Recommended Topic Related To:

Suprane

"FDA is recommending health care professionals discontinue prescribing and dispensing prescription combination drug products that contain more than 325 milligrams (mg) of acetaminophen per tablet, capsule or other dosage unit. There are no"...

Suprane

INDICATIONS

Induction of Anesthesia

SUPRANE (desflurane, USP) is indicated as an inhalation agent for induction of anesthesia for inpatient and outpatient surgery in adults.

SUPRANE (desflurane, USP) is contraindicated as an inhalational agent for the induction of anesthesia in pediatric patients because of a high incidence of moderate to severe upper airway adverse events.

Maintenance of Anesthesia

SUPRANE (desflurane, USP) is indicated as an inhalation agent for maintenance of anesthesia for inpatient and outpatient surgery in adults and in pediatric patients.

After induction of anesthesia with agents other than SUPRANE (desflurane, USP), and tracheal intubation, SUPRANE (desflurane, USP) is indicated for maintenance of anesthesia in infants and children. SUPRANE (desflurane, USP) is not approved for maintenance of anesthesia in non-intubated children due to an increased incidence of respiratory adverse reactions, including coughing, laryngospasm, and secretions [see WARNINGS AND PRECAUTIONS and Clinical Studies].

DOSAGE AND ADMINISTRATION

Only persons trained in the administration of general anesthesia should administer SUPRANE (desflurane, USP). Only a vaporizer specifically designed and designated for use with SUPRANE (desflurane, USP), should be utilized for its administration. Facilities for maintenance of a patent airway, artificial ventilation, oxygen enrichment, and circulatory resuscitation must be immediately available.

SUPRANE (desflurane, USP) is administered by inhalation. The administration of general anesthesia must be individualized based on the patient's response. Hypotension and respiratory depression increase as anesthesia with Suprane is deepened. The minimum alveolar concentration (MAC) of SUPRANE (desflurane, USP) decreases with increasing patient age. The MAC for SUPRANE (desflurane, USP) is also reduced by concomitant N2O administration (see Table 1). The dose should be adjusted accordingly. The following table provides mean relative potency based upon age and effect of N2O in predominately ASA physical status I or II patients.

Benzodiazepines and opioids decrease the MAC of SUPRANE (desflurane, USP). [see DRUG INTERACTIONS, Table 3]. SUPRANE (desflurane, USP) also decreases the doses of neuromuscular blocking agents required [see DRUG INTERACTIONS, Table 4]. The dose should be adjusted accordingly.

Table 1 : Effect of Age on Minimum Alveolar Concentration of Desflurane Mean ± SD (percent atmospheres)

Age N O2 100% N N2O 60%/40% O2
2 weeks 6 9.2 ± 0.0 - -
10 weeks 5 9.4 ± 0.4 - -
9 months 4 10.0 ± 0.7 5 7.5 ± 0.8
2 years 3 9.1 ± 0.6 - -
3 years - - 5 6.4 ± 0.4
4 years 4 8.6 ± 0.6 - -
7 years 5 8.1 ± 0.6 - -
25 years 4 7.3 ± 0.0 4 4.0 ± 0.3
45 years 4 6.0 ± 0.3 6 2.8 ± 0.6
70 years 6 5.2 ± 0.6 6 1.7 ± 0.4
N = number of crossover pairs (using up-and-down method of quantal response)

Preanesthetic Medication

Issues such as whether or not to premedicate and the choice of premedication(s) must be individualized. In clinical studies, patients scheduled to be anesthetized with SUPRANE (desflurane, USP) frequently received IV preanesthetic medication, such as opioid and/or benzodiazepine.

Induction

In adults, some premedicated with opioid, a frequent starting concentration was 3% SUPRANE (desflurane, USP), increased in 0.5-1.0% increments every 2 to 3 breaths. End-tidal concentrations of 4-11%, SUPRANE (desflurane, USP) with and without N2O, produced anesthesia within 2 to 4 minutes. When SUPRANE (desflurane, USP) was tested as the primary anesthetic induction agent, the incidence of upper airway irritation (apnea, breathholding, laryngospasm, coughing and secretions) was high. During induction in adults, the overall incidence of oxyhemoglobin desaturation (SpO2 < 90%) was 6% [see ADVERSE REACTIONS].

After induction in adults with an intravenous drug such as thiopental or propofol, SUPRANE (desflurane, USP) can be started at approximately 0.5-1 MAC, whether the carrier gas is O2 or N2O/O2.

Inspired concentrations of SUPRANE (desflurane, USP) greater than 12% have been safely administered to patients, particularly during induction of anesthesia. Such concentrations will proportionately dilute the concentration of oxygen; therefore, maintenance of an adequate concentration of oxygen may require a reduction of nitrous oxide or air if these gases are used concurrently.

Maintenance

Surgical levels of anesthesia in adults may be maintained with concentrations of 2.5-8.5% SUPRANE (desflurane, USP) with or without the concomitant use of nitrous oxide. In children, surgical levels of anesthesia may be maintained with concentrations of 5.2-10% SUPRANE (desflurane, USP) with or without the concomitant use of nitrous oxide.

During the maintenance of anesthesia with inflow rates of 2 L/min or more, the alveolar concentration of SUPRANE (desflurane, USP) will usually be within 10% of the inspired concentration. [FA/FI, see Figure 2 in CLINICAL PHARMACOLOGY].

