Fluoxetina, cloridrato de

Nome original: Fluoxetina, hidrocloruro de

Compatibilidade

Compatibilidade provável

Bastante seguro

Bastante seguro. Efeitos adversos leves ou pouco prováveis. Compatível em determinadas circunstâncias. Acompanhamento recomendado. Leia o Comentário.

Leia o comentário completo: o nível resume o risco, mas não substitui contexto clínico, dose, idade do bebê ou orientação profissional.

Outros nomes
Φλουοξετίνη υδροχλωρική, Флуоксетина Гидрохлорид, 塩酸フルオキセチン, N06AB03
Marcas comerciais
Actan, Adofen, Alental, Animex-On, Anisimol, Aniup, Aprinol, Astrin… Ver todas as 56
Procedência
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Comentário

É um antidepressivo inibidor seletivo da recaptação de serotonina (ISRS). É utilizado para o tratamento da depressão, do transtorno de ansiedade generalizada, do transtorno obsessivo-compulsivo, dos transtornos de pânico com ou sem agorafobia, da fobia social e do transtorno de estresse pós-traumático, assim como para o tratamento da bulimia nervosa e do transtorno disfórico pré-menstrual. Seu metabólito ativo é a norfluoxetina (Martindale, Larsen 2015). Administração oral em uma dose ao dia. É excretada no leite materno em pequena quantidade, com dose relativa (DR) < 7% (Lopes 2018, Weisskopf 2017, Salazar 2016, Tanoshima 2014, Kim 2006, Oberlander 2005, Berle 2004, Heikkinen 2003, Suri 2002, Hendrick 2001, Kristensen 1999, Yoshida 1998, Burch 1992, Isenberg 1990), embora em um trabalho tenham sido encontradas doses relativas (DR) de 13 e 20% (Pogliani 2019) e, em geral, sua DR seja maior que a de outros antidepressivos ISRS (Pogliani 2019, Sriraman 2015, Sachs 2013, Taddio 1996, Nordeng 2001). Os níveis plasmáticos de lactentes cujas mães tomavam fluoxetina foram de 3% a 10% dos níveis plasmáticos maternos (Kim 2006, Oberlander 2005, Weissman 2004, Epperson 2003, Hendrick 2001, Hale 2001, Birnbaum 1999, Brent 1998, Yoshida 1998, Lester 1993). Um lactente de mãe que tomava fluoxetina durante a gravidez e a amamentação tinha níveis plasmáticos de norfluoxetina de 38% dos da mãe aos 15 dias de vida; posteriormente baixaram para 6,5% aos dois meses de vida (Heikkinen 2003). Foram descritos casos ocasionais de cólica, irritabilidade, insônia ou sonolência, anorexia e menor ganho de peso (Hale 2001, Kristensen 1999, Chambers 1999, Lester 1993), mas na maioria das publicações não foram observados problemas, especialmente fora do período neonatal (Taddio 1996). Há muitos casos publicados sem efeitos adversos no peso ou no desenvolvimento neurológico dos lactentes, nem a curto nem a longo prazo (Heinonen 2025, Pogliani 2019, Gashlin 2016, Berle 2004, Epperson 2003, Heikkinen 2003, Hendrick 2003 e 2001, Nulman 2002 e 1996, Birnbaum 1999, Yoshida 1998). Pode haver problemas de adaptação durante o período neonatal imediato, de hiperestimulação de serotonina ou síndrome de abstinência em recém-nascidos a termo ou prematuros que nascem com níveis plasmáticos altos porque suas mães tomam fluoxetina durante a gravidez (Cantin 2024, Keymer 2023, Kieviet 2015, Morris 2015, Hale 2010, Nordeng 2001). A adaptação neonatal é pior quando os lactentes não são amamentados (Kieviet 2015). A fluoxetina, como outros antidepressivos, pode causar problemas de galactorreia e/ou hiperprolactinemia (Suthar 2018, Kaba 2017, Trenque 2011, Papakostas 2006, Peterson 2001, Egberts 1997, Arya 1995). Diversas sociedades médicas e consensos de especialistas consideram seguro o uso desta medicação durante a amamentação (Hale, Lactmed, Uguz 2021, Amir 2011, Berle 2011, Lanza 2009, ABM 2008, Pomp 2001). Podem ser preferíveis alternativas conhecidas mais seguras durante a amamentação, especialmente durante o período neonatal e em caso de prematuridade (Larsen 2015, Davanzo 2011, Patil 2011, Gentile 2005, Rubin 2004, Weissman 2004, Gjerdingen 2003, Wisner 2002, Nordeng 2001, Wisner 1996). As mulheres com depressão durante a gravidez precisam de mais apoio à amamentação, por terem maior risco de problemas e de interrupção precoce da amamentação (Grzeskowiak 2018, Leggett 2017, Venkatesh 2017, Gorman 2012). Consulte abaixo a informação deste produto relacionado: Depressão Materna (Produto seguro e/ou a amamentação é a melhor opção.)

