SEVOFLURANE liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SEVOFLURANE (UNII: 38LVP0K73A) (SEVOFLURANE - UNII:38LVP0K73A)

Available from:

Baxter Healthcare Corporation

INN (International Name):

SEVOFLURANE

Composition:

SEVOFLURANE 250 mL in 250 mL

Administration route:

RESPIRATORY (INHALATION)

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Sevoflurane, USP is indicated for induction and maintenance of general anesthesia in adult and pediatric patients for inpatient and outpatient surgery. Sevoflurane, USP should be administered only by persons trained in the administration of general anesthesia. Facilities for maintenance of a patent airway, artificial ventilation, oxygen enrichment, and circulatory resuscitation must be immediately available. Since level of anesthesia may be altered rapidly, only vaporizers producing predictable concentrations of sevoflurane, USP should be used.

Product summary:

Sevoflurane, USP, Volatile Liquid for Inhalation, is available as: NDC 10019-651-64 - Aluminum bottle with plastic screw-on cap containing 250 mL sevoflurane, USP. NDC 10019-655-06 - Aluminum bottle with an integrated crimped-on valve closure containing 250 mL sevoflurane, USP. There is no specific work exposure limit established for sevoflurane, USP. However, the National Institute for Occupational Safety and Health has recommended an 8 hour time-weighted average limit of 2 ppm for halogenated anesthetic agents in general (0.5 ppm when coupled with exposure to N2 O) (see ADVERSE REACTIONS). Store at controlled room temperature 15°- 30°C (59°- 86°F). See USP. The bottle cap should be replaced securely after each use of sevoflurane, USP.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SEVOFLURANE- SEVOFLURANE LIQUID
BAXTER HEALTHCARE CORPORATION
----------
SEVOFLURANE, USP
VOLATILE LIQUID FOR INHALATION
DESCRIPTION
Sevoflurane, USP, volatile liquid for inhalation, a nonflammable and
nonexplosive liquid
administered by vaporization, is a halogenated general inhalation
anesthetic drug.
Sevoflurane, USP is fluoromethyl 2,2,2,-trifluoro-1-(trifluoromethyl)
ethyl ether and its
structural formula is:
SEVOFLURANE, USP, PHYSICAL CONSTANTS ARE:
Molecular weight
200.05
Boiling point at 760 mm Hg
58.6°C
Specific gravity at 20°C
1.520 - 1.525
Vapor pressure in mm Hg
157 mm Hg at 20°C
197 mm Hg at 25°C
317 mm Hg at 36°C
DISTRIBUTION PARTITION COEFFICIENTS AT 37°C:
Blood/Gas
0.63 - 0.69
Water/Gas
0.36
Olive Oil/Gas
47 - 54
Brain/Gas
1.15
MEAN COMPONENT/GAS PARTITION COEFFICIENTS AT 25°C FOR POLYMERS USED
COMMONLY IN MEDICAL APPLICATIONS:
Conductive rubber
14.0
Butyl rubber
7.7
Polyvinylchloride
17.4
Polyethylene
1.3
Sevoflurane, USP is nonflammable and nonexplosive as defined by the
requirements of
International Electrotechnical Commission 601-2-13.
Sevoflurane, USP is a clear, colorless, liquid containing no
additives. Sevoflurane, USP is
not corrosive to stainless steel, brass, aluminum, nickel-plated
brass, chrome-plated
brass or copper beryllium. Sevoflurane, USP is nonpungent. It is
miscible with ethanol,
ether, chloroform, and benzene, and it is slightly soluble in water.
Sevoflurane, USP is
stable when stored under normal room lighting conditions according to
instructions. No
discernible degradation of sevoflurane, USP occurs in the presence of
strong acids or
heat. When in contact with alkaline CO absorbents (e.g., Baralyme and
to a lesser
extent soda lime) within the anesthesia machine, Sevoflurane, USP can
undergo
degradation under certain conditions. Degradation of sevoflurane, USP
is minimal, and
degradants are either undetectable or present in non-toxic amounts
when used as
directed with fresh absorbents. Sevoflurane, USP degradation and
subsequent
degradant formation are enhanced by inc