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Isoflurane is a brand name for Isoflurane. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 1 INDICATIONS AND USAGE 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. Isoflurane USP, a general anesthetic, is an inhalation agent indicated for induction and maintenance of general…
Verbatim from this product's FDA label. Tap a section to expand.
2 DOSAGE AND ADMINISTRATION • Isoflurane USP should be administered only by persons trained in the administration of general anesthesia. Isoflurane USP 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. 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 [see Drug Interactions (7) ]. Isoflurane potentiates the muscle relaxant effect of all neuromuscular blockers and decreases the required doses of neuromuscular blocking agents [see Drug Interactions (7) ] .
The dose should be adjusted accordingly. , monitoring of the electrocardiogram, blood pressure, oxygen saturation, and end tidal CO 2 ). Isoflurane is a profound respiratory depressant. Excessive respiratory depression may be related to depth of anesthesia and respond to decreasing the inspired concentration of isoflurane.
The depressant effect is accentuated by concurrent use of opioids and other respiratory depressants. Respiration should be closely monitored and assisted or controlled ventilation employed when necessary. 2 Premedication Premedication should be selected according to the need of the individual patient, taking into account that secretions are weakly stimulated by Isoflurane USP, and the heart rate tends to be increased.
3 Induction Induction with isoflurane in oxygen or in combination with oxygen-nitrous oxide mixtures may produce coughing, breath holding, laryngospasm and bronchospasm, which increases with the concentration of isoflurane. These difficulties may be avoided by the use of a hypnotic dose of an ultra-short-acting barbiturate.
6 ADVERSE REACTIONS Most common adverse reactions (incidence > 5%) are agitation, cough, breath holding, nausea, chills/shivering, vomiting, laryngospasm, delirium. 1 ) To report SUSPECTED ADVERSE REACTIONS, contact Piramal Critical Care, Inc.
gov/medwatch. 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 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.
, patients receiving inhalation induction). 2 Reflects the number of patients with recorded body temperature measurements. , patients receiving inhalation induction). 0% (N=359) 3 1 Reflects the number of patients interviewed by a physician in the recovery period.
2 Reflects the number of recorded electroencephalograms. , patients receiving inhalation induction). The following adverse reactions (see Table 5 ) were observed, but due to limited data, frequency could not be determined. 2 Post-Marketing Experience The following adverse reactions have been identified during post-approval use of Isoflurane USP.
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.
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.
2 ) • Hepatic Reactions : May cause sensitivity hepatitis in patients sensitized by previous exposure to halogenated anesthetics. Approach repeated anesthesia with caution. 3 ) • Hypersensitivity Reactions : Allergic-type hypersensitivity reactions, including anaphylaxis, have been reported with isoflurane.
4 ) • Abortions : Increased blood loss comparable to that seen with halothane has been observed in patients undergoing abortions. 5 ) • QT Prolongation : Carefully monitor cardiac rhythm when administering Isoflurane USP to susceptible patients.
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 Isoflurane USP. 7 ) • Pediatric Neurotoxicity : In developing animals, exposures greater than 3 hours cause neurotoxicity.
Weigh benefits against potential risks when considering elective procedures in children under 3 years old. 1 Malignant Hyperthermia In susceptible individuals, volatile anesthetic agents, including Isoflurane USP, may trigger malignant hyperthermia, a skeletal muscle hypermetabolic state leading to high oxygen demand.
Fatal outcomes of malignant hyperthermia have been reported. The risk of developing malignant hyperthermia increases with the concomitant administration of succinylcholine and volatile anesthetic agents. 5) ]. , particularly that unresponsive to deepening anesthesia or analgesic medication administration), tachypnea, cyanosis, arrhythmias, hypovolemia, and hemodynamic instability.
4 CONTRAINDICATIONS Isoflurane USP is contraindicated in patients: • in whom general anesthesia is contraindicated. 3 )]. 5 )]. , jaundice associated with fever and/or eosinophilia) after anesthesia with isoflurane or other halogenated inhalational anesthetics.
, jaundice associated with fever and/or eosinophilia) after anesthesia with Isoflurane USP or other halogenated inhalational anesthetics ( 4 )
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5 to 3% isoflurane usually produce surgical anesthesia in 7 to 10 minutes. 37% Dosage for induction and maintenance must be individualized and titrated to the desired effect according to the patient’s age and clinical status. 5% concentration when nitrous oxide is used concomitantly.
