ISOFLURANE - isoflurane liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Clipper Distributing Co.

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 57319-396-05) and 250 mL (NDC 57319-396-06) amber-colored bottles. Store at room temperature 20o to 25o C (68o to 77o F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

ISOFLURANE - ISOFLURANE LIQUID
CLIPPER DISTRIBUTING CO.
----------
CAUTION
Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
WARNING: NOT FOR USE IN HORSES INTENDED FOR FOOD.
DESCRIPTION
Isoflurane, USP is a nonflammable, nonexplosive general inhalation
anesthetic agent. Its chemical name
is l-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 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: log10Pvap = 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
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 horses1 and 1.28% in
dogs.6 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