Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/941
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Isoflurane (Liquid)
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Premedication: Premedication should be selected according to the need of the individual
patient, taking into account that secretions are weakly stimulated
by Isoflurane, USP and the heart rate tends to be increased. The use
of anticholinergic drugs is a matter of choice. Inspired Concentration: The concentration
of isoflurane being delivered from a vaporizer during anesthesia should
be known. This may be accomplished by using: Isoflurane contains no stabilizer. Nothing in the
agent alters calibration or operation of these vaporizers. Induction: Induction
with isoflurane in oxygen or in combination with oxygen-nitrous oxide
mixtures may produce coughing, breath holding, or laryngospasm. These
difficulties may be avoided by the use of a hypnotic dose of an ultra-short-acting
barbiturate. Inspired concentrations of 1.5 to 3 % isoflurane usually
produce surgical anesthesia in 7 to 10 minutes. Maintenance: Surgical levels
of anesthesia may be sustained with a 1 to 2.5% concentration when
nitrous oxide is used concomitantly. An additional 0.5 to 1 % may
be required when isoflurane is given using oxygen alone. If added
relaxation is required, supplemental doses of muscle relaxant may
be used. The level of blood pressure during
maintenance is an inverse function of isoflurane concentration in
the absence of other complicating problems. Excessive decreases may
be due to depth of anesthesia and in such instances may be corrected
by lightening anesthesia.
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Isoflurane, USP, a nonflammable liquid administered
by vaporizing, is a general inhalation anesthetic drug. It is 1-chloro-2,2,2-trifluoroethyl
difluoromethyl ether, and its structural formula is: Isoflurane is a clear, colorless, stable liquid
containing no additives or chemical stabilizers. Isoflurane has a
mildly pungent, musty, ethereal odor. Samples stored in stability
chambers in amber glass for five years, as well as samples directly
exposed for 7 days to accelerated light conditions were unchanged
in composition as determined by gas chromatography. Isoflurane in
one normal sodium methoxide-methanol solution, a strong base, for
over six months consumed essentially no alkali, indicative of strong
base stability. Isoflurane does not decompose in the presence of soda
lime, (at normal operating temperatures), and does not attack aluminum,
tin, brass, iron or copper.
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Isoflurane, USP is an inhalation anesthetic. The
MAC (minimum alveolar concentration) in man is as follows: Induction of and recovery from isoflurane anesthesia
are rapid. Isoflurane has a mild pungency which limits the rate of
induction, although excessive salivation or tracheobronchial secretions
do not appear to be stimulated. Pharyngeal and laryngeal reflexes
are readily obtunded. The level of anesthesia may be changed rapidly
with isoflurane. Isoflurane is a profound respiratory depressant.
RESPIRATION MUST BE MONITORED CLOSELY AND SUPPORTED WHEN NECESSARY.
As anesthetic dose is increased, tidal volume decreases and respiratory
rate is unchanged. This depression is partially reversed by surgical
stimulation, even at deeper levels of anesthesia. Isoflurane evokes
a sigh response reminiscent of that seen with diethyl ether and enflurane,
although the frequency is less than with enflurane. Blood pressure decreases with induction of anesthesia but returns
toward normal with surgical stimulation. Progressive increases in
depth of anesthesia produce corresponding decreases in blood pressure.
Nitrous oxide diminishes the inspiratory concentration of isoflurane
required to reach a desired level of anesthesia and may reduce the
arterial hypotension seen with isoflurane alone. Heart rhythm is remarkably
stable. With controlled ventilation and normal PaCO, cardiac
output is maintained despite increasing depth of anesthesia primarily
through an increase in heart rate which compensates for a reduction
in stroke volume. The hypercapnia which attends spontaneous ventilation
during isoflurane anesthesia further increases heart rate and raises
cardiac output above awake levels. Isoflurane does not sensitize the
myocardium to exogenously administered epinephrine in the dog. Limited
data indicate that subcutaneous injection of 0.25 mg of epinephrine
(50 mL of 1:200,000 solution) does not produce an increase in ventricular
arrhythmias in patients anesthetized with isoflurane. Muscle relaxation is often adequate for intra-abdominal operations
at normal levels of anesthesia. Complete muscle paralysis can be attained
with small doses of muscle relaxants. ALL COMMONLY USED MUSCLE RELAXANTS
ARE MARKEDLY POTENTIATED WITH ISOFLURANE, THE EFFECT BEING MOST PROFOUND
WITH THE NONDEPOLARIZINGTYPE. Neostigmine reverses the effect of
nondepolarizing muscle relaxants in the presence of isoflurane. Allcommonly used muscle relaxants are compatible with isoflurane. Isoflurane can produce coronary vasodilation at the arteriolar
level in selected animal models; the drug is probably
also a coronary dilator in humans. Isoflurane, like some other coronary
arteriolar dilators, has been shown to divert blood from collateral
dependent myocardium to normally perfused areas in an animal model
(���coronary steal���). Clinical studies to
date evaluating myocardial ischemia, infarction and death as outcome
parameters have not established that the coronary arteriolar dilation
property of isoflurane is associated with coronary steal or myocardial
ischemia in patients with coronary artery disease. Pharmacokinetics: Isoflurane undergoes minimal biotransformation in man. In the postanesthesia
period, only 0.17% of the isoflurane taken up can be recovered as
urinary metabolites.
