Protamine

Protamine
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Gerald Chi

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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.

Overview

Protamine is a heparin antagonist that is FDA approved for the {{{indicationType}}} of heparin overdosage. There is a Black Box Warning for this drug as shown here. Common adverse reactions include flushing, dyspnea, nausea, and vomiting.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Heparin Overdosage

• Dosing Information

• 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

There is limited information regarding Off-Label Guideline-Supported Use of Protamine in adult patients.

Non–Guideline-Supported Use

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)

• Safety and effectiveness in children have not been established.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Protamine in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Protamine in pediatric patients.

Contraindications

• Protamine sulfate is contraindicated in patients who have shown previous intolerance to the drug.

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.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Protamine in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Protamine during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Protamine with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Protamine with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Protamine with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Protamine with respect to specific gender populations.

Race

There is no FDA guidance on the use of Protamine with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Protamine in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Protamine in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Protamine in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Protamine in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Protamine in the drug label.

Condition1

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Protamine in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Protamine in the drug label.

Pharmacology

There is limited information regarding Protamine Pharmacology in the drug label.

Mechanism of Action

Structure

File:Protamine01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

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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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Protamine in the drug label.

Precautions with Alcohol

• Alcohol-Protamine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• Protamine sulfate®

Look-Alike Drug Names

• protamine — Protonix®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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