Cimetidina 150 mg/ml ampola 2 ml e seu processo de não padronização no âmbito do Distrito Federal
DOI:
https://doi.org/10.51208/saudeinovacao.v2i1.55Abstract
The medicine called cimetidine 150 mg/ml ampoule 2 ml is indicated for the treatment of disorders of the upper gastrointestinal tract in which the reduction of acid secretion, its remission and the prevention of its recurrence are beneficial for symptomatic relief. Standardization of this drug was requested in the List of Medicines of the Federal District (REME-DF), together with the drug diphenhydramine 50 mg/ml - 1 ml ampoule, with indication of pre-chemotherapy histamine blockade (pre-QT). For this, a health technology assessment tool was used, through a bibliographic survey in Medline databases via Pubmed; Embase, Cochrane Library and Biblioteca Virtual em Saúde - BVS. In view of this request, received by the CCFT, an analysis was carried out considering up-to-date literature on this product. A total of 314 articles were found, 21 of which were included in this analysis. In conclusion, due to the withdrawal from the Brazilian market of the medicine standardized in the SESDF, ranitidine, and with the favorable safety and efficacy assessment for cimetidine, this medicine was standardized within the Federal District.
References
TEUTO. https://consultas.anvisa.gov.br/#/bulario/detalhe/2409?nomeProduto=cimetidina. Acesso em: 24.11.2021
Collen MJ, Howard JM, McArthur KE, Raufman JP, Cornelius MJ, Ciarleglio CA, Gardner JD, Jensen RT. Comparison of ranitidine and cimetidine in the treatment of gastric hypersecretion. Ann Intern Med. 1984 Jan;100(1):52-8. doi: 10.7326/0003-4819-100-1-52. PMID: 6318628.
Berardi RR, Tankanow RM, Nostrant TT. Comparison of famotidine with cimetidine and ranitidine. Clin Pharm. 1988 Apr;7(4):271-84. PMID: 2896559.
Sato A, Sakashita A, Taguchi S. [Hypersensitivity reactions to cancer chemotherapeutic agents]. Gan To Kagaku Ryoho. 2003 Jun;30(6):793-800. Japanese. PMID: 12852346.
Liberati A, Altman DG, Tetzlaff J, Mulrow C, Gøtzsche P, Ioannidis JPA, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration. PLoS Med. 2009 Jul;6(7):e1000100.
J.M. Cox1 , L. Van Doorn2 , R. Malmberg1 , E. Oomen-de Hoop2 , T.M. Bosch3 , P.M.L.A. van den Bemt4 , I.A. Boere2 , A. Jager2 , R.H. Mathijssen2 , R.W.F. van Leeuwen. The added value of the H2 blocker ranitidine in premedication regimens during paclitaxel treatment. https://doi.org/10.1016/j.annonc.2020.08.1498
Lal, L.S.; Gerber, D.L.; Lau, J.; Dana, W.; Retrospective evaluation of weekly paclitaxel hypersensitivity reactions reported utilizing an electronic medical record system at a tertiary cancer center.
Nishio S, Ota S, Sugiyama T, Matsuo G, Kawagoe H, Kumagai S, Ushijima K, Nishida T, Kamura T. Weekly 1-h paclitaxel infusion in patients with recurrent endometrial cancer: a preliminary study. Int J Clin Oncol. 2003 Feb;8(1):45-8. doi: 10.1007/s101470300006. PMID: 12601542.
Quock J, Dea G, Tanaka M, Gandara D, Lara P, Lau D. Premedication strategy for weekly paclitaxel. Cancer Invest. 2002;20(5-6):666-72. doi: 10.1081/cnv-120003535. PMID: 12197222.
Bookman MA, Kloth DD, Kover PE, Smolinski S, Ozols RF. Intravenous prophylaxis for paclitaxel-related hypersensitivity reactions. Semin Oncol. 1997 Dec;24(6 Suppl 19):S19-13-S19-15. PMID: 9427258.
Bookman MA, Kloth DD, Kover PE, Smolinski S, Ozols RF. Short-course intravenous prophylaxis for paclitaxel-related hypersensitivity reactions. Ann Oncol. 1997 Jun;8(6):611-4. doi: 10.1023/a:1008207025430. PMID: 9261533.
Blom R, Palm N, Simonsen E. Paclitaxel (Taxol) monotherapy in the treatment of progressive and recurrent ovarian carcinoma after platinum-based chemotherapy. Acta Oncol. 1996;35(6):733-6. doi: 10.3109/02841869609084007. PMID: 8938222.
Einzig AI, Neuberg D, Remick SC, Karp DD, O'Dwyer PJ, Stewart JA, Benson AB 3rd. Phase II trial of docetaxel (Taxotere) in patients with adenocarcinoma of the upper gastrointestinal tract previously untreated with cytotoxic chemotherapy: the Eastern Cooperative Oncology Group (ECOG) results of protocol E1293. Med Oncol. 1996 Jun;13(2):87-93. doi: 10.1007/BF02993858. PMID: 9013471.
Dreyfuss AI, Clark JR, Norris CM, Rossi RM, Lucarini JW, Busse PM, Poulin MD, Thornhill L, Costello R, Posner MR. Docetaxel: an active drug for squamous cell carcinoma of the head and neck. J Clin Oncol. 1996 May;14(5):1672-8. doi: 10.1200/JCO.1996.14.5.1672. PMID: 8622087.
Rosell R, González-Larriba JL, Alberola V, Molina F, Monzó M, Benito D, Pérez JM, de Anta JM. Single-agent paclitaxel by 3-hour infusion in the treatment of non-small cell lung cancer: links between p53 and K-ras gene status and chemosensitivity. Semin Oncol. 1995 Dec;22(6 Suppl 14):12-8. PMID: 8553077.
