| PROTAMINE SULFATE
Classifications: antidote; Therapeutic: antidote
Pregnancy Category: C
10 mg/mL injection
Because protamine is strongly basic, it combines with strongly acidic heparin to produce a stable complex; thus anticoagulant
effect of both drugs is neutralized.
Effective antidote to heparin overdose.
Antidote for heparin overdosage (after heparin has been discontinued).
Antidote for heparin administration during extracorporeal circulation.
Hemorrhage not induced by heparin overdosage; pregnancy (category C); lactation.
Cardiovascular disease; history of allergy to fish; vasectomized or infertile males; diabetes mellitus; patients who have
received protamine-containing insulin.
Route & Dosage
|Antidote for Heparin Overdose
Adult/Child: IV 1 mg for every 100 units of heparin to be neutralized (max: 100 mg in a 2 h period), give the first 2550 mg by slow
direct IV and the rest over 23 h
Note: Titrate dose carefully to prevent excess anticoagulation because protamine has a longer half-life than heparin and also has
some anticoagulant effect of its own.
Note: Verify correct IV concentration and rate of infusion for infants or children with physician.
PREPARE: Direct: May be given as supplied direct IV. Continuous: Dilute in 50 mL or more of NS or D5W.
ADMINISTER: Direct: Give each 50 mg or fraction thereof slowly over 1015 min. NEVER give more than 50 mg in any 10 min period or 100 mg
in any 2 h period. Continuous: Do not exceed direct rate. Give over 23 h or longer as determined by coagulation studies.
INCOMPATIBILITIES Solution/additive: radiocontrast materials, furosemide.
- Store protamine sulfate injection at 15°30° C (59°86° F).
- Solutions do not contain preservatives and should not be stored.
Adverse Effects (≥1%)CV: Abrupt drop in BP
(with rapid IV
infusion), bradycardia. Body as a Whole:
Urticaria, angioedema, pulmonary
edema, anaphylaxis, dyspnea
, lassitude; transient flushing and feeling of warmth. GI:
Nausea, vomiting. Hematologic:
Protamine overdose or "heparin rebound" (hyperheparinemia).
No clinically significant interactions established.
5 min. Duration:
Assessment & Drug Effects
- Do not use protamine if only minor bleeding occurs during heparin therapy because withdrawal of heparin will usually correct
minor bleeding within a few hours.
- Monitor BP and pulse q1530min, or more often if indicated. Continue for at least 23 h after each dose, or longer
as dictated by patient's condition. Be prepared to treat patient for shock as well as hemorrhage.
- Lab tests: Monitor effect of protamine in neutralizing heparin by aPTT or ACT values. Coagulation tests are usually performed
515 min after administration of protamine, and again in 28 h if desirable.
- Observe patients undergoing extracorporeal dialysis or patients who have had cardiac surgery carefully for bleeding (heparin
rebound). Even with apparent adequate neutralization of heparin by protamine, bleeding may occur 30 min to 18 h after surgery.
Monitor vital signs closely. Additional protamine may be required in these patients.