A small proportion of the drug may be cleaved between the S atom and the purine ring. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard, or search for MHRA Yellow Card in the Google Play or Apple App Store. After 6 to 8 weeks . This content does not have an English version. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication. Avoid contact with people who have cold, flu or other contagious illness. U take hom No, you may get a bad taste in the mouth or have loose stools for a few days due to the antibiotics, but the therapy will not affect the Crohns disease. Azathioprine 50 MG Tablet acts as an immuno-suppressant drug, which is used to treat ulcerative colitis, rheumatoid arthritis, Crohn's disease, and in kidney transplants to prevent the rejection of a new kidney. It belongs to the group of medicines known as immunosuppressive agents. Azathioprine sometimes causes nausea or vomiting. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Inform your doctor if you have the following medical conditions to make sure this medicine will be safe for you : Take this medication with food to reduce stomach upset. HSTCL is an aggressive, rare type of T-cell lymphoma that is usually fatal. Follow your doctors instructions on this. Due to the genotoxic potential of azathioprine (see section 5.3), women of childbearing potential should use effective contraceptive measures while being treated with azathioprine and for one month following completion of treatment. Chromosomal abnormalities, which disappear with time, have been demonstrated in lymphocytes from the off-spring of patients treated with azathioprine. Also, a possible association between decreased TPMT activity and secondary leukaemias and myelodysplasia has been reported in individuals receiving 6-mercaptopurine (the active metabolite of azathioprine) in combination with other cytotoxics (see section 4.8). Evidence indicates that azathioprine therapy should be maintained indefinitely, even if only low doses are necessary, because of the risk of graft rejection. Careful monitoring by your doctor may decrease your risk. In Canada - Call your doctor for medical advice about side effects. This medicine helps treat inflammatory conditions such as: rheumatoid arthritis Crohn's disease and ulcerative colitis Rare postmarketing cases of HSTCL reported primarily in adolescent and young adult patients with Crohn disease and ulcerative colitis treated with. Let's have a detailed discussion to ensure proper treatment. This medication contains azathioprine. What Other Drugs Interact with Azathioprine? What is vardenafil used for? Your medication may look different. Kaiser Permanente health plans around the country: Kaiser Foundation Health Plan, Inc., in Northern and Southern California and Hawaii Kaiser Foundation Health Plan of Colorado Kaiser Foundation Health Plan of Georgia, Inc., Nine Piedmont Center, 3495 Piedmont Road NE, Atlanta, GA 30305, 404-364-7000 Kaiser Foundation Health Plan of the Mid-Atlantic States, Inc., in Maryland, Virginia, and Washington, D.C., 2101 E. Jefferson St., Rockville, MD 20852 Kaiser Foundation Health Plan of the Northwest, 500 NE Multnomah St., Suite 100, Portland, OR 97232 Kaiser Foundation Health Plan of Washington or Kaiser Foundation Health Plan of Washington Options, Inc.,1300 SW 27thSt., Renton, WA 98057. DESCRIPTION: Azathioprine, an immunosuppressive antimetabolite, is available in tablet form for oral administration. Immunisation using a live organism vaccine has the potential to cause infection in immunocompromised hosts. Dosage is as directed by your doctor, usually once or twice daily. 3. Megaloblastic bone marrow changes have also been observed but severe megaloblastic anaemia and erythroid hypoplasia are rare. The dose should not be taken with milk or dairy products since they contain xanthine oxidase, an enzyme which metabolises 6mercaptopurine and might therefore lead to reduced plasma concentrations of 6mercaptopurine (see sections 4.2 and 5.2). Take your next dose at the regular time. The tablet can be divided into equal doses. The risk of developing non-Hodgkin's lymphomas and other malignancies, notably skin cancers (melanoma and nonmelanomas), sarcomas (Kaposi's and non-Kaposi's) and uterine cervical cancer in situ, is increased in patients who receive immunosuppressants, particularly in transplant recipients receiving aggressive treatment and such therapy should be maintained at the lowest effective levels. Damage to deoxyribonucleic acid (DNA) through incorporation of purine thio-analogues. Azathioprine 50 MG Tablet shows side effects like nausea, vomiting, diarrhoea, loss of appetite, stomach pain, upset stomach, low blood cell count, etc. Unit tablet. Consult your doctor for more details. Serologic testing may be useful in determining previous exposure. Anesthesiologists should check whether their patients are administered azathioprine prior to surgery. If a decision is made to breastfeed, because 6-mercaptopurine is a strong immunosuppressant, the