Aerrane
AERRANE (isoflurane, USP) Inhalation Anesthetic For Use in Horses and Dogs
FULL PRESCRIBING INFORMATION: CONTENTS*
- AERRANE DESCRIPTION
- CLINICAL PHARMACOLOGY
- INDICATIONS
- AERRANE CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- AERRANE ADVERSE REACTIONS
- OVERDOSAGE
- AERRANE DOSAGE AND ADMINISTRATION
- HOW SUPPLIED
- REFERENCES
- PACKAGE LABELING - PRINCIPAL DISPLAY PANEL
FULL PRESCRIBING INFORMATION
WARNING: Not for use in horses intended for food
CAUTION:AERRANE DESCRIPTION
Each mL contains 99.9% isoflurane.
Some physical constants are:
| Molecular weight |
|
184.5 |
| Boiling point at 760 mmHg |
|
48.5°C (uncorr.) |
| Refractive i n d e x n 20/D |
|
1.2990-1.3005 |
| Specific gravity 25°/25°C |
|
1.496 |
| Vapor pressure in mmHg** |
|
20°C 238 |
|
|
|
25°C 295 |
|
|
|
30°C 367 |
|
|
|
35°C 450 |
10vap
Partition coefficients at 37°C
| Water/gas |
0.61 |
| Blood/gas |
1.43 |
| Oil/gas |
90.8 |
| 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. |
MAC (Minimum Alveolar Concentration) is 1.31% in horses1 and 1.28 in dogs6.
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
AERRANE (isoflurane, USP) is an inhalation anesthetic. Inductionand recovery from anesthesia with isoflurane are rapid.2,5
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 and respiratory rate
decrease.3,6
. 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 output is maintained with controlled
ventilation and normal PaCO2 despite
increasing depth of anesthesia. The hypercapnia which attends
spontaneous ventilation during isoflurane anesthesia increases heart
rate and raises cardiac output above levels observed with controlled
ventilation.3 Isoflurane does not sensitize the myocardium to exogenously administered epinephrine in the dog.
INDICATIONS
AERRANE (isoflurane, USP) is used for induction and maintenance of general anesthesia in horses and dogs.
AERRANE CONTRAINDICATIONS
WARNINGS
Increasing depth of anesthesia with AERRANE
(isoflurane, USP) may increase hypotension and respiratory depression.
The electroencephalographic pattern associated with deep anesthesia is
characterized by burst suppression, spiking, and isoelectric periods.4
Since
levels of anesthesia may be altered easily and rapidly, only vaporizers
producing predictable percentage concentrations of isoflurane should be
used (see DOSAGE AND ADMINISTRATION).
PRECAUTIONS
AERRANE (isoflurane, USP), like some other inhalational anesthetics, can react with desiccated carbon dioxide (CO2) absorbents to produce carbon monoxide which may result in elevated carboxyhemoglobin levels in some patients. Case reports suggest that barium hydroxide lime and soda lime become desiccated when fresh gases are passed through the CO2 absorber cannister at high flow rates over many hours or days. When a clinician suspects that CO2 absorbent may be desiccated, it should be replaced before the administration of AERRANE.
Usage in Pregnancy:
Reproduction studies have been performed in mice and rats with no evidence of fetal malformation attributable to AERRANE (isoflurane, USP). Adequate data concerning the safe use of isoflurane in pregnant and breeding horses and dogs have not been obtained.
AERRANE ADVERSE REACTIONS
Hypotension, respiratory depression and arrhythmias have been reported.
OVERDOSAGE
AERRANE DOSAGE AND ADMINISTRATION
Caution: Operating rooms should be provided with adequate ventilation to prevent the accumulation of anesthetic vapors.
Premedication:
A premedication regimen, which may be employed depending upon the
patient status, to avert excitement during induction, might include an
anticholinergic, a tranquilizer, a muscle relaxant, and a short-acting
barbiturate.
Inspired Concentration: The delivered concentration of
AERRANE (isoflurane, USP) should be known. Isoflurane may be vaporized
using a flow-through vaporizer specifically calibrated for isoflurane.