Younes A, Sarris A, Melnyk A, Romaguera J, McLaughlin P, Swan F, Rodriguez MA, Hagemeister F, Moore D, North L, et al. Three-hour paclitaxel infusion in patients with refractory and relapsed non-Hodgkin's lymphoma. J Clin Oncol. 1995 Mar;13(3):583-7. doi: 10.1200/JCO.1995.13.3.583. PMID: 7884419.
Alberola V, Rosell R, González-Larriba JL, Molina F, Ayala F, García-Conde J, Benito D, Pérez JM. Single agent Taxol, 3-hour infusion, in untreated advanced non-small-cell lung cancer. Ann Oncol. 1995;6 Suppl 3:S49-52. doi: 10.1093/annonc/6.suppl_3.s49. PMID: 8616116.
Greco FA, Hainsworth JD. Paclitaxel (Taxol): phase I/II trial comparing 1-hour infusion schedules. Semin Oncol. 1994 Oct;21(5 Suppl 8):3-8. PMID: 7939760.
Wiernik PH, Schwartz EL, Einzig A, Strauman JJ, Lipton RB, Dutcher JP. Phase I trial of taxol given as a 24-hour infusion every 21 days: responses observed in metastatic melanoma. J Clin Oncol. 1987 Aug;5(8):1232-9. doi: 10.1200/JCO.1987.5.8.1232. PMID: 2887641.
Murphy WK, Fossella FV, Winn RJ, Shin DM, Hynes HE, Gross HM, Davilla E, Leimert J, Dhingra H, Raber MN, et al. Phase II study of taxol in patients with untreated advanced non-small-cell lung cancer. J Natl Cancer Inst. 1993 Mar 3;85(5):384-8. doi: 10.1093/jnci/85.5.384. PMID: 8094466.
Wiernik PH, Schwartz EL, Strauman JJ, Dutcher JP, Lipton RB, Paietta E. Phase I clinical and pharmacokinetic study of taxol. Cancer Res. 1987 May 1;47(9):2486-93. PMID: 2882837.
Treon SP, Tripsas CK, Meid K, Kanan S, Sheehy P, Chuma S, Xu L, Cao Y, Yang G, Liu X, Patterson CJ, Warren D, Hunter ZR, Turnbull B, Ghobrial IM, Castillo JJ. Carfilzomib, rituximab, and dexamethasone (CaRD) treatment offers a neuropathy-sparing approach for treating Waldenström's macroglobulinemia. Blood. 2014 Jul 24;124(4):503-10. doi: 10.1182/blood-2014-03-566273. Epub 2014 May 23. PMID: 24859363.
Kidera Y, Satoh T, Ueda S, Okamoto W, Okamoto I, Fumita S, Yonesaka K, Hayashi H, Makimura C, Okamoto K, Kiyota H, Tsurutani J, Miyazaki M, Yoshinaga M, Fujiwara K, Yamazoe Y, Moriyama K, Tsubaki M, Chiba Y, Nishida S, Nakagawa K. High-dose dexamethasone plus antihistamine prevents colorectal cancer patients treated with modified FOLFOX6 from hypersensitivity reactions induced by oxaliplatin. Int J Clin Oncol. 2011 Jun;16(3):244-9. doi: 10.1007/s10147-010-0170-6. Epub 2011 Jan 18. PMID: 21243395.
Christian BA, Poi M, Jones JA, Porcu P, Maddocks K, Flynn JM, Benson DM Jr, Phelps MA, Wei L, Byrd JC, Wegener WA, Goldenberg DM, Baiocchi RA, Blum KA. The combination of milatuzumab, a humanized anti-CD74 antibody, and veltuzumab, a humanized anti-CD20 antibody, demonstrates activity in patients with relapsed and refractory B-cell non-Hodgkin lymphoma. Br J Haematol. 2015 Jun;169(5):701-10. doi: 10.1111/bjh.13354. Epub 2015 Apr 7. PMID: 25847298; PMCID: PMC7297055.
Young, D.; Bowen, C.; Arwood, N.; Poggi, S.; Cooper, S.; Brown, P.;Universal pretreatment for asparaginase-based therapy should be standard of care. Pediatr. Blood Cancer - Volume 65, Issue 0, pp. S10-S11 - published 2018-01-01
Rosko, N.; Mo, H.; Rudoni, J.; Siebenaller, C.; Lee, S.S.; Chakraborty, R.; Faiman, B.M.; Khouri, J.; Mejia Garcia, A.V.; Samaras, C.J.; Anwer, F.; Valent, J.; Rapid infusion daratumumab is safe in patients with AL amyloidosis. Blood - Volume 134, Issue 0, pp. - published 2019-01-01
Downloads
Published
Issue
Section
License
Copyright (c) 2025 Juliana Carvalho Rocha Alves da Silva, Marcus Tulio Batista Silva, Walleska Fidelis Gomes Borges
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
Os autores declaram aceitar a política de direito autoral praticada pela revista. A submissão de originais para a Revista Saúde e Inovação implica na transferência, pelos autores, dos direitos de publicação impressa e digital. Os direitos autorais para os artigos publicados nesta revista são do autor, com direitos da revista sobre a primeira publicação. Os autores somente poderão utilizar os mesmos resultados em outras publicações indicando claramente a Revista Saúde e Inovação como o meio da publicação original. Em virtude de tratar-se de um periódico de acesso aberto, é permitido o uso gratuito dos artigos, principalmente em aplicações educacionais e científicas, desde que citada a fonte. A Revista Saúde e Inovação adota a licença Creative Commons Atribuição 4.0 Internacional (CC BY 4.0): https://creativecommons.org/licenses/by/4.0/deed.pt_BR
A 