breastfed infant should be closely monitored for signs of immunosuppression, leukopenia, thrombocytopenia, hepatotoxicity, pancreatitis or other symptoms of 6-mercaptopurine exposure. Physicians should be attentive to symptoms of infection such as EBV and cytomegalovirus (CMV), as these are known triggers for MAS. Azathioprine 50 MG Tablet acts as an immuno-suppressant drug, which is used to treat ulcerative colitis, rheumatoid arthritis, Crohn's disease, and in kidney transplants to prevent the rejection of a new kidney.Azathioprine 50 MG Tablet is also an anti-metabolite. Azathioprine may be taken with food or on an empty stomach, but patients should standardise the method of administration. To help you remember, take it at the same time(s) each day. Viral, fungal, and bacterial infections in other patient populations. When the Melanocytes cel PhD (Pharmacology) Pursuing, M.Pharma (Pharmacology), B.Pharma - Certificate in Nutrition and Child Care, MBBS, Master in Healthcare Administration, Diploma in Occupational Health, What are the uses of Azathioprine 50 MG Tablet. It has been suggested that cimetidine and indomethacin may have myelosuppressive effects which may be enhanced by concomitant administration of azathioprine. Therefore, given the abnormal metabolism in these patients, it is not prudent to recommend that these patients should receive azathioprine. Except in extremely rare cases, no overt physical evidence of abnormality has been observed in the off-spring of patients treated with azathioprine (see section 4.6). US residents can call their local poison control center at 1-800-222-1222. Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. Tell your doctor if your condition does not get better after 3 months of treatment. If you have questions, ask your pharmacist. Lab and/or medical tests (such as complete blood count, liver/kidney function) should be done while you are taking this medication. Always ask your health care professional for complete information about this product and your specific health needs. Patients receiving azathioprine should be instructed to report immediately any evidence of infection, unexpected bruising or bleeding or other manifestations of bone marrow depression. ED is often a symptom of another health problem or health-related factor. Other marked underlying pathology has contributed to the very rare deaths reported. Register, The photos shown are samples only Specialist medical literature should be consulted for guidance as to clinical experience in particular conditions. Azathioprine may rarely increase your risk of developing certain types of cancer (such as lymphoma, skin cancer). Each film-coated tablet contains 50 mg azathioprine. Azasan; Imuran; Descriptions. Infection with varicella zoster virus (VZV; chickenpox and herpes zoster) may become severe during the administration of immunosuppressants. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Reversible, dose-related increases in mean corpuscular volume and red cell haemoglobin content have occurred in association with azathioprine therapy. DESCRIPTION: IMURAN (azathioprine), an immunosuppressive antimetabolite, is available in tablet form for oral administration. Do not increase your dose or use this drug more often or for longer than prescribed. This is not an estimate of the half-life of azathioprine itself, but is the decay rate for all 35 S-containing metabolites of the drug. Some patients experience nausea when first given azathioprine. It's been used in some patients with multiple sclerosis (MS), usually if they have problems with standard FDA-approved medications for their MS. Allopurinol/oxipurinol/thiopurinol and other xanthine oxidase inhibitors. We proof read and recheck at various steps to provide you the right medication in the correct form and dose, Most medicines cannot be sold without a valid prescription, as per the Drugs and Cosmetics Act, 1940 and Rules, 1945. 4. Most reported cases with TNF blockers have occurred in context of concomitant treatment with azathioprine or 6-. Azathioprine (AZA) is an immunosuppressive agent that acts through its effects as an antagonist of purine metabolism, resulting in the inhibition of deoxyribonucleic acid (DNA), ribonucleic acid (RNA) Overview of medical management of high-risk, adult patients with moderate to severe Crohn disease Undesirable effects may vary in their incidence depending on the indication. It should be prescribed only if the patient can be adequately monitored for toxic effects throughout the duration of therapy. Drugs A to Z Azathioprine Print Save Azathioprine Generic name: azathioprine [ ay-za-THYE-oh-preen ] Brand names: Azasan, Imuran Dosage form: oral tablet (100 mg; 50 mg; 75 mg) Drug classes: Antirheumatics, Other immunosuppressants Medically reviewed by Drugs.com on Jan 27, 2023. Erectile dysfunction Vardenafil dosage forms tablet 2.5mg 5mg 10mg 20mg Typical dosing for vardenafil The typical starting dose is 10 mg by mouth about 1 hour before sexual activity. Serious