Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED: Product Code Unit of Sale Strength Each 22905 NDC 63323-229-05 Unit of 25 50 mg per 5 mL (10 mg per mL) NDC 63323-229-01 5 mL Single Dose Flip-top Vial RF22905 NDC 65219-646-05 Unit of 25 50 mg per 5 mL (10 mg per mL) NDC 65219-646-02 5 mL Single Dose Flip-top Vial This product contains an RFID. 22930 NDC 63323-229-30 Individually Packaged 250 mg per 25 mL (10 mg per mL) NDC 63323-229-30 25 mL Single Dose Flip-top Vial Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not permit to freeze. CAUTION: The total dose of protamine sulfate contained in product No. 22925 and 22930 (250 mg in 25 mL) is 5 times greater than in product No. 22905 and product No. RF22905 (50 mg in 5 mL). The large size 25 mL vials are designed for antiheparin treatment only when large doses of heparin have been given during surgery and are to be neutralized by large doses of protamine sulfate after surgical procedures.; PACKAGE LABEL - PRINCIPAL DISPLAY - Protamine 25 mL Single Dose Vial Label NDC 63323-229-30 22930 Protamine Sulfate Injection, USP 250 mg per 25 mL (10 mg per mL) For Intravenous Use Only 25 mL Single Dose Vial Rx only PACKAGE LABEL - PRINCIPAL DISPLAY - Protamine 25 mL Single Dose Vial Label; PACKAGE LABEL - PRINCIPAL DISPLAY - Protamine 25 mL Single Dose Vial Carton Panel NDC 63323-229-30 22930 Protamine Sulfate Injection, USP 250 mg per 25 mL (10 mg per mL) For Intravenous Use Only 25 mL Single Dose Vial Rx only PACKAGE LABEL - PRINCIPAL DISPLAY - Protamine 25 mL Single Dose Vial Carton Panel; PACKAGE LABEL - PRINCIPAL DISPLAY - Protamine 5 mL Single Dose Vial Label NDC 63323-229-01 22905 Protamine Sulfate Injection, USP 50 mg per 5 mL (10 mg per mL) For Intravenous Use Only Rx only 5 mL Single Dose Vial PACKAGE LABEL - PRINCIPAL DISPLAY - Protamine 5 mL Single Dose Vial Label; PACKAGE LABEL - PRINCIPAL DISPLAY - Protamine 5 mL Single Dose Vial Tray Label NDC 63323-229-05 22905 Protamine Sulfate Injection, USP 50 mg per 5 mL (10 mg per mL) For Intravenous Use Only Rx only 25 x 5 mL Single Dose Vials PACKAGE LABEL - PRINCIPAL DISPLAY - Protamine 5 mL Single Dose Vial Tray Label
- HOW SUPPLIED: Product Code Unit of Sale Strength Each 22905 NDC 63323-229-05 Unit of 25 50 mg per 5 mL (10 mg per mL) NDC 63323-229-01 5 mL Single Dose Flip-top Vial RF22905 NDC 65219-646-05 Unit of 25 50 mg per 5 mL (10 mg per mL) NDC 65219-646-02 5 mL Single Dose Flip-top Vial This product contains an RFID. 22930 NDC 63323-229-30 Individually Packaged 250 mg per 25 mL (10 mg per mL) NDC 63323-229-30 25 mL Single Dose Flip-top Vial Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not permit to freeze. CAUTION: The total dose of protamine sulfate contained in product No. 22925 and 22930 (250 mg in 25 mL) is 5 times greater than in product No. 22905 and product No. RF22905 (50 mg in 5 mL). The large size 25 mL vials are designed for antiheparin treatment only when large doses of heparin have been given during surgery and are to be neutralized by large doses of protamine sulfate after surgical procedures.
- PACKAGE LABEL - PRINCIPAL DISPLAY - Protamine 25 mL Single Dose Vial Label NDC 63323-229-30 22930 Protamine Sulfate Injection, USP 250 mg per 25 mL (10 mg per mL) For Intravenous Use Only 25 mL Single Dose Vial Rx only PACKAGE LABEL - PRINCIPAL DISPLAY - Protamine 25 mL Single Dose Vial Label
- PACKAGE LABEL - PRINCIPAL DISPLAY - Protamine 25 mL Single Dose Vial Carton Panel NDC 63323-229-30 22930 Protamine Sulfate Injection, USP 250 mg per 25 mL (10 mg per mL) For Intravenous Use Only 25 mL Single Dose Vial Rx only PACKAGE LABEL - PRINCIPAL DISPLAY - Protamine 25 mL Single Dose Vial Carton Panel
- PACKAGE LABEL - PRINCIPAL DISPLAY - Protamine 5 mL Single Dose Vial Label NDC 63323-229-01 22905 Protamine Sulfate Injection, USP 50 mg per 5 mL (10 mg per mL) For Intravenous Use Only Rx only 5 mL Single Dose Vial PACKAGE LABEL - PRINCIPAL DISPLAY - Protamine 5 mL Single Dose Vial Label
- PACKAGE LABEL - PRINCIPAL DISPLAY - Protamine 5 mL Single Dose Vial Tray Label NDC 63323-229-05 22905 Protamine Sulfate Injection, USP 50 mg per 5 mL (10 mg per mL) For Intravenous Use Only Rx only 25 x 5 mL Single Dose Vials PACKAGE LABEL - PRINCIPAL DISPLAY - Protamine 5 mL Single Dose Vial Tray Label
Overview
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.
Indications & Usage
: Protamine Sulfate Injection, USP is indicated in the treatment of heparin overdosage.
Dosage & 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 inspected for particulate matter and discoloration prior to administration, whenever solution and container permit.
Warnings & Precautions
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.
Boxed 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 (see WARNINGS and DOSAGE AND 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). Allergy to fish, previous vasectomy, and severe left ventricular dysfunction and abnormal preoperative pulmonary hemodynamics also may be risk factors. In patients with any of these risk factors, the risk to benefit of administration of protamine sulfate should be carefully considered. Vasopressors and resuscitation equipment should be immediately available in case of a severe reaction to protamine. Protamine sulfate should not be given when bleeding occurs without prior heparin use.
Contraindications
: Protamine sulfate is contraindicated in patients who have shown previous intolerance to the drug.
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 reduced cardiac output can also occur. The mechanism(s) of this reaction and the role played by concurrent factors are unclear. High-protein, noncardiogenic pulmonary edema associated with the use of protamine has been reported in patients on cardiopulmonary bypass who are undergoing cardiovascular surgery. The etiologic role of protamine in the pathogenesis of this condition is uncertain, and multiple factors have been present in most cases. The condition has been reported in association with administration of certain blood products, other drugs, cardiopulmonary bypass alone, and other etiologic factors. It is difficult to treat, and it can be life-threatening. Because fatal anaphylactic and anaphylactoid reactions have been reported after the administration of protamine sulfate, the drug should be given only when resuscitation techniques and treatment of anaphylactic and anaphylactoid shock are readily available.
Similar Drugs
Related medications based on brand, generic name, substance, active ingredients.