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

Terrell (isoflurane, USP) is contraindicated in patients: • in whom general anesthesia is contraindicated. • with known sensitivity to Terrell (isoflurane, USP) 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 Terrell (isoflurane, USP) 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 …

• 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. ( 5.3 ) • Hypersensitivity Reactions : Allergic-type hypersensitivity reactions, including anaphylaxis, have been reported with isoflurane. ( 5.4 ) • Abortions : Increased blood loss comparable to that seen with halothane has been observed in patients undergoing abortions. ( 5.5 ) • QT Prolongation : Carefully monitor cardiac rhythm when administering Terrell (isoflurane, USP) to susceptible patients. ( 5.6 ) • Interactions with Desiccated Carbon Dioxide (CO 2 ) Absorbents: May react with desiccated CO 2 absorbents to produce carbon monoxide. Replace desiccated CO 2 absorbent before administration of Terrell (isoflurane, USP) . ( 5.7 ) • Pediatric Neurotoxicity : In developing animals, exposures greater than 3 hours cause neurotoxicity. Weigh benefits against potential risks when …

8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies in pregnant women. In animal reproduction studies, embryofetal toxicity was noted in pregnant mice exposed to 0.075% (increased post implantation losses) and 0.3% isoflurane (increased post implantation losses and decreased livebirth index) during organogenesis. Published studies in pregnant primates demonstrate that the administration of anesthetic and sedation drugs that block NMDA receptors and/or potentiate GABA activity during the period of peak brain development increases neuronal apoptosis in the developing brain of the offspring when used for longer than 3 hours. There are no data on pregnancy exposures in …