DRUGS & SUPPLEMENTS

Endoxan

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Endoxan uses


INDICATIONS AND USAGE

Malignant Diseases

Endoxan 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 Endoxan treatment:

  • Malignant lymphomas, Hodgkin’s disease, lyphocytic lymphoma (nodular or diffuse), mixed-cell type lymphoma, histiocytic lymphoma, Burkitt’s lymphoma.
  • Multiple myeloma.
  • Leukemias: Chronic lymphocytic leukemia, chronic granulocytic leukemia (it is usually ineffective in acute blastic crisis), acute myelogenous and monocytic leukemia; acute lymphoblastic (stem-cell) leukemia in children (cyclophosphamide given during remission is effective in prolonging its duration).
  • Mycosis fungoides (advanced disease).
  • Neuroblastoma (disseminated disease).
  • Adenocarcinoma of the ovary.
  • Retinoblastoma.
  • Carcinoma of the breast.

Nonmalignant Disease

Biopsy Proven “Minimal Change” Nephrotic Syndrome in Children

Endoxan 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, Endoxan may induce a remission. Endoxan is not indicated for the nephrotic syndrome in adults or for any other renal disease.

CONTRAINDICATIONS

Continued use of Endoxan is contraindicated in patients with severely depressed bone marrow function. Endoxan is contraindicated in patients who have demonstrated a previous hypersensitivity to it. See WARNINGS and PRECAUTIONS sections.

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WARNINGS

Carcinogenesis, Mutagenesis, Impairment of Fertility

Second malignancies have developed in some patients treated with Endoxan 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 Endoxan treatment had been discontinued. In a single breast cancer trial utilizing two to four times the standard dose of Endoxan 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 Endoxan therapy for cerebral vasculitis. The possibility of cyclophosphamide-induced malignancy should be considered in any benefit-to-risk assessment for use of the drug.

Endoxan can cause fetal harm when administered to a pregnant woman and such abnormalities have been reported following Endoxan therapy in pregnant women. Abnormalities were found in two infants and a six-month old fetus born to women treated with Endoxan. Ectrodactylia was found in two of the three cases. Normal infants have also been born to women treated with Endoxan 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 Endoxan, 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 Endoxan. Affected patients generally resume regular menses within a few months after cessation of therapy. Girls treated with Endoxan during prepubescence generally develop secondary sexual characteristics normally and have regular menses. Ovarian fibrosis with apparently complete loss of germ cells after prolonged Endoxan treatment in late prepubescence has been reported. Girls treated with Endoxan during prepubescence subsequently have conceived. Men treated with Endoxan 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 Endoxan 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 Endoxan have subsequently fathered normal children.

Urinary System

Hemorrhagic cystitis may develop in patients treated with Endoxan. 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 Endoxan and the duration of therapy. Such bladder injury is thought to be due to Endoxan 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 Endoxan 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 Endoxan therapy in instances of severe hemorrhagic cystitis.

Cardiac Toxicity

Although a few instances of cardiac dysfunction have been reported following use of recommended doses of Endoxan, 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 Endoxan, severe, and sometimes fatal, congestive heart failure has occurred after the first Endoxan 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 Endoxan. Cyclophosphamide has been reported to potentiate doxorubicin-induced cardiotoxicity.

Infections

Treatment with Endoxan may cause significant suppression of immune responses. Serious, sometimes fatal, infections may develop in severely immunosuppressed patients. Endoxan 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.

Other

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.

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PRECAUTIONS

General

Special attention to the possible development of toxicity should be exercised in patients being treated with Endoxan if any of the following conditions are present:

  • Leukopenia
  • Thrombocytopenia
  • Tumor cell infiltration of bone marrow
  • Previous X-ray therapy
  • Previous therapy with other cytotoxic agents
  • Impaired hepatic function
  • Impaired renal function

Laboratory Tests

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.

Drug Interactions

The rate of metabolism and the leukopenic activity of Endoxan 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 Endoxan even though Endoxan 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 Endoxan within 10 days of general anesthesia, the anesthesiologist should be alerted.

Adrenalectomy

Since Endoxan has been reported to be more toxic in adrenalectomized dogs, adjustment of the doses of both replacement steroids and Endoxan may be necessary for the adrenalectomized patient.

Wound Healing

Endoxan may interfere with normal wound healing.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Pregnancy

Pregnancy Category D

Nursing Mothers

Endoxan is excreted in breast milk. Because of the potential for serious adverse reactions and the potential for tumorigenicity shown for Endoxan 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.