5 to 1% may be required when isoflurane is given using oxygen alone. If added relaxation is required, supplemental doses of neuromuscular blocking agents may be used. The level of blood pressure during maintenance is an inverse function of isoflurane concentration in the absence of other complicating problems.
Excessive decreases may be due to depth of anesthesia and in such instances may be corrected by lightening anesthesia. Isoflurane causes a dose-dependent reduction in systemic vascular resistance and blood pressure. , due to concomitant medications.
Isoflurane USP markedly increases cerebral blood flow at deeper levels of anesthesia to produce a transient increase in intracranial pressure. In patients with or at risk for elevations of intracranial pressure (ICP), administer isoflurane in conjunction with ICP- reducing strategies, as clinically appropriate.
5 Use in Patients with Coronary Artery Disease Regardless of the anesthetics employed, maintenance of normal hemodynamics is important to the avoidance of myocardial ischemia in patients with coronary artery disease. Isoflurane can cause dose-dependent coronary vasodilation and has been shown to divert blood from collateral-dependent myocardium to normally perfused areas in an animal model (“coronary steal”).
The extent to which coronary steal occurs in patients with steal-prone coronary anatomy is unclear. , ECG, blood pressure) during isoflurane administration. Consider additional cardiac monitoring in patients with known coronary artery disease, as clinically necessary.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Post-marketing adverse reactions are listed by MedDRA System Organ Class (SOC), then by preferred term in order of decreasing severity.
BLOOD AND LYMPHATIC SYSTEM DISORDERS:
Carboxyhemoglobin increased IMMUNE SYSTEM DISORDERS: Anaphylactic reaction METABOLISM AND NUTRITION DISORDERS: Hyperkalemia in patients with underlying myopathies PSYCHIATRIC DISORDERS: Withdrawal syndrome (following multi-day exposure; symptoms include seizure, hallucination, ataxia, agitation, confusion) NERVOUS SYSTEM DISORDERS: Brain edema, Intracranial pressure increased, Migraine, Myoclonus, Nystagmus, Pupils unequal, Headache CARDIAC DISORDERS: Cardiac arrest, Ventricular fibrillation, Torsade de pointes, Myocardial infarction, Myocardial ischemia, Atrioventricular block complete, Atrioventricular block second degree, Atrial fibrillation, Electrocardiogram QT prolonged, Atrioventricular block first degree, Ventricular tachycardia, Ventricular extrasystoles, Tachycardia, Bradycardia, Cardiac output decreased VASCULAR DISORDERS: Flushing RESPIRATORY, THORACIC, AND MEDIASTINAL DISORDERS: Apnea, Hypoxia, Bronchospasm, Airway obstruction, Respiratory depression, Hypercapnia, Stridor, Hiccough GASTROINTESTINAL DISORDERS: Pancreatitis HEPATOBILIARY DISORDERS: Hepatic necrosis, Hepatic failure, Hepatitis fulminant, Cholestatic hepatitis, Hepatitis, Hepatic steatosis, Jaundice, Gamma- glutamyltransferase increased SKIN AND SUBCUTANEOUS TISSUE DISORDERS: Rash MUSCULOSKELETAL, CONNECTIVE TISSUE AND BONE DISORDERS: Rhabdomyolysis RENAL AND URINARY DISORDERS: Acute renal failure**, Oliguria** GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS: Malignant hyperthermia, hypothermia INJURY, POISONING, AND PROCEDURAL COMPLICATIONS*: Unwanted awareness during anesthesia; Dyspnea, Bronchospasm, Stridor, Cough, Dizziness, Paresthesia, Hepatic reactions, Flushing, Rash, Contact dermatitis, Erythema, Periorbital edema, Eye irritation, Conjunctival hyperemia, Headache *All reactions categorized within this SOC, with the exception of, Unwanted awareness during anesthesia, were from occupational exposure in non-patients.
**Cases of acute renal failure and oliguria have been reported after isoflurane anesthesia. These events may be secondary to hypotension or other effects of isoflurane.
Skin mottling, coagulopathies, and renal failure may occur later in the course of the hypermetabolic process. Successful treatment of malignant hyperthermia depends on early recognition of the clinical signs. , volatile anesthetic agents and succinylcholine), administer intravenous dantrolene sodium, and initiate supportive therapies.
Consult prescribing information for intravenous dantrolene sodium for additional information on patient management. Supportive therapies include administration of supplemental oxygen and respiratory support based on clinical need, maintenance of hemodynamic stability and adequate urinary output, management of fluid and electrolyte balance, correction of acid base derangements, and institution of measures to control rising temperature.
