DeWitte et al reported pancytopenia and severe immune deficiency in a preterm infant whose mother received mg Azathioprine and Williamson and Karp described an infant born with preaxial polydactyly whose mother received Azathioprine mg daily and prednisone 20 mg every other day during pregnancy. The father was on long-term Azathioprine therapy.

There are no adequate and well-controlled studies in pregnant women. 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 age should be advised to avoid becoming pregnant. Precautions General A gastrointestinal hypersensitivity reaction characterized by severe nausea and vomiting has been reported.

These symptoms may also be accompanied by diarrhea, rash, fever, malaise, myalgias, elevations in liver enzymes, and occasionally, hypotension. Symptoms of gastrointestinal toxicity most often develop within the first several weeks of therapy with Azathioprine tablets and are reversible upon discontinuation of the drug. The reaction can recur within hours after rechallenge with a single dose of Azathioprine tablets.

Information for Patients Patients being started on Azathioprine tablets should be informed of the necessity of periodic blood counts while they are receiving the drug and should be encouraged to report any unusual bleeding or bruising to their physician. Patients should be advised of the potential risks of the use of Azathioprine tablets during pregnancy and during the nursing period.

The increased risk of malignancy following therapy with Azathioprine tablets should be explained to the patient. Laboratory Tests Complete Blood Count CBC Monitoring Patients on Azathioprine tablets should have complete blood counts, including platelet counts, weekly during the first month, twice monthly for the second and third months of treatment, then monthly or more frequently if dosage alterations or other therapy changes are necessary. Phenotyping and genotyping methods are commercially available.

Patients with two non-functional alleles homozygous have low or absent TPMT activity and those with one non-functional allele heterozygous have intermediate activity. Accurate phenotyping red blood cell TPMT activity results are not possible in patients who have received recent blood transfusions.

Early drug discontinuation in these patients is advisable. Drug Interactions Use with Allopurinol One of the pathways for inactivation of Azathioprine is inhibited by allopurinol. Use with Aminosalicylates There is in vitro evidence that aminosalicylate derivatives e. Concomitant use of these agents with Azathioprine tablets should be done with caution.

Use with Other Agents Affecting Myelopoesis Drugs which may affect leukocyte production, including co-trimoxazole, may lead to exaggerated leukopenia, especially in renal transplant recipients. Use with Angiotensin-Converting Enzyme Inhibitors The use of angiotensin-converting enzyme inhibitors to control hypertension in patients on Azathioprine has been reported to induce anemia and severe leukopenia.

I can't remember how long I was on the high dose of prednisone but I do remember the cut down factor of it. My numbers are good but I have been told by my hepatologist that these are both drugs I will be on forever. Not good but a have to case as quite alot of damage was done to my liver by the aih. Never though did any doctor tell me that I could develop cancer from the drugs but maybe it is a question to ask in Feb when I see my hepatologist again.

Jody zmombomb I always look up the medications on the net. Yes, Aza CAN cause cancer. Yes, Lymphoma is the typical cancer. If you don't take it, you may die from Chirrosis of the liver. I have autoimmune hep and take Milk Thistle to regenerate healthy liver cell growth and L-Carnitine to expel excess fat from my liver , and also cut back on beef and man made carbs.

All of this has helped tremendously! Long term side effects Metabolic pathway for azathioprineIt is listed as a human carcinogen in the 11th Report on Carcinogens of the U. Department of Health and Human Services, although they note that the International Agency for Research on Cancer IARC considered some of the animal studies to be inconclusive because of limitations in the study design and inadequate reporting.

People who have previously been treated with an alkylating agent may have an excessive risk of cancers if treated with azathioprine. Epidemiological studies have provided "sufficient" evidence of Azathioprine carcinogenicity in humans,[4] although the methodology of past studies and the possible underlying mechanisms are questioned.

Data on file, Prometheus Laboratories Inc. Azathioprine-induced myelosuppression in thiopurine methyltransferase deficient heart transplant patients. Hepatic veno-occlusive disease associated with renal transplantation and azathioprine therapy. Azathioprine and hepatic veno-occlusive disease in renal transplant patients.

Veno-occlusive disease of the liver in patients receiving immunosuppressive therapy. As usual for patients with increased risk for skin cancer, exposure to sunlight and ultraviolet light should be limited by wearing protective clothing and using a sunscreen with a high protection factor. Post-transplant Renal transplant patients are known to have an increased risk of malignancy , predominantly skin cancer and reticulum cell or lymphomatous tumors. The risk of post-transplant lymphomas may be increased in patients who receive aggressive treatment with immunosuppressive drugs, including IMURAN.

Therefore, immunosuppressive drug therapy should be maintained at the lowest effective levels. The data suggest the risk may be elevated in patients with rheumatoid arthritis , though lower than for renal transplant patients.

However, acute myelogenous leukemia as well as solid tumors have been reported in patients with rheumatoid arthritis who have received IMURAN. These cases have had a very aggressive disease course and have been fatal. Abnormalities included skeletal malformations and visceral anomalies. The father was on long-term azathioprine therapy. There are no adequate and well-controlled studies in pregnant women.

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 age should be advised to avoid becoming pregnant. Azathioprine is stable in solution at neutral or acid pH but hydrolysis to mercaptopurine occurs in excess sodium hydroxide 0.

