ISOFLURANE liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Piramal Critical Care Inc

INN (International Name):

ISOFLURANE

Composition:

ISOFLURANE 1 mL in 1 mL

Administration route:

RESPIRATORY (INHALATION)

Prescription type:

PRESCRIPTION

Therapeutic indications:

Isoflurane, USP is used for induction and maintenance of general anesthesia in horses and dogs. Isoflurane, USP is contraindicated in horses and dogs with known sensitivity to isoflurane or to other halogenated agents.

Product summary:

Isoflurane, USP is packaged in 100 mL (NDC 66794-013-10) and 250 mL (NDC 66794-013-25) amber-colored bottles.

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

ISOFLURANE - ISOFLURANE LIQUID
PIRAMAL CRITICAL CARE INC
----------
WARNING: NOT FOR USE IN HORSES INTENDED FOR FOOD
ISOFLURANE, USP
INHALATION ANESTHETIC
FOR VETERINARY USE IN HORSES AND DOGS
CAUTION:
Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
DESCRIPTION
Isoflurane, USP is a nonflammable, nonexplosive general inhalation
anesthetic agent. Its
chemical name is 1-chloro-2,2,2-trifluoroethyl difluoromethyl ether,
and its structural
formula is:
Each mL contains 99.9% isoflurane.
Some physical constants are:
Molecular weight 184.5
Boiling point at 760 mm Hg 48.5° C (uncorr.)
Refractive index _n_ 20
1.2990-1.3005
D
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 + 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
10 vap
Partition coefficients at 25° C - rubber and plastic:
Conductive rubber/gas 62.0
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 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.
MAC (Minimum Alveolar Concentration) is 1.31% in horses and 1.28% in
dogs.
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, indicat