use of recommended doses of Cyclophosphamide Monohydrate, no causal relationship has been established. Acute cardiac toxicity has been reported with doses as low as 2.4 g/m2 to as high as 26 g/m2, usually as a portion of an intensive antineoplastic multidrug regimen or in conjunction with transplantation procedures. In a few instances with high doses of Cyclophosphamide Monohydrate, severe, and sometimes fatal, congestive heart failure has occurred after the first Cyclophosphamide Monohydrate dose. Histopathologic examination has primarily shown hemorrhagic myocarditis. Hemopericardium has occurred secondary to hemorrhagic myocarditis and myocardial necrosis. Pericarditis has been reported independent of any hemopericardium.
No residual cardiac abnormalities, as evidenced by electrocardiogram or echocardiogram appear to be present in patients surviving episodes of apparent cardiac toxicity associated with high doses of Cyclophosphamide Monohydrate. Cyclophosphamide has been reported to potentiate doxorubicin-induced cardiotoxicity.
Treatment with Cyclophosphamide Monohydrate may cause significant suppression of immune responses. Serious, sometimes fatal, infections may develop in severely immunosuppressed patients. Cyclophosphamide Monohydrate treatment may not be indicated or should be interrupted or the dose reduced in patients who have or who develop viral, bacterial, fungal, protozoan, or helminthic infections.
Anaphylactic reactions have been reported; death has also been reported in association with this event. Possible cross-sensitivity with other alkylating agents has been reported.
Special attention to the possible development of toxicity should be exercised in patients being treated with Cyclophosphamide Monohydrate if any of the following conditions are present:
During treatment, the patient’s hematologic profile should be monitored regularly to determine the degree of hematopoietic suppression. Urine should also be examined regularly for red cells which may precede hemorrhagic cystitis.
The rate of metabolism and the leukopenic activity of Cyclophosphamide Monohydrate 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 Monohydrate even though Cyclophosphamide Monohydrate 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 Monohydrate within 10 days of general anesthesia, the anesthesiologist should be alerted.
Since Cyclophosphamide Monohydrate has been reported to be more toxic in adrenalectomized dogs, adjustment of the doses of both replacement steroids and Cyclophosphamide Monohydrate may be necessary for the adrenalectomized patient.
Cyclophosphamide Monohydrate may interfere with normal wound healing.
Cyclophosphamide Monohydrate is excreted in breast milk. Because of the potential for serious adverse reactions and the potential for tumorigenicity shown for Cyclophosphamide Monohydrate in humans, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Information on adverse reactions associated with the use of Cyclophosphamide Monohydrate is arranged according to body system affected or type of reaction. The adverse reactions are listed in order of decreasing incidence. The most serious adverse reactions are described in the WARNINGS section.
Nausea and vomiting commonly occur with Cyclophosphamide Monohydrate therapy. Anorexia and, less frequently, abdominal discomfort or pain and diarrhea may occur. There are isolated reports of hemorrhagic colitis, oral mucosal ulceration and jaundice occurring during therapy. These adverse drug effects generally remit when Cyclophosphamide Monohydrate treatment is stopped.
Alopecia occurs commonly in patients treated with Cyclophosphamide Monohydrate. The hair can be expected to grow back after treatment with the drug or even during continued drug treatment, though it may be different in texture or color. Skin rash occurs occasionally in patients receiving the drug. Pigmentation of the skin and changes in nails can occur.
Leukopenia occurs in patients treated with Cyclophosphamide Monohydrate, is related to the dose of drug, and can be used as a dosage guide. Leukopenia of less than 2000 cells/mm3 develops commonly in patients treated with an initial loading dose of the drug, and less frequently in patients maintained on smaller doses. The degree of neutropenia is particularly important because it correlates with a reduction in resistance to infections. Fever has also been reported in patients with neutropenia.