2 Perioperative Hyperkalemia Use of inhaled anesthetic agents has been associated with rare increases in serum potassium levels that have resulted in cardiac arrhythmias and death in pediatric patients during the postoperative period.
Patients with latent as well as overt neuromuscular disease, particularly Duchenne muscular dystrophy, appear to be most vulnerable. Concomitant use of succinylcholine has been associated with most, but not all, of these cases. These patients also experienced significant elevations in serum creatinine kinase levels and, in some cases, changes in urine consistent with myoglobinuria.
Despite the similarity in presentation to malignant hyperthermia, none of these patients exhibited signs or symptoms of muscle rigidity or hypermetabolic state. Early and aggressive intervention to treat the hyperkalemia and resistant arrhythmias is recommended, as is subsequent evaluation for latent neuromuscular disease.
3 Hepatic Reactions Cases of mild, moderate and severe postoperative hepatic dysfunction or hepatitis with or without jaundice, including fatal hepatic necrosis and hepatic failure, have been reported with isoflurane. Such reactions can represent hypersensitivity hepatitis, a known risk of exposure to halogenated anesthetics, including isoflurane.
As with other halogenated anesthetic agents, Isoflurane USP may cause sensitivity hepatitis in patients who have been sensitized by previous exposure to halogenated anesthetics [see Contraindications ( 4 )]. Clinical judgment should be exercised when isoflurane is used in patients with underlying hepatic conditions or under treatment with drugs known to cause hepatic dysfunction.
[see Contraindications (4) ]. As with all halogenated anesthetics, repeated anesthetics within a short period of time may result in increased effects, particularly in patients with underlying hepatic conditions, or additive effects in patients treated with drugs known to cause hepatic dysfunction.
Evaluate the need for repeated exposure in each individual patient and adjust the dose of isoflurane based on signs and symptoms of adequate depth of anesthesia if repeated exposure in a short period of time is clinically indicated.
4 Hypersensitivity Reactions Allergic-type hypersensitivity reactions, including anaphylaxis, have been reported with isoflurane. Manifestations of such reactions have included hypotension, rash, difficulty breathing and cardiovascular collapse.
5 Abortions Increased blood loss comparable to that seen with halothane has been observed in patients undergoing abortions. 6 QT Prolongation QT prolongation, with rare instances of torsade de pointes, have been reported. , patients with congenital Long QT Syndrome or patients taking drugs that can prolong the QT interval).
7 Interactions with Desiccated Carbon Dioxide Absorbents Isoflurane USP, like some other inhalational anesthetics, can react with desiccated carbon dioxide (CO 2 ) absorbents to produce carbon monoxide, which may result in elevated levels of carboxyhemoglobin in some patients.
Barium hydroxide lime and soda lime become desiccated when fresh gases are passed through the CO 2 absorber canister at highflow rates over many hours or days. When a clinician suspects that CO 2 absorbent may be desiccated, it should be replaced before the administration of Isoflurane USP.
The color indicator of most CO 2 absorbents does not necessarily change as a result of desiccation. Therefore, the lack of significant color change should not be taken as assurance of adequate hydration of the CO 2 absorbent material.
CO 2 absorbents should be replaced routinely regardless of the state of color indicator following current manufacturer’s guidelines for use of anesthesiology equipment. 8 Pediatric Neurotoxicity Published animal studies demonstrate that the administration of anesthetic and sedation drugs that block NMDA receptors and/or potentiate GABA activity increase neuronal apoptosis in the developing brain and result in long-term cognitive deficits when used for longer than 3 hours.
The clinical significance of these findings is not clear. 2) ]. Some published studies in children suggest that similar deficits may occur after repeated or prolonged exposures to anesthetic agents early in life and may result in adverse cognitive or behavioral effects.
These studies have substantial limitations, and it is not clear if the observed effects are due to the anesthetic/sedation drug administration or other factors such as the surgery or underlying illness. Anesthetic and sedation drugs are a necessary part of the care of children needing surgery, other procedures, or tests that cannot be delayed, and no specific medications have been shown to be safer than any other.
Decisions regarding the timing of any elective procedures requiring anesthesia should take into consideration the benefits of the procedure weighed against the potential risks. 9 Laboratory Tests Transient increases in BSP retention, blood glucose and serum creatinine with decrease in BUN, serum cholesterol and alkaline phosphatase have been observed.