Protamine Sulfate
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Questions & Answers
Side Effects & Adverse Reactions
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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Protamine Sulfate Injection, USP is indicated in the treatment of heparin overdosage.
History
There is currently no drug history available for this drug.
Other Information
Protamines are simple proteins of low molecular weight that are rich in arginine and strongly basic. They occur in the sperm of salmon and certain other species of fish.
Protamine sulfate occurs as fine white or off-white amorphous or crystalline powder. It is sparingly soluble in water. The pH is between 6.0 and 7.0. The cationic hydrogenated protamine at a pH of 6.8 to 7.1 reacts with anionic heparin at a pH of 5.0 to 7.5 to form an inactive complex.
Protamine Sulfate Injection, USP is a sterile, isotonic solution of protamine sulfate. It acts as a heparin antagonist. It is also a weak anticoagulant.
Each mL contains: Protamine sulfate 10 mg; sodium chloride 9 mg; Water for Injection q.s. Sulfuric acid and/or dibasic sodium phosphate (heptahydrate) may have been added for pH adjustment.
The preparation is preservative free.
Protamine sulfate is administered intravenously.
Sources
Protamine Sulfate Manufacturers
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Cardinal Health
![Protamine Sulfate Injection, Solution [Cardinal Health]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Protamine Sulfate | Cardinal Health
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 inspected for particulate matter and discoloration prior to administration, whenever solution and container permit.
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Fresenius Kabi Usa, Llc
Protamine Sulfate | Fresenius Kabi Usa, Llc
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 inspected for particulate matter and discoloration prior to administration, whenever solution and container permit.
-
Fresenius Kabi Usa, Llc
Protamine Sulfate | Fresenius Kabi Usa, Llc
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 inspected for particulate matter and discoloration prior to administration, whenever solution and container permit.
-
Fresenius Kabi Usa, Llc
Protamine Sulfate | Fresenius Kabi Usa, Llc
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 inspected for particulate matter and discoloration prior to administration, whenever solution and container permit.
![Protamine Sulfate Injection, Solution [Fresenius Kabi Usa, Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=7a31fc4c-579f-45cc-9559-39cfad9a57b3&name=protamine-sulfate-injection-usp-figure-2-vial-np22930.jpg)
![Protamine Sulfate Injection, Solution [Fresenius Kabi Usa, Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e1964129-33f4-4e4e-86e3-8e6a4e65bd83&name=protamine-sulfate-injection-usp-figure-2-22930-vial.jpg)
![Protamine Sulfate Injection, Solution [Fresenius Kabi Usa, Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8df0a819-9e1a-44ce-97a6-3ea82c867d44&name=protamine-sulfate-injection-usp-figure-2-prx22930-vial.jpg)
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