FORANE

Isoflurane undergoes minimal biotransformation in man. In the postanesthesia period, only 0.17% of the isoflurane taken up can be recovered as urinary metabolites.

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 variet...

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...

• 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 ...

7 DRUG INTERACTIONS

• 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 s...