PROTAMINE SULFATE 10 mg/mL
PROTAMINE SULFATE · INJECTION, SOLUTION · HF Acquisition Co LLC, DBA HealthFirst
Protamine sulfate is an injectable medication used to reverse the effects of heparin, a blood thinner, when excessive bleeding occurs. It works by binding to heparin in the bloodstream to quickly neutralize its anticoagulant effects.
Key Facts
- Brand Name
- PROTAMINE SULFATE
- Generic Name
- PROTAMINE SULFATE
- NDC Code (Product)
51662-1414- Manufacturer
- HF Acquisition Co LLC, DBA HealthFirst
- Strength
- 10 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA089454
- Marketing Start
- 10/13/2019
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE: Protamine Sulfate Injection, USP is indicated in the treatment of heparin overdosage.
Dosage & Administration
DOSAGE AND ADMINISTRATION: 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 (see WARNINGS ). 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. For example, if the protamine sulfate is administered 30 minutes after the heparin, one-half the usual dose may be sufficient. The dosage of protamine sulfate should be guided by blood coagulation studies (see WARNINGS ). Parenteral drug products should be visually in…
Warnings
WARNINGS: 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. Additional doses of protamine sulfate should be administered if indicated by coagulation studies, such as the heparin titration test with protamine and the determination of plasma thrombin time. Too-rapid administration of protamine sulfate can cause severe hypotensive and anaphylactoid reactions (see DOSAGE AND ADMINISTRATION and WARNINGS ). Facilities to treat shock should be available.
Contraindications
CONTRAINDICATIONS: Protamine sulfate is contraindicated in patients who have shown previous intolerance to the drug.
Adverse Reactions
ADVERSE REACTIONS: To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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: (1) Anaphylaxis that resulted in severe respiratory distress, circulation collapse and capillary leak (see PRECAUTIONS ). Fatal anaphylaxis has been reported in one patient with no prior history of allergies; (2) Anaphylactoid reactions with circulatory collapse, capillary leak, and noncardiogenic pulmonary edema; acute pulmonary hypertension. Complement activation by the heparin-protamine complexes, release of lysosomal enzymes from neutrophils, and prostaglandin and thomboxane generation have been associated with the development of anaphylactoid reactions. Severe and potentially irreversible circulatory collapse associated with myocardial failure and re…
Frequently Asked Questions
What is PROTAMINE SULFATE used for?
Protamine sulfate is an injectable medication used to reverse the effects of heparin, a blood thinner, when excessive bleeding occurs. It works by binding to heparin in the bloodstream to quickly neutralize its anticoagulant effects.
Is PROTAMINE SULFATE a controlled substance?
PROTAMINE SULFATE is not classified as a controlled substance by the DEA.
What is the generic name for PROTAMINE SULFATE?
The generic name for PROTAMINE SULFATE is PROTAMINE SULFATE. There are 2 other brand versions of PROTAMINE SULFATE.
What is the NDC code for PROTAMINE SULFATE 10 mg/mL?
The NDC (National Drug Code) for PROTAMINE SULFATE 10 mg/mL is 51662-1414, listed by HF Acquisition Co LLC, DBA HealthFirst.