FORANE- isoflurane inhalant

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ISOFLURANE (UNII: CYS9AKD70P) (ISOFLURANE - UNII:CYS9AKD70P)

Available from:

Baxter Healthcare Corporation

INN (International Name):

ISOFLURANE

Composition:

ISOFLURANE 1 mL in 1 mL

Administration route:

RESPIRATORY (INHALATION)

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

FORANE may be used for induction and maintenance of general anesthesia. Adequate data have not been developed to establish its application in obstetrical anesthesia. Isoflurane is contraindicated in patients:

Product summary:

FORANE is available in the following presentations: FILL CONTAINER PACK SIZE NDC 100 mL Amber-colored Glass 6 Bottles 10019-360-40 250 mL Amber-colored Glass 6 Bottles 10019-360-60 250 mL Aluminum 6 Bottles 10019-360-64 There is no specific work exposure limit established for FORANE. 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 FORANE include headache, dizziness or (in extreme cases) unconsciousness. There are no documented adverse effects of chronic exposure to halogenated anesthetic vapors (W aste A nesthetic G ases 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 (See PRECAUTIONS). Store at room temperature 15°C-30°C (59°F-86°F). Isoflurane contains no additives and has been demonstrated to be stable at room temperature for periods in excess of five years.

Authorization status:

New Drug Application

Summary of Product characteristics

FORANE- ISOFLURANE INHALANT
BAXTER HEALTHCARE CORPORATION
----------
FORANE (ISOFLURANE, USP) LIQUID FOR INHALATION
DESCRIPTION
FORANE (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
Refractive index _n _
1.2990-1.3005
Specific gravity 25°/25°C
1.496
Vapor pressure in mm Hg**
20°C
238
25°C
295
30°C
367
35°C
450
**Equation for vapor pressure calculation:
log
P
= A +
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
Butyl rubber/gas
75.0
Polyvinyl chloride/gas
110.0
20
D
10 vap
B
T
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 23°C
None
Lower limit of flammability in oxygen
or nitrous oxide at 900 joules/sec. and 23°C
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
Induction of and recovery from isoflurane anesthesia are rapid.
Isoflurane