Isoflurane

Isoflurane
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

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

Adverse reactions encountered in the administration of FORANE (isoflurane, USP) are in general dose dependent extensions of pharmacophysiologic effects and include respiratory depression, hypotension and arrhythmias.

Shivering, nausea, vomiting and ileus have been observed in the postoperative period.

As with all other general anesthetics, transient elevations in white blood count have been observed even in the absence of surgical stress. See WARNINGS for information regarding malignant hyperthermia and elevated carboxyhemoglobin levels.

During marketing, there have been rare reports of mild, moderate and severe (some fatal) postoperative hepatic dysfunction and hepatitis.

FORANE (isoflurane, USP) has also been associated with perioperative hyperkalemia (see WARNINGS).

Postmarketing Experience

The following adverse events have been identified during post-approval use of FORANE (isoflurane, USP). Due to the spontaneous nature of these reports, the actual incidence and relationship of FORANE (isoflurane, USP) to these events cannot be established with certainty.

Cardiac Disorders: Cardiac arrest

Hepatobiliary Disorders: Hepatic necrosis, Hepatic failure

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.