A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Levophed Warnings, Precautions, Pregnancy, Nursing, Abuse - Norepinephrine Bitartrate
Levophed Warnings, Precautions, Pregnancy, Nursing, Abuse - Norepinephrine Bitartrate
WARNINGS
Norepinephrine Bitartrate Injection, USP, should be used with extreme
caution in patients receiving monoamine oxidase inhibitors (MAOI) or antidepressants
of the triptyline or imipramine types, because severe, prolonged hypertension
may result.
Norepinephrine Bitartrate Injection, USP, contains sodium metabisulfite,
a sulfite that may cause allergic type reactions including anaphylactic
symptoms and life-threatening or less severe asthmatic episodes in certain
susceptible people. The overall prevalence of sulfite sensitivity in the
general population is unknown. Sulfite sensitivity is seen more frequently
in asthmatic than in nonasthmatic people.
PRECAUTIONS
General
Avoid Hypertension: Because of the potency of norepinephrine and
because of varying response to pressor substances, the possibility always
exists that dangerously high blood pressure may be produced with overdoses
of this pressor agent. It is desirable therefore, to record the blood
pressure every two minutes from the time administration is started until
the desired blood pressure is obtained, then every five minutes if administration
is to be continued.
The rate of wflow must be watched constantly, and the patient should never
be left unattended while receiving norepinephrine. Headache may be a symptom
of hypertension due to overdosage.
Site of Infusion: Whenever possible, infusions of norepinephrine
should be given into a large vein particularly an antecubital vein because,
when administered into this vein, the risk of necrosis of the overlying
skin from prolonged vasoconstriction is apparently very slight. Some authors
have indicated that the femoral vein is also an acceptable route of administration.
A catheter tie-in technique should be avoided, if possible, since the
obstruction to blood wflow around the tubing may cause stasis and increased
local concentration of the drug. Occlusive vascular diseases (for example,
atherosclerosis, arteriosclerosis, diabetic endarteritis, Buerger’s disease)
are more likely to occur in the lower than in the upper extremity. Therefore,
one should avoid the veins of the leg in elderly patients or in those
suffering from such disorders. Gangrene has been reported in a lower extremity
when infusions of norepinephrine were given in an ankle vein.
Extravasation: The infusion site should be checked frequently
for free flow. Care should be taken to avoid extravasation of norepinephrine
into the tissues, as local necrosis might ensue due to the vasoconstrictive
action of the drug. Blanching along the course of the infused vein, sometimes
without obvious extravasation has been attributed to vasa vasorum constriction
with increased permeability of the vein wall, permitting some leakage.
This also may progress on rare occasions to superficial slough, particularly
during infusion into leg veins in elderly patients or in those suffering
from obliterative vascular disease. Hence, if blanching occurs, consideration
should be given to the advisability of changing the infusion site at intervals
to allow the effects of local vasoconstriction to subside.
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IMPORTANT—Antidote for Extravasation Ischemia: To prevent sloughing and necrosis
in areas in which extravasation has taken place, the area should be
infiltrated as soon as possible with 10 mL to 15 mL of
saline solution containing from 5 mg to 10 mg of
Regitine® (brand of phentolamine), an
adrenergic blocking agent. A syringe with a fine hypodermic needle should be
used,with the solution being infiltrated liberally throughout the area,
which is easily identified by its cold, hard and pallid appearance.
Sympathetic blockade with phentolamine causes immediate
and conspicuous local hyperemic changes if the area
is infiltrated within 12 hours. Therefore, phentolamine
should be given as soon as possible after the
extravasation is noted .
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Drug Interactions
See DRUG INTERACTIONS section.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Studies have not been performed .
Pregnancy Category C
Animal reproduction studies have not been conducted with norepinephrine.
It is also not known whether norepinephrine can cause fetal harm when
administered to a pregnant woman or can affect reproduction capacity.
Norepinephrine should be given to a pregnant woman only if clearly needed
Nursing Mothers
It is not known whether this drug is excreted in human milk. Because
many drugs are excreted in human milk, caution should be exercised when
Norepinephrine Bitartrate Injection, USP, is administered to a nursing
woman.
Pediatric Use
Safety and effectiveness in children has not been established
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