Isoflurane
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Chetan Lokhande, M.B.B.S [2]
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Overview
Isoflurane is a general anesthetic that is FDA approved for the {{{indicationType}}} of general anesthesia. Common adverse reactions include gastrointestinal: nausea, vomiting.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
- General anesthesia: induction, 1.5 to 3% isoflurane with oxygen or oxygen-nitrous oxide mixture.
- General anesthesia: maintenance, 1 to 2.5% with nitrous oxide, additional 0.5 to 1% with oxygen alone.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information about Off-Label Guideline-Supported Use of Isoflurane in adult patients.
Non–Guideline-Supported Use
There is limited information about Off-Label Non–Guideline-Supported Use of Isoflurane in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
- Safety in children under 2 yr of age has not been established
- General anesthesia: dosage must be individualized
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information about Off-Label Guideline-Supported Use of Isoflurane in pediatric patients.
Non–Guideline-Supported Use
There is limited information about Off-Label Non–Guideline-Supported Use of Isoflurane in pediatric patients.
Contraindications
- Known sensitivity to FORANE (isoflurane, USP) or to other halogenated agents. Known or suspected genetic susceptibility to malignant hyperthermia.
Warnings
Perioperative Hyperkalemia
Use of inhaled anesthetic agents has been associated with rare increases in serum potassium levels that have resulted in cardiac arrhythmias and death in pediatric patients during the postoperative period. Patients with latent as well as overt neuromuscular disease, particularly Duchenne muscular dystrophy, appear to be most vulnerable. Concomitant use of succinylcholine has been associated with most, but not all, of these cases. These patients also experienced significant elevations in serum creatinine kinase levels and, in some cases, changes in urine consistent with myoglobinuria. Despite the similarity in presentation to malignant hyperthermia, none of these patients exhibited signs or symptoms of muscle rigidity or hypermetabolic state. Early and aggressive intervention to treat the hyperkalemia and resistant arrhythmias is recommended, as is subsequent evaluation for latent neuromuscular disease.
Malignant Hyperthermia
In susceptible individuals, isoflurane anesthesia may trigger a skeletal muscle hypermetabolic state leading to high oxygen demand and the clinical syndrome known as malignant hyperthermia. The syndrome includes nonspecific features such as muscle rigidity, tachycardia, tachypnea, cyanosis, arrhythmias, and unstable blood pressure. (It should also be noted that many of these nonspecific signs may appear with light anesthesia, acute hypoxia, etc.) An increase in overall metabolism may be reflected in an elevated temperature, (which may rise rapidly early or late in the case, but usually is not the first sign of augmented metabolism) and an increased usage of the CO2 absorption system (hot canister). PaO2 and pH may decrease, and hyperkalemia and a base deficit may appear. Treatment includes discontinuance of triggering agents (e.g., isoflurane), administration of intravenous dantrolene sodium, and application of supportive therapy. Such therapy includes vigorous efforts to restore body temperature to normal, respiratory and circulatory support as indicated, and management of electrolyte-fluid-acid-base derangements. (Consult prescribing information for dantrolene sodium intravenous for additional information on patient management). Renal failure may appear later, and urine flow should be sustained if possible.
Since levels of anesthesia may be altered easily and rapidly, only vaporizers producing predictable concentrations should be used. Hypotension and respiratory depression increase as anesthesia is deepened.
Increased blood loss comparable to that seen with halothane has been observed in patients undergoing abortions.
FORANE (isoflurane, USP) markedly increases cerebral blood flow at deeper levels of anesthesia. There may be a transient rise in cerebral spinal fluid pressure, which is fully reversible with hyperventilation.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Isoflurane Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Isoflurane Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Isoflurane Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Isoflurane in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Isoflurane in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Isoflurane during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Isoflurane in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Isoflurane in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Isoflurane in geriatric settings.
Gender
There is no FDA guidance on the use of Isoflurane with respect to specific gender populations.
Race
There is no FDA guidance on the use of Isoflurane with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Isoflurane in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Isoflurane in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Isoflurane in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Isoflurane in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Isoflurane Administration in the drug label.
Monitoring
There is limited information regarding Isoflurane Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Isoflurane and IV administrations.
Overdosage
There is limited information regarding Isoflurane overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Isoflurane Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Isoflurane Mechanism of Action in the drug label.
Structure
There is limited information regarding Isoflurane Structure in the drug label.
Pharmacodynamics
There is limited information regarding Isoflurane Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Isoflurane Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Isoflurane Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Isoflurane Clinical Studies in the drug label.
How Supplied
There is limited information regarding Isoflurane How Supplied in the drug label.
Storage
There is limited information regarding Isoflurane Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Isoflurane Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Isoflurane interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Isoflurane Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Isoflurane Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.