complications, including colitis, diverticulitis and bowel perforation, have been described in transplant recipients receiving immunosuppressive therapy. Learn about side effects, dosages, drug interactions, and more. Azathioprine 50 MG Tablet is also an anti-metabolite. With oral administration, nausea appears to be relieved by administering the tablets after meals. These signs are more likely to be manifest following chronic overdosage, rather than after a single acute overdose. Concomitant administration is not recommended as data are insufficient to determine an adequate dose reduction of azathioprine. The posology in children is the same as in adults (see section 4.2 Adults Other Indications). Since azathioprine pharmacokinetics has not been formally studied in hepatic impairment, no specific dose recommendations can be given. Women of childbearing potential/contraception in men and women. Do not use medications containing mercaptopurine while using azathioprine. Agranulocytosis, pancytopenia, aplastic anaemia, megaloblastic anaemia, erythroid hypoplasia, Stevens-Johnson syndrome and toxic epidermal necrolysis, Respiratory, thoracic and mediastinal disorders, Colitis, diverticulitis and bowel perforation reported in transplant population, severe diarrhoea in inflammatory bowel disease population, Acute febrile neutrophilic dermatosis (Sweet's syndrome), photosensitivity, Description of selected adverse reactions. Based on non-clinical data, other xanthine oxidase inhibitors, such as febuxostat, may prolong the activity of azathioprine possibly resulting in enhanced bone marrow suppression. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment. Vitiligo is a disease which results in the loss of skin colouring pigment and ultimately the person loose his or her skin colour in blotches. Learn more about link terms and conditions. 6-Mercaptopurine has been identified in the colostrum and breast-milk of women receiving azathioprine treatment. Close monitoring of blood cell count is necessary while taking this medication so It should be used under the supervision of a qualified physician. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Bleeding per rectum: Bleeding through the anal canal or rectum is usually the most common problem of MBBS Bachelor of Medicine and Bachelor of Surgery. 6-mercaptopurine is not stable in milk due to the presence of xanthine oxidase (30% degradation within 30 minutes) (see section 4.2). The maintenance dosage required may range from less than 1mg/kg bodyweight/day to 3mg/kg bodyweight/day, depending on the clinical condition being treated and the individual patient response, including haematological tolerance. 1 mg/kg/day IV/PO initially in single daily dose or divided q12hr; after 6-8 weeks, increase by 0.5 mg/kg/day every 4 weeks; not to exceed 2.5 mg/kg/day. This disease often affects a part of the eye called the uvea, from which it has derived it MBBS, MD -Pulmonary Medicine-Tuberculosis ,Respiratory Disease Medicine , Diploma in Tuberculosis and Chest Diseases (DTCD), European Diploma in Respiratory Medicine. Patients should be monitored for dose related adverse effects (see sections 4.4 and 5.2). Legal category POM (Prescription-only medicine) Show Imuran 50mg tablets Aspen Pharma Trading Ltd Show Cautionary and advisory labels. If it is near the time of the next dose, skip the missed dose. In the FDA Adverse Event Reporting System (AERS) database, the literature, and the HSTCL Cancer Survivors' Network, HSTCL cases have been identified in association with the following drugs: Use azathioprine during pregnancy only in LIFE-THREATENING emergencies when no safer drug is available. Azathioprine is available under the following different brand names: Azasan, and Imuran. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. Select one or more newsletters to continue. What are the side effects of Azathioprine 50 MG Tablet ? Individuals with TPMT deficiency develop very high cytotoxic thioguanine nucleotide concentrations. The dosage is based on your medical condition, weight, and response to treatment. Pharmacotherapeutic group: Antineoplastic and Immunomodulating agents. It reduces the action of body's own defense system (the immune system) and prevents rejection of the transplanted organ. Learn the symptoms of organ rejection such as a feeling of being ill, fever, pain around the transplanted organ, and the signs of a failing transplanted organ (a decrease in the amount of urine with kidney transplant). More frequent monitoring may be advisable in those with pre-existing liver disease or receiving other potentially hepatotoxic therapy. Health professionals who handle uncoated azathioprine tablets should follow guidelines for the handling of cytotoxic medicinal products according to prevailing local recommendations and/or regulations. rapid heartbeats, shortness of breath; pale skin, cold hands and feet; or. In a US clinical study, 18 children (aged 3 to 14 years) were evenly divided into two groups; either a weight to height ratio above or below the 75th percentile. US Brand Name. Mild interactions of azathioprine include: Administration concomitantly with or within 14 days of, Pheochromocytoma: Serious reactions, including elevated blood pressure and tachyarrhythmia, have been reported in patients with current or previous pheochromocytoma, See "What Are Side Effects Associated with Using Azathioprine?". Consult your doctor before breast-feeding. This information is for use by healthcare professionals, 220 Butterfield, Great Marlings, Luton, LU2 8DL, UK. Drug information provided by: Merative, Micromedex. 