First-generation antipsychotics. Butyrophenone derivatives
Código ATC: N05AD01 (Haloperidol)
Marcas comerciales
Haldol, Haldol Decanoate, Serenace
Potent D2 receptor antagonist in mesolimbic, mesocortical, and nigrostriatal tracts. Controls positive psychosis symptoms and acute agitation. High risk of extrapyramidal side effects, neuroleptic malignant syndrome, and QT prolongation.
Primera línea
Parenteral haloperidol (IM 2.5–10 mg) is used for acute agitation in psychotic, manic, or toxicological states. Onset 20–40 minutes. 2020 and Russian clinical guidelines support this approach. May be combined with lorazepam or midazolam for additional sedation.
Assess QT interval and potassium/magnesium levels before administration, especially before repeat dosing.
Primera línea
Haloperidol is used in schizophrenia for acute positive symptom control and maintenance therapy. 2020 and CG178 list haloperidol as a standard first-generation antipsychotic; current guidelines favor atypical antipsychotics as first-line due to a more favorable side-effect profile, but haloperidol retains its role when parenteral administration is required and in resource-limited settings. The decanoate form provides a 4-week depot effect for patients with poor adherence.
High risk of extrapyramidal symptoms and tardive dyskinesia with long-term therapy. Not first-line in elderly patients with dementia.
Sources
Decisión individual
Low-dose haloperidol (0.5–2 mg orally or IM) is used for symptomatic management of delirium with severe agitation, psychotic features, or risk of self-harm. A 2018 Cochrane systematic review showed no advantage of antipsychotics over placebo for delirium duration or mortality. Use is individual and time-limited.
Halve the dose in elderly patients. Benzodiazepines (except alcohol withdrawal delirium) worsen delirium and are not used as monotherapy.
No recomendado
In elderly patients with dementia, antipsychotics are used only for severe aggression or psychotic features with risk of harm. The boxed warning (2008) and notice (2011) cite a 1.6–1.7-fold increased mortality risk with antipsychotics in elderly dementia. and Beers Criteria 2023 recommend avoiding routine use, employing minimal doses and short courses (no more than 6–12 weeks) with regular discontinuation attempts.
Use only after failure of non-pharmacological approaches and careful benefit-risk assessment. Family informed consent is mandatory.
No recomendado
In non-psychotic patients haloperidol is not used for anxiety or insomnia. International guidelines ( CG113, ) treat anxiety with SSRIs, SNRIs, CBT; benzodiazepines short-term only. Antipsychotic use for anxiety carries risks of extrapyramidal effects and QT prolongation without proven benefit.
Grapefruit juice inhibits intestinal CYP3A4, increasing haloperidol plasma concentrations. May potentiate sedation and QT prolongation. Patients are advised to avoid regular grapefruit and grapefruit juice consumption during therapy.
Fuente: FDA: Haldol (haloperidol) prescribing information (2024)
1 par encontrado. Ordenadas de críticas a menores.
Mecanismo
Аддитивное удлинение QT + ингибиция CYP3A4 повышает концентрацию галоперидола.
Manejo
ЭКГ-контроль исходно и через 48 часов. У пожилых и при сердечной патологии – избегать.
Importante
Resumen breve de la ficha técnica oficial. No sustituye el texto completo ni la consulta médica. Ficha del 09/07/2020. Fuente: AEMPS.
Pacientes adultos de 18 años de edad y mayores Tratamiento de la esquizofrenia y el trastorno esquizoafectivo. Tratamiento urgente del síndrome confusional que no responde a terapias no farmacológicas. Tratamiento de los episodios maníacos moderados o graves asociados al trastorno bipolar I. Tratamiento de la agitación psicomotora aguda asociada a trastornos psicóticos o episodios maníacos del trastorno bipolar I. Tratamiento de la agresividad persistente y los síntomas psicóticos en pacientes con demencia de Alzheimer moderada o grave y demencia vascular que no responde a tratamientos no farmacológicos y cuando hay riesgo de que el paciente se dañe a sí mismo o a otros. Tratamiento de los trastornos de tics, incluido el síndrome de Gilles de la Tourette, en pacientes menores de 65 años gravemente afectados que no han respondido a los tratamientos educacionales, psicológicos o farmacológicos de otro tipo. Tratamiento de la corea de Huntington leve o moderada, cuando otros medicamentos resultan ineficaces o no se toleran. Pacientes pediátricos Tratamiento de: Esquizofrenia en adolescentes de 13 a 17 años cuando otros tratamientos farmacológicos resultan ineficaces o no se toleran.…
Hipersensibilidad al principio activo o a alguno de los excipientes incluidos en la sección 6.1. Estado comatoso. Depresión del sistema nervioso central (SNC) Enfermedad de Parkinson. Demencia con cuerpos de Lewy. Parálisis supranuclear progresiva. Antecedentes de prolongación del intervalo QTc o síndrome del QT largo congénito. Infarto de miocardio reciente. Insuficiencia cardíaca descompensada. Antecedentes de arritmia ventricular o torsade de pointes. Hipopotasemia no corregida Tratamiento concomitante con medicamentos que prolongan el intervalo QT (ver sección 4.5)
Advertencia destacada
FDA boxed warning: increased mortality in elderly patients with dementia-related psychosis treated with antipsychotics. Haloperidol is not FDA-approved for dementia-related psychosis. An additional warning concerns sudden death, QT prolongation, and torsades de pointes with intravenous use and high doses.
