SEVOFLURANE liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Piramal Critical Care Inc

INN (International Name):

SEVOFLURANE

Composition:

SEVOFLURANE 1 mL in 1 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. • Known or suspected genetic susceptibility to malignant hyperthermia. (see WARNINGS - Malignant Hyperthermia, CLINICAL PHARMACOLOGY - Pharmacogenomics ). • Known or suspected sensitivity to sevoflurane or to other halogenated inhalational anesthetics.

Product summary:

Sevoflurane, USP, Volatile Liquid for Inhalation, is packaged in amber-colored bottles containing 250 mL Sevoflurane, USP, NDC # 66794-015-25 and 100 mL Sevoflurane, USP, NDC # 66794-015-10.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SEVOFLURANE- SEVOFLURANE LIQUID
PIRAMAL CRITICAL CARE INC
----------
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 is fluoromethyl 2,2,2-trifluoro-1-(trifluoromethyl) ethyl
ether and its
structural formula is:
SEVOFLURANE, 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 is nonflammable and nonexplosive as defined by the
requirements of
International Electrotechnical Commission 601-2-13.
Sevoflurane is a clear, colorless, liquid containing no additives.
Sevoflurane is not
corrosive to stainless steel, brass, aluminum, nickel-plated brass,
chrome-plated brass
or copper beryllium. Sevoflurane is nonpungent. It is miscible with
ethanol, ether,
chloroform and benzene, and it is slightly soluble in water.
Sevoflurane is stable when
stored under normal room lighting conditions according to
instructions. No discernible
degradation of sevoflurane 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 can undergo degradation
under certain
conditions. Degradation of sevoflurane is minimal, and degradants are
either
undetectable or present in non-toxic amounts when used as directed
with fresh
absorbents. Sevoflurane degradation and subsequent degradant formation
are
enhanced by increasing absorbent temperature increased sevoflurane
concentrati