ISOFLURANE- isoflurane inhalant

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ISOFLURANE (UNII: CYS9AKD70P) (ISOFLURANE - UNII:CYS9AKD70P)

Available from:

Clipper Distributing Company LLC

INN (International Name):

ISOFLURANE

Composition:

ISOFLURANE 1 mL in 1 mL

Administration route:

RESPIRATORY (INHALATION)

Prescription type:

PRESCRIPTION

Therapeutic indications:

Isoflurane, USP is used for induction and maintenance of general anesthesia in horses and dogs. Isoflurane, USP is contraindicated in horses and dogs with known sensitivity to isoflurane or to other halogenated agents.

Product summary:

Isoflurane, USP is packaged in 100 mL and 250 mL amber-colored bottles. 100 ml - NDC 57319-507-05 250 ml - NDC 57319-507-06 Storage: Store at controlled room temperature 15° to 30°C (59° to 86°F). References: 1. Steffey, E.P., Howland, D. Jr., Giri, S. and Eger, E.l. II.: Enflurane, Halothane and Isoflurane      Potency in Horses.      Am. J. Vet. Res. 38(7): 1037-1039, 1977. 2. Auer, J.A., Garner, H.E., Amend, J.F., Hutcheson, D.P. and Salem, C.A.: Recovery from      Anesthesia in Ponies: A Comparative Study of the Effects of Isoflurane, Enflurane,      Methoxyflurane and Halothane. Equine Vet. J. 10(1): 18-23, 1978. 3. Steffey, E.P. and Howland, D. Jr.: Comparison of Circulatory and Respiratory Effects of      Isoflurane and Halothane Anesthesia in Horses.      Am. J. Vet. Res. 41(5): 821-825, 1980. 4. Auer, J.A., Amend, J.F., Garner, H.E., Hutcheson, D.P. and Salem, C.A.:      Electroencephalographic Responses During Volatile Anesthesia in Domestic Ponies: A      Comparative Study of Isoflurane, Enflurane, Methoxyflurane and Halothane.      Equine Practice 3: 130-134, 1979. 5. Klide A.M.: Cardiopulmonary Effects of Enflurane and Isoflurane in the Dog.      Am. J. Vet. Res., Vol. 37, No. 2: 127-131, 1976. 6. Steffey, E.P. and Howland, D. Jr.: Isoflurane Potency in the Dog and Cat.      Am. J. Vet. Res., Vol. 38, No. 11: 1833-1836, 1977. Manufactured for: Clipper Distributing Company, LLC St. Joseph, MO  64507, USA Product of United Kingdom ANADA # 200-070, Approved by FDA Distributed Exclusively By: Clipper Distributing Company, LLC St Joseph, MO  64507, USA Revised 2014 Product inquiries should be directed to Abbott Laboratories North Chicago, IL 60064, USA

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

ISOFLURANE- ISOFLURANE INHALANT
CLIPPER DISTRIBUTING COMPANY LLC
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03-A936/R3 5260-04-10 AND 5260-04-11
ISOFLURANE, USP
WARNING: NOT FOR USE IN HORSES INTENDED FOR FOOD.
INHALATION ANESTHETIC FOR USE
IN HORSES AND DOGS
CAUTION: Federal law restricts this drug to use by or on the order of
a licensed veterinarian.
DESCRIPTION
Isoflurane, USP is a nonflammable, nonexplosive general inhalation
anesthetic agent. Its chemical name
is 1-chloro-2,2,2-trifluoroethyl difluoromethyl ether, and its
structural formula is:
Each mL contains 99.9% isoflurane.
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
Isoflurane, USP is an inhalation anesthetic. Induction and recovery
from anesthesia with isoflurane are
rapid.
The level of anesthesia may be changed rapidly with isoflurane.
Isoflurane is a profound
respiratory depressant. RESPIRATION MUST BE MONITORED CLOSELY IN THE
HORSE AND
DOG AND SUPPORTED WHEN NECESSARY. As anesthetic dose is increased,
both tidal volume
2,5
3,6
and respiratory rate decrease.
This depression is partially reversed by surgical stimulation, even at
deeper levels of anesthesia.
Blood pressure decreases with induction of anesthesia but returns
toward normal with surgical
stimulation. Progressive increases in depth of anesthesia produce
corresponding decreases in blood
pressure; however, heart rhythm is stable and cardiac out