During the maintenance of anesthesia, increasing concentrations of SUPRANE (desflurane, USP) produce dose-dependent decreases in blood pressure. Excessive decreases in blood pressure may be due to depth of anesthesia and in such instances may be corrected by decreasing the inspired concentration of SUPRANE (desflurane, USP).

Concentrations of SUPRANE (desflurane, USP) exceeding 1 MAC may increase heart rate. Thus with this drug, an increased heart rate may not serve reliably as a sign of inadequate anesthesia.

Maintenance of Anesthesia in Intubated Pediatric Patients

SUPRANE (desflurane, USP) is indicated for maintenance of anesthesia in infants and children after induction of anesthesia with agents other than SUPRANE (desflurane, USP), and tracheal intubation.

SUPRANE (desflurane, USP), with or without N2O, and halothane, with or without N2O were studied in three clinical trials of pediatric patients aged 2 weeks to 12 years (median 2 years) and ASA physical status I or II. The concentration of SUPRANE (desflurane,

Baxter Confidential Reference ID: 3375412 Suprane Page 5 of 31 Full Prescribing Information (FPI) USP) required for maintenance of general anesthesia is age-dependent. Changes in blood pressure during maintenance of and recovery from anesthesia with SUPRANE (desflurane, USP) /N2O/O2 are similar to those observed with halothane/N2O/O2. Heart rate during maintenance of anesthesia is approximately 10 beats per minute faster with SUPRANE than with halothane. Patients were judged fit for discharge from post-anesthesia care units within one hour with both SUPRANE (desflurane, USP) and halothane. There were no differences in the incidence of nausea and vomiting between patients receiving SUPRANE (desflurane, USP) or halothane.

Recovery

The recovery from general anesthesia should be assessed carefully before patients are discharged from the post anesthesia care unit (PACU).

Use in Patients with Coronary Artery Disease

In patients with coronary artery disease, maintenance of normal hemodynamics is important to prevent myocardial ischemia. SUPRANE (desflurane, USP) should not be used as the sole agent for anesthetic induction in patients with coronary artery disease or patients where increases in heart rate or blood pressure are undesirable. It should be used with other medications, preferably intravenous opioids and hypnotics [see Clinical Studies].

Neurosurgical Use

SUPRANE (desflurane, USP) may produce a dose-dependent increase in cerebrospinal fluid pressure (CSFP) when administered to patients with intracranial space occupying lesions. SUPRANE (desflurane, USP) should be administered at 0.8 MAC or less, and in conjunction with a barbiturate induction and hyperventilation (hypocapnia) until cerebral decompression in patients with known or suspected increases in CSFP. Appropriate attention must be paid to maintain cerebral perfusion pressure [see Clinical Studies].

HOW SUPPLIED

Dosage Forms And Strengths

Colorless, non-flammable, volatile liquid (below 22.8°C) for inhalation, 100% SUPRANE (desflurane, USP).

Storage And Handling

SUPRANE (desflurane, USP), NDC 10019-641-24, is packaged in amber-colored bottles containing 240 mL SUPRANE (desflurane, USP).

Safety and Handling

Occupational Caution

There is no specific work exposure limit established for SUPRANE (desflurane, 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.

Principle routes of exposure include:

Skin contact May cause skin irritation. In case of contact, immediately flush skin with plenty of water. Remove contaminated clothing and shoes. Seek medical attention if irritation develops.

Eye contact May cause eye irritation. In case of contact, immediately flush eyes with plenty of water for at least 15 minutes. Seek medical attention if irritation develops.

Ingestion No specific hazards other than therapeutic effects. Do NOT induce vomiting unless directed to do so by medical personnel. Never give anything by mouth to an unconscious person. If large quantities of this material are swallowed, seek medical attention immediately.

Inhalation If individuals smell vapors, or experience dizziness or headaches, they should be moved to an area with fresh air. Individuals could also experience the following: Cardiovascular effects: may include fluctuations in heart rate, changes in blood pressure, chest pain. Respiratory effects: may include shortness of breath, bronchospasms, laryngospasms, respiratory depression. Gastrointestinal effects: may include nausea, upset stomach, loss of appetite. Nervous System effects: may include ataxia, tremor, disturbance of speech, lethargy, headache, dizziness, blurred vision.

The predicted effects of acute overexposure by inhalation of SUPRANE desflurane, USP) include headache, dizziness or (in extreme cases) unconsciousness. [see OVERDOSAGE]

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.

Consistent with clinical data, concentrations would need to reach 2-3% in inspired air before individuals would likely experience dizziness or other physiologic effects.

Storage

Store at room temperature, 15°-30°C (59°-86°F). SUPRANE (desflurane, USP) has been demonstrated to be stable for the period defined by the expiration dating on the label. The bottle should be recapped after each use of SUPRANE (desflurane, USP).

Manufactured for : Baxter Healthcare Corporation Deerfield, IL 60015 USA. Revised 01/2013

Last reviewed on RxList: 10/3/2013
This monograph has been modified to include the generic and brand name in many instances.

A A A

Additional Suprane Information

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Women's Health

Find out what women really need.

Related Drugs
advertisement
advertisement
Use Pill Finder Find it Now See Interactions

Pill Identifier on RxList

  • quick, easy,
    pill identification

Find a Local Pharmacy

  • including 24 hour, pharmacies

Interaction Checker

  • Check potential drug interactions
Search the Medical Dictionary for Health Definitions & Medical Abbreviations