Terrell 1 mL/mL
Isoflurane · LIQUID · Piramal Critical Care Inc
Terrell is a liquid containing isoflurane at 1 mL/mL, taken respiratory (inhalation). Manufactured by Piramal Critical Care Inc.
Key Facts
- Brand Name
- Terrell
- Generic Name
- Isoflurane
- NDC Code (Product)
66794-019- Manufacturer
- Piramal Critical Care Inc
- Strength
- 1 mL/mL
- Dosage Form
- LIQUID
- Route
- RESPIRATORY (INHALATION)
- Marketing Status
- Application #
- ANDA074502
- Drug Class
- General Anesthetic [EPC]
- Marketing Start
- 03/21/2012
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Terrell may be used for induction and maintenance of general anesthesia. Adequate data have not been developed to establish its application in obstetrical anesthesia. Terrell, a general anesthetic, is an inhalation agent indicated for induction and maintenance of general anesthesia. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION . Terrell should be administered only by persons trained in the administration of general anesthesia. Terrell 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. Isoflurane should be delivered from a vaporizer specifically designed for use with isoflurane. Dosage for induction and maintenance must be individualized and titrated to the desired effect according to the patient’s age and clinical status. With the exception of neonates, the minimum alveolar concentration (MAC) of isoflurane decreases with increasing patient age. Nitrous oxide decreases the MAC of isoflurane ( see Table 1 ). Opioids decrease the MAC of isoflurane [se…
Contraindications
4 CONTRAINDICATIONS Terrell is contraindicated in patients: in whom general anesthesia is contraindicated. with known sensitivity to Terrell 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 historycof unexplained moderate to severe hepatic dysfunction (e.g., jaundice associated with fevercand/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 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 feverand/or eosinophilia) after anesthesia with Terrell or other halogenated inhalational anesthetics ( 4 )
Drug Interactions
7 DRUG INTERACTIONS . Concomitant use of N 2 O and/or opioids reduces the MAC of Terrell. Adjust dose accordingly. ( 7.1 , 7.2 ) Terrell 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) ]. 7.3 Neuromuscular Blocking Agents Isoflurane potentiates the muscle relaxant effect of all neuromuscular blocking agents and decreases the required doses of neuromuscular blocking agents. In general, anesthetic concentrations of isoflurane at equilibrium reduce the ED95 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 Isoflurane is similar to sevoflurane in the sensitization of the myocardium to arrhythmogenic effect of e…
Adverse Reactions
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 Terrell. 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 observ…
Frequently Asked Questions
What is Terrell used for?
Terrell contains Isoflurane. It is a liquid taken respiratory (inhalation). Consult your doctor for specific uses.
Is Terrell a controlled substance?
Terrell is not classified as a controlled substance by the DEA.
What is the generic name for Terrell?
The generic name for Terrell is Isoflurane. There are 8 other brand versions of Isoflurane.
What is the NDC code for Terrell 1 mL/mL?
The NDC (National Drug Code) for Terrell 1 mL/mL is 66794-019, listed by Piramal Critical Care Inc.