Conversion to mercaptopurine also occurs in the presence of sulfhydryl compounds such as cysteine, glutathione, and hydrogen sulfide. Azathioprine is well absorbed following oral administration.

This is not an estimate of the half-life of azathioprine itself, but is the decay rate for all 35S-containing metabolites of the drug. Because of extensive metabolism, only a fraction of the radioactivity is present as azathioprine. Blood levels are of little predictive value for therapy since the magnitude and duration of clinical effects correlate with thiopurine nucleotide levels in tissues rather than with plasma drug levels.

Azathioprine is metabolized to 6-mercaptopurine 6-MP. Activation of 6-mercaptopurine occurs via hypoxanthine-guanine phosphoribosyltransferase HGPRT and a series of multi-enzymatic processes involving kinases to form 6-thioguanine nucleotides 6-TGNs as major metabolites See Metabolism Scheme in Figure 1.

TPMT activity is controlled by a genetic polymorphism. Non-functional alleles are less common in Asians. TPMT activity correlates inversely with 6-TGN levels in erythrocytes and presumably other hematopoietic tissues, since these cells have negligible xanthine oxidase involved in the other inactivation pathway activities, leaving TPMT methylation as the only inactivation pathway.

Patients with intermediate TPMT activity may be at increased risk of myelotoxicity if receiving conventional doses of Imuran. Patients with low or absent TPMT activity are at an increased risk of developing severe, life-threatening myelotoxicity if receiving conventional doses of Imuran. Metabolism pathway of azathioprine: Inosine monophosphate dehydrogenase; MeMP: Xanthine oxidase Adapted from Pharmacogenomics ; 3: Another inactivation pathway is oxidation, which is catalyzed by xanthine oxidase XO to form 6-thiouric acid.

Proportions of metabolites are different in individual patients, and this presumably accounts for variable magnitude and duration of drug effects. Renal clearance is probably not important in predicting biological effectiveness or toxicities, although dose reduction is practiced in patients with poor renal function.

The use of azathioprine for inhibition of renal homograft rejection is well established, the mechanism s for this action are somewhat obscure. The drug suppresses hypersensitivities of the cell-mediated type and causes variable alterations in antibody production. Suppression of T-cell effects, including ablation of T-cell suppression, is dependent on the temporal relationship to antigenic stimulus or engraftment.

This agent has little effect on established graft rejections or secondary responses. Alterations in specific immune responses or immunologic functions in transplant recipients are difficult to relate specifically to immunosuppression by azathioprine.

Ulcerative Colitis

The data suggest the risk may 12.5 elevated in patients with rheumatoid arthritisthough lower than for renal transplant patients. Hematologic toxicities are dose-related and may be more severe in renal transplant patients whose homograft is undergoing rejection. If you don't take it, you may die from Chirrosis of the liver. Serious infections Patients receiving immunosuppressants, including Azathioprine, are at increased risk for bacterial, viral, fungal,protozoal, and opportunistic infections, including reactivation of latent infections. Azathioprine is immunosuppressive, delayed hypersensitivity and cellular cytotoxicity tests being suppressed to a greater degree than are antibody responses. This drug should not be used for treating rheumatoid arthritis in pregnant women, imuran 12.5 mg. Use with Other Agents Affecting Myelopoesis Drugs which may 12.5 leukocyte production, including co-trimoxazole, may lead to exaggerated leukopenia, especially in renal transplant recipients. In addition, each tablet contains the following inactive ingredients: The use of azathioprine for 12.5 of renal homograft rejection is well established, imuran 12.5 mg, the mechanism s for this action are somewhat obscure. The combined use of Azathioprine tablets with disease modifying anti-rheumatic drugs DMARDs has not been studied for either added benefit or unexpected adverse effects. The risk of post-transplant lymphomas may imuran increased in patients who receive aggressive treatment with immunosuppressive drugs, including IMURAN, imuran 12.5 mg. The drug suppresses hypersensitivities of the cell-mediated type and causes variable alterations in antibody production. Imuran inactivation pathway is oxidation, which is catalyzed by xanthine oxidase XO to form 6-thiouric acid. Carcinogenesis, Mutagenesis, Impairment of Fertility: Make sure your imuran is rich in calcium:

Azathioprine

Leukopenia does not correlate with therapeutic effect; therefore the dose should not be increased intentionally to lower the white blood cell count. Patients with low or absent TPMT activity are at an increased risk of developing severe, life-threatening myelotoxicity if receiving conventional doses of Imuran. These cases have had a very aggressive disease course and have been fatal. Use with Other Agents Affecting Myelopoesis Drugs which may affect leukocyte production, imuran 12.5 mg, including co-trimoxazole, may lead to exaggerated leukopenia, especially in renal transplant recipients. Physicians using this drug should be very familiar with this risk as well as with the mutagenic potential to both men and women and with possible hematologic toxicities. There is in vitro evidence that aminosalicylate derivatives e. Imuran receiving azathioprine with ribavirin should have complete blood counts, including platelet counts, monitored weekly for the first month, twice monthly for the second and third months of treatment, then monthly or more frequently if dosage or other therapy changes are necessary, imuran 12.5 mg. I tried at 2 different times to get off meds, but both times my 's went back up as soon as I was off. Risk factors for PML include treatment 12.5 immunosuppressant therapies and impairment of immune function. Renal clearance is probably not important in predicting biological effectiveness or toxicities, although hydrocodone sinus headaches reduction is practiced in patients with poor renal function.

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