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Adverse Reactions

Information on adverse reactions associated with the use of Endoxan 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.

Reproductive System

Digestive System

Nausea and vomiting commonly occur with Endoxan 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 Endoxan treatment is stopped.

Skin and Its Structures

Alopecia occurs commonly in patients treated with Endoxan. 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.

Hematopoietic System

Leukopenia occurs in patients treated with Endoxan, 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 Endoxan. 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.

Urinary System

Hemorrhagic ureteritis and renal tubular necrosis have been reported to occur in patients treated with Endoxan. Such lesions usually resolve following cessation of therapy.

Infections

Carcinogenesis

Respiratory System

Interstitial pneumonitis has been reported as part of the postmarketing experience. Interstitial pulmonary fibrosis has been reported in patients receiving high doses of Endoxan over a prolonged period.

Other

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 Endoxan. Malaise and asthenia have been reported as part of the postmarketing experience.

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OVERDOSAGE

No specific antidote for Endoxan is known. Overdosage should be managed with supportive measures, including appropriate treatment for any concurrent infection, myelosuppression, or cardiac toxicity should it occur.

DOSAGE AND ADMINISTRATION

Treatment of Malignant Diseases

Adults and Children

Oral Endoxan 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 Endoxan 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 Endoxan is included in combined cytotoxic regimens, it may be necessary to reduce the dose of Endoxan 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 Endoxan metabolism, but there is no consistent evidence indicating a need for Endoxan dosage modification in patients with renal function impairment.

Treatment of Nonmalignant Diseases

Biopsy Proven “Minimal Change” Nephrotic Syndrome in Children

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 Endoxan treatment exceeds 60 days. Treatment beyond 90 days increases the probability of sterility. Adrenocorticosteroid therapy may be tapered and discontinued during the course of Endoxan therapy. See PRECAUTIONS section concerning hematologic monitoring.

Extemporaneous liquid preparations of Endoxan for oral administration may be prepared by dissolving Endoxan 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.

HOW SUPPLIED

Endoxan 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).

References

  • Recommendations for the Safe Handling of Parenteral Antineoplastic Drugs, NIH Publication No. 83-2621. For sale by the Superintendent of Documents, US Government Printing Office, Washington, DC 20402.
  • AMA Council Report. Guidelines for Handling Parenteral Antineoplastics. JAMA 1985; March 15.
  • National Study Commission on Cytotoxic Exposure - Recommendations for Handling Cytotoxic Agents. Available from Louis P. Jeffrey, ScD, Chairman, National Study Commission on Cytotoxic Exposure, Massachusetts College of Pharmacy and Allied Health Science, 179 Longwood Ave., Boston, Massachusetts 02115.
  • Clinical Oncological Society of Australia: Guidelines and Recommendations for Safe Handling of Antineoplastic Agents. Med J Australia 1983; 1:426-428.
  • Jones RB, et al: Safe handling of chemotherapeutic agents: A report from the Mount Sinai Medical Center. CA - A Cancer Journal for Clinicians 1983; (Sept/Oct) 258-263.
  • American Society of Hospital Pharmacists Technical Assistance Bulletin on Handling Cytotoxic and Hazardous Drugs. Am J Hosp Pharm 1990; 47:1033-1049.
  • Controlling Occupational Exposure to Hazardous Drugs. (OSHA WORK PRACTICE GUIDELINES). Am J Health-Syst Pharm 1996; 53:1669-1685.

 

4047200//01April 2001Roxane Laboratories, Inc. Columbus, Ohio 43216© RLI, 2001

Endoxan pharmaceutical active ingredients containing related brand and generic drugs:

infoActive ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Endoxan available forms, composition, doses:

infoForm of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Endoxan destination | category:

infoDestination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Endoxan Anatomical Therapeutic Chemical codes:

infoA medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Endoxan pharmaceutical companies:

infoPharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."CYCLOPHOSPHAMIDE (CYCLOPHOSPHAMIDE) TABLET [ROXANE LABORATORIES, INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."CYCLOPHOSPHAMIDE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. "cyclophosphamide". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Endoxan?

Depending on the reaction of the Endoxan after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Endoxan 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 Endoxan 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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Review

sDrugs.com conducted a study on Endoxan, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Endoxan consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Arunabha Ray, MD Pharmacology

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