10 Things People With Depression Wish You Knew, 3-5 mg/kg/day intravenously/orally initially on day of transplant or 3 days before transplant (rare), Maintenance: 1-3 mg/kg/day intravenously/orally, 1 mg/kg/day intravenously/orally initially in single daily dose or divided every 12 hours; may be increased by 0.5 mg/kg/day after 6-8 weeks, then by 0.5 mg/kg/day every 4 weeks; not to exceed 2.5 mg/kg/day, Maintenance: Reduce daily dose by 0.5 mg/kg every 4 weeks until lowest effective dosage is reached, Adult: 2 mg/kg/day orally with or without low-dose corticosteroids, Induction and maintenance therapy for lupus nephritis (2012 American College of Rheumatology guidelines), Children under 12 years: Safety and efficacy not established, Children over 12 years: 2 mg/kg/day orally with or without low-dose corticosteroids, Maintenance, remission, or reduction of steroid, 1-2 mg/kg orally once daily to maximum daily dose of 150 mg for at least 3-6 months before typical response is observed, Lower dosage (100 mg/day) is reported effective in some patients, Longer treatment duration (up to 84 months) is reported in some patients, Bacterial, fungal, protozoan, viral infections. It is also used in the treatment of rheumatoid arthritis. It may be harmful and can lead to other complications. Genotypic and phenotypic tests of TPMT are available (see sections 4.4 and 5.2). Not all photos of the drug may be displayed. Follow us on these external social media sites that will open in a new browser window. Evidence of the teratogenicity of azathioprine in man is equivocal. Product introduction Azathioprine 50mg Tablet belongs to a group of medicines called immunosuppressants. 1-methyl-4-nitro-5-thioimidazole has also been detected in urine as a minor excretory product. You may report side effects to Health Canada at 1-866-234-2345. Do not take Azasan or Imuran if you are allergic to azathioprine or any ingredients contained in this drug. Since azathioprine pharmacokinetics has not been formally studied in renal impairment, no specific dose recommendations can be given. As is usual for patients with increased risk for skin cancer, exposure to sunlight and UV light should be limited, and patients should wear protective clothing and use a sunscreen with a high protection factor. Available for Android and iOS devices. Azathioprine can make you more likely to get infections or may make current infections worse. An interaction has been observed between azathioprine and infliximab. Keep all medical and lab appointments. Store at room temperature away from light and moisture. This oxidation is brought about by xanthine oxidase, an enzyme that is inhibited by allopurinol. TPMT activity is inversely related to red blood cell 6-mercaptopurine derived thioguanine nucleotide concentration, with higher thioguanine nucleotide concentrations resulting in greater reductions in white blood cell and neutrophil counts. The dose should not be taken with milk or dairy products (see section 4.5). The cause of sweet's syndrome is still not known. Reporting suspected adverse reactions after authorisation of the medicinal product is important. Co-administration of ribavirin and azathioprine is not advised. To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports. Ribavirin may reduce efficacy and increase toxicity of azathioprine (see section 4.5). We don't support your browser. The following convention has been utilised for the classification of frequency: very common (1/10), common ( 1/100, <1/10), uncommon ( 1/1,000, <1/100), rare ( 1/10,000, <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data). The film-coated tablets are packed in either polypropylene-aluminium blister or PVC/PVDC-aluminium blister in a carton box. In general, the starting dosage is 1 to 3mg/kg bodyweight/day, and should be adjusted, within these limits, depending on the clinical response (which may not be evident for weeks or months) and haematological tolerance. As there is no specific antidote, blood counts should be closely monitored and general supportive measures, together with appropriate blood transfusion, instituted if necessary. However, in several systems it appears to modify the activity of azathioprine as compared with that of 6-MP. Only a small amount of the dose of azathioprine administered is excreted unmetabolised in the urine. Talk to your doctor if you have been exposed to an infection or for more details. Excipient with known effect: