Sulfato de protamina
Protamine Sulfate
Protamini sulfas
También conocido como: Prosulf · protamine sulphate · protamini sulfas · sulfato de protamina · Protamine sulfate
Revisado por el equipo veterinario de VetSheetActualizado 5 abr 2026Referencia veterinaria basada en la evidencia
Las dosis son una referencia clínica para profesionales veterinarios autorizados. Confirme siempre con el prospecto actual y cada paciente individual.
Dosis por especie
🌎 NA — North America🌍 EU — Europe
Perros
| Indicación | Dosis | Vía | Frecuencia | Duración | Región |
|---|---|---|---|---|---|
| Heparin overdosage | 1-1.5 mg protamine sulfate to antagonize each mg (100 units) of heparin via slow IV injection. Reduce dose as time increases between heparin dose and start of treatment (after 30 minutes give only 0.5 mg). | IV | Single dose | — | 🌎 NA |
| Heparin overdosage | Administer 1 mg protamine for each 100 Units of heparin to be inactivated. Decrease protamine dose by ½ for every 30 minutes that have lapsed since heparin was administered | IV | Single dose | — | 🌎 NA |
- Heparin overdosage: Give slowly.
- Heparin overdosage: May be ineffective if heparin was given deep SC. Do not give faster than 50 mg over 10 minutes.
Gatos
| Indicación | Dosis | Vía | Frecuencia | Duración | Región |
|---|---|---|---|---|---|
| Heparin overdosage | 1-1.5 mg protamine sulfate to antagonize each mg (100 units) of heparin via slow IV injection. Reduce dose as time increases between heparin dose and start of treatment (after 30 minutes give only 0.5 mg). | IV | Single dose | — | 🌎 NA |
| Heparin overdosage | Administer 1 mg protamine for each 100 Units of heparin to be inactivated. Decrease protamine dose by ½ for every 30 minutes that have lapsed since heparin was administered | IV | Single dose | — | 🌎 NA |
- Heparin overdosage: Give slowly.
- Heparin overdosage: May be ineffective if heparin was given deep SC. Do not give faster than 50 mg over 10 minutes.
Ganado
| Indicación | Dosis | Vía | Frecuencia | Duración | Región |
|---|---|---|---|---|---|
| Bracken Fern (Pteridium spp.) poisoning | 1 injection of 10 mL of 1% protamine sulfate IV | IV | Single dose | — | 🌎 NA |
- Bracken Fern (Pteridium spp.) poisoning: In combination with whole blood (2.25-4.5 L)
Las dosis son una referencia clínica para profesionales veterinarios autorizados. Confirme siempre con el prospecto actual y cada paciente individual.
Resumen
El sulfato de protamina es una proteína catiónica simple de bajo peso molecular derivada originalmente del esperma o los testículos maduros del salmón y especies de peces relacionadas. En medicina veterinaria, se utiliza principalmente como un antídoto específico y vital para la sobredosis de heparina cuando se produce una hemorragia significativa e incontrolada.
Puntos clínicos clave:
- Heparina no fraccionada vs. HBPM: Aunque la protamina neutraliza completamente la heparina no fraccionada, solo neutraliza parcialmente la actividad anti-Xa de las heparinas de bajo peso molecular (HBPM) como la dalteparina o la enoxaparina. Sin embargo, sigue mejorando la hemorragia microvascular en casos de sobredosis de HBPM.
- Usos alternativos: Se ha sugerido como tratamiento coadyuvante para la toxicidad por helecho águila (Pteridium spp.) en rumiantes.
Perla clínica: Debido a que la protamina es una proteína extraña, son posibles las reacciones de hipersensibilidad (incluida la anafilaxia), particularmente en pacientes con exposición previa o alergias al pescado.
Mecanismo de acción
Protamine works via direct acid-base neutralization.
- Mechanism: Heparin is a strongly acidic molecule, while protamine is strongly basic.
- Pathway: Protamine → binds directly to circulating heparin → forms an inactive, stable salt complex → neutralizes heparin's anticoagulant activity.
Pharmacology Note: Protamine possesses weak intrinsic anticoagulant activity of its own. If administered in large doses without heparin present, it can theoretically interfere with coagulation, though this rarely causes clinical hemorrhage.
