ANALGÉSICO · OPIOIDE
Hidromorfona
Ficha de consulta para farmacia hospitalaria: indicaciones, preparación, dilución, estabilidad y compatibilidad de hidromorfona, con la fuente oficial de cada dato.
- Medicamento de alto riesgo
- Proteger de la luz
También conocido como: hydromorphone, Dilaudid
Presentación
1–4 mg/mL (Hikma, FDA) y 10 mg/mL de alta potencia (Hospira, FDA)
| Producto de referencia | Titular | Vía | Fuente |
|---|---|---|---|
| Hydromorphone Hydrochloride | Hospira, Inc. | Intramuscular, Intravenous, Subcutaneous | FDA (DailyMed) |
| Hydromorphone Hydrochloride | Hikma Pharmaceuticals USA Inc. | Intramuscular, Intravenous, Subcutaneous | FDA (DailyMed) |
¿Para qué sirve hidromorfona? Indicaciones autorizadas
1 INDICATIONS AND USAGE Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] is indicated for use in opioid-tolerant patients who require higher doses of opioids for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate. Patients considered opioid tolerant are those who are taking for one week or longer, around-the-clock medicine…
FDA (DailyMed) · Hydromorphone Hydrochloride · Indications and usage · texto original en inglésLeer la sección completa
1 INDICATIONS AND USAGE Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] is indicated for use in opioid-tolerant patients who require higher doses of opioids for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate. Patients considered opioid tolerant are those who are taking for one week or longer, around-the-clock medicine consisting of at least 60 mg oral morphine per day, or at least 25 mcg transdermal fentanyl per hour, or at least 30 mg oral oxycodone per day, or at least 8 g oral hydromorphone per day, or at least 25 mg oral oxymorphone per day, or at least 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid for one week or longer. Patients must remain on around-the-clock opioids while administering Hydromorphone Hydrochloride Injection [high potency formulation (HPF)]. Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] is an opioid agonist indicated for use in opioid-tolerant patients who require higher doses of opioids for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate. Patients considered opioid tolerant are those who are taking, for one week or longer, around-the-clock medicine consisting of at least 60 mg of oral morphine per day, at least 25 mcg/hr of transdermal fentanyl per hour, at least 30 mg of oral oxycodone per day, at least 8 mg of oral hydromorphone per day, at least 25 mg oral oxymorphone per day, at least 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid daily for a week or longer. Patients must remain on around-the-clock opioids when administering Hydromorphone Hydrochloride Injection [high potency formulation (HPF)]. Limitations of Use: Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including Hydromorphone Hydrochloride Injection [high potency formulation (HPF)], for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. ( 1 , 5.2 ) Limitations of Use: Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.2) ] , reserve opioid analgesics, including Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
1 INDICATIONS AND USAGE Hydromorphone hydrochloride injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate. Limitation of Use: Because of the risks of addiction, abuse, misuse,overdose, and death,, which can occur at any dosage or duration, and persist over the course of therapy [see WARNINGS AND PRECAUTIONS (5.2) ] , reserve…
FDA (DailyMed) · Hydromorphone Hydrochloride · Indications and usage · texto original en inglésLeer la sección completa
1 INDICATIONS AND USAGE Hydromorphone hydrochloride injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate. Limitation of Use: Because of the risks of addiction, abuse, misuse,overdose, and death,, which can occur at any dosage or duration, and persist over the course of therapy [see WARNINGS AND PRECAUTIONS (5.2) ] , reserve opioid analgesics, including hydromorphone hydrochloride injection for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Hydromorphone hydrochloride injection is an opioid agonist indicated for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate. ( 1 ) Limitations of Use: Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including hydromorphone hydrochloride injection, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. ( 1 , 5.1 )
Contraindicaciones de hidromorfona
4 CONTRAINDICATIONS Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] is contraindicated in patients with: • Significant respiratory depression [see Warnings and Precautions (5.3) ] • Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions (5.7) ] • Known or suspected gastrointestinal obstruction, including paralytic…
FDA (DailyMed) · Hydromorphone Hydrochloride · Contraindications · texto original en inglésLeer la sección completa
