Protamine Sulfate

A to Z Drug Facts

Protamine Sulfate

	Action
	Indications
	Contraindications
	Route/Dosage
	Interactions
	Lab Test Interferences
	Adverse Reactions
	Precautions
Patient Care Considerations
	Administration/Storage
	Assessment/Interventions
	Patient/Family Education

(PRO-tuh-meen SULL-fate)

Class: Heparin antagonist

Action Neutralizes heparin by forming heparin-protamine complex.

Indications Treatment of heparin overdose.

Contraindications Standard considerations.

Route/Dosage

ADULTS: IV 1 mg for each 90 USP units of heparin derived from lung tissue or 115 USP units of heparin derived from intestinal mucosa. Because heparin disappears rapidly from circulation, the dose of protamine required decreases rapidly with time following IV injection of heparin. For example, if protamine is administered 30 min after heparin, ½ the usual dose may be sufficient. The dose of protamine should be determined by blood coagulation studies.

Interactions None well documented. INCOMPATIBILITIES: Protamine should not be mixed with other drugs without knowledge of their compatibility.

Lab Test Interferences None well documented.

Adverse Reactions

CV: Hypotension; bradycardia; circulatory collapse. CNS: Lassitude. GI: Nausea; vomiting. RESP: Shortness of breath; pulmonary edema; acute pulmonary hypertension. OTHER: Anaphylaxis (severe respiratory distress, circulatory collapse, capillary leak, noncardiogenic pulmonary edema); transient flushing and feeling of warmth; back pain.

Precautions

Pregnancy: Category C. Lactation: Undetermined. Children: Safety and efficacy not established. Circulatory collapse: Can occur along with myocardial failure and reduced cardiac output. Heparin rebound: When used to neutralize large doses of heparin, protamine can be inactivated by blood; treatment consists of giving additional protamine. Hypersensitivity: Fatal anaphylaxis may occur. Pulmonary edema: High-protein noncardiogenic pulmonary edema has occurred with use of protamine in patients on cardiopulmonary bypass undergoing cardiovascular surgery. Too rapid administration: Can result in severe hypotension and anaphylactoid reactions.

PATIENT CARE CONSIDERATIONS

Administration/Storage

Discontinue IV heparin infusion and maintain IV route access.
Flush IV line completely to clear previously administered medications.
When given via direct IV injection, use 10 mg/ml concentration and administer slowly over 1 to 3 min. No more than 50 mg should be given in any 10 min period.
Protamine sulfate injection is not intended to be further diluted. If further dilution is desired, dilute with D5W or normal saline.
Store protamine sulfate injection in refrigerator. Do not freeze.

Assessment/Interventions

Obtain patient history, including drug history and any known allergies, particularly hypersensitivity to drug, fish (salmon) or previous reaction to or use of isophane or protamine insulins. Note if male patient has had vasectomy or history of infertility (either can increase risk of hypersensitivity reaction).
Assess for hypovolemia before initiating therapy, because peripheral vasodilation of protamine sulfate can result in cardiovascular collapse if hypovolemia is uncorrected.
Have resuscitation equipment available.
Monitor patient for urticaria, edema, rash, wheezing and coughing (hypersensitivity symptoms).
Monitor activated clotting time, activated partial thromboplastin time, and thrombin time 5 to 15 min after therapy is begun and prn.
Monitor vital signs frequently.
Assess for bleeding during and after therapy (heparin rebound can precipitate hemorrhage 8 to 9 hr after therapy; after cardiopulmonary bypass, rebound can occur as late as 18 hr after therapy). Monitor for severe headache, gingival erythema or bleeding, complaint of abdominal or back pain, petechiae or bruises and excessive bleeding from cuts or venipuncture sites. Check urine and stool for visible and occult blood. Ask female patient about increased amount of menstrual discharge.
To prevent bleeding, avoid injections and rectal temperatures and provide gentle mouth care.

OVERDOSAGE: SIGNS & SYMPTOMS
	Bleeding

Patient/Family Education

Instruct patient to notify physician immediately if any bleeding occurs.
Tell patient to report the following symptoms to physician: Shortness of breath, dizziness, or swelling.
Advise patient to avoid activities that could damage blood vessels or precipitate bleeding (eg, shaving, vigorous brushing of teeth, ambulation) until risk of hemorrhage has passed.