Protamine sulfate
protamine
What it isCationic peptide binding heparin; heparin reversal.
Why this oneIt neutralizes unfractionated heparin within minutes, which nothing else does.
What limits itAnaphylaxis, especially after prior protamine-containing insulin or vasectomy. It only partially reverses low molecular weight heparin and can itself cause bleeding in excess.
FDA label
Read the full label on DailyMed ↗
BOXED WARNING Can cause severe hypotension, cardiovascular collapse, noncardiogenic pulmonary edema, catastrophic pulmonary vasoconstriction, and pulmonary hypertension; risk with high/overdose, rapid or repeated administration, prior protamine or protamine-containing drug exposure (NPH/protamine zinc insulin), fish allergy, vasectomy. Keep vasopressors and resuscitation available; do not give without prior heparin use.
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Heparin neutralization | Adults | ~1 mg per 100 USP units of heparin; guided by coagulation studies | 50 mg per slow IV dose (over 10 min) |
Renal Undefined
Hepatic Undefined
Required dose decreases with time elapsed since heparin injection
Instructions
- Give by very slow IV injection over a 10-minute period; do not exceed 50 mg
- Reduce dose as time elapses since heparin (e.g., about half dose if given 30 min after heparin)
- Do not give when bleeding occurs without prior heparin use
- Do not mix with incompatible drugs (certain cephalosporins and penicillins)
Available strengths
- inj 10 mg/mL
Cautions
- Severe hypotension and bradycardia on IV administration
- Fatal anaphylactic and anaphylactoid reactions — resuscitation must be available
- Noncardiogenic (high-protein) pulmonary edema, esp. on cardiopulmonary bypass
- Acute pulmonary hypertension / circulatory collapse
- Higher risk with fish allergy, prior protamine/NPH insulin exposure, vasectomy, LV dysfunction
Adverse reactions
- Sudden fall in blood pressure
- Bradycardia
- Transitory flushing/warmth
- Dyspnea
- Nausea/vomiting
- Lassitude
- Back pain
- Anaphylaxis/anaphylactoid reactions with circulatory collapse and capillary leak
- Noncardiogenic pulmonary edema
- Acute pulmonary hypertension
Pregnancy Undefined
Lactation Undefined
Cost
Protamine sulfate (PROTAMINE)
| Strength | #/mo | generic $/unit | CostPlus | |
|---|---|---|---|---|
| 10 mg/mL | inj | per unit | not offered |
NADAC is a voluntary CMS survey of what retail community pharmacies pay for the drugs they stock. Protamine sulfate is administered under clinical supervision and dispensed outside retail pharmacies, so it rarely appears on surveyed invoices.
⚠ BOXED WARNING
- Severe hypotension, anaphylaxis and pulmonary hypertension
Classes and tags
Clinical profile
Legacy pregnancy categoryC
Defining liabilityCatastrophic hemodynamic or anaphylactic reactions during IV reversal