ISOFLURANE liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Isoflurane (UNII: CYS9AKD70P) (Isoflurane - UNII:CYS9AKD70P)

Available from:

Halocarbon Life Sciences, LLC

INN (International Name):

Isoflurane

Composition:

Isoflurane 1 mL in 1 mL

Administration route:

RESPIRATORY (INHALATION)

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Isoflurane may be used for induction and maintenance of general anesthesia. Adequate data have not been developed to establish its application in obstetrical anesthesia. Known sensitivity to isoflurane, or to other halogenated agents. Known or suspected genetic susceptibility to malignant hyperthermia.

Product summary:

Isoflurane, USP is available in unit packages of 100 mL (NDC 12164-012-10) and 250 mL (NDC 12164-012-25) amber colored bottles. 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 a 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. Store at controlled room temperature 15° - 30°C (59° - 86°F) (see USP). Isoflurane contains no additives and has been demonstrated to be stable at room temperature for a period in excess of five years.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ISOFLURANE- ISOFLURANE LIQUID
HALOCARBON LIFE SCIENCES, LLC
----------
ISOFLURANE, USP
LIQUID FOR INHALATION
RX ONLY
DESCRIPTION
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:
Some physical constants are:
*
Molecular weight
184.5
Boiling point at 760 mm Hg
48.5°C (uncorr.)
Refractive index n
1.2990-1.3005
Specific gravity 25° / 25°C
1.496
Vapor pressure in mm Hg
20°C
238
25ºC
295
30°C
367
35°C
450
Log
P
=
A + B
T
where:
A=8.056
B=-1664.58
T=°C = 273.16 (Kelvin
Partition coefficients at 37°C:
Water / gas
0.61
Blood / gas
1.43
Oil / gas
90.8
Partition coefficients at 25°C - rubber and plastic
Conductive rubber / gas
62.0
Equation for vapor pressure calculation:
20
D
*
10
vap
Butyl rubber / gas
75.0
Polyvinyl chloride / gas
110.0
Polyethylene / gas
~2.0
Polyurethane / gas
~1.4
Polyolefin / gas
~1.1
Butyl acetate / gas
~2.5
Purity by gas chromatography
>99.9%
Lower limit of flammability in
oxygen or nitrous oxide at 9
joules/sec. and 23ºC
None
Lower limit of flammability in
oxygen or nitrous oxide at 900
joules/sec. and 23ºC
Greater than useful
concentration in
anesthesia
Isoflurane is a clear, colorless, stable liquid containing no
additives or chemical stabilizers. Isoflurane
has a mildly pungent, musty, ethereal odor. Samples stored in indirect
sunlight in clear, colorless glass
for five years, as well as samples directly exposed for 30 hours to a
2 amp, 115 volt, 60 cycle long
wave U.V. light 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.
CLINICAL PHARMACOLOGY
Isoflurane is an inhalation anesthetic. The MAC (minimum alveo