* Protamine Sulfate Injection, USP, 50 mg (10 mg/mL, 5 mL) in a single dose flip-top vial, in packages of 25.
* Protamine Sulfate Injection, USP, 250 mg (10 mg/mL, 25 mL) in a single dose flip-top vial, packaged individually.
* 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. 22930 (250 mg in 25 mL) is 5 times greater than in product No. 22905 (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.
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Black Box Warning
BOXED WARNING
See full prescribing information for complete 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, 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.
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. 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.
Parenteral drug products should be visually inspected for particulate matter and discoloration prior to administration, whenever solution and container permit.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
Condition1
Developed by:
Class of Recommendation:
Strength of Evidence:
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Protamine in adult patients.
Non–Guideline-Supported Use
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Protamine in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding FDA-Labeled Use of Protamine in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
Condition1
Developed by:
Class of Recommendation:
Strength of Evidence:
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Protamine in pediatric patients.
Non–Guideline-Supported Use
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Protamine in pediatric patients.
Contraindications
Condition1
Warnings
BOXED WARNING
See full prescribing information for complete 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, 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.
Description
Precautions
Description
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Protamine in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Protamine in the drug label.
There is limited information regarding Pharmacodynamics of Protamine in the drug label.
Pharmacokinetics
There is limited information regarding Pharmacokinetics of Protamine in the drug label.
Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Protamine in the drug label.
Clinical Studies
There is limited information regarding Clinical Studies of Protamine in the drug label.
Condition1
Description
How Supplied
Protamine Sulfate Injection, USP, 50 mg (10 mg/mL, 5 mL) in a single dose flip-top vial, in packages of 25.
Protamine Sulfate Injection, USP, 250 mg (10 mg/mL, 25 mL) in a single dose flip-top vial, packaged individually.
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. 22930 (250 mg in 25 mL) is 5 times greater than in product No. 22905 (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.
Storage
There is limited information regarding Protamine Storage in the drug label.
Images
Drug Images
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