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protamine sulfate
generic
Black Box Warnings .
Serious Adverse Events
severe hypotension, cardiovascular collapse, noncardiogenic pulmonary edema, catastrophic pulmonary vasoconstriction, and pulmonary HTN can occur; risk factors incl. high dose or overdose, repeat doses, prior protamine use, current or prior protamine-containing product use (NPH or protamine zinc insulin, certain beta blockers), hypersens. to fish, prior vasectomy, severe LV dysfxn, abnormal preop pulmonary hemodynamics; weigh risk/benefit in pts w/ 1 or more risk factors; vasopressors and resucitation equipment must be avail.
Appropriate Use
do not give if bleeding occurs without prior heparin use
Adult Dosing .
Dosage forms: INJ
heparin reversal
- [1-1.5 mg IV per 100 units heparin]
- Max: 50 mg/dose; 5 mg/min; Info: may adjust dose based on time from heparin admin; if 0-30min give 1-1.5 mg/100 units; if 30-60min give 0.5-0.75 mg/100 units; if >2h give 0.25-0.375 mg/100 units; may give additional 25 mg/h IV x6h to minimize heparin rebound if post-cardiac bypass
LMWH reversal (off-label)
- [<8h since last LMWH dose]
- Dose: 1 mg IV per 100 anti-Xa units LMWH; Max: 50 mg/dose; 5 mg/min; Info: may give additional 0.5 mg IV per 100 anti-Xa units LMWH if bleeding continues; protamine incompletely neutralizes LMWH effects; 1 mg enoxaparin = 100 anti-Xa units
- [>8h since last LMWH dose]
- Dose: 0.5 mg IV per 100 anti-Xa units LMWH; Max: 50 mg/dose; 5 mg/min; Info: may repeat dose x1 if bleeding continues; protamine incompletely neutralizes LMWH effects; 1 mg enoxaparin = 100 anti-Xa units
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Peds Dosing .
- Dosage forms: INJ
heparin reversal
- [1-1.5 mg IV per 100 units heparin]
- Max: 50 mg/dose; 5 mg/min; Info: may adjust dose based on time from heparin admin; if 0-30min give 1-1.5 mg/100 units; if 30-60min give 0.5-0.75 mg/100 units; if >2h give 0.25-0.375 mg/100 units; may give additional 25 mg/h IV x6h to minimize heparin rebound if post-cardiac bypass
LMWH reversal (off-label)
- [<8h since last LMWH dose]
- Dose: 1 mg IV per 100 anti-Xa units LMWH; Max: 50 mg/dose; 5 mg/min; Info: may give additional 0.5 mg IV per 100 anti-Xa units LMWH if bleeding continues; protamine incompletely neutralizes LMWH effects; 1 mg enoxaparin = 100 anti-Xa units
- [>8h since last LMWH dose]
- Dose: 0.5 mg IV per 100 anti-Xa units LMWH; Max: 50 mg/dose; 5 mg/min; Info: may repeat dose x1 if bleeding continues; protamine incompletely neutralizes LMWH effects; 1 mg enoxaparin = 100 anti-Xa units
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]