Azathioprine

The restrictions on CellCept were finally removed under a new agreement in September 2005 and CellCept is now available for use in renal and cardiac transplant patients and transplant patients unsuitable for azathioprine for an unrestricted treatment period. In order to secure this, a further increase in the rebate was agreed to. 2.2.6 Concerta methylphenidate ; - Treatment of Attention Deficit Hyperactivity Disorder Janssen-Cilag CONCERTA is a sustained release dosage form of methylphenidate that has been specifically designed for once daily treatment of attention deficit hyperactivity disorder. The pharmacokinetic profile ensures that medication has an adequate duration to give a full day's coverage from a single morning dose. The daily dose of medication can be taken at home, thereby reducing stigma and burden of administration that is currently assumed by the school. As the medication does not have to leave the home, there is also reduced potential for diversion and abuse. Brief History In February 2003, the Mental Health Subcommittee of PTAC noted deficiencies of existing products for treatment of ADHD and considered it would be desirable to enquire whether Janssen-Cilag would be prepared to submit an application for the listing of CONCERTA on the Pharmaceutical Schedule. New Zealand marketing approval Medsafe ; for CONCERTA was gazetted in August 2003. An application for listing of CONCERTA was submitted in October 2004. PTAC considered this application in November 2004 and recommended listing with a moderate priority. Subsequently, Janssen-Cilag approached PHARMAC on a number of occasions to ascertain how PHARMAC wished to move forward with a listing. Janssen-Cilag submitted a commercial proposal for listing CONCERTA in September 2005. There were no further developments until Janssen-Cilag received minutes of a MHSC meeting more than one year later in October 2006, recommending listing with a high priority. It went back to PTAC in February 2007 who recommended only a medium priority. No explanation has been given for the relegation to medium priority. Australia Concerta will be listed on the Australian PBS from 1 April 2007 and is reimbursed for the treatment of Attention Deficit Hyperactivity Disorder ADHD ; in children and adolescents aged 6-18 years who have demonstrated a response to immediate-release methylphenidate hydrochloride with no emergence of serious adverse side events, and who require continuous coverage over 12 hours. Time taken from PBS application to listing was 14 months. Summary of Issues The MHSC of PTAC first recommended that PHARMAC pursue listing of CONCERTA in February 2003. More than 4 years after this recommendation PHARMAC has failed to implement a listing for a product their clinical advisors confirm is a high priority. This case demonstrates the delays in accessing pharmaceuticals even those considered high priority under PHARMAC's Decision Criteria ; under the current system in New Zealand. This case also highlights the uncertainty for patients and manufactures when PTAC and specialist subcommittee's have different views on priority. This is mental health care in the national health service, remember and clarithromycin.

With Category 0 being hospitals with no known cases of SARS. During these consultations the Ministry reviewed infection control precautions, use of respirators and respirator fit testing and the function of the internal responsibility system. As a result of the consultations and complaints, a total of 16 orders were issued under the Occupational Health and Safety Act and regulations to five of ten health care facilities781 . The orders included undertaking risk assessments and providing and fit testing respirators to all health care workers in high-risk areas. No violations of the Act or regulations were found in five of the institutions.782 Although it is puzzling why the ministry did not act sooner, the answer may lie in its exclusion from the central SARS command, its too long held assumption that the health care sector was able to protect its workers, its reliance on the 1984 agreement, and its emphasis on a reactive approach. Regardless of the reasons, the bottom line is that no proactive inspections were conducted during virtually all the outbreak. There were no proactive inspections of SARS hospitals in March 2003, or in April 2003, or in May 2003, even though health workers continued to get sick during each of those months and inadvertently infected colleagues, patients and members of their households. That more and more health workers were getting sick was not a secret. One only had to read the newspapers, watch television newscasts or listen to the radio. As each month passed, the widely available evidence mounted that health workers were not protected and that the system in charge of the SARS response was unable to safeguard them. Yet the Ministry did not act proactively. In April and May it had the capacity to do what it finally did in June by way of proactive safety work with SARS hospitals. This was a missed opportunity, although we will never know what impact that might have had on the SARS response. As noted earlier, Labour's approach was vastly different to what occurred in British Columbia. When a nurse contracted SARS at Royal Columbian Hospital, the Workers' Compensation Board made five inspections at the hospital to make sure workers were protected.783.

