Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
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 Piramal Critical Care, Inc.
at 1-888-822-8431 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.
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.
The most frequent adverse reactions (incidence ³ 5%) described in Table 1 are agitation, breath holding, chills/shivering, cough, delirium, laryngospasm, nausea, and vomiting.
Adverse reactions with an incidence between 1% and 5% are provided in Table
Adverse reactions with an incidence less than 1% are provided in Table
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
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.
Like all medications, Isoflurane can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: