Regulatory product record
ISOFLURANE USP
Product identity, ingredients and source provenance from the regulatory catalogue. Linked clinical evidence has a separate review status.
Product identity
- Brand name
- ISOFLURANE USP
- DIN
- 02237518
- DPD drug code
- 60853
- Regulatory category
- APPROVED_VET_DRUG
- Market status
- MARKETED
- Route(s)
- INHALATION
- Pharmaceutical form(s)
- LIQUID
- Ingredients
- ISOFLURANE (99.9 %)
- Species (DPD record)
- DOGS
- Company
- FRESENIUS KABI CANADA LTD (DIN owner)
Source and provenance
- Source dataset
- health_canada_dpd_marketed
- Source snapshot date
- Not available in this source
- Source record key
- 60853
- Archive fingerprint (SHA-256)
- 85cc3ce208af3aa57018c3d14d83f90220c436baef7455384b6d48d9774e1c88
Linked clinical reference
Clinical entries are linked through the active molecule. Check their species, formulation, source and review status separately from this product record.
Clinical evidence
Pending clinical review (PROPOSED)Rule-based (RULE_BASED)— applies to the facts and dose entries in this species selection; individual source records retain their own status.
Indications2
Isoflurane is used for induction and maintenance of general anesthesia in horses and dogs.
DogOn-label (ON_LABEL)United States1 source record · View provenance
- Dog · SPL section 34067-9 (INDICATIONS & USAGE SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Isoflurane, USP is used for induction and maintenance of general anesthesia in horses and dogs.
DogOn-label (ON_LABEL)United States1 source record · View provenance
- Dog · SPL section 34067-9 (INDICATIONS & USAGE SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Dose regimens2
This calculator performs arithmetic only on the sourced dosing field shown for each result — it does not verify the field's accuracy, does not select which field to use for a patient, and does not replace a veterinarian's order. Not for clinical use. Confirm every result against the primary source before dispensing.
Dose calculation
Species: Dog. Results use the source regimens shown below.
- Review the source route shown below.
- Enter patient weight and its unit.
- For volume, optionally enter a matching label concentration.
Source route: Route not specified
Manual verification required — this source did not state a per-weight dose this calculator can compute from.
- Source regimen: Not available in this source
- Source formulation
- Not specified in this source
- Dose basis
- Not specified in this source
Indication: Not specified in this source field
Manual verification required — this source did not state a per-weight dose this calculator can compute from.
SPL section 34068-7 (DOSAGE & ADMINISTRATION SECTION)
- Source regimen: Not available in this source
- Source formulation
- Not specified in this source
- Dose basis
- Not specified in this source
Indication: Not specified in this source field
Manual verification required — this source did not state a per-weight dose this calculator can compute from.
SPL section 34068-7 (DOSAGE & ADMINISTRATION SECTION)
Adverse effects202
Hypotension, respiratory depression and arrhythmias have been reported.
DogOn-label (ON_LABEL)United States1 source record · View provenance
- Dog · SPL section 34084-4 (ADVERSE REACTIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Hypotension, respiratory depression, and arrhythmias have been reported.
DogOn-label (ON_LABEL)United States1 source record · View provenance
- Dog · SPL section 34084-4 (ADVERSE REACTIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
These are counts of spontaneously reported events, not proven adverse effects, causal relationships, or incidence rates.
Bars compare report counts within each species; they do not show incidence.
More reportsFewer reportsDog
- Death373 reports
- Vomiting345 reports
- Bradycardia311 reports
- Cardiac arrest229 reports
- INEFFECTIVE, ANESTHESIA220 reports
- Anorexia214 reports
- Lethargy (see also Central nervous system depression in 'Neurological')209 reports
- Lack of efficacy - NOS174 reports
- Diarrhoea169 reports
- Other abnormal test result NOS151 reports
- Death by euthanasia144 reports
- Apnoea139 reports
Cat
- Death279 reports
- Behavioural disorder NOS218 reports
- Not eating185 reports
- Dilated pupils170 reports
- Cardiac arrest139 reports
- Lethargy (see also Central nervous system depression in 'Neurological')133 reports
- Hyperactivity128 reports
- Fever127 reports
- Anorexia125 reports
- Ataxia124 reports
- Hyperthermia124 reports
- Dysphoria121 reports
Contraindications2
Isoflurane is contraindicated in horses and dogs with known sensitivity to isoflurane or to other halogenated agents.
