Generic
Protamine Sulfate
1 brands available in the market
At a glance
Protamine Sulfate is used to counteract the anticoagulant effect of heparin: before surgery, after renal dialysis, after open-heart surgery, if excessive bleeding occurs, and when an overdose has inadvertently been given.
Description
Protamine sulfate is a basic protein that binds with strongly acidic heparin to form a stable and inactive complex. This inactive complex neutralizes the anticoagulant effect of heparin and is useful for treating hemorrhage due to severe heparin or low-molecular-weight heparin overdosage.
Indications
- Counteract anticoagulant effect of heparin (before surgery)
- After renal dialysis
- After open-heart surgery
- Excessive bleeding
- Heparin overdose
Therapeutic class
Anti-coagulants, Parenteral anti-coagulants
Pharmacological class
Heparin Antidote
Pharmacology
Protamine sulfate is a basic protein that binds with strongly acidic heparin to form a stable inactive complex. This complex neutralizes the anticoagulant effect of heparin. In gross excess, protamine itself acts as an anticoagulant.
Mechanism of action
Neutralizes heparin's anticoagulant effect by binding with it.
Dosage
Adult Dose (IV):
- Heparin neutralization: 1-1.5 mg per 100 units of heparin; max 50 mg
- If >15 min since IV heparin: reduce dose: 30-60 min: 0.5-0.75 mg/100 units; ≥2 hours: 0.25-0.375 mg/100 units
- Dalteparin/Tinzaparin overdose: 1 mg per 100 units; if PTT prolonged after 4 hr, give 0.5 mg per 100 units
- Enoxaparin overdose: 1 mg per mg enoxaparin (if within 8 hr); if >8 hr or bleeding continues after 4 hr, give 0.5 mg per mg
Administration
- Administered by slow IV injection over about 10 minutes
- Administered by healthcare professional; do not self-administer
- Monitor APTT or ACT 5-15 minutes after administration
Missed dose
If you miss a dose, consult your doctor.
Side effects
Side Effects:
- Anticoagulant effect (at excess doses)
- Hypersensitivity reactions (angioedema, anaphylactoid, anaphylaxis)
- Bradycardia
- Sudden fall in blood pressure
- Pulmonary and systemic hypertension
- Dyspnea
- Nausea
- Vomiting
- Back pain
Precautions & warnings
- Too rapid administration may cause severe hypotension and anaphylactoid reactions
- Caution in patients allergic to fish, protamine insulin, vasectomy, infertility
- Monitor clotting parameters with repeated doses
- Rebound bleeding may occur up to 18 hours post-operatively
Contraindications
- Hypersensitivity to protamine sulfate
Drug interactions
- Not suitable for reversing the effects of oral anticoagulants
Food interactions
It is not known whether it is safe to consume alcohol with Protamine Sulfate.
Use in pregnancy
Use in Pregnancy: Use only if clearly indicated; caution required.
Pregnancy Category: C — always consult a doctor before taking during pregnancy.
Use in lactation
Use in Lactation: Caution required; limited information on use.
Pediatric use
Safety and efficacy not established in children; not recommended.
Geriatric use
No current evidence for alteration of recommended dose in elderly.
Renal / hepatic impairment
Renal Impairment: Safe in kidney disease; dose adjustment may not be needed; consult your doctor.
Hepatic Impairment: Safe in liver disease; dose adjustment may not be needed; consult your doctor.
Overdose effects
Overdose: Protamine itself acts as an anticoagulant when given in excess of the dose required to neutralize heparin; treatment: symptomatic supportive care.
Storage conditions
Store between 15°C and 25°C.
Chemical structure
Protamine Sulfate