Leitura clínica
Comentário
É um antibiótico derivado da hidrazida utilizado no tratamento da tuberculose. Administração oral diária ou uma três vezes por semana. É excretada no leite materno em quantidade moderada (DR 10 a 16%) que é muito inferior à dose utilizada habitualmente em recém-nascidos e lactentes. (Zuma 2022, Garessus 2019, Singh 2008, Snider 1984, Ricci 1954, Lass 1953) Não foram observados problemas relevantes em lactentes cujas mães a tomavam (Keskin 2008, Drobac 2005) . Um lactente, cuja mãe foi tratada com antituberculosos durante a gravidez e 7 meses de amamentação, apresentou níveis moderadamente altos de transaminases hepáticas com estado clínico e de desenvolvimento normais (Peters 2008) . Foram encontrados níveis plasmáticos baixos de 6-beta-hidroxicortisol em 10 lactentes de mães tratadas com INH. (Toddywalla 1995) Foram detectados níveis baixos de INH no plasma (Garessus 2019) e na urina (Ricci 1954) de lactentes cujas mães tomavam INH. Diversas sociedades médicas e consensos de especialistas consideram seguro o uso desta medicação durante a amamentação. (Algharably 2023, Nahid(CDC) 2016, Malhamé 2016, Baquero-Artigao 2015, Mittal 2014, Singh 2008, WHO 2007, Schram 2005, Blumberg 2003, Dautzenberg 1988, Tran 1998) Academia Americana de Pediatria: medicação usualmente compatível com a amamentação (AAP 2001) . Lista de medicamentos essenciais OMS 2002: compatível com a amamentação. (WHO 2002) Para evitar o risco de neuropatia, é preciso adicionar ao tratamento da mãe e do lactente vitamina B 6 (piridoxina), em especial em caso de desnutrição, diabetes ou outras doenças ou nova gravidez (Di Comite 2016, Principi 2016, Baquero-Artigao 2015, Steichen 2006, Blumberg 2003, CDC 2003) . Convém adicionar também vitamina B 3 (niacina) para evitar o risco de pelagra. (Nabity 2022) Você pode consultar abaixo as informações deste produto relacionado: Tuberculose (TBC) materna (Bastante seguro. Efeitos adversos leves ou pouco prováveis. Compatível em determinadas circunstâncias. Acompanhamento recomendado. Leia o Comentário.)
Encontrabilidade
Outros nomes e marcas
Sinônimos e grafias 7
- Hidrazida del ácido isonicotínico (INAH)
- Ισονιαζίδιο
- إيزونيازيد
- Изониазид
- 异烟肼
- イソニアジド
- J04AC01
Marcas comerciais na fonte 31
- Bitub (Битуб)
- Cemidon
- Cemidon B6
- Dianicotyl
- Dotbal
- Hidrasix
- Inapas
- Isodo Tbal
- Isokin-T Forte
- Isoniac
- Isopask (Изопаск)
- Isotamine
- Isozid (Изозид)
- Jieheqing (结核清)
- Laniazid
- Mac-Pas Plus (Мак-Пас Плюс)
- Nicizina
- Nicotibina
- Nicotibine
- Nicozid
- Nidrazid
- Pi Jin (匹金)
- Rifalep Plus
- Rifater
- Rimcure
- Rimifon
- Rimstar
- Sheng Jun (胜君)
- Tubilysin
- Valifol
- Voractiv
Dados da fonte
Farmacocinética
| Variável | Valor | Unidade |
|---|---|---|
| Biodisp. oral | 90 | % |
| Peso Molecular | 137 | daltons |
| Unión proteínas | 10 | % |
| Vd | 0,6 | l/Kg |
| pKa | 3,35 | - |
| Tmax | 1 - 2 | horas |
| T½ | 0,5 - 5 | horas |
| Índice L/P | 1 - 3 | - |
| Dosis Teórica | 0,1 - 1,6 | mg/Kg/d |
| Dosis Relativa | 1,2 - 16 | % |
| Dosis Rel. Ped. | 0,4 - 16 | % |
Rastreabilidade
Bibliografia
- Algharably EA, Kreutz R, Gundert-Remy U. Infant Exposure to Antituberculosis Drugs via Breast Milk and Assessment of Potential Adverse Effects in Breastfed Infants: Critical Review of Data. Pharmaceutics. 2023 Apr 13;15(4). pii: 1228. Resumen Texto completo (enlace a fuente original)
