protamine

ROUTE	ONSET	PEAK	DURATION
IV	30 sec–1 min	unknown	2 hr‡

Contraindicated in:

Hypersensitivity to protamine or fish
.

Use Cautiously in:

Patients who have received previous protamine-containing insulin or vasectomized men (↑ risk of hypersensitivity reactions)
;
OB: Safety not established in pregnancy; use during pregnancy only if clearly needed;
Lactation: Safety not established in breastfeeding; use while breastfeeding only if clearly needed.

Adv. Reactions/Side Effects ⬆ ⬇

CV: bradycardia, hypertension, hypotension

Derm: flushing

GI: nausea, vomiting

Hemat: bleeding

MS: back pain

Resp: dyspnea, pulmonary edema, pulmonary hypertension

Misc: HYPERSENSITIVITY REACTIONS(INCLUDING ANAPHYLAXIS AND ANGIOEDEMA)

Interactions ⬆ ⬇

Drug-drug:

None reported.

Route/Dosage ⬆ ⬇

IV (Adults and Children ): Heparin overdose: 1 mg of protamine/100 units of heparin. If given >30 min after heparin, give 0.5 mg of protamine/100 units of heparin (not to exceed 100 mg/2 hr). Further doses should be determined by coagulation tests. If heparin was administered subcutaneously, use 1–1.5 mg of protamine per 100 units of heparin (give 25–50 mg of the protamine dose slowly followed by a continuous infusion over 8–16 hr). Enoxaparin overdose (unlabeled use): 1 mg of protamine/1 mg of enoxaparin. Dalteparin overdose (unlabeled use): 1 mg of protamine/100 anti-Xa units of dalteparin. If required, a 2nd dose of 0.5 mg of protamine/100 anti-Xa units of dalteparin may be given 2–4 hr later if laboratory assessment indicates need.

Availability ⬆ ⬇

(Generic available)

Solution for injection: 10 mg/mL

Assessment ⬆ ⬇

Monitor for signs/symptoms of bleeding or hemorrhage during therapy (weakness, tachycardia, dyspnea, dizziness, pallor, fatigue, tarry stools, coffee ground emesis, obvious severe bleeding [bleeding gums, epistaxis, bleeding wounds]). Hemorrhage may recur 8–9 hr after therapy because of rebound effects of heparin. Rebound may occur as late as 18 hr after therapy in patients heparinized for cardiopulmonary bypass.
BP should be monitored throughout therapy for immediate recognition of hypotensive reactions.
Assess for allergy to fish (salmon) or previous reaction to or use of protamine insulin or protamine sulfate. Vasectomized men and individuals with severe left ventricular dysfunction or abnormal pulmonary hemodynamics also have higher risk of hypersensitivity reaction. Observe patient for signs and symptoms of hypersensitivity reaction (hives, edema, coughing, wheezing). Keep epinephrine, an antihistamine, and resuscitative equipment close by in the event of anaphylaxis.
Assess for hypovolemia before initiation of therapy. Failure to correct hypovolemia may result in cardiovascular collapse from peripheral vasodilating effects of protamine sulfate.

Lab Test Considerations:

Monitor clotting factors, activated clotting time (ACT), aPTT, and thrombin time (TT) 5–15 min after therapy and again as necessary.

Implementation ⬆ ⬇

Do not confuse protamine with Protonix.
Discontinue heparin infusion. In milder cases, overdose may be treated by heparin withdrawal alone.
- In severe cases, fresh frozen plasma or whole blood may also be required to control bleeding.
- Dose varies with type of heparin, route of heparin therapy, and amount of time elapsed since discontinuation of heparin.
- Do not administer >100 mg in 2 hr without rechecking clotting studies, as protamine sulfate has its own anticoagulant properties.

IV Administration:

IV Push: Diluent: May be administered undiluted. If further dilution is desired, D5W or 0.9% NaCl may be used. Concentration: 10 mg/mL.
Rate: Administer by slow IV push over 1–3 min. Rapid infusion rate may result in hypotension, bradycardia, flushing, feeling of warmth, or anaphylaxis-like reaction. If these symptoms occur, stop infusion and notify health care provider. No more than 50 mg should be administered within a 10-min period.
Y-Site Compatibility:
- acetaminophen
- amikacin
- aminophylline
- ascorbic acid
- atropine
- azathioprine
- aztreonam
- benztropine
- bumetanide
- buprenorphine
- butorphanol
- calcium chloride
- calcium gluconate
- chlorpromazine
- clindamycin
- cyanocobalamin
- cyclosporine
- digoxin
- diphenhydramine
- dobutamine
- dopamine
- doxycycline
- enalaprilat
- ephedrine
- epinephrine
- epoetin alfa
- erythromycin
- esmolol
- famotidine
- fentanyl
- fluconazole
- ganciclovir
- gentamicin
- glycopyrrolate
- imipenem/cilastatin
- isoproterenol
- labetalol
- lidocaine
- magnesium sulfate
- mannitol
- meperidine
- metoclopramide
- metoprolol
- midazolam
- morphine
- multivitamins
- nalbuphine
- naloxone
- nitroglycerin
- nitroprusside
- norepinephrine
- ondansetron
- oxytocin
- papaverine
- phentolamine
- phenylephrine
- phytonadione
- potassium chloride
- procainamide
- prochlorperazine
- promethazine
- propranolol
- pyridoxine
- sodium bicarbonate
- succinylcholine
- sufentanil
- theophylline
- thiamine
- tobramycin
- vancomycin
- vasopressin
- verapamil
Y-Site Incompatibility:
- amphotericin B deoxycholate
- ampicillin
- ampicillin/sulbactam
- cefazolin
- cefotaxime
- cefotetan
- cefoxitin
- ceftazidime
- ceftriaxone
- cefuroxime
- chloramphenicol
- dantrolene
- dexamethasone
- diazepam
- folic acid
- furosemide
- heparin
- hydrocortisone
- indomethacin
- insulin regular
- ketorolac
- methylprednisolone
- nafcillin
- oxacillin
- penicillin G
- pentamidine
- pentobarbital
- phenobarbital
- phenytoin
- trimethoprim/sulfamethoxazole

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of protamine. Advise patient to read Medication Guide before starting and periodically during therapy in case of changes.
Tell patient to report and seek treatment for signs and symptoms of bleeding (weakness; fast heartbeat; trouble breathing; dizziness; pale skin; tiredness; obvious bleeding in urine, stool, mouth, or nose).
Advise patient to avoid activities that may result in bleeding (shaving, brushing teeth, receiving injections or rectal temperatures, ambulating) until risk of hemorrhage has passed.
Advise patient to notify health care provider of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care provider before taking other medications.
Rep: Advise women of reproductive potential to notify health care provider if pregnancy is planned or suspected or if breastfeeding.

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Contraind./Precautions ⬆ ⬇