"Consumers and health care professionals will soon find updated labeling for extended-release and long-acting opioid pain relievers to help ensure their safe and appropriate use.
In addition to requiring new labeling on these prescript"...
ETHRANE (enflurane, USP) may be used for induction and maintenance of general anesthesia. Enflurane may be used to provide analgesia for vaginal delivery. Low concentrations of enflurane (see DOSAGE AND ADMINISTRATION) may also be used to supplement other general anesthetic agents during delivery by Cesarean section. Higher concentrations of enflurane may produce uterine relaxation and an increase in uterine bleeding.
DOSAGE AND ADMINISTRATION
The concentration of ETHRANE (enflurane, USP) being delivered from a vaporizer during anesthesia should be known. This may be accomplished by using:
- vaporizers calibrated specifically for enflurane;
- vaporizers from which delivered flows can easily and readily be calculated.
Preanesthetic medication should be selected according to the need of the individual patient, taking into account that secretions are weakly stimulated by enflurane and that enflurane does not alter heart rate. The use of anticholinergic drugs is a matter of choice.
Induction may be achieved using enflurane alone with oxygen or in combination with oxygen-nitrous oxide mixtures. Under these conditions some excitement may be encountered. If excitement is to be avoided, a hypnotic dose of a short-acting barbiturate should be used to induce unconsciousness, followed by the enflurane mixture. In general, inspired concentrations of 2.0 to 4.5% enflurane produce surgical anesthesia in 7 to 10 minutes.
Surgical levels of anesthesia may be maintained with 0.5 to 3.0% enflurane. Maintenance concentrations should not exceed 3.0%. If added relaxation is required, supplemental doses of muscle relaxants may be used. Ventilation to maintain the tension of carbon dioxide in arterial blood in the 35 to 45 mm Hg range is preferred. Hyperventilation should be avoided in order to minimize possible CNS excitation.
The level of blood pressure during maintenance is an inverse function of enflurane concentration in the absence of other complicating problems. Excessive decreases (unless related to hypovolemia) may be due to depth of anesthesia and in such instances should be corrected by lightening the level of anesthesia.
Enflurane 0.25 to 1.0% provides analgesia for vaginal delivery equal to that produced by 30 to 60% nitrous oxide. These concentrations normally do not produce amnesia. See also the information on the effects of enflurane on uterine contraction contained in the CLINICAL PHARMACOLOGY section.
Enflurane should ordinarily be administered in the concentration range of 0.5 to 1.0% to supplement other general anesthetics. See also the information on the effects of enflurane on uterine contraction contained in the CLINICAL PHARMACOLOGY section.
ETHRANE (enflurane, USP) is packaged in 125 and 250 mL amber-colored bottles.
125 mL — NDC 10019-350-50
250 mL — NDC 10019-350-60
Safety and Handling
There is no specific work exposure limit established for ETHRANE (enflurane, USP). However, the National Institute for Occupational Safety and Health Administration (NIOSH) recommends that no worker should be exposed at ceiling concentrations greater than 2 ppm of any halogenated anesthetic agent over a sampling period not to exceed one hour.
The predicted effects of acute overexposure by inhalation of ETHRANE (enflurane, USP) include headache, dizziness or (in extreme cases) unconsciousness. There are no documented adverse effects of chronic exposure to halogenated anesthetic vapors (Waste Anesthetic Gases or WAGs) in the workplace. Although results of some epidemiological studies suggest a link between exposure to halogenated anesthetics and increased health problems (particularly spontaneous abortion), the relationship is not conclusive. Since exposure to WAGs is one possible factor in the findings for these studies, operating room personnel, and pregnant women in particular, should minimize exposure. Precautions include adequate general ventilation in the operating room, the use of a well-designed and well-maintained scavenging system, work practices to minimize leaks and spills while the anesthetic agent is in use, and routine equipment maintenance to minimize leaks.
Store at room temperature 15º-30ºC (59º-86ºF). Enflurane contains no additives and has been demonstrated to be stable at room temperature for periods in excess of five years.
Manufactured for: Baxter Healthcare Corporation, Deerfield, IL 60015 USA. For Product Inquiry 1 800 ANA DRUG (1-800-262-3784). Revised: January 2010
Last reviewed on RxList: 2/10/2010
This monograph has been modified to include the generic and brand name in many instances.
Additional Ethrane Information
Report Problems to the Food and Drug Administration
Chronic Pain/Back Pain
Find tips and advances in treatment.