Protamine Sulfate

Pronunciation: PRO-tuh-meen SULL-fate
Class: Heparin antagonist

Trade Names

Protamine Sulfate
- Injection 10 mg/mL

Pharmacology

Neutralizes heparin by forming heparin-protamine complex.

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Pharmacokinetics

Metabolism

May be partially metabolized or may be cleaved by fibrinolysin, thus freeing heparin.

Onset

Rapid, neutralization occurs within 5 min.

Duration

Duration is 2 h, dependent on body temperature.

Indications and Usage

Treatment of heparin overdose.

Contraindications

Standard considerations.

Dosage and Administration

IV 1 mg for each 90 units of heparin derived from lung tissue or 115 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.

General Advice

• 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.

Storage/Stability

Store protamine sulfate injection in refrigerator (36° to 46°F). Do not freeze.

Drug Interactions

None well documented.

Incompatibility

Protamine should not be mixed with other drugs without knowledge of their compatibility.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Hypotension; bradycardia; circulatory collapse.

CNS

Lassitude.

GI

Nausea; vomiting.

Respiratory

Shortness of breath; pulmonary edema; acute pulmonary hypertension.

Miscellaneous

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.

Hypersensitivity

Fatal anaphylaxis may occur.

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.

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.

Overdosage

Symptoms

Bleeding.

Patient Information

• Instruct patient to notify health care provider immediately if any bleeding occurs.
• Tell patient to report the following symptoms to health care provider: 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.

Copyright © 2009 Wolters Kluwer Health.