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 DRUG

Therapeutic indications:

Isoflurane 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: • in whom general anesthesia is contraindicated. • with known sensitivity to isoflurane or to other halogenated agents. • with known or suspected genetic susceptibility to malignant hyperthermia (see WARNINGS /Malignant Hyperthermia, CLINICAL PHARMACOLOGY / Pharmacogenomics). • with a history of confirmed hepatitis due to a halogenated inhalational anesthetic or a history of unexplained moderate to severe hepatic dysfunction (e.g., jaundice associated with fever and/or eosinophilia) after anesthesia with isoflurane or other halogenated inhalational anesthetics.

Product summary:

Isoflurane, USP is packaged in 100 mL and 250 mL amber-colored bottles. 100 mL - NDC 66794-017-10 250 mL - NDC 66794-017-25

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ISOFLURANE- ISOFLURANE LIQUID
PIRAMAL CRITICAL CARE, INC.
----------
ISOFLURANE, USP
LIQUID FOR INHALATION
RX ONLY
DESCRIPTION
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
1.2990-1.3005
Specific gravity 25°/25°C
1.496
Vapor pressure in mm Hg**20°C238
25°C295
30°C367
35°C450
**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
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 has a mild
pungency which limits the rate of induction, although excessive
salivation or
tracheobronchial