Vaporizers delivering a saturated vapor which then is diluted (e.g.,
Vernitrol® Vaporizer) also may be used. The delivered concentration
from such a vaporizer may be calculated using the formula:
Isoflurane contains no stabilizer. Nothing in the drug product alters calibration or operation of these vaporizers.
Induction:
Horses:
Inspired concentrations of 3.0 to 5.0% isoflurane alone with oxygen
following a barbiturate anesthetic induction are usually employed to
induce surgical anesthesia
in the horse.
Dogs:
Inspired concentrations of 2.0 to 2.5% isoflurane alone with oxygen
following a barbiturate anesthetic induction are usually employed to
induce surgical anesthesia in the dog.
These concentrations can be expected to produce surgical anesthesia in 5 to 10 minutes.
Maintenance: The concentration of vapor necessary to maintain anesthesia is much less than that required to induce it.
Horses: Surgical levels of anesthesia in the horse may be sustained with a 1.5 to 1.8% concentration of isoflurane in oxygen.
Dogs:
2
HOW SUPPLIED
AERRANE (isoflurane, USP) is packaged in 100 mL and 250 mL
amber-colored bottles.
100 mL - NDC 10019-773-40
250 mL - NDC 10019-773-60
Storage
Store at room temperature 15°-30°C (59°-86°F).REFERENCES
- Steffey, E.P., Howland, D. Jr., Giri, S. and Eger, E.I.II. Enflurane,Halothane and Isoflurane Potency in Horses. Am. J. Vet. Res.1977; 38(7):1037-1039.
- 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. 1978; 10(1): 18-23.
- Steffey, E.P., and Howland, D. Jr. Comparison of Circulatory and Respiratory Effects of Isoflurane and Halothane Anesthesia in Horses. Am. J. Vet. Res. 1980;41(5): 821-825.
- 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 1979; 3: 130-134.
- Klide, A.M. Cardiopulmonary Effects of Enflurane and Isoflurane in the Dog. Am. J. Vet. Res. 1976; Vol 37, No 2: 127-131.
- Steffey, E.P., and Howland, D. Jr. Isoflurane Potency in the Dog and Cat.
Am. J. Vet. Res. 1977; Vol 38, No 11: 1833-1836.
[NADA 135-773, Approved by FDA]
Baxter and AErrane are trademarks of Baxter International Inc.
Baxter logo
Manufactured for
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
To report adverse reaction or obtain MSDS,
call 1 800 ANA DRUG (1-800-262-3784)
Revised: August 2006
400-226-08
PACKAGE LABELING - PRINCIPAL DISPLAY PANEL
NDC 10019-773-40
AERRANE
(isoflurane, USP)
For Use In Horses and Dogs
Caution: Federal law restricts this drug
to use by or on order of
a licensed veterinarian.
[NADA 135-773, Approved by FDA]
Baxter logo
Manufactured for
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
400-224-07
A nonflammable, nonexplosive
inhalation anesthetic
Each mL container 99.9% isofurane.
Caution:Operating rooms should be pro-
vided with adequate ventilation to prevent the
accumulation of anesthetic vapors.
Store at room temperature 15°-30°C
(59°-86°F).
IMPORTANT: See package insert for dosage
and directions for use.
To report adverse reaction or obtain MSDS,
call 1 800 ANA DRUG (1-800-262-3784)
Baxter and Aerrane are trademarks of Baxter
International Inc.
100 mL
WARNING:
Not for Use
in horses
intended
for food.
N3 10019 77340 7
AERRANE
(isoflurane, USP)
NDC 10019-773-40
6 x 100 mL Bottles
For use in Horses and Dogs
Store at room temperature 15°-30°C (59°-86°F).
Exp 10 2007
Lot A111A111
(17) 071000(10) A111A111
(01) 5 0310019 77340 2(30) 0006
Mfd. for Baxter Healthcare Corporation, Deerfield, IL 60015 USA
0001
475-235-04
AerraneIsoflurane INHALANT
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