DogOn-label (ON_LABEL)United States1 source record · View provenance
- Dog · SPL section 34070-3 (CONTRAINDICATIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Isoflurane, USP is contraindicated in horses and dogs with known sensitivity to isoflurane or to other halogenated agents.
DogOn-label (ON_LABEL)United States1 source record · View provenance
- Dog · SPL section 34070-3 (CONTRAINDICATIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Precautions5
Increasing depth of anesthesia with Isoflurane may increase hypotension and respiratory depression. The electroencephalographic pattern associated with deep anesthesia is characterized by burst suppression, spiking, and isoelectric periods⁴. DOSAGE AND ADMINISTRATION Since levels of anesthesia may be altered easily and rapidly, only vaporizers producing predictable percentage concentrations of isoflurane should be used (see). 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. Not for use in Humans. Keep Out of Reach of Children.
DogOn-label (ON_LABEL)United States1 source record · View provenance
- Dog · SPL section 34071-1 (WARNINGS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Not for use in horses intended for human consumption.Not for use in Humans. Keep Out of Reach of Children. CAUTION Federal law restricts this drug to use by or on the order of a licensed veterinarian.
DogOn-label (ON_LABEL)United States1 source record · View provenance
- Dog · SPL section 34071-1 (WARNINGS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
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. Usage in Pregnancy: Reproduction studies have been performed in mice and rats with no evidence of fetal malformation attributable to isoflurane. Adequate data concerning the safe use of isoflurane in pregnant and breeding horses and dogs have not been obtained.
DogOn-label (ON_LABEL)United States1 source record · View provenance
- Dog · SPL section 42232-9 (PRECAUTIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
4 Increasing depth of anesthesia with isoflurane may increase hypotension and respiratory depression. The electroencephalographic pattern associated with deep anesthesia is characterized by burst suppression, spiking, and isoelectric periods. DOSAGE AND ADMINISTRATION Since levels of anesthesia may be altered easily and rapidly, only vaporizers producing predictable percentage concentrations of isoflurane should be used. (See). 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 food. Keep out of reach of children.
DogOn-label (ON_LABEL)United States1 source record · View provenance
- Dog · SPL section 34071-1 (WARNINGS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
2 2 2 Isoflurane, USP like other inhalational anesthetics, can react with desiccated carbon dioxide (CO) 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 COabsorber canister at high flow rates over many hours or days. When a clinician suspects that COabsorbent may be desiccated, it should be replaced before the administration of Isoflurane, USP.
DogOn-label (ON_LABEL)United States1 source record · View provenance
- Dog · SPL section 42232-9 (PRECAUTIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Pharmacokinetics2
Isoflurane is an inhalation anesthetic. Induction and recovery from anesthesia with isoflurane are rapid.²⁵ 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.³⁶ 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.
DogOn-label (ON_LABEL)United States1 source record · View provenance
- Dog · SPL section 34090-1 (CLINICAL PHARMACOLOGY SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
2,5 3,6 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 and respiratory rate decrease.This depression is partially reversed by surgical stimulation, even at deeper levels of anesthesia. 2 3 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 PaCOdespite 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.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.
DogOn-label (ON_LABEL)United States1 source record · View provenance
- Dog · SPL section 34090-1 (CLINICAL PHARMACOLOGY SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Literature references12
References are linked to this drug. Species applicability is not recorded here, so the species filter does not narrow this list. Imported dates do not retain their original precision; confirm dates in the original citation.
- Pharmacokinetics of Intravenous and Intramuscular Nalbuphine in Isoflurane-Anesthetized Chickens (Gallus gallus domesticus).
Study summary not available in the imported record. Open the original citation to review the study.
- Implementation of a low-flow intervention at a veterinary teaching hospital: an environmental initiative.
Study summary not available in the imported record. Open the original citation to review the study.
- INVESTIGATION OF ANESTHESIA TECHNIQUES IN PAPER KITE BUTTERFLIES (IDEA LEUCONOE).
Study summary not available in the imported record. Open the original citation to review the study.
- EVALUATION OF OPEN-DROP ISOFLURANE ANESTHESIA IN MADAGASCAR HISSING COCKROACHES (GROMPHADORHINA PORTENTOSA).
Study summary not available in the imported record. Open the original citation to review the study.
- Pharmacokinetics of Bupivacaine in Chickens (Gallus gallus domesticus) During Isoflurane Anesthesia.
Study summary not available in the imported record. Open the original citation to review the study.
Sources: DailyMed, U.S. National Library of Medicine; PubMed, National Library of Medicine; openFDA, U.S. Food and Drug Administration.