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
Inapsine Warnings, Precautions, Pregnancy, Nursing, Abuse - Droperidol
Inapsine Warnings, Precautions, Pregnancy, Nursing, Abuse - Droperidol
WARNINGS
FLUIDS AND OTHER COUNTERMEASURES TO
MANAGE HYPOTENSION SHOULD BE READILY AVAILABLE.
As with other CNS depressant
drugs, patients who have received INAPSINE (droperidol) should have
appropriate surveillance.
It is recommended that opioids, when required, initially be used
in reduced doses.
As with other neuroleptic
agents, very rare reports of neuroleptic
malignant syndrome (altered consciousness, muscle
rigidity and autonomic
instability) have occurred in patients who have received INAPSINE
(droperidol).
Since it may be difficult to distinguish neuroleptic
malignant syndrome
from malignant hyperpyrexia
in the perioperative
period, prompt treatment
with dantrolene should be considered if increases in temperature
heart rate or carbon
dioxide production
occur.
Cases of sudden death
have been reported following use of droperidol at high doses (generally
25 mg or greater) in patients
at risk for cardiac dysrhythmia
due to anoxia, hypercarbia, severe electrolyte
disturbances, or alcohol
withdrawal. While these reports do not establish the cause
of such death, QT prolongation
after INAPSINE administration
has been reported and there is at least one case
of nonfatal torsade de pointes confirmed by rechallenge.
Because of these reports, INAPSINE is not recommended in the treatment
of alcohol withdrawal
or in other clinical
situations where high doses are likely to be needed in patients
at risk for dysrhythmia.
PRECAUTIONS
General
The initial dose
of INAPSINE (droperidol) should be appropriately reduced in elderly,
debilitated and other poor-risk patients. The effect
of the initial dose should
be considered in determining incremental doses.
Certain forms of conduction
anesthesia, such
as spinal anesthesia
and some peridural
anesthetics, can alter respiration
by blocking intercostal
nerves and can cause peripheral
vasodilatation
and hypotension
because of sympathetic
blockade. Through other mechanisms (see CLINICAL
PHARMACOLOGY), INAPSINE can also alter circulation. Therefore,
when INAPSINE is used to supplement these forms of anesthesia,
the anesthetist should be familiar with the physiological
alterations involved, and be prepared to manage them in the patients
elected for these forms of anesthesia.
If hypotension
occurs, the possibility of hypovolemia
should be considered and managed with appropriate
parenteral fluid
therapy. Repositioning the patient to improve venous
return to the heart should
be considered when operative conditions permit. It should be noted
that in spinal and peridural
anesthesia, tilting the patient
into a head-down position
may result in a higher level of anesthesia
than is desirable, as well as impair venous return to the heart.
Care should be exercised in moving and positioning of patients because
of a possibility of orthostatic
hypotension. If volume expansion with fluids plus these other countermeasures
do not correct the hypotension, then the administration
of pressor agents other
than epinephrine should be considered. Epinephrine may paradoxically
decrease the blood pressure in patients treated with INAPSINE due
to the alpha- adrenergic blocking action
of INAPSINE.
Since INAPSINE may decrease pulmonary
arterial pressure,
this fact should be considered by those who conduct diagnostic
or surgical procedures
where interpretation of pulmonary
arterial pressure
measurements might determine final management of the patient. Vital
signs should be monitored routinely. When the EEG
is used for postoperative monitoring, it may be found that the EEG
pattern returns to normal
slowly.
Impaired Hepatic or Renal Function
INAPSINE should be administered with caution to patients with liver
and kidney dysfunction
because of the importance of these organs in the metabolism and
excretion of drugs.
Pheochromocytoma
In patients with diagnosed/suspected pheochromocytoma,
severe hypertension and tachycardia
have been observed after the administration
of INAPSINE (droperidol).
Carcinogenesis, Mutagenesis, Impairment of Fertility
No carcinogenicity studies have been carried out with INAPSINE.
The micronucleus test in
female rats revealed
no mutagenic effects in single
oral doses as high as 160 mg/kg. An
oral study in rats (Segment
1) revealed no impairment
of fertility in either
male or females at 0.63,
2.5 and 10 mg/kg doses (approximately 2, 9 and 36 times maximum
recommended human iv/im dosage).
Pregnancy
Category C: INAPSINE administered intravenously has
been shown to cause a
slight increase in mortality
of the newborn rat
at 4.4 times the upper human
dose. At 4.4 times the upper
human dose, mortality
rate was comparable to that for control
animals. Following intramuscular administration, increased mortality
of the offspring at 1.8 times the upper human dose
is attributed to CNS depression
in the dams who neglected to remove placentae from their offspring.
INAPSINE has not been shown to be teratogenic in animals. There
are no adequate and well-controlled
studies in pregnant
women. INAPSINE should be used during pregnancy
only - if the potential benefit
justifies the potential
risk to the fetus.
Labor and Delivery
There are insufficient data to support
the use of INAPSINE in labor and delivery. Therefore such
use is not recommended.
Nursing Mothers
It is not known whether INAPSINE is excreted in human
milk. Because many, drugs are excreted in human
milk, caution should be exercised when INAPSINE is administered
to a nursing mother.
Pediatric Use
The safety of INAPSINE in children younger than two years of age
has not been established.
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