PROTAMINE SULFATE- protamine sulfate injection, solution

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Fresenius Kabi USA, LLC

Laluan pentadbiran:

INTRAVENOUS

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

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.

Ringkasan produk:

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.

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

PROTAMINE SULFATE - PROTAMINE SULFATE INJECTION, SOLUTION
FRESENIUS KABI USA, LLC
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PROTAMINE SULFATE INJECTION, USP
FOR INTRAVENOUS USE
Rx only
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