Outros nomes e marcas

Sinônimos e grafias 4
  • Φλουοξετίνη υδροχλωρική
  • Флуоксетина Гидрохлорид
  • 塩酸フルオキセチン
  • N06AB03
Marcas comerciais na fonte 56
  • Actan
  • Adofen
  • Alental
  • Animex-On
  • Anisimol
  • Aniup
  • Aprinol
  • Astrin
  • Auroken
  • Auscap
  • Axtin
  • Daforin
  • Deprozin
  • Digassim
  • Dominium (Chile)
  • F-Exina
  • Farmaxetina
  • Florexal
  • Fluctin
  • Fluctine
  • Fluneurin
  • Fluox
  • Fluox-Purem
  • Fluoxac
  • Fluxen (Флуксен)
  • Fluxene
  • Fluxet
  • Fontex
  • Indozul
  • Lebensart
  • Livertox
  • Lovan
  • Luramon
  • Luzati
  • Nodepe
  • Ovisen
  • Pisaurit
  • Prodep (Продеп)
  • Prozac
  • Prozen
  • Psipax
  • Quanilene
  • Regultron
  • Reneuron
  • Salipax
  • Siquial
  • Sostac
  • Symbyax
  • Teczac
  • Tuneluz
  • Ulmely
  • Ultiflox
  • Verotina
  • Zactin
  • Zatin
  • Zyfloxin

Farmacocinética

VariávelValorUnidade
Biodisp. oral100%
Peso Molecular346daltons
Unión proteínas94,5%
Vd2,6l/Kg
Tmax6 - 8horas
144horas
Índice L/P0,3 - 0,9-
Dosis Teórica0,01 - 0,06mg/Kg/d
Dosis Relativa3 - 20,0%

Bibliografia

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  2. Royal Pharmaceutical Society. Martindale: The Complete Drug Reference Medicines Complete. available online from: https://www.medicinescomplete.com 2026 Resumen
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  4. Cantin C, Li W, Snelgrove-Clarke E, Corsi D, Dennis CL, Ross-White A, Brogly S, Gaudet L. Neonates With In-Utero SSRI Exposure (NeoWISE): a retrospective cohort study examining the effect of newborn feeding method on newborn withdrawal. Int J Popul Data Sci. 2024 Dec 10;9(2):2458. Resumen Texto completo (enlace a fuente original)
  5. Keymer NI, Phakey A, Bradberry SM, et al. Fluoxetine toxicity in a neonate due to maternal exposure with apparent improvement on cessation of breastfeeding. Clin Toxicol 2023;61 (Suppl 1):112. Abstract 235. Texto completo (enlace a fuente original)
  6. Uguz F. A New Safety Scoring System for the Use of Psychotropic Drugs During Lactation. Am J Ther. 2021 Jan-Feb 01;28(1):e118-e126. Resumen
  7. Pogliani L, Baldelli S, Cattaneo D, Pileri P, Clementi E, Cetin I, Zuccotti G. Selective serotonin reuptake inhibitors' passage into human milk of lactating women. J Matern Fetal Neonatal Med. 2019 Sep;32(18):3020-3025. Resumen
  8. Grzeskowiak LE, Leggett C, Costi L, Roberts CT, Amir LH. Impact of serotonin reuptake inhibitor use on breast milk supply in mothers of preterm infants: a retrospective cohort study. Br J Clin Pharmacol. 2018 Jun;84(6):1373-1379. Resumen Texto completo (enlace a fuente original)
  9. Suthar N, Pareek V, Nebhinani N, Suman DK. Galactorrhea with antidepressants: A case series. Indian J Psychiatry. 2018 Jan-Mar;60(1):145-146. Resumen
  10. Lopes BR, Cassiano NM, Carvalho DM, Moisés ECD, Cass QB. Simultaneous quantification of fluoxetine and norfluoxetine in colostrum and mature human milk using a 2-dimensional liquid chromatography-tandem mass spectrometry system. J Pharm Biomed Anal. 2018 Feb 20;150:362-367. Resumen
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  14. Weisskopf E, Panchaud A, Nguyen KA, Grosjean D, Hascoët JM, Csajka C, Eap CB, Ansermot N; collaborators of the SSRI-Breast Milk study.. Simultaneous determination of selective serotonin reuptake inhibitors and their main metabolites in human breast milk by liquid chromatography-electrospray mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci. 2017 Jul 1;1057:101-109. Resumen
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  31. Lanza di Scalea T, Wisner KL. Antidepressant medication use during breastfeeding. Clin Obstet Gynecol. 2009 Resumen Texto completo (enlace a fuente original) Texto completo (en nuestros servidores)
  32. Academy of Breastfeeding Medicine Protocol Committee. ABM clinical protocol #18: use of antidepressants in nursing mothers. Breastfeed Med. 2008 Resumen Texto completo (enlace a fuente original) Texto completo (en nuestros servidores)
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  40. Berle JØ, Steen VM, Aamo TO, Breilid H, Zahlsen K, Spigset O. Breastfeeding during maternal antidepressant treatment with serotonin reuptake inhibitors: infant exposure, clinical symptoms, and cytochrome p450 genotypes. J Clin Psychiatry. 2004 Resumen
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Como ler os níveis

  1. CompatívelSeguro, melhor opção
  2. Compatibilidade provávelBastante seguro
  3. Compatibilidade limitadaPouco seguro
  4. IncompatívelMuito inseguro

A cor ajuda a localizar o nível; o símbolo, o rótulo e o texto trazem a mesma informação.