- Zuma P, Joubert A, van der Merwe M, Norman J, Waitt C, Court R, Loveday M, Castel S, Wiesner L. Validation and application of a quantitative LC-MS/MS assay for the analysis of first-line anti-tuberculosis drugs, rifabutin and their metabolites in human breast milk. J Chromatogr B Analyt Technol Biomed Life Sci. 2022 Nov 15;1211:123489. Resumen Texto completo (enlace a fuente original)
- Nabity SA, Mponda K, Gutreuter S, Surie D, Zimba SB, Chisuwo L, Moffitt A, Williams AM, Sharma AJ, Marshall RE, Chiwaula MJ, da Silva R, Kumwenda T, Chilikutali L, Mwamale S, Nagoli E, Mwenyeheri G, Ngongonda D, Kaunda E, Mtoto F, Mhango V, Mbewe K, et al. Isoniazid-associated pellagra during mass scale-up of tuberculosis preventive therapy: a case-control study. Lancet Glob Health. 2022 May;10(5):e705-e714. Resumen Texto completo (enlace a fuente original)
- Garessus EDG, Mielke H, Gundert-Remy U. Exposure of Infants to Isoniazid via Breast Milk After Maternal Drug Intake of Recommended Doses Is Clinically Insignificant Irrespective of Metaboliser Status. A Physiologically-Based Pharmacokinetic (PBPK) Modelling Approach to Estimate Drug Exposure of Infants via Breast-Feeding. Front Pharmacol. 2019 Jan 22;10:5. Resumen Texto completo (enlace a fuente original)
- Di Comite A, Esposito S, Villani A, Stronati M; Italian Pediatric TB Study Group. How to manage neonatal tuberculosis. J Perinatol. 2016 Resumen
- Nahid P, Dorman SE, Alipanah N, Barry PM, Brozek JL, Cattamanchi A, Chaisson LH, Chaisson RE, Daley CL, Grzemska M, Higashi JM, Ho CS, Hopewell PC, Keshavjee SA, Lienhardt C, Menzies R, Merrifield C, Narita M, O'Brien R, Peloquin CA, Raftery A, Saukkonen J, et al. Official American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of America Clinical Practice Guidelines: Treatment of Drug-Susceptible Tuberculosis. Clin Infect Dis. 2016 Oct 1;63(7):e147-e195. Resumen Texto completo (enlace a fuente original)
- Baquero-Artigao F, Mellado Peña MJ, del Rosal Rabes T, Noguera Julián A, Goncé Mellgren A, de la Calle Fernández-Miranda M, Navarro Gómez ML; Working Group on gestational, congenital, and postnatal tuberculosis, Spanish Society of Pediatric Infectious Diseases (PFIC). Guía de la Sociedad Española de Infectología Pediátrica sobre tuberculosis en la embarazada y el recién nacido (ii): profilaxis y tratamiento. [Spanish Society for Pediatric Infectious Diseases guidelines on tuberculosis in pregnant women and neonates (ii): Prophylaxis and treatment]. An Pediatr (Barc). 2015 Resumen Texto completo (enlace a fuente original) Texto completo (en nuestros servidores)
- Mittal H, Das S, Faridi MM. Management of newborn infant born to mother suffering from tuberculosis: current recommendations & gaps in knowledge. Indian J Med Res. 2014 Resumen Texto completo (enlace a fuente original) Texto completo (en nuestros servidores)
- Peters C, Nienhaus A. [Case report--tuberculosis in a health care worker during pregnancy]. Pneumologie. 2008 Resumen
- Singh N, Golani A, Patel Z, Maitra A. Transfer of isoniazid from circulation to breast milk in lactating women on chronic therapy for tuberculosis. Br J Clin Pharmacol. 2008 Resumen Texto completo (enlace a fuente original) Texto completo (en nuestros servidores)
