ISOFLURANE liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Akorn

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 250 mL (NDC 59399-106-01) amber-colored bottles.

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

ISOFLURANE- ISOFLURANE LIQUID
AKORN
----------
WARNING: Not for use in horses intended for food.
ISOFLURANE,USP
INHALATION ANESTHETIC
FOR 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 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
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:
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
Greater than useful
or nitrous oxide at 900 joules/sec.
concentration in
and 23°C
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, indicative of strong base stability.
Isoflurane does not
decompose in the presence of soda lime (at normal operating
temperatures), and do