Isoflurane

Generic Name: isoflurane

General Anesthetic [EPC]Over-the-Counter (OTC)

Brand Names:

Isoflurane

11. DESCRIPTION Isoflurane, USP liquid for inhalation, a nonflammable liquid administered by vaporizing, is a general inhalation anesthetic drug. It is 1-chloro-2,2,2-trifluoroethyl difluoromethyl ether, and its structural formula is: Some physical constants are: Molecular weight 184.5 Boiling point at 760 mm Hg 48.5°C Refractive index n 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: log 10 P...

Overview

Uses

1 INDICATIONS AND USAGE Isoflurane, USP liquid for inhalation may be used for induction and maintenance of general anesthesia. Adequate data have not been developed to establish its application in obstetrical anesthesia. Isoflurane, USP liquid for inhalation, a general anesthetic, is an inhalation agent indicated for induction and maintenance of general anesthesia. (1)

Dosage

2 DOSAGE AND ADMINISTRATION Isoflurane, USP liquid for inhalation should be administered only by persons trained in the administration of general anesthesia. Isoflurane, USP liquid for inhalation should only be delivered using a vaporizer specifically designed and designated for use with isoflurane. (2) The administration of general anesthesia must be individualized and titrated based on the patient’s age and clinical status. (2) 2.1 Important Dosage and Administration Information Isoflurane should be administered only by persons trained in the administration of general anesthesia. Facilities for maintenance of a patent airway, artificial ventilation, oxygen enrichment, and circulatory resuscitation must be immediately available. Isoflurane is administered by inhalation.

Side Effects

6. ADVERSE REACTIONS Most common adverse reactions (incidence ≥ 5%) are agitation, cough, breath holding, nausea, chills/shivering, vomiting, laryngospasm, delirium. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Emprise Pharma LLC. at (610) 933-1969 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience The following adverse reactions were identified from controlled clinical trials of adult and pediatric subjects exposed to isoflurane, USP liquid for inhalation. The trials were conducted using a variety of pre-medications, other anesthetics, and surgical procedures of varying lengths. The most serious reported adverse reactions in alphabetical order are agitation, arrhythmia, breath holding, elevated liver enzyme, hypotension and laryngospasm.

Interactions

7. DRUG INTERACTIONS Concomitant use of N 2 O and/or opioids reduces the MAC of isoflurane, USP liquid for inhalation. Adjust dose accordingly. (7.1, 7.2) Isoflurane, USP liquid for inhalation decreases the doses of neuromuscular blocking agents required. Adjust dose accordingly. (7.3) 7.1 Opioids Opioids decrease the Minimum Alveolar Concentration (MAC) of isoflurane. Opioids such as fentanyl and its analogues, when combined with isoflurane, may lead to a synergistic fall in blood pressure and respiratory rate. 7.2 Nitrous Oxide Nitrous oxide decreases the MAC of isoflurane [see Dosage and Administration (2.1)] .

Warnings

5. WARNINGS AND PRECAUTIONS Malignant Hyperthermia : Malignant hyperthermia may occur, especially in individuals with known or suspected susceptibility based on genetic factors or family history. Discontinue triggering agents, administer intravenous dantrolene sodium, and apply supportive therapies. (5.1) Perioperative Hyperkalemia : Perioperative hyperkalemia may occur. Patients with latent or overt neuromuscular disease, particularly with Duchenne muscular dystrophy, appear to be most vulnerable. Early, aggressive intervention is recommended. (5.2) Hepatic Reactions : May cause sensitivity hepatitis in patients sensitized by previous exposure to halogenated anesthetics. Approach repeated anesthesia with caution. 4. CONTRAINDICATIONS Isoflurane, USP liquid for inhalation is contraindicated in patients: in whom general anesthesia is contraindicated. with known sensitivity to isoflurane, USP liquid for inhalation or to other halogenated agents [see Warnings and Precautions (5.3)] .

Storage

16. HOW SUPPLIED/STORAGE AND HANDLING Isoflurane, USP liquid for inhalation, a clear, colorless, volatile liquid, having a slight odor, is available in the following presentations: FILL CONTAINER PACK SIZE NDC 100 mL Amber-colored Glass 1 Bottle 42677-326-01 250 mL Amber-colored Glass 1 Bottle 42677-327-01 16.1 Safety and Handling Occupational Caution The following reactions have been reported fol...

Frequently Asked Questions

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Medical Disclaimer

This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.