Seguridad y advertencias
Contraindicaciones
- Known hypersensitivity or intolerance to protamine
- Hypersensitivity to protamine
- Conditions where heparin has not been administered
Efectos adversos
- Acute hypotension (if given too rapidly)
- Bradycardia
- Pulmonary hypertension
- Dyspnea
- Hypersensitivity/Anaphylaxis
- Heparin 'rebound' effect (bleeding hours after neutralization)
- Anaphylactoid reactions
- Paradoxical bleeding (at high doses)
Precauciones
Administration Warnings
- Rate of Injection: Must be administered via slow IV injection (over 1-3 minutes). Rapid IV injection can cause severe acute hypotension, bradycardia, pulmonary hypertension, and dyspnea. Do not exceed a rate of 50 mg over a 10-minute period.
- Heparin Rebound: A 'rebound' effect may occur where anticoagulation and bleeding resume several hours after apparent neutralization. This is likely due to the release of heparin from extravascular compartments or degradation of the protamine-heparin complex by fibrinolysin.
- Pregnancy: FDA Category C. Use only if clearly needed.
Interacciones farmacológicas
Forms a stable salt, causing the loss of anticoagulant activity of both compounds (therapeutic intent).
Monitorización
- Coagulation parameters (e.g., aPTT, ACT) to assess heparin neutralization
- Blood pressure (monitor for hypotension during administration)
- Heart rate and rhythm (monitor for bradycardia)
- Respiratory rate and effort
- Signs of recurrent bleeding (heparin rebound effect) for several hours post-administration
- Coagulation times (aPTT, ACT)
- Signs of anaphylaxis during administration
Farmacocinética
Vida media
Absorción
Binds to heparin within 5 minutes after IV injection.
Distribución
Forms a complex with heparin in the intravascular space.
Metabolismo
The exact metabolic fate is unknown, but evidence suggests the heparin-protamine complex is partially metabolized and/or degraded by fibrinolysin, which can free previously bound heparin.
Eliminación
Clearance mechanisms are not fully defined, but degradation of the complex can lead to a clinical 'rebound' effect.
Sobredosis
Because protamine has inherent, albeit weak, anticoagulant activity, massive overdoses could theoretically result in hemorrhage.
However, clinical data in humans suggests that significant overdoses (600-800 mg) typically result in only mild, transient effects on coagulation. The LD50 of protamine in mice is reported to be 100 mg/kg. Treatment of overdose should be supportive.
Productos disponibles
Formulaciones
- Injection: 10 mg/mL
- 10 mg/ml injectable solution
Etiquetado para humanos
- Protamine Sulfate Injection: 10 mg/mL preservative-free in 5 mL and 25 mL vials
- Protamine sulphate 10 mg/ml solution for injection
Estado regulador
POM (Prescription Only Medicine)
POM (Prescription Only Medicine)
Sin datos reguladores para: 🇺🇸 US · 🇭🇰 HK · 🇹🇼 TW · 🇯🇵 JP · 🇰🇷 KR · 🇦🇺 AU
Almacenamiento y estabilidad
Powder for injection: Store at room temperature (15-30°C). Liquid injection: Store in the refrigerator (2-8°C); avoid freezing (though stable at room temperature for at least 2 weeks). Reconstituted powder: Use immediately if mixed with Sterile Water for Injection, or within 72 hours if mixed with Bacteriostatic Water for Injection. Compatible with D5W, normal saline, cimetidine, and verapamil.
Información para el cliente
Información importante para los propietarios de mascotas
- Solo para uso de emergencia: El sulfato de protamina es un medicamento de rescate especializado que se utiliza exclusivamente en un entorno hospitalario para tratar hemorragias graves causadas por una sobredosis de heparina.
- Monitoreo intensivo: Su mascota será monitoreada de cerca en la UCI mientras recibe este medicamento, ya que puede causar caídas repentinas en la presión arterial o la frecuencia cardíaca si se administra demasiado rápido.
- Hemorragia de rebote: Incluso después de un tratamiento exitoso, su mascota deberá ser observada durante varias horas, ya que los efectos hemorrágicos de la heparina a veces pueden tener un efecto de 'rebote' y reaparecer.
La referencia de medicamentos de VetSheet está destinada a profesionales veterinarios autorizados como ayuda para la toma de decisiones clínicas, no como sustituto del criterio profesional ni del prospecto actual del fabricante.