PROTAMINE SULFATE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PROTAMINE SULFATE (UNII: 0DE9724IHC) (PROTAMINE - UNII:72G3UY6T4N)

Available from:

HF Acquisition Co LLC, DBA HealthFirst

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Protamine Sulfate Injection, USP is indicated in the treatment of heparin overdosage. Protamine sulfate is contraindicated in patients who have shown previous intolerance to the drug.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PROTAMINE SULFATE- PROTAMINE SULFATE INJECTION, SOLUTION
HF ACQUISITION CO LLC, DBA HEALTHFIRST
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PROTAMINE SULFATE INJECTION, USP 50MG/5ML (10MG/ML) 5ML VIAL
BOXED WARNING
SPL UNCLASSIFIED
For Intravenous Use
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
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.
INDICATIONS & USAGE
Protamine Sulfate Injection, USP is indicated in the treatment of
heparin overdosage.
CONTRAINDICATIONS
Protamine sulfate is contraindicated in patients who have shown
previous intolerance to
the drug.
WARNINGS
Hyperheparinemia or blee