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Protamine sulfate

Generic Name
Protamine sulfate
Drug Type
Biotech
CAS Number
9009-65-8
Unique Ingredient Identifier
0DE9724IHC

Overview

Since it's earliest discovery in salmon rine sperm heads in the late 1800's to its formal introduction via US FDA approval in 1939, protamine sulfate has occupied an important therapeutic niche as perhaps the only viable option for reversing the anticoagulant effect of heparin use for over 77 years . Subsequently, because most invasive surgical procedures involve the routine use of heparin to prevent potentially surgery-complicating blood clotting, most cases of major bleeding in these frequent procedures are managed with the use of protamine sulfate . The agent elicits this heparin reversal predominantly via the formation of an inactive complex between the anionic nature of heparin and its own cationic state . Despite the relative importance of protamine sulfate's medical indication, the medication can notoriously cause a variety of potentially rare but genuinely severe adverse effects that include systemic hypotension, pulmonary hypertension, liver and kidney tissue damage, and anaphylactic reaction, amongst others . As a consequence, whenever protamine sulfate use is clinically considered, careful consideration must be given as to whether the use of the agent could decrease the safety of the procedure or worsen the recovery of a patient after the procedure . Regardless, protamine sulfate continues to see contemporary use given its genuine effectiveness in reversing heparin effects. Although current up to date reviews and studies continue to search for new therapeutic alternatives to protamine sulfate, most substitutes possess similar and unacceptable adverse effects . Of the few agents that may be considered potentially successful alternatives - including idarucizumab for dabigatran reversal - their cost of procurement and potential range in reversing all parenteral anticoagulants are sometimes considered high and limited, respectively .

Indication

Protamine sulfate is indicated for counteracting or reversing the anticoagulant effect of heparin as necessary . Such reversal may, for example, be required often before surgery; after renal hemodialysis; post open heart surgery; whenever excessive bleeding results from heparin use; and/or for the treatment of heparin overdosage, among other similar or related circumstances .

Associated Conditions

  • Heparin overdose

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Fresenius Kabi USA, LLC
63323-229
INTRAVENOUS
10 mg in 1 mL
3/17/2023
HF Acquisition Co LLC, DBA HealthFirst
51662-1414
INTRAVENOUS
10 mg in 1 mL
1/22/2024
Fresenius Kabi USA, LLC
63323-229
INTRAVENOUS
10 mg in 1 mL
3/18/2024

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
PROSULF INJECTION 1%
SIN03696P
INJECTION
1%
10/2/1989

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
FISONS PROTAMINE SULFATE 50mg/5mL injection ampoule
27971
Medicine
A
10/21/1991

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
PROTAMINE SULFATE INJECTION, USP
fresenius kabi canada ltd
02139537
Solution - Intravenous
10 MG / ML
12/31/1989
PROTAMINE SULFATE INJECTION USP
omega laboratories limited
02240618
Liquid - Intravenous
10 MG / ML
1/26/2000
PROTAMINE SULFATE INJ 10MG/ML USP
lyphomed, division of fujisawa canada inc.
01944851
Liquid - Intravenous
10 MG / ML
12/31/1989
PROTAMINE SULFATE INJECTION USP
02231674
Solution - Intravenous
10 MG / ML
3/3/1998

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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