国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
ISOFLURANE (UNII: CYS9AKD70P) (ISOFLURANE - UNII:CYS9AKD70P)
Piramal Critical Care Inc
RESPIRATORY (INHALATION)
PRESCRIPTION DRUG
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.
Isoflurane, USP is packaged in 100 mL and 250 mL amber-colored bottles. 100 mL - NDC 66794-020-10 250 mL - NDC 66794-020-25
Abbreviated New Drug Application
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: log _P_ = A+ B where: A = 8.056 T B = -1664.58 T = °C + 273.16 (Kelvin) PARTITION COEFFICIENTS AT 37°C Water/gas 0.61 Blood/gas 1.43 Oil/gas 90.8 10 vap 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 li 阅读完整的文件