4 CONTRAINDICATIONS Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] is contraindicated in patients with: • Significant respiratory depression [see Warnings and Precautions (5.3) ] • Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions (5.7) ] • Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions (5.11) ] • Hypersensitivity to hydromorphone, hydromorphone salts, or any other components of the product (e.g., anaphylaxis) [see Adverse Reactions (6) ] . Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] is contraindicated in patients who are not opioid tolerant [see Warnings and Precautions (5.1) ] . • Significant respiratory depression. ( 4 ) • Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment. ( 4 ) • Known or suspected gastrointestinal obstruction, including paralytic ileus. ( 4 ) • Known hypersensitivity to hydromorphone, hydromorphone salts, or any other components of the product. ( 4 ) • Hydromorphone Hydrochloride Injection [high potency formulation (HPF)]: Patients who are not opioid tolerant. ( 4 )
4 CONTRAINDICATIONS Hydromorphone hydrochloride injection is contraindicated in patients with: Significant respiratory depression [see Warnings and Precautions (5.2) ] Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions (5.6) ] Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions (5.10) ] Hypersensitivity to hydromorphone, hydromorphone salts, any other components of the product (e.g., anaphylaxis) Significant respiratory depression. ( 4 ) Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment. ( 4 ) Known or suspected gastrointestinal obstruction, including paralytic ileus. ( 4 ) Known hypersensitivity to hydromorphone, hydromorphone salts, or any other components of the product. ( 4 )
FDA (DailyMed) · Hydromorphone Hydrochloride · Contraindications · texto original en inglés
Ajuste en insuficiencia renal
( 2.3 ) • Renal Impairment: Initiate treatment with one-fourth to one-half the usual starting dose, depending on degree of renal impairment.
FDA (DailyMed) · Hydromorphone Hydrochloride · Dosage and administration · texto original en inglés
Base the starting dose for Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] on the prior dose of Hydromorphone Hydrochloride Injection or on the prior dose of an alternate opioid. 2.3 Dosage Modifications in Patients With Hepatic Impairment Start patients with hepatic impairment on one-fourth to one-half the usual Hydromorphone Hydrochloride Injection starting dose depending on the extent of…
FDA (DailyMed) · Hydromorphone Hydrochloride · Dosage and administration · texto original en inglésLeer la sección completa
Base the starting dose for Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] on the prior dose of Hydromorphone Hydrochloride Injection or on the prior dose of an alternate opioid. 2.3 Dosage Modifications in Patients With Hepatic Impairment Start patients with hepatic impairment on one-fourth to one-half the usual Hydromorphone Hydrochloride Injection starting dose depending on the extent of impairment [see Clinical Pharmacology (12.3) ] . 2.4 Dosage Modifications in Patients With Renal Impairment Start patients with renal impairment on one-fourth to one-half the usual Hydromorphone Hydrochloride Injection starting dose depending on the degree of impairment [see Clinical Pharmacology (12.3) ] . 2.5 Titration and Maintenance of Therapy Titrate the dose based upon the individual patient’s response to their initial dose of Hydromorphone Hydrochloride Injection [high potency formulation (HPF)].
In general, use caution when selecting a dosage for an elderly patient, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy.
FDA (DailyMed) · Hydromorphone Hydrochloride · Use in specific populations · texto original en inglés
Hydromorphone is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. 8.6 Hepatic Impairment The pharmacokinetics of hydromorphone are affected by hepatic impairment.
FDA (DailyMed) · Hydromorphone Hydrochloride · Use in specific populations · texto original en inglés
A further increase in C max and AUC of hydromorphone in this group is expected and should be taken into consideration when selecting a starting dose [see Clinical Pharmacology (12.3 )] . 8.7 Renal Impairment The pharmacokinetics of hydromorphone are affected by renal impairment. Start patients with renal impairment on one-fourth to one-half the usual starting dose depending on the degree of impairment. Patients with renal impairment should be closely monitored during dose titration [see Clinical Pharmacology (12.3) ] .
FDA (DailyMed) · Hydromorphone Hydrochloride · Use in specific populations · texto original en inglés
( 2.3 ) Renal Impairment: Initiate treatment with one-fourth to one-half the usual starting dose, depending on degree of renal impairment.
