SEVOFLURANE liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Sandoz Inc.

INN (International Name):

SEVOFLURANE

Composition:

SEVOFLURANE 250 mL in 250 mL

Administration route:

RESPIRATORY (INHALATION)

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Sevoflurane is indicated for induction and maintenance of general anesthesia in adult and pediatric patients for inpatient and outpatient surgery. Sevoflurane 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 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 is a volatile, clear and colorless inhalation liquid, and is packaged in Type III amber glass bottles containing 250 mL sevoflurane, NDC # 0781-6160-43. Each individual bottle is supplied in a carton of 6, NDC 0781-6160-86.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SEVOFLURANE- SEVOFLURANE LIQUID
SANDOZ 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 mmHg 58.6°C
Specific gravity at 20°C
1.520 to 1.525
Vapor pressure in mm Hg 157 mmHg at 20°C
197 mmHg at 25°C
317 mmHg at 36°C
DISTRIBUTION PARTITION COEFFICIENTS AT 37°C:
Blood/Gas
0.63 to 0.69
Water/Gas
0.36
Olive Oil/Gas
47 to 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
concentration,
decreased