Spiers, A. S., Mibashan, R. S. 1974 ; Increased warfarin requirement during mercaptopurine therapy: a new drug interaction. Lancet; 2, 221. Singleton, J. D., Conyers, L. 1992 ; Warfarin and azathioprine: an important drug interaction. Am. J. Med.; 92, 217. Martini, A., Jahnchen, E. 1977 ; Studies in rats on the mechanism by which 6-mercaptopurine inhibits the anticoagulant effect of warfarin. J. Pharmacol. Exp. Ther.; 201, 547553. Haworth, E., Burroughs, A. K. 1977 ; Disopyramide and warfarin interaction. Br. Med. J.; 2, 866867. Gazzaniga, A. B., Stewart, D. R. 1969 ; Possible quinidineinduced hemorrhage in a patient on warfarin sodium. N. Engl. J. Med.; 280, 711712. Sylven, C., Anderson, P. 1983 ; Evidence that disopyramide does not interact with warfarin. Br. Med. J.; 286, 1181. Jones, F. L. J. 1968 ; More on quinidine-induced hypoprothrombinemia. Ann. Intern. Med.; 69, 1074. O'Reilly, R. A. 1981 ; Lack of effect of fortified wine ingested during fasting and anticoagulant therapy. Arch. Intern. Med.; 141, 458459. Koch-Weser, J. 1970 ; Potentiation by glucagon of the hypoprothrombinemic action of warfarin. Ann. Intern. Med.; 72, 331335. Roth, G. J., Majerus, P. W. 1975 ; The mechanism of the effect of aspirin on human platelets. I. Acetylation of a particulate fraction protein. Journal of Clinical Investigation; 56, 624632. Roth, G. J., Stanford, N., Majerus, P. W. 1975 ; Acetylation of prostaglandin synthetase by aspirin. Proceedings of the National Academy of Science; 72, 30733076. Quick, A. J., Clesceri, L. 1960 ; Influence of acetylosalicylic acid and salicylamide on the coagulation of blood. Journal of Pharmacology and Experimental Therapeutics; 128, 9598. Chan, T. Y. K. 1995 ; Adverse interactions between warfarin and nonsteroidal antiinflammatory drugs: mechanisms, clinical significance, and avoidance. Ann. Pharmacother.; 29, 12741283. O'Reilly, R. A. 1987 ; Warfarin metabolism and drug-drug interactions. Advances in Experimental Medicine & Biology; 214, 205212. Estes, D., Kaplan, K. 1980 ; Lack of platelet effect with the aspirin analog, salsalate. Arthritis Rheum.; 23, 13031307. Roth, S. H. 1988 ; Salicylates revisited. Are they still the hallmark of anti-inflammatory therapy? Drugs; 36, 16. Brown, Ch., Natelson, E. A., Bradshaw, M. W. 1975 ; Study of the effect of ticarcillin on blood coagulation and platelet function. Antimicrobial Agents and Chemotherapy; 7, 652657. Vesell, E. S., Passananti, G. T., Johnson, A. O. 1975 ; Failure of indomethacin and warfarin to interact in normal human volunteers. J. Clin. Pharmacol. 1975; 15, 486495. Self, T. H., Evans, W. E., Ferguson, T. 1975 ; Drug enhancement of warfarin activity. Lancet; 2, 557558. Pullar, T., Capell, H. A. 1982 ; Interaction of indomethacin and warfarin. Br. Med. J. Clin. Res.; 284, 198. Stricker, B. H., Delhez, J. L. 1982 ; Interactions between flurbiprofen and coumarins. Br. Med. J.; 285, 812813. Barager, F. D., Smith, T. C. 1978 ; Drug interaction studies with sodium meclofenamate Meclomen R . Curr. Ther. Res.; 23, 51. Diana, F. J., Veronich, K., Kapoor, A. L. 1989 ; Binding of nonsteroidal anti-inflammatory agents and their effect on binding of racemic warfarin and its enantiomers to human serum albumin. J. Pharm. Sci.; 78, 195199. Holmes, E. L. 1966 ; Experimental observations on flufenamic, mefenamic, and meclofenamic acids. IV. Toleration by normal human subjects. Ann. Phys. Med.; 9 suppl ; , 3649. Rhodes, R. S., Rhodes, P. J., Klein, C. et al. 1985 ; A warfarinpiroxicam drug interaction. Drug Intell. Clin. Pharm.; 19, 556558. Carter, S. A. 1979 ; Potential effect of sulindac on response of prothrombin-time to oral anticoagulants. Lancet; 2, 698699. Ross, J. R., Beeley, L. 1979 ; Sulindac, prothrombin time, and anticoagulants. Lancet; 2, 1075 and bricanyl and azathioprine.

