Uses
Protamine Sulfate Injection, USP is indicated in the treatment of heparin overdosage.
Source: US FDA prescribing information
- Presentations
- 2
- Brands
- 0
- Manufacturers
- 0
- Available from stock
- 0
Protamine is a heparin reversal agent indicated in the treatment of heparin overdosage. It is available as injection for intravenous use. MedsAcross supplies Protamine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Key facts
- Pharmacological class
- Heparin Reversal Agent, Heparin Binding Activity, Reversed Anticoagulation Activity
- ATC classification
- V03AB14 Protamine · Antidote
- US FDA first approval
- 13 August 1969
- EU status
- Not recorded
- Orphan designation
- Not recorded
- WHO essential medicine
- Not recorded
- India (CDSCO)
- Not yet confirmed against CDSCO approval lists
- Routes
- Intravenous
- Dosage forms
- Injection
- Identifiers
- UNII 72G3UY6T4NRxCUI 8826CAS 9012-00-4Q5449573
Clinical information
From the regulator-approved product information. Each section names its source.
Dosing overview
Each mg of protamine sulfate, calculated on the dried basis, neutralizes not less than 100 USP Heparin Units. Protamine sulfate injection should be given by very slow intravenous injection over a 10-minute period in doses not to exceed 50 mg. Protamine sulfate is intended for injection without further dilution, however, if further dilution is desired, D5-W or normal saline may be used. Diluted solutions should not be stored since they contain no preservative. Protamine sulfate should not be mixed with other drugs without knowledge of their compatibility, because protamine sulfate has been shown to be incompatible with certain antibiotics, including several of the cephalosporins and penicillins. Because heparin disappears rapidly from the circulation, the dose of protamine sulfate required also decreases rapidly with the time elapsed following intravenous injection of heparin.
Source: US FDA prescribing information
Contraindications
Protamine sulfate is contraindicated in patients who have shown previous intolerance to the drug.
Source: US FDA prescribing information
Warnings and precautions
WARNING Protamine sulfate can cause severe hypotension, cardiovascular collapse, noncardiogenic pulmonary edema, catastrophic pulmonary vasoconstriction, and pulmonary hypertension. Risk factors include high dose or overdose, rapid administration, repeated doses, previous administration of protamine, and current or previous use of protamine-containing drugs (NPH insulin, protamine zinc insulin, and certain beta-blockers). Hyperheparinemia or bleeding has been reported in experimental animals and in some patients 30 minutes to 18 hours after cardiac surgery (under cardiopulmonary bypass) in spite of complete neutralization of heparin by adequate doses of protamine sulfate at the end of the operation. It is important to keep the patient under close observation after cardiac surgery.
Source: US FDA prescribing information
Side effects
The intravenous administration of protamine sulfate may cause a sudden fall in blood pressure and bradycardia. Other reactions include transitory flushing and feeling of warmth, dyspnea, nausea, vomiting and lassitude. Back pain has been reported in conscious patients undergoing such procedures as cardiac catheterization. Severe adverse reactions have been reported including: Anaphylaxis that resulted in severe respiratory distress, circulation collapse and capillary leak. Fatal anaphylaxis has been reported in one patient with no prior history of allergies,. Anaphylactoid reactions with circulatory collapse, capillary leak, and noncardiogenic pulmonary edema, acute pulmonary hypertension.
Source: US FDA prescribing information
Storage
Store at 20° to 25°C (68° to 77°F). Do not permit to freeze.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
All presentations
2 presentations of Protamine, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Protamine 50 mg/5 mL injectionIntravenousGeneric name | — | US FDA | Available on request |
| Protamine 250 mg/25 mL injectionIntravenousGeneric name | — | US FDA | Available on request |
Regulatory status
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 13 August 1969 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Questions and answers
Is Protamine available for export from India?
Yes, on request. MedsAcross lists 2 presentations of Protamine and sources them for licensed hospitals, importers and physicians against valid import documents.
Is Protamine approved by the US FDA?
Yes. The US FDA first approved Protamine on 13 August 1969, according to Drugs@FDA.
Does Protamine need cold chain shipping?
No listed presentation of Protamine is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Which ATC class is Protamine in?
Protamine is classified under ATC code V03AB14 (Protamine).
References
- Protamine Sulfate prescribing information (Fresenius Kabi). U.S. National Library of Medicine, DailyMed. Retrieved 29 April 2025
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