PROTAMINE SULFATE- 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:

Fresenius Kabi USA, LLC

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.

Product summary:

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. PRX22930 (250 mg in 25 mL) is 5 times greater than in product No. PRX22905 (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. PREMIERProRx ® is a registered trademark of Premier Healthcare Alliance, L.P., used under license.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PROTAMINE SULFATE - PROTAMINE SULFATE INJECTION, SOLUTION
FRESENIUS KABI USA, LLC
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PROTAMINE SULFATE INJECTION, USP
Rx only
FOR INTRAVENOUS USE
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 (see WARNINGS and DOSAGE AND 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:
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 admini