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
Suprane Side Effects, and Drug Interactions - Desflurane
Suprane Side Effects, and Drug Interactions - Desflurane
SIDE EFFECTS
Adverse event information is derived from controlled clinical trials, the majority
of which were conducted in the United States. The studies were conducted using
a variety of premedications, other anesthetics, and surgical procedures of varying
length. Most adverse events reported were mild and transient, and may reflect
the surgical procedures, patient characteristics (including disease) and/or
medications administered.
Of the 1,843 patients exposed to SUPRANE® (desflurane, USP) in clinical trials,
370 adults and 152 children were induced with desflurane alone and 687 patients
were maintained principally with desflurane. The frequencies given reflect the
percent of patients with the event. Each patient was counted once for each type
of adverse event. They are presented in alphabetical order according to body
system.
PROBABLY CAUSALLY RELATED: Incidence greater than 1%.
|
Induction (use as a mask inhalation agent):
|
|
ADULT PATIENTS (N=370):
|
Coughing 34%, breathholding 30%, apnea 15%,
increased secretions * , laryngospasm *
oxyhemoglobin desaturation (SpO 2 <90%) *
pharyngitis *
|
|
PEDIATRIC PATIENTS (N=152):
|
Coughing 72%, breathholding 68%, laryngospasm
50%, oxyhemoglobin desaturation (SpO 2 <90%)
26%, increased secretions 21%, bronchospasm *
(See WARNINGS )
|
|
Maintenance or Recovery
|
|
ADULT AND PEDIATRIC PATIENTS (N=687):
|
|
Body as a Whole:
|
Headache.
|
|
Cardiovascular:
|
Bradycardia, hypertension, nodal arrhythmia, tachycardia.
|
|
Digestive:
|
Nausea 27%, vomiting 16%.
|
|
Nervous system:
|
Increased Salivation.
|
|
Respiratory:
|
Apnea * , breathholding, cough increased * laryngospasm
* , pharyngitis.
|
|
Special Senses:
|
Conjunctivitis (conjunctival hyperemia)
|
|
* Incidence of events: 3%-10%
|
| |
|
PROBABLY CAUSALLY RELATED: Incidence less than 1% and
reported in 3 or more patients, regardless of severity (N=1,843) Adverse
reactions reported only from postmarketing experience or in the literature,
not seen in clinical trials, are considered rare and are italicized.
|
|
Cardiovascular:
|
Arrhythmia, bigeminy, abnormal electrocardiogram, myocardial
ischemia, vasodilation.
|
|
Digestive:
|
Hepatitis .
|
|
Nervous System:
|
Agitation, dizziness.
|
|
Respiratory:
|
Asthma, dyspnea, hypoxia.
|
|
CAUSAL RELATIONSHIP UNKNOWN: Incidence less than 1%
and reported in 3 or more patients, regardless of severity (N=1,843)
|
|
Body as a Whole:
|
Fever.
|
|
Cardiovascular:
|
Hemorrhage, myocardial infarct.
|
|
Metabolic and Nutrition:
|
Increased creatinine phosphokinase.
|
|
Musculoskeletal System:
|
Myalgia.
|
|
Skin and Appendages:
|
Pruritis.
|
See PRECAUTIONS for information regarding pediatric use and malignant hyperthermia.
Laboratory Findings: Transient elevations in glucose and
white blood cell count may occur as with use of other anesthetic agents.
DRUG ABUSE AND DEPENDENCE
The potential drug abuse liability, and dependence associated with SUPRANE®
(desflurane, USP) have not been studied.
DRUG INTERACTIONS
No clinically significant adverse interactions with commonly used preanesthetic
drugs, or drugs used during anesthesia (muscle relaxants, intravenous agents,
and local anesthetic agents) were reported in clinical trials. The effect of
desflurane on the disposition of other drugs has not been determined.
Like isoflurane, desflurane does not predispose to premature ventricular arrhythmias
in the presence of exogenously infused epinephrine in swine.
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