FDA (DailyMed) · Hydromorphone Hydrochloride · Dosage and administration · texto original en inglés
Titrate the dose according to the patient's response. 2.3 Dosage Modifications in Patients with Hepatic Impairment Start patients with hepatic impairment on one-fourth to one-half the usual hydromorphone hydrochloride injection starting dose depending on the extent of impairment [see Clinical Pharmacology (12.3) ] . 2.4 Dosage Modifications in Patients with Renal Impairment Start patients with renal impairment on one-fourth to one-half the usual hydromorphone hydrochloride injection starting dose depending on the degree of impairment [see Clinical Pharmacology (12.3) ]. 2.5 Titration and Maintenance of Therapy Titrate the dose based upon the individual patient’s response to their initial dose of hydromorphone hydrochloride injection.
FDA (DailyMed) · Hydromorphone Hydrochloride · Dosage and administration · texto original en inglés
In general, use caution when selecting a dosage for an elderly patient, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy.
FDA (DailyMed) · Hydromorphone Hydrochloride · Use in specific populations · texto original en inglés
Hydromorphone is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. 8.6 Hepatic Impairment The pharmacokinetics of hydromorphone are affected by hepatic impairment.
FDA (DailyMed) · Hydromorphone Hydrochloride · Use in specific populations · texto original en inglés
A further increase in C max and AUC of hydromorphone in this group is expected and should be taken into consideration when selecting a starting dose [see Clinical Pharmacology (12.3) ]. 8.7 Renal Impairment The pharmacokinetics of hydromorphone are affected by renal impairment. Start patients with renal impairment on one-fourth to one-half the usual starting dose depending on the degree of impairment. Patients with renal impairment should be closely monitored during dose titration [see Clinical Pharmacology (12.3) ].
FDA (DailyMed) · Hydromorphone Hydrochloride · Use in specific populations · texto original en inglés
Ajuste en insuficiencia hepática
( 2.2 ) • Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] is for opioid-tolerant patients only and should be used only if the amount of hydromorphone required can be delivered accurately with this formulation. ( 2.2 ) • Hepatic Impairment: Initiate treatment with one-fourth to one-half the usual starting dose, depending on degree of hepatic impairment.
FDA (DailyMed) · Hydromorphone Hydrochloride · Dosage and administration · texto original en inglés
Because of its high concentration, the delivery of precise doses of Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] may be difficult if low doses of hydromorphone are required. Therefore, use Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] only if the amount of hydromorphone required can be delivered accurately with this formulation. Base the starting dose for…
FDA (DailyMed) · Hydromorphone Hydrochloride · Dosage and administration · texto original en inglésLeer la sección completa
Because of its high concentration, the delivery of precise doses of Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] may be difficult if low doses of hydromorphone are required. Therefore, use Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] only if the amount of hydromorphone required can be delivered accurately with this formulation. Base the starting dose for Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] on the prior dose of Hydromorphone Hydrochloride Injection or on the prior dose of an alternate opioid. 2.3 Dosage Modifications in Patients With Hepatic Impairment Start patients with hepatic impairment on one-fourth to one-half the usual Hydromorphone Hydrochloride Injection starting dose depending on the extent of impairment [see Clinical Pharmacology (12.3) ] . 2.4 Dosage Modifications in Patients With Renal Impairment Start patients with renal impairment on one-fourth to one-half the usual Hydromorphone Hydrochloride Injection starting dose depending on the degree of impairment [see Clinical Pharmacology (12.3) ] . 2.5 Titration and Maintenance of Therapy Titrate the dose based upon the individual patient’s response to their initial dose of Hydromorphone Hydrochloride Injection [high potency formulation (HPF)].
Labor or Delivery Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates.
FDA (DailyMed) · Hydromorphone Hydrochloride · Use in specific populations · texto original en inglés
In general, use caution when selecting a dosage for an elderly patient, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy.
FDA (DailyMed) · Hydromorphone Hydrochloride · Use in specific populations · texto original en inglés
Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. 8.6 Hepatic Impairment The pharmacokinetics of hydromorphone are affected by hepatic impairment. Due to increased exposure of hydromorphone, patients with moderate hepatic impairment should be started at one-fourth to one-half the recommended starting dose depending on the degree of hepatic dysfunction and closely monitored during dose titration. The pharmacokinetics of hydromorphone in patients with severe hepatic impairment has not been studied.