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Known sensitivity to Isoflurane, USP or to other
halogenated agents. Known or suspected genetic
susceptibility to malignant hyperthermia.
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Isoflurane, USP, is supplied in 100 mL and 250 mL
amber-colored bottles (NDC 0409-3292-01 and NDC 0409-3292-02). Safety and Handling: Occupational Caution: There is no specific work exposure limit established
for Isoflurane, USP. However, the National Institute for Occupational
Safety and Health Administration (NIOSH) recommends that no worker
should be exposed at ceiling concentrations greater than 2 ppm of
any halogenated anesthetic agent over a sampling period not to exceed
one hour. The predicted effects of acute overexposure
by inhalation of Isoflurane, USP include headache, dizziness or (in
extreme cases) unconsciousness. There are no documented adverse effects
of chronic exposure to halogenated anesthetic vapors (Waste Anesthetic
Gases or WAGs) in the workplace. Although results of some epidemiological
studies suggest a link between exposure to halogenated anesthetics
and increased health problems (particularly spontaneous abortion),
the relationship is not conclusive. Since exposure to WAGs is one
possible factor in the findings for these studies, operating room
personnel, and pregnant women in particular, should minimize exposure.
Precautions include adequate general ventilation in the operating
room, the use of well-designed and well-maintained scavenging system,
work practices to minimize leaks and spills while the anesthetic agent
is in use, and routine equipment maintenance to minimize leaks. Storage: Store at
20 to 25��C (68 to 77��F). [See USP Controlled Room Temperature.]
Isoflurane contains no additives and has been demonstrated to be stable
at room temperature for periods in excess of five years.
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General:: As with any potent general anesthetic, Isoflurane,
USP should only be administered in an adequately equipped anesthetizing
environment by those who are familiar with the pharmacology of the
drug and qualified by training and experience to manage the anesthetized
patient. Regardless of the anesthetics employed,
maintenance of normal hemodynamics is important to the avoidance of
myocardial ischemia in patients with coronary artery disease. Isoflurane, like some other inhalational
anesthetics, can react with desiccated carbon dioxide (CO) absorbents to produce carbon monoxide which may result in elevated
levels of carboxyhemoglobin in some patients. Case reports suggest
that barium hydroxide lime and soda lime become desiccated when fresh
gases are passed through the COabsorber canister at high
flow rates over many hours or days. When a clinician suspects that
COabsorbent may be desiccated, it should be replaced
before the administration of isoflurane. As
with other halogenated anesthetic agents, isoflurane may cause sensitivity
hepatitis in patients who have been sensitized by previous exposure
to halogenated anesthetics (see CONTRAINDICATIONS).<br/>Information to Patients:: Isoflurane, as well as other general anesthetics,
may cause a slight decrease in intellectual function for 2 or 3 days
following anesthesia. As with other anesthetics, small changes in
moods and symptoms may persist for up to 6 days after administration.<br/>Laboratory Tests:: Transient increases in BSP retention, blood glucose
and serum creatinine with decrease in BUN, serum cholesterol and alkaline
phosphatase have been observed.<br/>Drug Interactions:: Isoflurane potentiates the muscle relaxant effect
of all muscle relaxants, most notably nondepolarizing muscle relaxants,
and MAC (minimum alveolar concentration) is reduced by concomitant
administration of NO. See CLINICAL PHARMACOLOGY.<br/>Carcinogenesis, Mutagenesis,
Impairment of Fertility:: Swiss ICR mice were given isoflurane to determine
whether such exposure might induce neoplasia. Isoflurane was given
at 1/2, 1/8 and 1/32 MAC for four in-utero exposures and for 24 exposures
to the pups during the first nine weeks of life. The mice were killedat 15 months of age. The incidence of tumors in these mice was the
same as in untreated control mice, which were given the same background
gases, but not the anesthetic.<br/>Pregnancy Category C:: Isoflurane has been shown to have a possible anesthetic-related
fetotoxic effect in mice when given in doses 6 times the human dose.
