Isoflurane by is a Animal medication manufactured, distributed, or labeled by Akorn Animal Health, Inc., Halocarbon Products Corp.. Drug facts, warnings, and ingredients follow.
Isoflurane, USP is a nonflammable, nonexplosive general inhalation anesthetic agent. Its chemical name is l-chloro-2,2,2- trifluoroethyl difluoromethyl ether, and its structural formula is:
Each mL contains 99.9% isoflurane.
|Some physical constants are:|
|Boiling point at 760 mm Hg||48.5°C|
|Specific gravity 25°/25°C||1.496|
|Vapor pressure in mm Hg**||20°C||238|
|Partition coefficients at 37°C:|
|Partition coefficients at 25°C - rubber and plastic:|
|Butyl acetate/gas||~ 2.5|
|Purity by gas chromatography||>99.9%|
|Lower limit of flammability|
| in oxygen or nitrous oxide at 9 joules/sec. |
|Lower limit of flammability in oxygen||Greater than useful|
|or nitrous oxide at 900 joules/sec.||concentration in|
|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.
Isoflurane, USP is an inhalation anesthetic. Induction and 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.
Muscle relaxation may be adequate for intra-abdominal operations at normal levels of anesthesia. However, if muscle relaxants are used to achieve greater relaxation, it should be noted that: ALL COMMONLY USED MUSCLE RELAXANTS ARE MARKEDLY POTENTIATED WITH ISOFLURANE, THE EFFECT BEING MOST PROFOUND WITH THE NONDEPOLARIZING TYPE. Neostigmine reverses the effect of nondepolarizing muscle relaxants in the presence of isoflurane but does not reverse the direct neuromuscular depression of isoflurane.
Increasing depth of anesthesia with 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).
The action of nondepolarizing relaxants is augmented by isoflurane. Less than the usual amounts of these drugs should be used. If the usual amounts of nondepolarizing relaxants are given, the time for recovery from myoneural blockade will be longer in the presence of isoflurane than in the presence of other commonly used anesthetics.
Not for use in horses intended for human consumption.
Isoflurane, 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 canister 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 isoflurane.
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 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., Verni-trol® vaporizer) also may be used. The delivered concentration from such a vaporizer may be calculated using the formula:
|where:||PA||= Pressure of atmosphere|
|PV||= Vapor pressure of isoflurane|
|FV||= Flow of gas through vaporizer (mL/min)|
|FT||= Total gas flow used (mL/min)|
Isoflurane contains no stabilizer. Nothing in the drug product alters calibration or operation of these vaporizers.
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: Surgical levels of anesthesia in the dog may be sustained with a 1.5 to 1.8% concentration of isoflurane in oxygen.
The level of blood pressure during maintenance is an inverse function of isoflurane concentration in the absence of other complicating problems. Excessive decreases, unless related to hypovolemia, may be due to depth of anesthesia and in such instances may be corrected by lightening the level of anesthesia.
Recovery from isoflurane anesthesia is typically uneventful.2
Isoflurane, USP is packaged in 250 mL (NDC: 59399-106-01) amber-colored bottles.
Distributed By: Akorn, Inc., Lake Forest, IL 60045
VI00N Rev. 10/16
Principal Display Panel Text for Container Label:
NDC: 59399-106-01 250 mL
A nonflammable, nonexplosive, inhalation anesthetic
FOR USE IN HORSES AND DOGS
Warning: Not for use in horses intended for human consumption.
Important: Read accompanying product information for directions pertaining to the use of
Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
ANADA 200-129, Approved by FDA.
Akorn Animal Health Logo
Distributed by: Akorn, Inc., Lake Forest, IL 60045
Principal Display Panel Text for Carton Label:
FOR USE IN
Caution: Federal law
restricts this drug to use
by or on the order of a
|Labeler - Akorn Animal Health, Inc. (078876357)|
|Halocarbon Products Corp.||109112409||MANUFACTURE, API MANUFACTURE|