- Keskin N, Yilmaz S. Pregnancy and tuberculosis: to assess tuberculosis cases in pregnancy in a developing region retrospectively and two case reports. Arch Gynecol Obstet. 2008 Nov;278(5):451-5. Resumen
- WHO: World Health Organization Stop TB Partnership Childhood TB Subgroup. Chapter 4: childhood contact screening and management. Int J Tuberc Lung Dis. 2007 Resumen Texto completo (en nuestros servidores)
- Steichen O, Martinez-Almoyna L, De Broucker T. [Isoniazid induced neuropathy: consider prevention]. Rev Mal Respir. 2006 Resumen
- Schram AJ, Holm JP, van Altena R. [Two pregnant immigrant women with tuberculous peritonitis]. Ned Tijdschr Geneeskd. 2005 Resumen
- Drobac PC, del Castillo H, Sweetland A, Anca G, Joseph JK, Furin J, Shin S. Treatment of multidrug-resistant tuberculosis during pregnancy: long-term follow-up of 6 children with intrauterine exposure to second-line agents. Clin Infect Dis. 2005 Jun 1;40(11):1689-92. Epub 2005 Apr 18. Resumen Texto completo (enlace a fuente original) Texto completo (en nuestros servidores)
- CDC. (American Thoracic Society); CDC; Infectious Diseases Society of America. Treatment of tuberculosis. MMWR Recomm Rep. 2003 Resumen Texto completo (enlace a fuente original) Texto completo (en nuestros servidores)
- ATS. Blumberg HM, Burman WJ, Chaisson RE, Daley CL, Etkind SC, Friedman LN, Fujiwara P, Grzemska M, Hopewell PC, Iseman MD, Jasmer RM, Koppaka V, Menzies RI, O'Brien RJ, Reves RR, Reichman LB, Simone PM, Starke JR, Vernon AA; American Thoracic Society, Centers for Disease Control and Prevention and the Infectious Diseases Society. American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of America: treatment of tuberculosis. Am J Respir Crit Care Med. 2003 Resumen Texto completo (enlace a fuente original) Texto completo (en nuestros servidores)
- WHO / UNICEF. BREASTFEEDING AND MATERNAL MEDICATION Recommendations for Drugs in the Eleventh WHO Model List of Essential Drugs. Department of Child and Adolescent Health and Development (WHO/UNICEF) 2002 Resumen Texto completo (enlace a fuente original) Texto completo (en nuestros servidores)
- AAP - American Academy of Pediatrics Committee on Drugs. Transfer of drugs and other chemicals into human milk. Pediatrics. 2001 Sep;108(3):776-89. Resumen Texto completo (enlace a fuente original) Texto completo (en nuestros servidores)
- Tran JH, Montakantikul P. The safety of antituberculosis medications during breastfeeding. J Hum Lact. 1998 Dec;14(4):337-40. Review. Resumen
- Toddywalla VS, Patel SB, Betrabet SS, Kulkarni RD, Kombo I, Saxena BN. Can chronic maternal drug therapy alter the nursing infant's hepatic drug metabolizing enzyme pattern? J Clin Pharmacol. 1995 Oct;35(10):1025-9. Resumen
- Dautzenberg B, Grosset J. [Tuberculosis and pregnancy]. Rev Mal Respir. 1988 Resumen
- Snider DE Jr, Powell KE. Should women taking antituberculosis drugs breast-feed? Arch Intern Med. 1984 Resumen
- Gsellman RM. Isoniazid and the nursing mother. Am Fam Physician. 1982 Resumen
- RICCI G, COPAITICH T. [Elimination of orally administered isoniazid in human milk]. Rass Clin Ter. 1954 Oct-Dec;53(4):209-14. Italian. No abstract available. Resumen
- LASS A, BUNGER P. [Studies on the diffusion of isoniazid in the fetal circulation, the amniotic fluid and human milk]. Klin Wochenschr. 1953 Jul 1;31(25-26):606-8. Undetermined Language. No abstract available. Resumen