ATTANE™ Isoflurane, USP Inhalation Anesthetic For Veterinary Use in Horses and Dogs
Product Type: Prescription Animal Drug Label
Autor Name: Piramal Critical Care Inc.
Code Source: 66794-014
Route of Administration: NASAL
Not for use in horses intended for food.
Isoflurane, USP, a nonflammable liquid administered by vaporizing, is a general inhalation anesthetic drug. It is l-chloro-2,2,2-trifluoroethyl difluoromethyl ether, and its structural formula is:
Each mL contains 99.9% isoflurane.
Some physical constants are:
Molecular weight 184.5
Boiling point at 760 mm Hg 48.5 °C
Refractive index n 20 D 1.2990-1.3005
Specific gravity 25 ° /25° C 1.496
Vapor pressure in mm Hg** 20 ° C 238
25 ° C 295
30 ° C 367
35 ° C 450
**Equation for vapor pressure calculation:
A = 8.056
log 10 P vap = A + B B = -1664.58
T T = o C + 273.16
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 None
nitrous oxide at 9 joules/sec. and 23 ° C
Lower limit of flammability in oxygen or Greater than useful
nitrous oxide at 900 joules/sec. and 23 ° C concentration in anesthesia.
MAC (Minimum Alveolar Concentration) is 1.31% in horses 1 and 1.28% in dogs. 6
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.
Structure
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 PaCO 2 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.
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.
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 non-depolarizing 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 food
Isoflurane, USP, like some other inhalational anesthetics, can react with desiccated carbon dioxide (CO 2 ) absorbents to produce carbon monoxide which may result in elevated levels of carboxyhemoglobin in some patients. Case reports suggest that barium hydroxide lime and soda lime become desiccated when fresh gases are passed through the CO 2 absorber canister at high flow rates over many hours or days. When a clinician suspects that CO 2 absorbent may be desiccated, it should be replaced before the administration of Isoflurane, USP
Hypotension, respiratory depression, and arrhythmias have been reported.
In the event of overdosage, or what may appear to be overdosage, the following action should be taken:
Stop drug administration, establish that the airway is clear and initiate assisted or controlled ventilation with pure oxygen as circumstances dictate.
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. (eg, Verni-trol (R) 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: 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
Formula
Isoflurane, USP is packaged in 100 mL and 250 mL amber-colored bottles.
100 ML - NDC 66794-014-10
250 ML - NDC 66794-014-25
1. Steffey EP, Howland D Jr, Giri S, Eger El II. Enflurane, Halothane and Isoflurane
Potency in Horses. Am J Vet Res. 1977; 38(7): 1037-1039.
2. Auer JA, Garner HE, Amend JF, Hutcheson DP, Salem CA. 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.
3. Steffey EP, 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.
4. Auer JA, Amend JF, Garner HE, Hutcheson DP, Salem CA. Electroencephalographic
Responses During Volatile Anesthesia in Domestic Ponies: A Comparative
Study of Isoflurane, Enflurane, Methoxyflurane, and Halothane. Equine Practice.
1979:3: 130-134.
5. Klide AM. Cardiopulmonary Effects of Enflurane and Isoflurane in the Dog. Am J
Vet Res. 1976; 37(2): 127-131.
6. Steffey EP, Howland D. Isoflurane Potency in the Dog and Cat. Am J Vet Res.
1977; 38(11): 1833-1836.
PACKAGING LABEL PRINCIPAL DISPLAY PANEL - Label - 100 mL
NDC 66794-014-10
Attane
Isoflurane, USP
Liquid for Inhalation
Label - 100ml
PACKAGING LABEL PRINCIPAL DISPLAY PANEL - Carton - 100 mL
NDC 66794-014-10
Attane
Isoflurane, USP
Liquid for Inhalation
Carton - 100ml
PACKAGING LABEL PRINCIPAL DISPLAY PANEL - Label - 250 mL
NDC 66794-014-25
Attane
Isoflurane, USP
Liquid for Inhalation
Label-250ml
PACKAGING LABEL PRINCIPAL DISPLAY PANEL - Carton - 250 mL
NDC 66794-014-25
Attane
Isoflurane, USP
Liquid for Inhalation
Carton-250ml
Autor Name: Piramal Critical Care Inc.
Code Source: 66794-014
Route of Administration: NASAL
Isoflurane
Generic: IsofluraneIngredients:
- ISOFLURANE ISOFLURANE : Active ingredient - basis of strength - 99.9 mL in 100 mL
Package Description:
- 100 mL in 1 BOTTLE, GLASS
- 250 mL in 1 BOTTLE, GLASS
BOXED WARNING
Not for use in horses intended for food.