haloperidol is evaluated for the following indications with varying evidence strength: Acute psychomotor agitation (evidence tier A), Schizophrenia (evidence tier A), Delirium (evidence tier B). See the full indication matrix with dosing and citations above on this page.
Common side effects of haloperidol (≥ 1 in 100): Extrapyramidal symptoms: akathisia, parkinsonism, acute dystonia, Sedation, somnolence, Dry mouth, constipation, Orthostatic hypotension, Hyperprolactinemia with galactorrhea and menstrual disturbances. See the Safety section for uncommon and serious reactions.
FDA category C. FDA category C. Third-trimester use is associated with extrapyramidal and withdrawal symptoms in the newborn. Used only when safer alternatives are unavailable and benefit outweighs risk. Decision made jointly with psychiatrist and obstetrician.
Passes into breast milk in small amounts. LactMed classifies as having limited data; if used during lactation, monitor the infant for sedation and extrapyramidal symptoms.
haloperidol is contraindicated in: Hypersensitivity to haloperidol; Coma of any cause; CNS depression (alcohol, opioids, barbiturates); Parkinson disease and parkinsonism; Dementia with Lewy bodies. Full list in the Safety section.
4.2.1. Posología Adultos Se recomienda una dosis inicial baja, que puede ir ajustándose posteriormente de acuerdo con la respuesta del paciente. La dosis de mantenimiento debe ser siempre la mínima dosis eficaz (ver sección 5.2). Comprimidos: Las dosis recomendadas de Haloperidol Esteve comprimidos se indican en la tabla 1. Solución oral: Las dosis recomendadas de Haloperidol Esteve solución oral se indican en la tabla 1. Tabla 1: Recomendaciones posológicas de haloperidol para adultos (18 años de edad y mayores) Tratamiento de la esquizofrenia y el trastorno esquizoafectivo 2 a 10 mg/día por vía oral, en una sola dosis o en 2 dosis divididas. Los pacientes con un primer episodio de esquizofrenia responden por lo general a dosis de 2 a 4 mg/día, mientras que los pacientes que han sufrido varios episodios de esquizofrenia podrían requerir dosis de hasta 10 mg/día. Se puede ajustar la dosis cada 1 a 7 días. No se ha demostrado que dosis superiores a 10 mg/día tengan una eficacia mayor que dosis inferiores en la mayoría de los pacientes y pueden aumentar la incidencia de síntomas extrapiramidales. La relación beneficio ‑ riesgo debe ser evaluada en cada caso cuando se considere el uso de dosis superiores a 10 mg/día. La dosis máxima es de 20 mg/día, ya que los problemas de seguridad sobrepasan los beneficios clínicos del tratamiento en dosis superiores. Tratamiento urgente del síndrome confusional que no responde a terapias no farmacológicas 1 a 10 mg/día por vía oral, en una…
FDA category C. Third-trimester use is associated with extrapyramidal and withdrawal symptoms in the newborn. Used only when safer alternatives are unavailable and benefit outweighs risk. Decision made jointly with psychiatrist and obstetrician.
Passes into breast milk in small amounts. LactMed classifies as having limited data; if used during lactation, monitor the infant for sedation and extrapyramidal symptoms.
FDA boxed warning: increased mortality in elderly patients with dementia-related psychosis treated with antipsychotics. Haloperidol is not FDA-approved for dementia-related psychosis. An additional warning concerns sudden death, QT prolongation, and torsades de pointes with intravenous use and high doses.
with appropriate dosing and side-effect monitoring, the drug remains a useful psychiatric tool. Modern algorithms prefer atypicals, but haloperidol holds a niche in resource-limited settings and as IM for agitation.
risk exists, but with routine AIMS monitoring and timely dose reduction or switch to atypicals, manifestations are often reversible or minimal.
FDA boxed warning cites increased mortality; use is limited to severe cases and short courses.