FDA (DailyMed) · Hydromorphone Hydrochloride · Use in specific populations · texto original en inglés
( 2.2 ) Hepatic Impairment: Initiate treatment with one-fourth to one-half the usual starting dose, depending on degree of hepatic impairment.
FDA (DailyMed) · Hydromorphone Hydrochloride · Dosage and administration · texto original en inglés
Titrate the dose according to the patient's response. 2.3 Dosage Modifications in Patients with Hepatic Impairment Start patients with hepatic impairment on one-fourth to one-half the usual hydromorphone hydrochloride injection starting dose depending on the extent of impairment [see Clinical Pharmacology (12.3) ] . 2.4 Dosage Modifications in Patients with Renal Impairment Start patients with renal impairment on one-fourth to one-half the usual hydromorphone hydrochloride injection starting dose depending on the degree of impairment [see Clinical Pharmacology (12.3) ]. 2.5 Titration and Maintenance of Therapy Titrate the dose based upon the individual patient’s response to their initial dose of hydromorphone hydrochloride injection.
FDA (DailyMed) · Hydromorphone Hydrochloride · Dosage and administration · texto original en inglés
Labor or Delivery Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates.
FDA (DailyMed) · Hydromorphone Hydrochloride · Use in specific populations · texto original en inglés
In general, use caution when selecting a dosage for an elderly patient, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy.
FDA (DailyMed) · Hydromorphone Hydrochloride · Use in specific populations · texto original en inglés
Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. 8.6 Hepatic Impairment The pharmacokinetics of hydromorphone are affected by hepatic impairment. Due to increased exposure of hydromorphone, patients with moderate hepatic impairment should be started at one-fourth to one-half the recommended starting dose depending on the degree of hepatic dysfunction and closely monitored during dose titration. The pharmacokinetics of hydromorphone in patients with severe hepatic impairment has not been studied.
FDA (DailyMed) · Hydromorphone Hydrochloride · Use in specific populations · texto original en inglés
Reconstitución de hidromorfona
No requiere.
Dilución de hidromorfona
Compatible con la mayoría de las soluciones de gran volumen.
Administración de hidromorfona
IV lenta (2–3 min), SC, IM o infusión/PCA.
Estabilidad y periodo de validez
| Condición | Tiempo | Nota |
|---|---|---|
| Diluida en soluciones de gran volumen, 25 °C, protegida de la luz | 24 h | Ambas etiquetas. |
Compatibilidad de hidromorfona
Compatible con
- SF 0.9%
- Glucosa 5%
Conservación y protección de la luz
A 20–25 °C.
PROTEGER DE LA LUZ. La estabilidad de 24 h en soluciones de gran volumen se demostró protegida de la luz.
Advertencias
- MEDICAMENTO DE ALTO RIESGO: unas 5 veces más potente que la morfina. Confusión hidromorfona/morfina y presentaciones HP (10 mg/mL) causan muertes.
- Una coloración amarillenta leve es aceptable.
Fuentes
- FDA (DailyMed) · Hydromorphone HydrochlorideHospira, Inc. · Hidromorfona HPF (alta potencia, 10 mg/mL) — Hospira · versión 2026-04-21
- FDA (DailyMed) · Hydromorphone Hydrochloride InjectionHikma Pharmaceuticals USA Inc. · 1, 2 y 4 mg/mL · versión 2026-07-24
Interacciones de hidromorfona
2 medicamentos del catálogo con una interacción documentada en sus fichas oficiales. Abre cada una para ver el efecto, la recomendación y su fuente.
Diagnósticos relacionados
Diagnósticos que la ficha técnica de hidromorfona menciona en sus indicaciones. Cada uno abre su definición y los demás medicamentos indicados.
Identificación
- SNOMED CT (VTM)
- 414428000
- RxNorm
- 3423
Información de consulta profesional extraída de las fichas técnicas y etiquetas oficiales citadas. Las condiciones de preparación, estabilidad y administración dependen del producto concreto: verifica el documento del producto que utilizas. No sustituye el criterio clínico ni la valoración del paciente.