Six women treated with cyclophosphamide alone or in combination with azafhioprine developed cervical intraepithelial neoplasia, compared with none of the women treated with prednisone alone or azathiopdine plus prednisone. The authors note that this translates into a three-fold elevation in the incidence of cervical intraepithelial neoplasia for women with SLE who received cyclophosphamide. A subset analysis of the women on cyclophosphamide showed a positive association between cumulative cyclophosphamide dose and development of cervical intraepithelial neoplasia. Two additional patients developed abnormal cervical smears in the ensuing 4 years. The researchers suggest that the frequency of monitoring should probably be increased in high-risk women, but there are no data to support a particular approach. It comes in several forms - white powder, pills and crystal-like rock and terbutaline.
To the Editor: Prolongation of the neuromuscular blocking effect of vecuronium with intravenous preparations of cyclosporine has been described.1-2 We observed this interaction in a 36-yr-old man two months after renal transplant receiving oral cyclosporine when he returned for internal urethrotomy. He was taking oral cyclosporine 180 mg bid, and azathioprin 75 mg and prednisolone 30 mg od. Physical examination and preoperative investigations were normal. On the morning of the operation, he took one dose of each of the three immunosuppressives. Premedication was with pentazocine 20 mg and phenergan 20 mg im and anaesthesia was induced with thiopentone 5 mg kg~' followed by vecuronium 0.08 mg kg" 1 iv, O2 + N2O 40: 60 ; and halothane 0.5%. Neuromuscular function was assessed continuously. Haemodynamic stability was maintained throughout the one-hour operation. No additional vecuronium was given. Neuromuscular blockade was reversed with neostigmine 0.05 mg-kg~' and atropine 0.02 mg kg" 1 iv after two definite and a faint third response to train-of-four stimulation were observed. Though the patient was awake and cooperative, incoordinate body movements, inability to sustain head lift, inadequate respiratory efforts and poorly sustained 50 Hz tetanus suggested residual neuromuscular blockade. The patient's temperature, serum electrolytes and arterial blood gas analysis were normal. Further neostigmine 1.0 mg and atropine 0.5 mg after ten minutes had no effect. Positive-pressure ventilation was continued for about three hours after which a satisfactory return of the neuromuscular function enabled extubation. In the absence of obvious renal, hepatic or metabolic derangement in this patient, the prolonged neuromuscular blocking effect of vecuronium was probably due to drug interaction. While azathioprine3 and chronic steroid therapy4 antagonize non-depolarizing neuromuscular blockade, cyclosporine appears to prolong it.l 2 5 Intravenous preparations of cyclosporine, however, contain cremophor as solvent, which may potentiate vecuronium-induced blockade5 and thus be partly responsible for this interaction. Oral cyclosporine Sandimmum, Sandoz ; does not contain cremophor. Thus, in light of the above interaction, continuous monitoring of neuromuscular block in post-transplant patients is reemphasized. Pragati Ganjoo DNB Prabhat Tewari MD Department of Anaesthesiology & Critical Care Medicine.

Health Service. t Stresscoat, Magnaflux Corp., Chicago 31, Illinois. + This investigation was supported by Research Grant D-548 from the N.I.D.R., U.S. Public Health Service.

Less Common Clinical Trial Adverse Drug Reactions 1% ; Additional side effects of low frequency have been reported. These include skin rashes, alopecia, fever, arthralgias, diarrhea, steatorrhea, negative nitrogen balance, and reversible interstitial pneumonitis. There have been rare reports of neoplasms including non-Hodgkins lymphomas, skin cancers melanoma and non-melanoma ; , sarcomas Kaposi's and non-Kaposi's ; , uterine cervical cancer in situ, acute myeloid leukaemia and myelodysplasia some in association with chromosomal abnormalities ; . Post-Market Adverse Drug Reactions Stevens Johnson syndrome and toxic epidermal necrolysis have been reported very rarely in post-marketing surveillance. DRUG INTERACTIONS Overview Drug-Drug Interactions Allopurinol: The principal pathway for detoxification of IMURAN is inhibited by allopurinol. In patients receiving IMURAN, the concomitant administration of ZYLOPRIM allopurinol ; will require a reduction in dose to approximately 1 3 to the usual dose of IMURAN. Subsequent adjustment of doses of IMURAN should be made on the basis of therapeutic response and any toxic effects. Other agents affecting myelopoesis: Drugs which may affect leukocyte production, including co-trimoxazole, may lead to exaggerated leukopenia, especially in renal transplant recipients. 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. Warfarin: IMURAN may inhibit the anticoagulant effect of warfarin. Non-depolarizing muscle relaxants: There is clinical evidence that IMURAN antagonizes the effect of non-depolarizing muscle relaxants such as curare, dtubocurarine and pancuronium. Experimental data confirm that azathioprine reverses the neuromuscular blockade caused by d-tubocurarine, and show that azathioprine potentiates the neuromuscular blockade caused by succinylcholine. As there is in vitro evidence that aminosalicylate derivatives e.g. olsalazine, mesalazine or sulphasalazine ; inhibit the TPMT enzyme, they should be administered with caution to.

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