contains 90 mg of lactose (as lactose monohydrate). Please upgrade your browser or download modern browsers from here! Genotypic testing of NUDT15 variants may be considered before initiating azathioprine therapy. Neoplasms including lymphoproliferative disorders, skin cancers (melanomas and non-melanomas), sarcomas (Kaposi's and non-Kaposi's) and uterine cervical cancer in situ, acute myeloid leukaemia and myelodysplasia (see section 4.4). Special care is necessary when azathioprine is given concomitantly with neuromuscular acting agents like tubocurarine or succinylcholine. Paediatric population - Overweight children. Therefore, it is recommended that patients do not receive live organism vaccines until at least 3 months after the end of their treatment with azathioprine (see section 4.5). . It is also used in the treatment of rheumatoid arthritis. Label . This problem could be exacerbated by co-administration with medicinal products that inhibit TPMT, such as olsalazine, mesalazine or sulfasalazine. The dosage is based on your medical condition, weight,. Azathioprine is also used to treat rheumatoid arthritis. Do not chew, crush or break it. Properly discard this product when it is expired or no longer needed. See additional information. Data sources include IBM Watson Micromedex (updated 5 June 2023), Cerner Multum (updated 5 June 2023), ASHP (updated 10 Apr 2023) and others. Descriptions. Azathioprine is indicated for the treatment of moderate to severe inflammatory bowel disease (IBD) (Crohn's disease or ulcerative colitis) in patients in whom corticosteroid therapy is required, in patients who cannot tolerate corticosteroid therapy, or in patients whose disease is refractory to other standard first line therapy. Azathioprine may be taken with food or on an empty stomach, but patients should standardise the method of administration. Severe diarrhoea, recurring on rechallenge, has been reported in patients treated with azathioprine for inflammatory bowel disease. Taking this medicine after meals, in divided doses, or at bedtime may lessen stomach upset. Since impaired renal function may result in slower elimination of azathioprine and its metabolites, consideration should be given to reducing the starting doses in patients with impaired renal function. If the patient is exposed to VZV, special care must be taken to avoid patients developing chickenpox or herpes zoster, and passive immunisation with varicella-zoster immunoglobulin (VZIG) may be considered. Active measures (such as the use of activated charcoal) may not be effective in the event of azathioprine overdose unless the procedure can be undertaken within 60 minutes of ingestion. Selecting these links will take you away from KP.org. Azathioprine will lower the body's natural immunity in patients who receive transplants to prevent rejection of the new kidney. Genotypic testing can determine the allelic pattern of a patient. Because of extensive metabolism, only a fraction of the radioactivity is . Severe myelosuppression has been reported following concomitant administration of azathioprine and ribavirin; therefore, co-administration is not advised (see sections 4.4 and 5.2). Call your doctor right away about the risks and benefits of this.. With people who have cold, flu or other contagious illness should not take Azasan or Imuran you! Should receive azathioprine 4.5 ) recommend that these patients should receive azathioprine is.... Tpmt are available ( see section 4.5 ) at 1-800-222-1222 section 4.5 ) to the. Either polypropylene-aluminium blister or PVC/PVDC-aluminium blister in a carton box tests ( such as EBV and cytomegalovirus ( CMV,. Lactase deficiency or glucose-galactose malabsorption should not take this medicinal product is important,... Dose should not be sold, redistributed or otherwise used for commercial purposes mesalazine sulfasalazine. Change the dosage is based on your medical condition, weight, stomach, but patients should be attentive symptoms. Packed in either polypropylene-aluminium blister or PVC/PVDC-aluminium blister in a carton box are allergic to azathioprine or 6- receive to. Have been demonstrated in lymphocytes from the off-spring of patients treated with azathioprine inflammatory... Xanthine oxidase, an immunosuppressive antimetabolite, is available in tablet form for oral.! Their local poison control center at 1-800-222-1222 register, the photos shown samples... From the off-spring of patients treated with azathioprine for inflammatory bowel disease group of medicines called immunosuppressants cases TNF! Allelic pattern of a qualified physician a carton box Prescription-only medicine ) Show Imuran 50mg tablets Pharma. Advisable in those with pre-existing liver disease or receiving other potentially hepatotoxic therapy tablet... Does not get better after 3 months of treatment instructed to do so determining... Us residents can Call their local poison control center at 1-800-222-1222, skip the missed dose talk! 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