Thrombocytopenia or anemia develop occasionally in patients treated with Cyclophosphamide Monohydrate. These hematologic effects usually can be reversed by reducing the drug dose or by interrupting treatment. Recovery from leukopenia usually begins in 7 to 10 days after cessation of therapy.
Interstitial pneumonitis has been reported as part of the postmarketing experience. Interstitial pulmonary fibrosis has been reported in patients receiving high doses of Cyclophosphamide Monohydrate over a prolonged period.
Anaphylactic reactions have been reported; death has also been reported in association with this event. Possible cross-sensitivity with other alkylating agents has been reported. SIADH (syndrome of inappropriate ADH secretion) has been reported with the use of Cyclophosphamide Monohydrate. Malaise and asthenia have been reported as part of the postmarketing experience.
No specific antidote for Cyclophosphamide Monohydrate is known. Overdosage should be managed with supportive measures, including appropriate treatment for any concurrent infection, myelosuppression, or cardiac toxicity should it occur.
Oral Cyclophosphamide Monohydrate dosing is usually in the range of 1 to 5 mg/kg/day for both initial and maintenance dosing.
Many other regimens of intravenous and oral Cyclophosphamide Monohydrate have been reported. Dosages must be adjusted in accord with evidence of antitumor activity and/or leukopenia. The total leukocyte count is a good, objective guide for regulating dosage. Transient decreases in the total white blood cell count to 2000 cells/mm3 or more persistent reduction to 3000 cells/mm3 (with continuing therapy) are tolerated without serious risk of infection if there is no marked granulocytopenia. When Cyclophosphamide Monohydrate is included in combined cytotoxic regimens, it may be necessary to reduce the dose of Cyclophosphamide Monohydrate as well as that of the other drugs. Cyclophosphamide and its metabolites are dialyzable although there are probably quantitative differences depending upon the dialysis system being used. Patients with compromised renal function may show some measurable changes in pharmacokinetic parameters of Cyclophosphamide Monohydrate metabolism, but there is no consistent evidence indicating a need for Cyclophosphamide Monohydrate dosage modification in patients with renal function impairment.
An oral dose of 2.5 to 3 mg/kg daily for a period of 60 to 90 days is recommended. In males, the incidence of oligospermia and azoospermia increases if the duration of Cyclophosphamide Monohydrate treatment exceeds 60 days. Treatment beyond 90 days increases the probability of sterility. Adrenocorticosteroid therapy may be tapered and discontinued during the course of Cyclophosphamide Monohydrate therapy. See PRECAUTIONS section concerning hematologic monitoring.
Extemporaneous liquid preparations of Cyclophosphamide Monohydrate for oral administration may be prepared by dissolving Cyclophosphamide Monohydrate for injection in Aromatic Elixir NF. Such preparations should be stored under refrigeration in glass containers and used within 14 days.Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published1-7. There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.
Cyclophosphamide Monohydrate is available as:
25 mg light blue, round, unscored tablets NDC 0054-8089-25: Unit dose, 10 tablets per strip, 10 strips per shelf pack, 10 shelf packs per shipper. NDC 0054-4129-25: Bottles of 100 tablets.50 mg light blue, round, unscored tablets (Identified 54 980)NDC 0054-8130-25: Unit dose, 10 tablets per strip, 10 strips per shelf pack, 10 shelf packs per shipper. NDC 0054-4130-25: Bottles of 100 tablets. Storage at or below 77°F (25°C) is recommended; this product will withstand brief exposure to temperatures up to 86°F (30°C) but should be protected from temperatures above 86°F (30°C).
4047200//01April 2001Roxane Laboratories, Inc. Columbus, Ohio 43216© RLI, 2001
Depending on the reaction of the Cyclophosphamide Monohydrate after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Cyclophosphamide Monohydrate not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.Is Cyclophosphamide Monohydrate addictive or habit forming?
Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
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The information was verified by Dr. Rachana Salvi, MD Pharmacology