Nervous System
Isotoran (Liquid for Inhalation) (Isoflurane)
CONTENT
Fluid for inhalation. 100 ml of the
preparation contain isoflurane 99,9 g.
PHARMACOLOGIC
PROPERTIES
PHARMACODYNAMICS
Isotoran is a medication for inhalation anesthesia. It
induces a rapid induction of general anesthesia, diminishing of pharyngeal and
laryngeal reflexes and moderate muscle relaxation.
Muscle relaxation may be adequate for some surgical
operations at normal levels of general anesthesia, but should greater muscle
relaxation be required small doses of muscle relaxants may be used. A depth of
anesthesia change rapidly with isoflurane. Although slight pungency may limit
the rate of Isotoran
induction, excessive secretion of salivary and tracheobronchial glands are not
stimulated.
pharmacokinetics
Relatively little metabolism of isoflurane occurs in
the human body. In the post operative period only 0.17% of isoflurane can be
found as urinary metabolites. Inorganic fluoride Cmax value in blood
serum averages less than 5 umol/l and it is determined during 4 hours after
anesthesia, returning to normal levels within the following 24 hours.
therapeutic indicationS
- for inhalation anesthesia
in combination with oxygen or with oxygen +
nitrous oxide mixture.
DOSAGE AND ADMINISTRATION
Vaporizers specially calibrated should be used so that
the concentration of isoflurane
delivered can be accurately controlled.
Minimum alveolar concentration
(MAC)
for isoflurane depends on the age
Age |
100% oxygen |
N2O (60%) + O2 |
N2O (70%) + O2 |
0 - 1
month (prematurely borns) |
1.60% |
- |
- |
1 - 6 months |
1.87% |
- |
- |
7 - 11 months |
1.80% |
- |
- |
1 - 2 years |
1.60% |
- |
- |
3 - 5 years |
1.62% |
- |
- |
6 - 10 years |
1.40% |
0.58% |
- |
10 - 15 years |
1.16% |
0.53% |
- |
26 +/- 4 years |
1.28% |
- |
0.56% |
44 +/- 7 years |
1.15% |
- |
0.50% |
64 +/- 5 years |
1.05% |
- |
0.37% |
Premedication. Drugs used for
premedication should be selected for individual patient bearing in mind the
respiratory depressant effect of isoflurane. In case of need anticholinergic
drugs can be used.
Induction. It is recommended
that inhalational induction with Isotoran be initiated at a concentration of
0.5%. Concentrations of 1.5 to 3.0% usually produce surgical anesthesia in 7 to
10 minutes.
Maintenance. Surgical levels
of anesthesia may be maintained with 1-2.5% isoflurane in oxygen/nitrous oxide
mixture. An additional 0.5-1% isoflurane may be required when given with oxygen
alone.
For caesarean section, 0.5-0.75% isoflurane in a mixture of oxygen/nitrous oxide
is suitable to maintain general anesthesia for this procedure.
CONTRAINDICATIONS
- malignant hyperthermiain anamnesis
- sensitivity to isoflurane.
SIDE EFFECTS
Cardiovascular system: heart
rhythm disturbances and arterial hypotension can occur.
Laboratory indices:
elevation leukocytes count even in the absence of surgical
stress.
Respiration system:
respiratory depression can occur.
During recovery: in rare cases
- tremor,
nausea,
vomiting.
PACKAGING
100 ml of liquid for inhalation anesthesia in umber vial with adapter for
vaporizer.
1 vial together with instruction on drug administration in a carton box.
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