DESCRIPTION
Isoflurane, USP, a nonflammable liquid administered by vaporizing, is a general inhalation anesthetic drug. It is l-chloro-2,2,2-trifluoroethyl difluoromethyl ether, and its structural formula is:
Each mL contains 99.9% isoflurane.
Some physical constants are:
Molecular weight 184.5
Boiling point at 760 mm Hg 48.5 °C
Refractive index n 20 D 1.2990-1.3005
Specific gravity 25 ° /25° C 1.496
Vapor pressure in mm Hg** 20 ° C 238
25 ° C 295
30 ° C 367
35 ° C 450
**Equation for vapor pressure calculation:
A = 8.056
log 10 P vap = A + B B = -1664.58
T T = o C + 273.16
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 None
nitrous oxide at 9 joules/sec. and 23 ° C
Lower limit of flammability in oxygen or Greater than useful
nitrous oxide at 900 joules/sec. and 23 ° C concentration in anesthesia.
MAC (Minimum Alveolar Concentration) is 1.31% in horses 1 and 1.28% in dogs. 6
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.
Structure
CLINICAL PHARMACOLOGY
Isoflurane, USP is an inhalation anesthetic. Induction and recovery from anesthesia withisoflurane 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 PaCO 2 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.
INDICATIONS & USAGE
Isoflurane, USP is used for induction and maintenance of general anesthesia in horses and dogs
CONTRAINDICATIONS
Isoflurane, USP is contraindicated in horses and dogs with known sensitivity to isoflurane or to other halogenated agents.
WARNINGS
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 non-depolarizing 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 food
PRECAUTIONS
Isoflurane, USP, like some other inhalational anesthetics, can react with desiccated carbon dioxide (CO 2 ) absorbents to produce carbon monoxide which may result in elevated levels of carboxyhemoglobin in some patients. Case reports suggest that barium hydroxide lime and soda lime become desiccated when fresh gases are passed through the CO 2 absorber canister at high flow rates over many hours or days. When a clinician suspects that CO 2 absorbent may be desiccated, it should be replaced before the administration of Isoflurane, USP
Caution
Federal Law restricts this drug to use by or on the order of a licensed veterinarian.STORAGE
Pregnancy
ADVERSE REACTIONS
Hypotension, respiratory depression, and arrhythmias have been reported.
OVERDOSAGE
In the event of overdosage, or what may appear to be overdosage, the following action should be taken:
Stop drug administration, establish that the airway is clear and initiate assisted or controlled ventilation with pure oxygen as circumstances dictate.
DOSAGE & 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 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. (eg, Verni-trol (R) 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: 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
Formula
HOW SUPPLIED
Isoflurane, USP is packaged in 100 mL and 250 mL amber-colored bottles.
100 ML - NDC 66794-014-10
250 ML - NDC 66794-014-25
REFERENCES
1. Steffey EP, Howland D Jr, Giri S, Eger El II. Enflurane, Halothane and Isoflurane
Potency in Horses. Am J Vet Res. 1977; 38(7): 1037-1039.
2. Auer JA, Garner HE, Amend JF, Hutcheson DP, Salem CA. 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.
3. Steffey EP, 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.
4. Auer JA, Amend JF, Garner HE, Hutcheson DP, Salem CA. Electroencephalographic
Responses During Volatile Anesthesia in Domestic Ponies: A Comparative
Study of Isoflurane, Enflurane, Methoxyflurane, and Halothane. Equine Practice.
1979:3: 130-134.
5. Klide AM. Cardiopulmonary Effects of Enflurane and Isoflurane in the Dog. Am J
Vet Res. 1976; 37(2): 127-131.
6. Steffey EP, Howland D. Isoflurane Potency in the Dog and Cat. Am J Vet Res.
1977; 38(11): 1833-1836.
Bottle Label - 100 ml
PACKAGING LABEL PRINCIPAL DISPLAY PANEL - Label - 100 mL
NDC 66794-014-10
Attane
Isoflurane, USP
Liquid for Inhalation
Label - 100ml
Carton 100 ml
PACKAGING LABEL PRINCIPAL DISPLAY PANEL - Carton - 100 mL
NDC 66794-014-10
Attane
Isoflurane, USP
Liquid for Inhalation
Carton - 100ml
Bottle Label - 250 ml
PACKAGING LABEL PRINCIPAL DISPLAY PANEL - Label - 250 mL
NDC 66794-014-25
Attane
Isoflurane, USP
Liquid for Inhalation
Label-250ml
Carton - 250 ml
PACKAGING LABEL PRINCIPAL DISPLAY PANEL - Carton - 250 mL
NDC 66794-014-25
Attane
Isoflurane, USP
Liquid for Inhalation
Carton-250ml