Protamine Sulfate Generic Name & Formulations
Legal Class
Rx
General Description
Protamine sulfate 10mg/mL; soln for inj; preservative-free.
Pharmacological Class
Heparin antagonist.
How Supplied
Vial (5mL)—25; 25mL—1
Manufacturer
Protamine Sulfate Indications
Indications
Heparin overdose.
Protamine Sulfate Dosage and Administration
Adult
Give by slow IV inj over 10mins. Determine dose by coagulation studies; dose requirement decreases with time elapsed after heparin administration. 1mg neutralizes ≥100units of heparin; max 50mg/dose.
Children
Not recommended.
Protamine Sulfate Contraindications
Not Applicable
Protamine Sulfate Boxed Warnings
Not Applicable
Protamine Sulfate Warnings/Precautions
Warnings/Precautions
Avoid rapid administration. Fish allergy. Previous exposure to protamine (including insulin). Severe left ventricular dysfunction. Abnormal pulmonary hemodynamics. Previous vasectomy. Pregnancy (Cat.C). Nursing mothers.
Protamine Sulfate Pharmacokinetics
See Literature
Protamine Sulfate Interactions
Interactions
Incompatible with certain antibiotics (eg, cephalosporins, penicillins).
Protamine Sulfate Adverse Reactions
Adverse Reactions
Hypotension, bradycardia, transient flushing, feeling of warmth, dyspnea, GI upset, lassitude, pulmonary edema, anaphylaxis, cardiovascular collapse, pulmonary vasoconstriction, pulmonary hypertension.
Protamine Sulfate Clinical Trials
See Literature
Protamine Sulfate Note
Not Applicable
Protamine Sulfate Patient Counseling
See Literature