There are no adequate and well-controlled studies in pregnant women.
Isoflurane should be used during pregnancy only if the potential benefit
justifies the potential risk to the fetus.<br/>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 isoflurane is administered to a nursing woman.
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In the event of overdosage, or what may appear to
be overdosage, the following action should be taken: Stop drug administration, establish a clear airway and initiate assisted
or controlled ventilation with pure oxygen.
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Isoflurane
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Isoflurane (Liquid)
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Adverse reactions encountered in the administration
of Isoflurane, USP are in general dose dependent extensions of pharmacophysiologic
effects and include respiratory depression, hypotension and arrhythmias. Shivering, nausea, vomiting and ileus have been observed
in the postoperative period. As with all other
general anesthetics, transient elevations in white blood count have
been observed even in the absence of surgical stress. See WARNINGS for information regarding malignant hyperthermia and elevated carboxyhemoglobin
levels. During marketing, there have been rare
reports of mild, moderate and severe (some fatal) post-operative hepatic
dysfunction and hepatitis. Isoflurane, USP has
also been associated with perioperative hyperkalemia (see WARNINGS). There have been rare post-marketing reports
of hepatic failure and hepatic necrosis associated with the use of
potent volatile anesthetic agents, including Isoflurane, USP. Due
to the spontaneous nature of these reports, the actual incidence and
relationship of Isoflurane, USP to these events cannot be established
with certainty.
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Perioperative Hyperkalemia: Use of inhaled anesthetic agents has been associated with rare increases
in serum potassium levels that have resulted in cardiac arrhythmias
and death in pediatric patients during the postoperative period. Patients
with latent as well as overt neuromuscular disease, particularly Duchenne
muscular dystrophy, appear to be most vulnerable. Concomitant used
of Succinylcholine has been associated with most, but not all, of
these cases. These patients also experienced significant elevations
in serum creatinine kinase levels and, in some cases, changes in urine
consistent with myoglobinuria. Despite the similarity in presentation
to malignant hyperthermia, none of these patients exhibited signs
or symptoms of muscle rigidity or hypermetabolic state. Early and
aggressive intervention to treat hyperkalemia and resistant arrhythmias
is recommended, as is subsequent evaluation for latent neuromuscular
disease. Malignant
Hyperthermia: In susceptible individuals, isoflurane anesthesia
may trigger a skeletal muscle hypermetabolic state leading to high
oxygen demand and the clinical syndrome known as malignant hyperthermia.
The syndrome includes nonspecific features such as muscle rigidity,
tachycardia, tachypnea, cyanosis, arrhythmias, and unstable blood
pressure. (It should also be noted that many of these nonspecific
signs may appear with light anesthesia, acute hypoxia, etc.) An increase
in overall metabolism may be reflected in an elevated temperature,
(which may rise rapidly early or late in the case, but usually is
not the first sign of augmented metabolism) and an increased usage
of the CO2 absorption system (hot canister). PaO2 and pH may decrease,
and hyperkalemia and a base deficit may appear. Treatment includes
discontinuance of triggering agents (e.g., isoflurane), administration
of intravenous dantrolene sodium, and application of supportive therapy.
Such therapy includes vigorous efforts to restore body temperature
to normal, respiratory and circulatory support as indicated, and management
of electrolyte-fluid-acid-base derangements. (Consult prescribing
information for dantrolene sodium intravenous for additional information
on patient management). Renal failure may appear later, and urine
flow should be sustained if possible. Since
levels of anesthesia may be altered easily and rapidly, only vaporizers
producing predictable concentrations should be used. Hypotension and
respiratory depression increase as anesthesia is deepened. Increased blood loss comparable to that seen with halothane
has been observed in patients undergoing abortions. Isoflurane, USP markedly increases cerebral blood flow at deeper
levels of anesthesia. There may be a transient rise in cerebral spinal
fluid pressure which is fully reversible with hyperventilation.
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Isoflurane, USP may be used for induction and maintenance
of general anesthesia. Adequate data have not been developed to establish
its application in obstetrical anesthesia.
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Isoflurane
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