Isoflurane: uses, dosing, side effects & brands

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 Baxter Healthcare Corporation at 1-800-262-3784 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 FORANE. 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 ≥ 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 2 . Adverse reactions with an incidence less than 1% are provided in Table 3 . 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. Table 2: Adverse Reactions ≥ 5% System Organ Class (SOC)…

FORANE is contraindicated in patients: • in whom general anesthesia is contraindicated. • with known sensitivity to FORANE or to other halogenated agents [see Warnings and Precautions (5.3) ] . • with known or suspected genetic susceptibility to malignant hyperthermia [see Warnings and Precautions (5.1) , Clinical Pharmacology (12.5) ] . • with a history of confirmed hepatitis due to a halogenated inhalational anesthetic or a history of unexplained moderate to severe hepatic dysfunction (e.g., jaundice associated with fever and/or eosinophilia) after anesthesia with isoflurane or other halogenated inhalational anesthetics. • Patients in whom general anesthesia is contraindicated ( 4 ) • Patients with known sensitivity to FORANE or other halogenated agents ( 4 ) • Patients with known or suspected genetic susceptibility to malignant hyperthermia ( 4 ) • Patients with a history of confirmed hepatitis due to a halogenated inhalational anesthetic or a history of unexplained moderate to severe hepatic dysfunction (e.g., jaundice associated with fever and/or eosinophilia) after anesthesia with FORANE or other halogenated inhalational anesthetics ( 4 )

Concomitant use of N 2 O and/or opioids reduces the MAC of FORANE. Adjust dose accordingly. ( 7.1 , 7.2 ) • FORANE decreases the doses of neuromuscular blocking agents required. Adjust dose accordingly. ( 7.3 ) 7.1 Opioids Opioids decrease the Minimum Alveolar Concentration (MAC) of FORANE. Opioids such as fentanyl and its analogues, when combined with FORANE, may lead to a synergistic fall in blood pressure and respiratory rate. 7.2 Nitrous Oxide Nitrous oxide decreases the MAC of FORANE [see Dosage and Administration (2.1) ] . 7.3 Neuromuscular Blocking Agents FORANE potentiates the muscle relaxant effect of all neuromuscular blocking agents and decreases the required doses of neuromuscular blocking agents. In general, anesthetic concentrations of FORANE at equilibrium reduce the ED 95 of succinylcholine, atracurium, pancuronium, rocuronium and vecuronium by approximately 25 to 40% or more compared to N 2 O/opioid anesthesia. If added relaxation is required, supplemental doses of neuromuscular blocking agents may be used. 7.4 Adrenaline FORANE is similar to sevoflurane in the sensitization of the myocardium to arrhythmogenic effect of exogenously administered adrenaline. Doses of adrenaline greater than 5mcg/kg, when administered submucosally may produce multiple ventricular arrhythmias. 7.5 Calcium Antagonists FORANE may lead to marked hypotension in patients treated with calcium antagonists. 7.6 Concomitant Use with Beta Blockers Concomitant use of beta blockers may exaggerate the cardiovascular effects of inhalational anesthetics, including hypotension and negative inotropic effects. 7.7 Concomitant Use with MAO Inhibitors Concomitant use of MAO inhibitors and inhalational anesthetics may increase the risk of hemodynamic instability during surgery or medical procedures.