ISOFLURANE liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Butler Animal Health Supply, LLC

Administration route:

RESPIRATORY (INHALATION)

Prescription type:

PRESCRIPTION

Therapeutic indications:

Isoflurane is used for induction and maintenance of general anesthesia in horses and dogs. Isoflurane 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 11695-6777-1) and 250 mL (NDC 11695-6777-2) amber-colored bottles. Storage: Store at room temperature 20o C to 25o C (68o F to 77o F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

ISOFLURANE - ISOFLURANE LIQUID
BUTLER ANIMAL HEALTH SUPPLY, LLC
----------
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.
SPL UNCLASSIFIED SECTION
WARNING: Not for use in horses intended for food
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 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 _n_ 20
D
1.2990 to 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 + B/T where: A = 8.056
B = -1664.58
T = °C + 273.16 (Kelvin)
10_ vap_
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 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