NOREPINEPHRINE BITARTRATE injection

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

NOREPINEPHRINE BITARTRATE (UNII: IFY5PE3ZRW) (NOREPINEPHRINE - UNII:X4W3ENH1CV)

Sẵn có từ:

Baxter Healthcare Corporation

Tuyến hành chính:

INTRAVENOUS

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

For blood pressure control in certain acute hypotensive states (e.g., pheochromocytomectomy, sympathectomy, poliomyelitis, spinal anesthesia, myocardial infarction, septicemia, blood transfusion, and drug reactions). As an adjunct in the treatment of cardiac arrest and profound hypotension. Norepinephrine Bitartrate Injection, USP should not be given to patients who are hypotensive from blood volume deficits except as an emergency measure to maintain coronary and cerebral artery perfusion until blood volume replacement therapy can be completed. If Norepinephrine Bitartrate Injection, USP is continuously administered to maintain blood pressure in the absence of blood volume replacement, the following may occur: severe peripheral and visceral vasoconstriction, decreased renal perfusion and urine output, poor systemic blood flow despite "normal" blood pressure, tissue hypoxia, and lactate acidosis. Norepinephrine Bitartrate Injection, USP should also not be given to patients with mesenteric or peripheral vascular thrombosis (because of the risk of increasing ischemia and extending the area of infarction) unless, in the opinion of the attending physician, the administration of Norepinephrine Bitartrate Injection, USP is necessary as a life-saving procedure. Cyclopropane and halothane anesthetics increase cardiac autonomic irritability and therefore seem to sensitize the myocardium to the action of intravenously administered epinephrine or norepinephrine. Hence, the use of Norepinephrine Bitartrate Injection, USP during cyclopropane and halothane anesthesia is generally considered contraindicated because of the risk of producing ventricular tachycardia or fibrillation. The same type of cardiac arrhythmias may result from the use of Norepinephrine Bitartrate Injection, USP in patients with profound hypoxia or hypercarbia.

Tóm tắt sản phẩm:

Norepinephrine Bitartrate Injection, USP, contains the equivalent of 4 mg base of norepinephrine per each 4 mL ampule (1 mg/mL), and is available as follows: AIN00610 NDC 36000-162-10 Ampules of 4 mL in shelf carton of 10 Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Retain in carton until time of use. Protect from light.

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

NOREPINEPHRINE BITARTRATE - NOREPINEPHRINE BITARTRATE INJECTION
BAXTER HEALTHCARE CORPORATION
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DESCRIPTION
Norepinephrine (sometimes referred to as _l-arterenol/Levarterenol or
l-norepinephrine)_ is
a sympathomimetic amine which differs from epinephrine by the absence
of a methyl
group on the nitrogen atom.
Norepinephrine bitartrate is (-)-α-(aminomethyl)-3,4-dihydroxybenzyl
alcohol tartrate
(1:1) (salt) monohydrate and has the following structural formula:
Norepinephrine is supplied in sterile aqueous solution in the form of
the bitartrate salt to
be administered by intravenous infusion following dilution.
Norepinephrine is sparingly
soluble in water, very slightly soluble in alcohol and ether, and
readily soluble in acids.
Each mL contains the equivalent of 1 mg base of norepinephrine, sodium
chloride for
isotonicity. It has a pH of 3 to 4.5. The air in the ampules has been
displaced by nitrogen
gas.
CLINICAL PHARMACOLOGY
Norepinephrine functions as a peripheral vasoconstrictor
(alpha-adrenergic action) and
as an inotropic stimulator of the heart and dilator of coronary
arteries (beta-adrenergic
action).
INDICATIONS AND USAGE
For blood pressure control in certain acute hypotensive states (e.g.,
pheochromocytomectomy, sympathectomy, poliomyelitis, spinal
anesthesia, myocardial
infarction, septicemia, blood transfusion, and drug reactions).
As an adjunct in the treatment of cardiac arrest and profound
hypotension.
CONTRAINDICATIONS
Norepinephrine Bitartrate Injection, USP should not be given to
patients who are
Norepinephrine Bitartrate Injection, USP should not be given to
patients who are
hypotensive from blood volume deficits except as an emergency measure
to maintain
coronary and cerebral artery perfusion until blood volume replacement
therapy can be
completed. If Norepinephrine Bitartrate Injection, USP is continuously
administered to
maintain blood pressure in the absence of blood volume replacement,
the following may
occur: severe peripheral and visceral vasoconstriction, decreased
renal perfusi