Protamine Sulfate
Hf Acquisition Co Llc, Dba Healthfirst
Human Prescription Drug
NDC 51662-1414Protamine Sulfate is a human prescription drug labeled by 'Hf Acquisition Co Llc, Dba Healthfirst'. National Drug Code (NDC) number for Protamine Sulfate is 51662-1414. This drug is available in dosage form of Injection, Solution. The names of the active, medicinal ingredients in Protamine Sulfate drug includes Protamine Sulfate - 10 mg/mL . The currest status of Protamine Sulfate drug is Active.
Drug Information:
| Drug NDC: | 51662-1414 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Protamine Sulfate |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Protamine Sulfate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Hf Acquisition Co Llc, Dba Healthfirst |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Injection, Solution |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | PROTAMINE SULFATE - 10 mg/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | INTRAVENOUS
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | ANDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 13 Oct, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 20 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | ANDA089454 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | HF Acquisition Co LLC, DBA HealthFirst
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1796672
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| UPC: | 0363323229054
|
| UPC stands for Universal Product Code. |
| UNII: | 0DE9724IHC
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class: | Heparin Binding Activity [MoA]
Heparin Reversal Agent [EPC]
Reversed Anticoagulation Activity [PE]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 51662-1414-1 | 5 mL in 1 VIAL, SINGLE-DOSE (51662-1414-1) | 13 Oct, 2019 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Protamine sulfate protamine sulfate protamine sulfate protamine sodium chloride sodium phosphate, dibasic sulfuric acid
Boxed Warning:
Boxed warning boxed warning
Indications and Usage:
Indications & usage protamine sulfate injection, usp is indicated in the treatment of heparin overdosage.
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 & administration and warnings ). facilities to treat shock should be available.
Dosage and Administration:
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
Read more...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.
Contraindications:
Contraindications protamine sulfate is contraindicated in patients who have shown previous intolerance to the drug.
Adverse Reactions:
Adverse reactions 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 ci
Read more...rculatory 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 anaphyactic and anaphylactoid shock are readily available.
Overdosage:
Overdosage signs and symptoms overdose of protamine sulfate may cause bleeding. protamine has a weak anticoagulant effect due to an interaction with platelets and with many proteins including fibrinogen. this effect should be distinguished from the rebound anticoagulation that may occur 30 minutes to 18 hours following the reversal of heparin with protamine. rapid administration of protamine is more likely to result in bradycardia, dyspnea, a sensation of warmth, flushing, and severe hypotension. hypertension has also occurred. the median lethal dose of protamine sulfate is 50 mg/kg in mice. serum concentrations of protamine sulfate are not clinically useful. information is not available on the amount of drug in a single dose that is associated with overdosage or is likely to be life-threatening. treatment to obtain up-to-date information about the treatment of overdose, a good resource is your certified regional poison control center. telephone numbers of certified poison control centers are listed in the physicians' desk reference (pdr). in managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs and unusual drug kinetics in your patient. replace blood loss with blood transfusions or fresh frozen plasma. if the patient is hypotensive, consider fluids, epinephrine, dobutamine or dopamine.
Description:
Description 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.
Clinical Pharmacology:
Clinical pharmacology when administered alone, protamine has an anticoagulant effect. however, when it is given in the presence of heparin (which is strongly acidic), a stable salt is formed and the anticoagulant activity of both drugs is lost. protamine sulfate has a rapid onset of action. neutralization of heparin occurs within five minutes after intravenous administration of an appropriate dose of protamine sulfate. although the metabolic fate of the heparin-protamine complex has not been elucidated, it has been postulated that protamine sulfate in the heparin-protamine complex may be partially metabolized or may be attacked by fibrinolysin, thus freeing heparin.
How Supplied:
How suplied protamine sulfate injection, usp is supplied in the following dosage forms. ndc 51662-1414-1 protamine sulfate injection, usp 50mg/5ml (10mg/ml) 5ml vial hf acquisition co llc, dba healthfirst mukilteo, wa 98275 also supplied in the following manufacture supplied dosage forms 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 (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. how supplied
Package Label Principal Display Panel:
Principal display panel - vial label vial 1 vial 2 vial3 vial 4
Principal display panel - serialized labeling serialized labeling